Prevention of Salmonella Enteritidis in Shell Eggs During Production

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 118

[Docket Nos. 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504]

RIN 0910-AC14

Prevention of

Salmonella

Enteritidis in Shell Eggs During Production

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule.

SUMMARY:

The Food and Drug Administration (FDA) is proposing to require shell egg producers to implement measures to prevent

Salmonella

Enteritidis (SE) from contaminating eggs on the farm. We are taking this action because of the number of outbreaks of foodborne illnesses and deaths caused by SE that are associated with the consumption of shell eggs that have not been treated to destroy this pathogen. We expect that the requirements that we are proposing in this rule, if finalized as proposed, will result in a significant decrease in the number of SE-contaminated eggs produced on farms. Ultimately, we expect that the proposed requirements in this rule will generate public health benefits through a decrease in the numbers of SE-associated illnesses and deaths caused by consumption of shell eggs.

DATES:

Submit written or electronic comments by December 21, 2004.

Submit written comments on the information collection provisions by October 22, 2004. See sections III.C and VI.C of this document for the proposed compliance dates of a final rule based on this document.

ADDRESSES:

You may submit comments, identified by [Docket Nos. 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504], by any of the following methods:

• Federal eRulemaking Portal:

http://www.regulations.gov

. Follow the instructions for submitting comments.

• Agency Web site:

http://www.fda.gov/dockets/ecomments

. Follow the instructions for submitting comments on the agency Web site.

• E-mail:

fdadockets@oc.fda.gov

. Include [Docket Nos. 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504 and RIN number 0910-AC14] in the subject line of your e-mail message.

• FAX: 301-827-6870.

• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions

: All submissions received must include the agency name and Docket No. or Regulatory Information Number (RIN) for this rulemaking. All comments received will be posted without change to

http://www.fda.gov/dockets/ecomments

, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the “Comments” heading of the

SUPPLEMENTARY INFORMATION

section of this document.

Docket

: For access to the docket to read background documents or comments received, go to

http://www.fda.gov/dockets/ecomments

and/or the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Rebecca Buckner, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy. College Park, MD 20740, 301-436-1486.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Highlights of the Proposed Rule

II. Background

A.

Salmonella

and SE Infection

1. Salmonellosis

2. SE

3. SE and Eggs

4. Mechanism of

Salmonella

Contamination in Eggs

5. Infectious Dose

B. U.S. Egg Industry

C. Federal Egg Safety Regulatory Agencies and Authorities

D. Current Federal Egg Safety Measures for Shell Egg Production and Retail

1. Refrigeration of Shell Eggs

2. Labeling of Shell Eggs

3. The FDA Food Code

4. Egg Safety Education Efforts

E. The SE Risk Assessment

F. Advanced Notice of Proposed Rulemaking on SE in Eggs

G. Egg Safety Public Meetings

H. Current On-Farm Practices

1. The Layers Study

2. Voluntary Egg Quality Assurance Programs (QA)

I. Petitions to the Agency

1. Center for Science in the Public Interest

2. Rose Acre Farms, Inc.

3. United Poultry Concerns, Inc., and the Association of Veterinarians for Animal Rights

III. The Proposal to Require SE Prevention Measures for Egg Production

A. Rationale for Proposal

B. Shell Egg Producers Covered by Proposed 21 CFR Part 118

C. Proposed Compliance Dates for Shell Egg Producers of Various Sizes

D. Definitions

E. The SE Prevention Measures

1. Chicks and Pullets

2. Biosecurity

3. Rodents, Flies, and Other Pest Control

4. Cleaning and Disinfection

5. Refrigeration of Shell Eggs Stored More Than 36 Hours

F. Indication of the Effectiveness of the SE Prevention Measures: Testing

1. Environmental Testing for SE

2. Egg Testing for SE

G. Sampling and Testing Methodology for SE

1. Sampling of the Poultry House Environment

2. Egg Sampling

H. Laboratory Methods for Testing for SE

I. Administration of the SE Prevention Measures

J. Recordkeeping Requirements for the SE Prevention Measures

1. Records That Egg Producers Are Required to Maintain

2. General Requirements for Records Maintained by Egg Producers

3. Length of Time Records Must Be Retained

4. Offsite Storage of Records

5. Official Review of Records

6. Public Disclosure of Records

7. Comment Solicitation on Recordkeeping Measures

K. Enforcement of On-Farm SE Prevention Measures for Shell Eggs

L. Legal Authority

M. Response to Comments Related to On-Farm SE Prevention Measures

N. Transportation of Shell Eggs

IV. Handling and Preparation of Eggs by Retail Establishments

A. Inappropriate Handling of Raw Shell Eggs by Food Preparers

B. SE and Highly Susceptible Populations

C. The FDA Food Code

D. Request for Comments

E. Response to Comments Related to Retail Standards

V. Preliminary Regulatory Impact Analysis (PRIA)

A. Introduction

B. Need for Regulation

C. Economic Analysis of Potential Mitigations: Overview

1. Measuring Benefits

2. Measuring Costs

3. Coverage of the Analysis

D. Summary of Costs and Benefits of Regulatory Options and the

Proposed Rule

1. No New Regulatory Action

2. Classification of SE-Positive Eggs as Restricted or SE Positive

3. HAACP

4. The Proposed Rule

5. More Extensive On-Farm SE Prevention Measures

6. Less Extensive On-Farm SE Prevention Measures

7. Retail SE Prevention Measures

E. Benefits and Costs of Potential SE Prevention Measures: Detailed Analysis

1. On-Farm SE Prevention Measures

2. Administrative Measures

3. Summary of On-Farm SE Prevention and Administrative Measures

4. Retail Provisions

F. Summary of Benefits and Costs of the Proposed Rule

1. Coverage

2. Provisions in the Proposed Rule

3. Summary of Costs and Benefits

4. Analysis of Uncertainty

VI. Initial Regulatory Flexibility Analysis

A. Introduction

B. Economic Effects on Small Entities

1. Number of Small Entities Affected

2. Costs to Small Entities

C. Regulatory Options

1. Exemption for Small Entities

2. Longer Compliance Periods

D. Description of Recordkeeping and Recording Requirements

E. Summary

VII. Unfunded Mandates

VIII. Federalism

IX. Environmental Impact

X. Paperwork Reduction Act of 1995

XI. Comments

XII. References

Appendix to the PRIA A: Costs of Alternative Testing and Diversion Scenarios

Appendix to the PRIA B: The Expected Cost of Testing and Diversion

Appendix to the PRIA C: Distributions Used in the Analysis of Uncertainty

I. Highlights of the Proposed Rule

In this proposed rulemaking, FDA is proposing egg safety SE prevention measures for egg production. This proposal is significant because a farm-to-table risk assessment of

Salmonella

Enteritidis (SE) in eggs identified implementation of on-farm prevention measures as a very important step that could be taken to reduce the occurrence of SE infections from eggs. Voluntary quality assurance programs for egg production have led to meaningful reductions in SE illnesses already. However, these programs are not always uniformly administered or uniformly comprehensive in their prevention measures.

Moreover, the most recent data from the Centers for Disease Control and Prevention (CDC) show that SE illnesses have essentially remained steady for the past several years. In 2001, CDC estimated that 118,000 illnesses were caused by consumption of SE-contaminated eggs. Accordingly, we believe that additional interventions are warranted. The proposed on-farm SE prevention measures and a more detailed rationale for these measures are found in section III of this document.

Following are the proposed SE prevention measures: (1) Provisions for procurement of chicks and pullets, (2) a biosecurity program, (3) a pest and rodent control program, (4) cleaning and disinfection of poultry houses that have had an environmental sample or egg test positive for SE, and (5) refrigerated storage of eggs at the farm. Moreover, a cornerstone of the proposal is a requirement that producers test the environment for SE in poultry houses. If the environmental test is positive, we are proposing that egg testing for SE be undertaken, and that if an egg test is positive, eggs be diverted from the table egg market to a technology or process that achieves at least a 5-log destruction of SE for shell eggs, or the processing of egg products in accordance with the Egg Products Inspection Act. As part of the SE prevention measures, we are proposing that producers identify a responsible person to administer the prevention measures at each farm. We also are proposing recordkeeping requirements for environmental and egg sampling and testing and for egg diversion. Finally, we are proposing that if a producer has 3,000 or more laying hens and all eggs at a farm are to be given a treatment that will achieve at least a 5-log destruction of SE or processed into egg products, then only the proposed refrigeration requirements would apply. The proposed rule would not apply to producers who sell all of their eggs directly to consumers or producers with fewer than 3,000 laying hens.

We also are soliciting comment on whether we should include additional requirements in the final rule, particularly in two areas. First, should we expand the recordkeeping requirements to include a written SE prevention plan and records for compliance with the SE prevention measures? Second, should the safe egg handling and preparation practices in FDA's 2001 Model Food Code (as outlined in section IV.D of this document) be federally mandated for retail establishments that specifically serve a highly susceptible population (e.g., nursing homes, hospitals, day care centers)? These issues are discussed in more detail in the following relevant sections of this document.

II. Background

A. Salmonella and SE Infection

1. Salmonellosis

Salmonella

microorganisms are ubiquitous and are commonly found in the digestive tracts of animals, especially birds and reptiles. Human illnesses are usually associated with ingesting food or drink contaminated with

Salmonella

, although infection also may be transmitted person to person through the fecal-oral route where personal hygiene is poor or by the animal-to-man route (Ref. 1).

The disease salmonellosis is the result of an intestinal infection with

Salmonella

and is characterized by diarrhea, fever, abdominal cramps, headache, nausea, and vomiting. Symptoms of salmonellosis usually begin within 6 to 72 hours after consuming a contaminated food or liquid and last for 4 to 7 days. Most healthy people recover without antibiotic treatment; however, the infection can spread into the bloodstream, then to other areas of the body such as the bone marrow or the meningeal linings of the brain. This infection can lead to a severe and fatal illness (Ref. 2). The complications associated with an infection are more likely to occur in children, the elderly, and persons with weakened immune systems. In addition, about 2 percent of those who recover from salmonellosis may later develop recurring joint pains and arthritis (Ref. 3).

Salmonellosis is a serious health concern. It is a notifiable disease, i.e., physicians and health laboratories are required to report cases (single occurrences of illness) to local health departments in accordance with procedures established by each State. These cases are then, in turn, reported to State health departments, and the

Salmonella

isolates

1

are referred to State Public Health laboratories for serotyping. Each case and each serotyped isolate is reported to CDC. These reports are made only for diagnosed cases of

Salmonella

infection.

1

When a physician sees a patient and suspects that the patient has a case of salmonellosis, the physician may obtain a patient's specimen (e.g. stool) for analysis. The specimen is sent to the laboratory to be tested to identify and confirm any

Salmonella

that may be present. Thus, the laboratory obtains the actual specimen of

Salmonella

.

A case of illness is confirmed as salmonellosis only if an isolate is confirmed by a laboratory as being

Salmonella

. Although all cases may not be confirmed, all confirmed cases are associated with isolates of

Salmonella

. Reported cases are likely to represent only a small portion of the actual number of illnesses that occurred because of the following reasons: (1) Ill individuals do not always seek care by medical professionals, especially if the symptoms are not severe; (2) medical professionals may not establish the cause of the illness but may simply treat the symptoms; and (3) medical professionals do not always report

Salmonella

cases to public health officials. CDC used updated information and data from a FoodNet population study to estimate that there are 38 cases of salmonellosis for every one that is reported (Ref. 4). This estimate was central to updating an estimate of the burden of salmonellosis. The overall burden of salmonellosis in 2001 was estimated to be 1,203,650 cases, including 14,000 hospitalizations, and 494 deaths (Refs. 4 and 5).

CDC surveillance data list close to 600 different

Salmonella

serotypes (a group of related microorganisms distinguished by their antigens) that have caused illness in the United States. Following are the four serotypes most frequently reported as causing illness: (1)

Salmonella enterica

serotype Typhimurium, (2)

Salmonella enterica

serotype Enteritidis (

Salmonella

Enteritidis or SE), (3)

Salmonella enterica

serotype Newport, and (4)

Salmonella enterica

serotype Heidelberg (Ref. 6). These microorganisms are found in poultry, eggs, and other foods.

2. SE

Currently, SE is one of the most commonly reported serotypes of

Salmonella

. SE accounted for only about 5 percent of the number of all reported

Salmonella

isolates in 1976. However, in 1985, 1990, 1994, and 1999, SE constituted 9.8 percent, 20.6 percent, 26.3 percent, and 16.3 percent, respectively, of all

Salmonella

isolates (Ref. 6). The rate of SE isolates reported to CDC increased from 0.6 per 100,000 population in 1976 to 3.6 per 100,000 in 1996 (Ref. 7). In 2001, the isolation rate of SE was 2.0 per 100,000 population and the contribution of SE (corrected for underreporting) to total salmonellosis was estimated to have been 213,046 illnesses, including 2,478 hospitalizations, and 87 deaths (Refs. 4 and 5).

In 1985, the States reported 26 SE-related outbreaks (i.e., occurrences of 2 or more cases of a disease related to a common source) to CDC; by 1990 the number of SE-related outbreaks reported to CDC had increased to 85. In 1995 there were 56 confirmed outbreaks of SE infection, in 2000 there were 50 and in 2002 there were 32 (Ref. 8).

3. SE and Eggs

In the mid-1980s, CDC made an epidemiological and laboratory association between eggs and

Salmonella

outbreaks. Shell eggs are now the predominant source of SE-related cases of salmonellosis in the United States where a food vehicle is identified. A food vehicle is identified in approximately half of the outbreaks of illness associated with SE. Between 1990 and 2001, an average of 78 percent of vehicle-confirmed SE outbreaks were egg associated (Ref. 9). These eggs were typically raw or undercooked. Although CDC can estimate the number of egg-associated SE illnesses as a percentage of all SE illnesses, the proportion of domestically acquired salmonellosis that is attributable to SE in eggs is difficult to estimate. The estimates have a broad range of uncertainty around them because of the variable nature of both foodborne disease outbreaks and investigations. However, the basic surveillance information on the number of reported SE cases and outbreaks is readily available and does not require further estimation. Although there are other sources of SE, actions to improve egg safety are the single most effective way to reduce the overall number of SE infections and outbreaks.

CDC has described several SE outbreaks that occurred between 1996 and 1998 and were associated with raw or undercooked eggs (Ref. 7).

• In November 1997, 91 persons who consumed broccoli with Hollandaise sauce at a Las Vegas restaurant became ill. Investigation showed that the Hollandaise sauce was prepared with pooled shell eggs, cooked to a temperature inadequate to kill SE, and then held at room temperature for several hours prior to service.

• In August 1997, 12 persons developed culture-confirmed cases of SE after consuming cheesecake prepared in a private residence in Los Angeles, CA. The cheesecake contained raw egg whites and egg yolks that were heated in a double boiler until slightly thickened. The California Department of Health Services and Department of Food and Agriculture investigated the farm that supplied the eggs and isolated SE from manure samples and from pooled egg samples.

• In October 1997, 75 persons at 7 different events in the District of Columbia developed salmonellosis after consuming lasagna supplied by the same commercial manufacturer. Cultures of leftover lasagna yielded SE. Investigation revealed that all of the lasagnas consumed at the different events were prepared from the same egg-cheese mixture. A traceback investigation led to farms at which 5 of 13 poultry houses had environmental samples positive for SE.

From 1990 to 2001, 14,319 illnesses were attributed to SE associated with shell eggs. Of those illnesses, 10,406 occurred during 1990 through 1995 and 3,913 occurred during 1996 through 2001 (Ref. 9). In 2002, there were 32 outbreaks of SE illness, and the SE isolation rate (illnesses per 100,000 population) was 1.77 (Ref. 8). Progress has been made and there has been a decrease in SE incidence since the mid-1990s, in part due to egg quality assurance (QA) programs, informing and educating consumers and retailers on proper handling, and nationwide regulations to keep eggs refrigerated. However, these gains are still far short of the public health and foodborne illness gains required to meet Healthy People 2010 goals. Healthy People 2010 sets forth significant and achievable goals, namely a 50 percent reduction in both outbreaks and salmonellosis from foodborne contamination (corresponding to a 50 percent reduction from the 2000 goals for SE outbreak reduction and a 50 percent reduction in salmonellosis in general) (Ref. 10). We estimate that the largest gains towards our public health goals will be achieved through implementation of this rule. The incidence of SE in the United States remains much higher than in the 1970s (1976 SE isolation rate = 0.56) (Ref. 11), and the decrease in reported cases of SE illness since 1999 has appeared to slow or stop compared to decreases seen in the mid-1990s (Ref. 9). Because progress in reducing the number of illnesses and outbreaks appears to have greatly slowed or stopped, we believe the additional preventive measures, proposed herein, for shell eggs may be needed to reduce further the incidence of SE illnesses and meet our public health goals.

4. Mechanism of

Salmonella

Contamination in Eggs

Previously,

Salmonella

contamination of shell eggs was thought most likely to be caused by trans-shell penetration of bacteria present in the egg's environment. The surface of an egg can become contaminated with any microorganism that is excreted by the laying hens. In addition, contact with nesting materials, dust, feedstuff, shipping and storage containers, human beings and other animals may be a source of shell contamination. The

likelihood of trans-shell penetration increases with the length of time that the eggs are in contact with contaminating materials.

While environmental contamination is still a route for

Salmonella

contamination, SE experts now believe that the predominant route through which eggs become contaminated with SE is the “transovarian” route. Though the mechanism is still not well understood, SE will infect the ovaries and oviducts of some egg-laying hens, permitting transovarian contamination of the interior of the egg while the egg is still inside the hen (Refs. 12 and 13). The site of contamination is usually the albumen (the egg white).

It is believed that only a small number of hens in an infected flock shed SE at any given time and that an infected hen may lay many uncontaminated eggs (Ref. 14). Nonetheless, it has been estimated that of the 47 billion shell eggs consumed annually as table eggs (eggs consumed as shell eggs, as opposed to eggs that are used to make egg products), 2.3 million are SE-positive, exposing a large number of people to the risk of illness (Ref. 15).

5. Infectious Dose

In general, the greater the numbers of microorganisms ingested, the greater the likelihood of disease. The likelihood of disease also is contingent on the virulence of the microorganism and the susceptibility of the host (Ref. 16). However, there is evidence that the infectious dose (i.e., amount of microorganisms capable of causing disease) for SE can be very low. For example, in a 1994 outbreak attributed to consumption of SE-contaminated ice cream, the highest level of contamination found in the implicated ice cream was only six microorganisms per half-cup (65 gram) serving (Ref. 17). Another report, using a different method of measurement, determined that the infective dose per serving was 25 microorganisms (Ref. 18). These reports indicate that low-level contamination of some foods with SE can lead to illness. It is generally believed that SE-contaminated eggs initially contain only a few SE microorganisms (less than 20 (Ref. 19)), which may be sufficient to cause illness.

B. U.S. Egg Industry

On a per capita basis, Americans consume about 234 eggs per year (Ref. 20). U.S. production is relatively stable and has increased only slightly, from about 60 billion eggs in 1984 to 67.3 billion eggs in 1998 (Ref. 21). Generally, about 70 percent of the edible shell eggs produced are sold as table eggs while the remainder are processed into liquid, frozen or dried pasteurized egg products. The majority of egg products are destined for institutional use or further processing into foods such as cake mixes, pasta, ice cream, mayonnaise, and bakery goods.

Geographically, commercial egg production in the western United States is concentrated in California, and in the eastern United States is centered in Ohio, Indiana, Iowa, and Pennsylvania. Other States in which major producers are located include Texas, Minnesota, and Georgia. Over 4,000 farm sites have 3,000 or more egg-laying hens, representing 99 percent of all domestic egg-laying hens and accounting for 99 percent of total egg production. There are an additional 65,000 farms with fewer than 3,000 egg-laying hens, accounting for the balance of eggs produced (Ref. 22).

C. Federal Egg Safety Regulatory Agencies and Authorities

Federal authority to regulate egg safety is shared by FDA and the U.S. Department of Agriculture's Food Safety and Inspection Service (USDA's FSIS). In addition, USDA's Animal and Plant Health Inspection Service (APHIS) conducts a control program that certifies poultry breeding stock and hatcheries as SE-monitored and USDA's Agricultural Marketing Service (AMS) conducts a surveillance program to ensure proper disposition of restricted shell eggs.

FDA has jurisdiction over the safety of foods generally, including shell eggs, under section 201 of the Federal Food, Drug, and Cosmetic Act (the FFDCA) (21 U.S.C. 321). The Public Health Service Act (the PHS Act) (42 U.S.C. 201

et seq.

) authorizes the FDA to make and enforce such regulations as “are necessary to prevent the introduction, transmission or spread of communicable diseases from foreign countries into the States * * * or from one State * * * into any other State” (section 361(a) of the PHS Act (42 U.S.C. 264(a)). Thus, under the FFDCA and the PHS Act, FDA has the authority to regulate a food when the food may act as a vector of disease, as in the case of SE-contaminated eggs.

USDA has primary responsibility for implementing the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031

et seq.

). Under the EPIA, FSIS has primary responsibility for the inspection of processed egg products to prevent the distribution of adulterated or misbranded egg products.

This proposed rule is part of a joint and coordinated strategy by FDA and FSIS to more effectively address egg safety. Pursuant to this coordinated strategy, FDA is focusing its efforts on farm practices, and on food manufacturing plants, institutions, and restaurants. FSIS, in turn, is focusing its efforts on egg products plants and egg handlers. Both agencies are evaluating additional measures to improve egg safety, and FSIS intends to issue proposed rules in the near future for egg products plants and egg handlers, including egg handlers who operate in-shell pasteurization treatments. FDA and FSIS will continue to work closely together to ensure that our egg safety measures are consistent, coordinated, and complementary.

D. Current Federal Egg Safety Measures for Shell Egg Production and Retail

Currently, there are no Federal regulations to reduce the presence of SE in eggs during production. However, we recognize that some State or local agencies may have requirements in place addressing egg safety during production.

There are several Federal activities related to egg safety at the retail level. FSIS issued a final rule for refrigeration and labeling of eggs during transport and storage when packed for the ultimate consumer (63 FR 45663, August 27, 1998). In addition, FDA issued a final rule that requires labeling of eggs and refrigeration of eggs at retail establishments (65 FR 76092, December 5, 2000). Further, FDA's Food Code provides guidance to retail establishments on the handling and storage of potentially hazardous foods, such as shell eggs. Also, there have been egg safety education campaigns specifically tailored for the retail sector. The following sections describe these egg safety measures.

1. Refrigeration of Shell Eggs

The EPIA was amended in 1991 (Public Law 102-237) to require that shell eggs packed for the ultimate consumer be stored and transported under refrigeration at an ambient temperature (i.e., the air temperature maintained in an egg storage facility or transport vehicle) not to exceed 45 °F. The 1991 Amendments to the EPIA also require that labels on egg containers indicate that refrigeration of eggs is required. Subsequently, USDA's FSIS amended its regulations to require shell egg handlers to store and transport shell eggs packed in containers destined for the ultimate consumer under refrigeration at an ambient temperature of no greater than 45 °F (7.2 °C) (63 FR 45663). In the FSIS regulation, an egg handler is defined as any person, excluding the ultimate consumer, who engages in any business in commerce that involves buying or selling any eggs

(as a poultry producer or otherwise), or processing any egg products, or otherwise using any eggs in the preparation of human food. In 9 CFR 590.5, FSIS defines an ultimate consumer as any household consumer, restaurant, institution, or other party who has purchased or received shell eggs or egg products for consumption. This regulation became effective August 27, 1999.

FSIS' regulation does not require the ultimate consumer, including restaurants and institutions, to maintain shell eggs under refrigeration. Consequently, we concluded that it was necessary to require that shell eggs be kept refrigerated throughout retail distribution. On December 5, 2000, we published a final rule requiring that retail establishments, such as grocery stores, farm stands, restaurants, schools, and nursing homes, promptly refrigerate eggs upon receipt and store and display eggs at an ambient temperature of 45 °F (7.2 °C) or less (65 FR 76092).

2. Labeling of Shell Eggs

In an effort to inform consumers of the risks associated with consuming raw or undercooked eggs, we require that egg cartons carry safe handling instructions (21 CFR 101.17(h)). All eggs not specifically processed to destroy

Salmonella

must carry the following safe handling statement: “SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly.”

3. The FDA Food Code

Through the Food Code, FDA endeavors to assist those local, State, tribal, and Federal governmental jurisdictions assuming primary responsibility for preventing foodborne illness and for licensing and inspecting establishments within the retail segment of the food industry. The Food Code, published by FDA, is not Federal law or regulation, and is not preemptive. Rather, it represents our best advice to States and local authorities to ensure that food at the retail level is safe, properly protected, and properly represented (i.e., is what it is purported to be). The Food Code provides guidance on food safety, sanitation, and fair dealing that can be uniformly adopted for the retail segment of the food industry. The document is the cumulative result of the efforts and recommendations of many contributing individuals with years of experience. These individuals represent a diverse group of regulators, educators, industry leaders, and consumer representatives acting through their agencies, companies, professional groups, or trade organizations.

Although the Food Code provisions are not Federal requirements, they are designed to be consistent with Federal food laws and regulations. The Food Code is written so that all levels of government can easily adopt the language of the Food Code into a legal requirement.

All segments of the food industry and Federal, State, and local governments share the responsibility to ensure food provided to the consumer is safe and does not become a vehicle for a disease outbreak or the transmission of communicable disease. By sharing in this responsibility, government and industry can ensure consumer expectations are met, and food is prepared in a sanitary environment, properly presented, and not adulterated.

The Food Code provides advice on how to prevent foodborne illness based on information obtained from CDC investigations. CDC has identified risk factors, such as unsafe sources, inadequate cooking, improper holding, contaminated equipment, and poor personal hygiene, which may lead to foodborne outbreaks. CDC further established five key public health interventions to protect consumer health: (1) Demonstration of knowledge, (2) employee health controls, (3) controlling hands as a vehicle of contamination, (4) time and temperature parameters for controlling pathogens, and (5) consumer advisories.

FDA revises sections of the Food Code every 2 years, and publishes the revision either as a supplement (most recently in 2003) to the existing edition or as a new edition (most recently in 2001), based on the extent of revision. Each new edition incorporates the provisions of supplements issued between editions. The next revision of the Food Code will be in 2005. Provisions relevant to egg safety can be found in the 2001 Food Code in sections 3-202.11, 3-202.13, 3-202.14, 3-302.13, 3-401.11, 3-603.11, and 3-801.11.

4. Egg Safety Education Efforts

Consumer food safety surveys conducted in 1993, 1998, and 2001 by FDA and FSIS suggested that consumers are less aware of or concerned about risks associated with eggs than they are of risks associated with other foods (Refs. 23 and 24). The data indicate that people are most likely to follow recommended practices when handling fish, somewhat less likely when handling meat or chicken, and much less likely to follow recommended practices when breaking eggs. In fact, the majority of people (65 percent) do not wash their hands with soap after breaking raw eggs (Refs. 23 and 24).

Comparing the 1998 survey findings with those of 1993, improvement in the safe handling of eggs by people 61 and older lagged considerably behind that of people 18 to 25 years old. The younger group showed a 42 percent improvement versus 9 percent for the older group. The 2001 survey showed no significant difference in consumers' egg-handling behavior from 1998 (Ref. 24).

In consideration of the survey findings, we developed a strategy for an education campaign on egg safety that targeted both the general public and at-risk populations. We began the campaign with the July 1, 1999, release of FDA's egg labeling and refrigeration proposed rule to take advantage of media and public interest in safe handling instructions for shell egg labels and refrigeration requirements for eggs at retail establishments. We prepared a video news release (VNR) to inform consumers of the proposed regulations and to alert them to the potential risks of, and steps to take to avoid, undercooked eggs. The VNR was released in conjunction with the July 1999 announcement of the proposed egg labeling and refrigeration rule.

To provide a basic source of print information for consumers on eggs and egg safety, we developed a fact sheet, “Food Safety Facts for Consumers: Playing It Safe With Eggs,” which was released in July 1999. The fact sheet covers safe buying, handling, preparation, and storage of eggs and egg dishes, as well as information on how to avoid the hidden risks in foods that contain raw or lightly cooked eggs. A corresponding fact sheet was developed for food service personnel, entitled “Food Service Safety Facts: Assuring the Safety of Eggs and Egg Dishes Made From Raw, Shell Eggs,” and was released in September 1999.

The consumer fact sheet was targeted to general consumers, especially parents of young children and older Americans. The food service fact sheet was targeted to institutional preparers of food for children, the elderly, and immunocompromised individuals. To reach the target audience, the fact sheets were distributed to the print and electronic media, 83,000 day care centers, 13,000 nursing home directors, school nurses, FDA field staff, extension agents, State and local health agencies, and food preparation trade associations. Both fact sheets are posted on FDA's Web site

www.foodsafety.gov

.

Egg safety information also is incorporated into other food safety

education initiatives. For example, the widely distributed English and Spanish Fight BAC! brochures produced by the public-private Partnership for Food Safety Education, of which FDA is a member, include safe egg cooking information. The Partnership's Virtual Toolbox, available on the

fightbac.org

Web site, features egg safety information prominently among a wide range of other education materials for use by health educators.

We initiated a second phase of the egg safety education campaign after publishing the final rules on safe handling labels and refrigeration at retail. Our strategy remained unchanged; we targeted the general public and at-risk populations. Our campaign message focused attention on the new labels on eggs, the potential for human sickness caused by bacteria from fresh eggs from any source, and the safety of eggs if selected, stored, and prepared properly.

In addition to the press information FDA distributed about the regulations, we prepared and distributed a range of consumer education materials, including a video news release; a public service announcement/flier sent to 600 publications specializing in health, food, elderly issues and parenting, as well as specialized health information providers, such as the National AIDS Clearinghouse and Hotline, the American Cancer Society and National Cancer Hotline, and the Arthritis Foundation; a consumer brochure; and a drop-in feature article in English and Spanish. All consumer education materials are available on our Web site.

We currently are distributing educational materials we developed for food service and food retail personnel incorporating existing FDA regulations and recommendations pertaining to egg safety. These materials consist of a brochure entitled “Assuring the Safety of Eggs and Menu and Deli Items Made From Raw, Shell Eggs—Information for Retail Food Stores and Food Service Operations,” and a poster, “Key Temperatures for Egg Safety in Food Service Operations and Retail Food Stores.” Initially, 250 copies each of the brochure and the poster were sent to State Egg Program Directors, State Food Service Program Directors, FDA Regional Food Specialists, and FDA Public Affairs Specialists in the field to use in generating demand for the information.

Since the initial mailing, orders have been steady. As of August 2004, approximately 202,000 posters and 246,000 brochures had been distributed. At least one State, Kentucky, ordered enough (22,000) to provide copies to each retail food store, food service establishment and food manufacturing firm in the State. In addition, the brochure, “Assuring the Safety of Eggs and Menu and Deli Items Made from Raw Shell Eggs—Information for Retail Food Stores and Food Service Operations,” was mailed to 70,300 restaurants in September 2002.

Consumer information on safe handling of eggs is also included in two widely distributed FDA consumer publications, To Your Health: Food Safety for Seniors and the Fight BAC! Flyer (originally developed as a patient handout for the AMA/ANA/FDA/CDC/USDA health professional education kit, Kiagnosis and Management of Foodborne Illnesses). Distribution of consumer and foodservice educational materials continues at professional meetings and conferences, most recently the 2003-2004 meetings of the American Dietetic Association, American Public Health Association, Food Safety Summit, National WIC Association, American College of Physicians, National Restaurant Association, American Nurses Association, National Association of Area Agencies on Aging, National Wellness Conference, and International Association for Food Protection.

E. The SE Risk Assessment

In December 1996, FSIS and FDA, with representatives from other government agencies and academia, began a comprehensive risk assessment in response to an increasing number of human illnesses associated with the consumption of eggs (Ref. 15). Following are the objectives of the risk assessment: (1) Establish the unmitigated (without any SE-prevention measures risk of foodborne illness from SE, (2) identify and evaluate potential prevention strategies, (3) identify data needs, and (4) prioritize future data collection efforts.

A team of scientists developed a quantitative model to characterize the risks associated with the consumption of eggs contaminated internally with SE, using information obtained from academic, government, and industry sources, along with scientific literature. The risk assessment model consists of five discrete modules (Egg Production Module, Shell Egg Module, Egg Products Module, Preparation and Consumption Module, and Public Health Module) that may be used independently to evaluate the effect of variable changes during a particular stage of the farm-to-table continuum. However, the overall model encompasses the entire continuum, from the chicken through egg production, to egg consumption and human illness. The model predicted that using any one intervention (e.g., egg refrigeration or consumer egg safety education) could achieve a modest reduction in human SE illnesses, while using multiple interventions could achieve a more substantial reduction for those interventions tested (Ref. 15). Though on-farm mitigations, as such, were not specified in the risk assessment, various inputs to the model were tested for cooling and refrigeration of eggs, including cooling eggs immediately after lay. The SE risk assessment concluded that a broad-based policy, encompassing interventions from farm to table, is likely to be more effective in eliminating egg-associated SE illnesses than a policy directed solely at one stage of the egg production-to-consumption continuum.

F. Advance Notice of Proposed Rulemaking on

Salmonella

Enteritidis in Eggs

In the

Federal Register

of May 19, 1998 (63 FR 27502), FDA and USDA jointly published an advance notice of proposed rulemaking (ANPRM) seeking to identify farm-to-table actions that would decrease the food safety risks associated with eggs. The agencies requested comment on these egg safety actions. In section III.M of this document, we respond to comments related to on-farm measures to prevent SE contamination of eggs. We respond to comments related to retail standards to reduce the risk of egg-associated SE illnesses in section IV.E of this document.

G. Egg Safety Public Meetings

To address the public health problem of SE, FDA and FSIS decided to coordinate efforts in a farm-to-table approach. Consistent with each agency's legislative authority, FDA would address egg safety issues at the producer and retail levels and FSIS would address these issues at egg packers and processors. On March 30, 2000, and April 6, 2000, FDA and FSIS held public meetings in Columbus, OH, and Sacramento, CA, respectively, to gather information for reducing or eliminating the risk of SE in eggs. Comments on specific egg safety questions were solicited in a

Federal Register

document (65 FR 15119, March 21, 2000). Interested persons were given until April 20, 2000, to comment.

In an effort to expand the public process and build upon the two public meetings, FDA and FSIS held a public meeting (65 FR 42707, July 11, 2000) on July 31, 2000, in Washington, DC. The purpose of this meeting was to obtain

comments on the agencies' current thinking on approaches to ensure egg safety from farm to table. A document outlining the agencies' current thinking on on-farm egg safety standards, packer/processor egg safety standards, and retail egg safety standards was made available at the public meeting and on the agencies' food safety Web site

www.foodsafety.gov

. Interested persons were given until August 14, 2000, to comment.

We are responding to comments from the public meetings in Columbus, OH, and Sacramento, CA, and the current thinking meeting in Washington, DC in this document. We have responded to comments related to on-farm measures to prevent SE contamination of eggs in section III.M of this document and to comments on retail standards to prevent egg-associated SE illnesses in section IV.E of this document.

H. Current On-Farm Practices

Most of the information on current on-farm practices comes from the APHIS National Animal Health Monitoring System (NAHMS) Layers '99 Study (the Layers study) and information on voluntary egg QA programs.

1. The Layers Study

In 1999, NAHMS conducted a study addressing national table egg layers and SE (Refs. 25, 26, and 27). The aim of the study was to include information from States that account for at least 70 percent of the animal and farm population in the United States. Fifteen States (Alabama, Arkansas, California, Florida, Georgia, Indiana, Iowa, Minnesota, Missouri, Nebraska, North Carolina, Ohio, Pennsylvania, Texas, and Washington) were chosen to participate in the study. These 15 States represented 82 percent of the 1997 U.S. table egg layers. The States, and the operations surveyed within those States, were chosen from a ranking of table egg layers summarized in a 1997 National Agricultural Statistics Service (NASS) survey of egg layers and egg production. NASS maintains information on laying operations that have more than 30,000 hens; therefore, each operation participating in the Layers study had more than 30,000 laying hens, although all hens may not have been on one farm.

a. Production facilities

. Egg laying operations varied considerably in size and style of poultry house. Of the farm sites surveyed by the Layers study, approximately 34 percent had fewer than 50,000 layers, 29 percent had 50,000 to 99,999 layers, 20 percent had 100,000 to 199,999 layers, and 17 percent had 200,000 or more layers. One-third of farm sites surveyed had only one layer house, while 16.5 percent had 6 or more layer houses.

Within a poultry house, style also varied. Approximately one-third of all poultry houses had six or more banks of cages. A bank is all cages between two walkways or between a walkway and a wall. Approximately 40 percent of houses had 4 or more vertical levels of cages, while approximately 25 percent had only one level. Less than 1 percent of all poultry houses were cage-free.

Manure handling varied with house style and also varied regionally. Houses with a manure pit at ground level with the house above (high rise) accounted for 63 percent of houses in the Great Lakes region and 48 percent of houses in the Central region. In the Southeast, 40 percent of farm sites flushed manure to a lagoon. Nonflush scraper systems were used on 44 percent of farms in the West region.

b. Chicks and pullets

. When a poultry house is repopulated with new laying hens, most of the new layers come from a pullet raising facility. A pullet is defined in the Layers study as a chicken less than 20 weeks of age. Less than 10 percent of layer farms raised pullets at the layer farm site, although some layer farms had their own pullet raising facilities at other locations.

The vast majority (95 percent) of pullets in pullet raising facilities came as chicks from National Poultry Improvement Plan (NPIP) monitored breeder flocks. USDA's NPIP is a cooperative Federal-State-industry mechanism intended to prevent and control egg-transmitted, hatchery-disseminated poultry diseases. NPIP has different monitoring programs for many avian diseases and pathogens, including SE, and all flocks in the program must meet the qualifications for “U.S. Pullorum-Typhoid Clean” classification (9 CFR 145.23(b)). Therefore, the fact that the chicks were from NPIP-monitored breeder flocks does not mean that they were from certified “U.S.

S

. Enteritidis Monitored” breeder flocks (9 CFR 145.23(d)).

Many pullet raising facilities in the Layers Study had their own programs for SE monitoring. In the West region, 83 percent of farms obtained layers from SE-monitored pullet facilities, and 70 percent of layers on all farms came from SE-monitored pullet facilities. Pullet facilities used one or more of the following methods to monitor SE: (1) Dead chick/chick paper testing, (2) environmental culture, (3) bird culture, and (4) serology. Some pullet facilities used competitive exclusion products

2

and/or vaccines to protect pullets against SE.

2

Competitive exclusion is a strategy in which benign bacteria are introduced into the gut to prevent a pathogen from colonizing the gut by blocking all of the sites on the walls of the intestines where the pathogen would attach.

c. Production

. In 1997, the average flock was placed for its first production cycle at 17.5 weeks of age. Flocks in their first production cycle reached peak production around 29 weeks of age. At peak production, the average maximum number of eggs produced was 90 eggs per 100 hens per day. Induced molting was used on many farms (83 percent of farm sites) to increase the laying cycles of the hens. In the West and Southeast regions, 95 percent or more of farms molted birds, while in the central region just over half (57 percent) of the farms molted birds. On average, molted flocks ended production at 111 weeks of age, while nonmolted flocks ended production at 74 weeks of age.

d. Feed and water

. Approximately half (48 percent) of layer houses used a chain feed delivery system. Well water was used for watering birds by 66 percent of farms. The percentage of farms that tested feed for SE varied regionally. For example, finished feed was tested for SE by 26 percent of farms in the central region, and 68 percent of farms in the West. Approximately 75 percent of farms in both the West and Southeast regions tested feed ingredients for SE.

e. Biosecurity

. Approximately two-thirds of farms instituted biosecurity measures that did not allow visitors without a business reason to enter poultry houses. Sixty-two percent of farms allowed business visitors provided they had not been on another poultry farm that day. Most farms (76 percent) required that visitors wear clean boots. At the majority of farms, employees were required not to be around other poultry and not to own their own birds.

f. Pest control

. The Layers study estimated that rodents and flies had access to feed in feed troughs on nearly all farms. Fly control was practiced on 90 percent of all farms; baiting was the most common form of fly control (72 percent of farms). Essentially all farms used some type of rodent control. Chemicals and baits were used by 93 percent of farms for rodent control. Professional exterminators were used on less than 15 percent of farms that used rodent control. Producers rated almost 30 percent of farms as having a moderate or severe problem with mice and almost 9 percent as having a moderate or severe problem with rats.

g. Depopulation practices

. Depopulation of a poultry house is the most opportune time for a producer to thoroughly clean and disinfect the house. Most farms did some sort of cleaning between flocks. Essentially all farms emptied feeders, 91 percent emptied feed hoppers, 81 percent flushed water lines, 79 percent dry cleaned cages, walls, and ceilings, and 71 percent cleaned fans and ventilation systems. Approximately one-third of farm sites never cleaned or disinfected egg belts/elevators between flocks. Down time between flocks varied regionally; most farms had a down time of more than 11 days, although some were down for less than 4 days.

h. Testing for SE

. A 1994 NAHMS survey of farms revealed that almost 16 percent of farms tested for SE. The Layers study showed that, in 1997, 58 percent of farms tested for SE. The number of farms testing for SE varied by region. In the Southeast, almost 84 percent of farms had an SE testing program, while in the West only 26 percent had an SE testing program. The number and regional distribution of farms doing testing for SE is very similar to the number and distribution of farms participating in an egg quality assurance (QA) program.

i. NAHMS Study Testing for SE

. In 1994, NAHMS undertook its own survey for SE in layer houses. It found that 7 percent of layer houses were positive for SE, based on environmental sampling. Only 4 percent of houses with fewer than 100,000 laying hens were positive for SE, while 16 percent of houses with greater than 100,000 laying hens were SE-positive. The study indicated that the number of rodents, cleaning and disinfection procedures, biosecurity, and the age of the flock were all related to the SE status of the layer house.

2. Voluntary Egg QA Programs

The Layers study found that 51 percent of all farm sites participated in an egg QA program sponsored by a State or commodity group (e.g., United Egg Producers (UEP)). Based on this information, we estimate that approximately 50 percent of the eggs in the United States are produced under an egg QA program.

In 1992, Congress provided special funding to USDA to begin the SE Pilot Project (SEPP). The SEPP was one of the first egg QA programs in the United States. The pilot project phase operated for 2 years and then, in 1994, the SEPP became the PA Egg QA Program (PEQAP). Currently, there are several voluntary egg QA programs operated and administered by states or other organizations (Refs. 28, 29, 30, 31, and 32). The states that have programs include PA, MD, NY, OH, SC, AL, OR, CA and the New England region. The UEP has a program called the UEP “Five Star” Total QA Program (Ref. 33) and the United States Animal Health Association has a protocol entitled “National Standardized

Salmonella

Enteritidis Reduction Program for Eggs” (Ref. 34). In addition, certain egg companies operate an egg QA program within their own facilities (Ref. 26).

Currently the egg QA programs that exist are voluntary for producers. All programs have similar requirements but vary in how they implement these requirements. All programs require use of chicks from NPIP “U.S.

S

. Enteritidis Monitored” breeders or equivalent, biosecurity, rodent control, and cleaning and disinfection of poultry houses. Most programs require some environmental testing; the amount varies among programs from once to four or five times during the life of a flock. If an environmental test is SE-positive, several programs require egg testing, with diversion if the egg testing is SE positive. Several programs also have State government oversight and recordkeeping requirements. All existing QA programs have some educational programs for participants. There is data indicating that QA programs have been effective in reducing SE contamination in poultry houses (see discussion in section III) and the provisions in this proposal are modeled on those successful programs.

I. Petitions to the Agency

FDA has received several citizen petitions relevant to this proposed rulemaking.

1. Center for Science in the Public Interest

We received a petition from the Center for Science in the Public Interest (CSPI) (filed May 14, 1997, Docket No. 97P-0197) requesting, among other things, that FDA require programs to reduce the risk of SE for all egg producers. In support of its request, CSPI stated that SE in eggs is a serious health problem, illnesses caused by SE in the United States have increased, and consumers are at risk of illness from SE in raw or undercooked eggs. CSPI requested that producers be required to implement on-farm SE prevention programs using Hazard Analysis and Critical Control Point (HACCP) principles and modeled after the PEQAP program. CSPI also requested the following program components: (1) Chicks from SE-monitored breeder flocks, (2) environmental sampling for SE of chicks, pullets, and twice during the life of layers, (3) cleaning and disinfection of poultry houses if environmental tests are SE positive, (4) egg testing if the environment is positive with diversion of SE-positive eggs to pasteurization plants, (5) biosecurity, (6) rodent control program, (7) program to control SE in feed, and (8) refrigerated storage of eggs at 41°F to ensure that SE cannot multiply. In addition, CSPI requested that producers be required to keep records that would be verified by FDA to indicate compliance with SE prevention programs.

2. Rose Acre Farms, Inc.

We received a petition from Rose Acre Farms, Inc. (filed November 4, 1996, Docket No. 96P-0418) requesting, among other things, that we issue a regulation requiring “Best Practices” of egg producers. The petitioner stated that “best practices” are a set of procedures used by egg producers to control the presence of SE to the lowest level practical. Rose Acre Farms, Inc. suggested that the “best practices” might include: (1) Environmental testing of a poultry house for SE, (2) egg testing if the environmental testing is SE-positive, (3) cleaning and disinfection of poultry houses, (4) a program to reduce SE in feed, (5) vaccines, (6) rodent control, (7) biosecurity, (8) egg washing, (9) recordkeeping requirements, and (10) use of appropriate third parties to audit compliance with program elements. The petitioner requested that “best practices” programs be accredited individually by FDA and USDA. The petitioner also requested that eggs produced under an accredited program could never be deemed adulterated, regardless of the outcome of environmental testing or implication of a flock in a traceback.

In addition, Rose Acre Farms, Inc. requested that the agency place greater emphasis on consumer education and retail foodservice. The petitioner suggested that FDA revise the FDA Food Code to prohibit pooling of more than three shell eggs by any restaurant or foodservice institution. For egg dishes requiring pooling of more than three eggs, pasteurized product would have to be used.

3. United Poultry Concerns, Inc. and the Association of Veterinarians for Animal Rights

We received a petition from United Poultry Concerns, Inc., and the Association of Veterinarians for Animal Rights (filed April 14, 1998, Docket No. 98P-0203/CP1) requesting that FDA eliminate forced molting of laying birds in the United States. The petitioners requested that forced molting be

stopped because it is cruel. The petitioners also stated that the stress of forced molting promotes a systemic disease in birds in the form of SE that renders products derived from these birds a health risk to consumers.

In support of the request to stop forced molting because it promotes SE-infection in layers and renders products from these birds a health risk to consumers, the petitioners stated that forced molting impairs the immune response of laying hens, which invites colonization of the intestine and other organs by SE. The petitioners also cited studies that they believe demonstrate SE is shed in large numbers in the feces of infected, molted birds and spreads more rapidly among molted laying hens than among nonmolted ones. The petitioners stated that molted birds are more susceptible to SE infection from rodents, which have been shown to harbor SE in the poultry house environment. The petitioners also cited information that indicates feathers can carry SE and that molted birds engage in abnormal feather pecking because of the molting conditions.

United Poultry Concerns, Inc. and the Association of Veterinarians for Animal Rights also requested that forced molting be eliminated because the living conditions under which forced molting is conducted are inherently disease producing. The petitioners cited studies that indicate that concentrated confinement of birds in cages allows 48 square inches of living space per bird. The petitioners stated that the confined living space puts an additional stress on birds that lowers immune response and exacerbates an SE infection if present.

III. The Proposal to Require SE Prevention Measures for Egg Production

A. Rationale for Proposal

The incidence and geographical distribution of egg-associated SE illnesses have made SE a significant public health concern. Although there are Federal rules requiring refrigeration of shell eggs packed for the ultimate consumer (FSIS) and at retail (FDA) to limit the growth of SE that may be present, there are no Federal requirements to address the introduction of SE into the egg during production. The

Salmonella

Enteritidis Risk Assessment Team (Ref. 15) estimated that 1 in 20,000 eggs are contaminated with SE. Based on annual egg production (Ref. 20), this means that 3.3 million SE-contaminated shell eggs may be produced annually. Thirty percent of total egg production is used in egg products (Ref. 20), leaving an estimated 2.3 million SE-contaminated shell eggs that may reach the consumer. Therefore, interventions that can reduce the number of SE-contaminated eggs produced are warranted from a public health standpoint.

As discussed in section II.I of this document, several States and organizations have established voluntary egg QA programs that show great promise in reducing the incidence of egg-associated SE illnesses in specific regions of the country. Data from the PEQAP program show that after three years on the program the number of poultry houses that had environmental samples positive for SE decreased from 38 percent in 1992 to 13 percent in 1995 (Refs. 35 and 36). PEQAP data initially indicated that approximately 50 percent of the flocks in the program had environmental samples positive for SE at some time during flock life, whereas in 1996 approximately 15 percent of PEQAP flocks had environmental samples positive for SE at some time during flock life (Ref. 36). From 1992 to 1995, there was a decrease in the SE isolation rate in humans in the three-State region (NY, NJ, PA) that constitutes the market for PA's eggs. This decrease in isolation rate has been attributed to the PEQAP program and consumer education (Refs. 35 and 36).

Currently in the United States, only 50 percent (Ref. 26) of shell eggs are produced under voluntary egg QA programs and the regions that have voluntary egg QA programs are not necessarily the regions that have had recent outbreaks of SE illnesses (Ref. 9). Therefore, we have tentatively concluded that a proposal to require that producers of shell eggs for the table market, other than those producers whose eggs are treated or sold directly to consumers or who have fewer than 3000 laying hens, comply with all of the proposed SE prevention measures would exclude SE on the farm and, thus, remove sources of SE contamination of shell eggs.

B. Shell Egg Producers Covered by Proposed 21 CFR Part 118

The proposed requirements for SE prevention measures do not apply to producers who sell all of their eggs directly to consumers (e.g., roadside stand operators) or producers with fewer than 3,000 laying hens. Although we could have proposed to require these producers to implement SE prevention measures, we opted not to do so because the sales by these producers do not contribute significantly to the table egg market. In addition, we have no information indicating that an outbreak of SE illness has ever been caused by eggs sold directly from farmer to consumer or from a producer with fewer than 3,000 laying hens. We are soliciting comment on the exemption for producers with fewer than 3,000 laying hens and producers who sell all of their eggs directly to consumers. Specifically, should these producers be covered by some or all of the SE prevention measures?

We are proposing in § 118.1(a) (21 CFR 118.1(a)) that if you are a producer with 3,000 or more laying hens at a particular farm whose eggs are going to the table egg market (eggs consumed as shell eggs, rather than eggs used in egg products), and not all of your eggs receive a treatment as defined in § 118.3, then you must comply with all of the requirements in proposed part 118 for eggs produced on that farm. You may be selling your eggs to restaurants or other foodservice establishments where the presence of SE-contaminated eggs could cause a severe public health threat by striking many people at one time. In establishments where eggs are combined to make food items, one SE-contaminated egg can contaminate a dish that will be served to many people. Thus, it is necessary for you to use SE prevention measures on your farm to prevent SE contamination of your eggs and illness in consumers.

It is our understanding that it would be difficult for a producer to keep eggs produced from individual poultry houses on a farm separate from other eggs that may be handled differently. For example, a producer could not easily segregate eggs destined for a breaking plant from three poultry houses, which would not have to comply with the SE prevention measures, from eggs not destined for a breaking plant from two other poultry houses, which would have to follow all of the SE prevention measures. Furthermore, it would be difficult for the producer to maintain proper biosecurity for the two poultry houses subject to all of the SE prevention measures if there were three other poultry houses on the farm not employing the same biosecurity measures. Therefore, we have tentatively concluded that, unless all of the eggs from a particular farm receive a treatment as defined in § 118.3 or are sold directly to consumers, producers who have 3000 or more laying hens on that farm must comply with all of the requirements of proposed part 118 if the eggs are produced for the table egg market.

We are proposing in § 118.1(b) that if you are a producer who produces eggs on a farm that will all receive a treatment as defined in § 118.3 and you

have 3,000 or more laying hens, you must comply only with the refrigeration requirements for on-farm storage found in proposed § 118.4(e). As defined in proposed § 118.3, “treatment” means a technology or process that achieves at least a 5-log destruction of SE for shell eggs, or the processing of egg products in accordance with the Egg Products Inspection Act. It is important that the load of SE within a contaminated egg be kept low prior to treatment so that the level of kill given to that egg by the treatment will be sufficient. For example, if the in-shell pasteurization process for eggs is designed to reduce the level of SE in an egg by “x” logs, then the incoming SE load of that egg must be less than “x” logs for the treatment to be successful.

Refrigeration at 45 °F within 36 hours of laying has been shown to slow the multiplication of SE within an egg substantially and is discussed in section III.E.5 of this document. We have tentatively concluded that, prior to treatment for SE destruction, producers who have 3,000 or more laying hens must keep eggs under refrigeration at 45 °F maximum if they are held at the farm for more than 36 hours. Although we are not proposing to require that producers who treat all of their eggs to achieve the required destruction of SE comply with all of the SE prevention measures, we strongly encourage all egg producers to follow non-mandatory SE prevention measures during egg production.

C. Proposed Compliance Dates for Shell Egg Producers of Various Sizes

We are proposing that, if a producer has 50,000 or more laying hens, according to the requirements of proposed part 118, compliance would be required 1 year after the date of publication of the final rule in the

Federal Register

. Although producers who currently participate in voluntary QA programs may already have some of the provisions in place, we recognize that producers will need time to implement SE prevention measures, train individuals to implement the measures, and begin to incorporate them in their farm practices. We believe that 1 year from the date that any final rule is published is a realistic timeframe for producers that have 50,000 or more laying hens on farm to put measures in place.

We recognize that smaller producers (those with fewer than 50,000 but at least 3,000 laying hens) may need more time to comply with the requirements of proposed part 118. We tentatively have concluded that it is reasonable to allow for extended compliance periods for smaller producers. For smaller producers, compliance would be required 2 years after the date of publication of the final rule in the

Federal Register

.

D. Definitions

We are proposing in the introductory paragraph of § 118.3 that the definitions and interpretations of terms in section 201 of the FFDCA, unless these terms are redefined in this part, are applicable to these terms when used in proposed part 118.

We are proposing in § 118.3 that the term “biosecurity” means a program to ensure that there is no introduction or transfer of SE onto a farm or among poultry houses. As specified in proposed § 118.4(b), a biosecurity program includes, but is not limited to, limiting visitors to a farm, keeping animals and wild birds out of poultry houses, requiring personnel to wear protective clothing, and ensuring that equipment is not moved among poultry houses or, if it is so moved, that it is adequately cleaned before it is moved.

We are proposing in § 118.3 that the term “farm” means all poultry houses and the grounds immediately surrounding the poultry houses covered under a single biosecurity program. We intend the term “farm” to encompass an entire farming operation at a single geographic location. We do not intend to allow, by this definition, multiple “farms” covered by multiple biosecurity programs at a particular geographic site. If we did allow multiple farms at a geographic location, a producer could have part of the operation under SE prevention measures for eggs going to the table egg market and part of the operation under no such measures for eggs going to treatment. Such an outcome is contrary to our rationale set forth for proposed § 118.1(a).

We are proposing in § 118.3 that the term “flock” means all laying hens within one poultry house. We recognize that laying hens of different ages sometimes are placed in the same poultry house. Research has indicated that once SE is introduced into a poultry house it spreads among the laying hens in that house (Refs. 37 and 38).

We are proposing in § 118.3 that the term “group” means all laying hens of the same age within one poultry house. This term particularly applies to laying hens of the same age that comprise part of a multi-aged flock of laying hens within one poultry house.

We are proposing in § 118.3 that the term “induced molting” means molting that is artificially initiated. Induced molting is done to improve egg production and egg quality.

We are proposing in § 118.3 that the term “laying cycle” means: (1) The period of time that a hen begins to produce eggs until it undergoes induced molting or is permanently taken out of production; and (2) the period of time that a hen produces eggs between successive induced molting periods or between induced molting and the time that the hen is permanently taken out of production.

We are proposing in § 118.3 that the term “molting” means a life stage during which a hen stops laying eggs and sheds its feathers.

We are proposing in § 118.3 that the term “pest” means any objectionable animals or insects, including, but not limited to, birds, rodents, flies, and larvae. This is also the definition of “pest” found in 21 CFR part 110.

We are proposing in § 118.3 that the term “positive flock” means a flock that produced eggs that tested positive for SE and applies until that flock meets the egg testing requirements in proposed § 118.6 to return to table egg production.

We are proposing in § 118.3 that the term “positive poultry house” means a poultry house from which there has been an environmental test that was positive for SE during a laying cycle. A poultry house would be considered positive until it had been cleaned and disinfected, even if an environmental test is positive for SE prior to a molt and then is SE-negative at the post-molt environmental test. A negative environmental test after a molt does not invalidate the initial positive environmental test or necessarily indicate that SE is no longer present. Data from the PEQAP program have indicated that cleaning and disinfection procedures can decontaminate an SE-positive poultry house (Ref.39). Therefore, we have tentatively concluded that a poultry house that has had an SE-positive environmental test must be considered positive until it has been cleaned and disinfected according to proposed § 118.4(d).

We are proposing in § 118.3 that the term “poultry house” means a building, other structure, or separate section within one structure used to house poultry. We have also tentatively concluded that, for structures comprising more than one section containing poultry, each section must have biosecurity procedures in place to ensure that there is no introduction or transfer of SE from one section to another. In addition, each section must be enclosed and separated from the other sections. We interpret “enclosed and separated” to mean that sections must be separated from one another by walls. Thus, under this proposed

definition, producers would have to limit their designation of “sections” representing separate poultry houses to areas that are physically separate from one another. It would not be acceptable under this proposed rule to designate areas that are separated, for example, only by a walkway or a gate as separate poultry houses.

We are proposing in § 118.3 that the term “producer” means a person who maintains laying hens for the purpose of producing shell eggs for human consumption.

We are proposing in § 118.3 that the term “shell egg (or egg)” means the egg of the domesticated chicken. This differs from the definition of “shell egg” in the EPIA, because, unlike the EPIA definition, FDA's definition does not cover shell eggs of the domesticated turkey, duck, goose, or guinea. FDA is focusing its resources on domesticated chicken eggs because they have been associated with numerous outbreaks of foodborne illness.

We are proposing in § 118.3 that the term “treatment” means technologies or processes that achieve at least a 5-log destruction of SE for shell eggs or the processing of egg products in accordance with the EPIA. In 1997, we recommended to AMS, in response to an AMS request to FDA on criteria for shell egg pasteurization, that processors attain a 5-log reduction in

Salmonella

in shell eggs in order for the eggs to be considered “pasteurized.” We recommended the 5-log lethality based on literature available at the time on naturally infected shell eggs that indicated, under most storage conditions, an intact shell egg could contain between 10

2

and 10

3

Salmonella

organisms (Ref. 19). FDA then added a 2-log safety factor to arrive at the recommendation for a 5-log lethality. AMS published this standard in its

Federal Register

notice on official identification of pasteurized shell eggs (62 FR 49955, September 24, 1997).

We are soliciting comment on whether a 5-log reduction or an alternative approach to achieve an equivalent level of protection is still appropriate to ensure the safety of shell eggs. We intend to work with USDA to ensure that shell eggs and egg products are given adequate treatments to destroy SE.

E. The SE Prevention Measures

Data indicate that voluntary egg QA programs have contributed to a decrease in SE in poultry houses and a decrease in SE illnesses. The particular program (PEQAP) from which the data were gathered includes provisions for chick and pullet procurement, biosecurity, rodent control, refrigeration, cleaning and disinfection of poultry houses, and monitoring of the poultry house environment through testing for SE (Ref. 28). Although the individual provisions were not evaluated for their relative importance, the PEQAP results indicate that, when used together, the provisions resulted in a decrease in the prevalence of SE within a poultry house (Ref. 35). Thus, the agency tentatively concludes that SE prevention measures are necessary to reduce the incidence of SE illness from consumption of shell eggs, when the eggs are not treated to destroy SE.

All of the provisions of proposed § 118.4 apply to you if you are a producer with at least 3,000 laying hens, you produce shell eggs for the table market, and you do not sell all of your eggs directly to consumers or treat all of your eggs to destroy SE as defined in proposed § 118.3 (§ 118.1(a)). We are proposing in § 118.4 that shell egg producers described in § 118.1(a) develop and implement the following SE prevention measures: Provisions for procurement of chicks and pullets, a biosecurity program, rodent, fly and other pest control, cleaning and disinfection of poultry houses that have had an environmental or egg test positive for SE, and refrigerated storage of eggs at the farm.

We also are proposing in § 118.4 that the particular form that SE prevention measures take be specific to each farm and poultry house where eggs are produced. Depending upon whether there are multiple poultry houses on a farm and whether the poultry houses vary in house style and location, the SE prevention measures may vary among poultry houses. For example, one poultry house may require certain rodent and pest control measures that another poultry house may not require.

Further, we are proposing that if you are a producer under section § 118.1(a), you must comply with the environmental and egg testing requirements in §§ 118.5 and 118.6, the sampling and testing methodology requirements in §§ 118.7 and 118.8, the administration requirements in § 118.9, and the recordkeeping requirements in § 118.10. We will discuss our rationale for compliance with these requirements in the relevant sections of this proposed rule.

1. Chicks and Pullets

We are proposing in § 118.4(a) that you must procure chicks and pullets that came as chicks from breeder flocks that meet NPIP's standards for “U.S.

S

. Enteritidis Monitored” status or equivalent standards. The fact that SE can be transmitted via the transovarian route means that chicks can be born SE-positive (Refs. 35 and 40). Therefore, they may remain infected as pullets and be placed into poultry houses as layers already carrying SE and then contaminate their eggs and, in addition, pass SE on to other layers within the poultry house (Refs. 38, 41, and 42). We tentatively have concluded that it is necessary for you to procure chicks and pullets that came as chicks from breeding flocks that meet NPIP's standards for “U.S.

S

. Enteritidis Monitored” status (9 CFR 145.23(d)) or equivalent standards in order to prevent SE contamination of shell eggs from SE-positive chicks. Producers that procure pullets from a pullet-raising facility need to have an assurance that those pullets came as chicks from a breeder flock that meets NPIP's standards for “U.S.

S

. Enteritidis Monitored” status or equivalent standards.

USDA's NPIP is a cooperative Federal-State-industry mechanism for controlling certain pathogens and poultry diseases. NPIP has established “U.S.

S

. Enteritidis Monitored” standards (9 CFR 145.23(d)) from which the breeding-hatching industry may conduct a program for the prevention and control of SE. Participation in the plan is voluntary, except under 9 CFR part 82, subpart C, no hatching eggs or newly-hatched chicks from egg-type chicken breeding flocks may be moved interstate unless they are classified “U.S.

S

. Enteritidis Monitored” under NPIP or meet equivalent standards.

To be classified “U.S.

S

. Enteritidis Monitored,” under 9 CFR 145.23(d), a flock and the hatching eggs and chicks produced must come from a “U.S. S. Enteritidis Monitored” flock, or meconium (first bowel movement) from chick boxes and a sample of chicks that died within 7 days after hatching must be examined and test negative for

Salmonella

. Throughout the life of a “U.S.

S

. Enteritidis Monitored” flock, environmental and blood samples are taken at specified times and examined for group D

Salmonella

(the group that includes SE). Breeder flocks may be vaccinated with an SE bacterin, provided that 350 birds remain unvaccinated until the flock is at least 4 months of age. Hatching eggs produced by the flock are collected as quickly as possible, sanitized or fumigated, and incubated in an approved hatchery. The flock must also meet feed, facilities, and transport requirements.

A flock is not eligible for the “U.S.

S

. Enteritidis Monitored” classification if SE is isolated from a specimen taken from a bird in the flock. Isolation of SE

from an environmental sample of a vaccinated or nonvaccinated flock necessitates bird testing. If bird testing reveals no SE contamination, then the flock qualifies for the classification. The classification may be revoked at any time if procedures are not followed.

We are aware that most producers purchase pullets from a pullet-raising facility to repopulate a poultry house. Some of these pullet-raising facilities have SE-monitoring programs (Ref. 25). We specifically request comment on whether we should include in any final rule based on this proposal, a requirement that producers certify that pullets they procure have come from a facility that has an SE-monitoring program. If so, what requirements should producers certify that a pullet-raising facility has met in order to ensure that the pullet raising facility has an adequate SE-monitoring program?

2. Biosecurity

We are proposing in § 118.4(b) that you develop and implement a biosecurity program. Biosecurity refers to procedures that must be instituted on farms to prevent SE from being transferred from the environment into the poultry house or among poultry houses. Biosecurity is a routine part of all existing egg QA programs and is aimed at preventing the horizontal spread of SE. According to the Layers study (Ref. 26), 66 percent of farm sites already practice some form of biosecurity, and poultry houses where visitors were not allowed were less likely to test positive for SE. The Swiss have identified control of the horizontal spread (i.e., cross contamination from layer to layer or poultry house to poultry house) of SE as a major success of their SE control program (Ref. 42). We have tentatively concluded that producers need to develop and implement a biosecurity program covering the grounds and all facilities, including poultry houses, for each egg farm in order to prevent the horizontal spread of SE.

As part of your biosecurity program, you must take measures to prevent cross-contamination among poultry houses and contamination of poultry houses from the environment. This includes, where practical, purchasing separate equipment for each poultry house within a farm because shared equipment can cause SE cross-contamination between poultry houses. For certain large pieces of equipment (e.g., manure removing equipment), we recognize that it is not practical to purchase separate pieces of equipment for each house. We also recognize that certain pieces of equipment are common to all houses (e.g., egg belts). In the Layers study, approximately one-half of the positive environments were identified by egg belt or elevator sampling (Ref. 27). You must keep egg belts, manure-removing equipment, and other similar pieces of equipment clean and ensure that these pieces of equipment are not sources of SE contamination that can be spread from one house to another.

A comprehensive biosecurity program must also include provisions to limit visitors to the farm and poultry houses and to ensure proper hygiene of personnel who do move among poultry houses. Proper hygiene includes the use of protective clothing that is changed as employees move between poultry houses and foot sanitizing stations or other appropriate means to protect against contamination. In addition, you must prevent stray poultry, wild birds, or other animals from entering into poultry houses or on the grounds. You must not allow employees to keep poultry at home. You must implement the biosecurity measures stated above to prevent spreading SE from one poultry house to another on contaminated clothing or spreading SE from the environment into a poultry house by allowing stray animals entrance into a poultry house or allowing employees to keep their own poultry, which may be carrying SE, at home.

3. Rodents, Flies, and Other Pest Control

We are proposing in § 118.4(c) that you must develop and implement a pest and rodent control program to control rodents, flies and other pests. Many of the comments that we received after the egg safety public meetings in Columbus, OH (March 30, 2000), and Sacramento, CA (April 6, 2000), stated that the most important SE prevention measure that can be taken within a poultry house is rodent and pest control.

Several investigators have found strong indications that mice are carriers of invasive SE in the poultry house (Refs. 43 and 44). Kreager (Ref. 45) has stated that the SE status of rodents in a poultry house is thought to be indicative of the status of the flock. In fact, data indicate that the environments of SE-contaminated flocks are usually infected with the same phage type of SE found in mice and eggs also in that environment (Ref. 39). According to Davison et al. (Ref. 46), a single mouse can produce 100 droppings per day, and each dropping can contain up to 230,000 SE organisms. Wray and Davies (Ref. 47) have stated that mice may shed

Salmonella

intermittently for up to 18 weeks and may infect chickens consuming the fecal matter. Mice may become infected with SE from contaminated manure and then may spread it to other poultry houses that were previously SE free (Refs. 46 and 47). A few mice in one house can proliferate to 10,000 or more during the life of a flock.

Henzler and Opitz (Ref. 48) found that a poultry house with a large rodent population was approximately four times more likely to have an SE-positive environment as a poultry house with a small rodent population. In the Layers study (Ref. 26), producers reported that they had a moderate to severe problem with mice on 30 percent of farms and a moderate to severe problem with rats on 9 percent of farms. Rats have also been shown to harbor SE and are important vectors because they can travel long distances (Ref. 47). Environmental testing for the Layers study (Ref. 27) indicated that poultry houses in which 20 or more mice were captured (equals a rodent index of 2 or 3, see discussion of rodent indexing later in this section) were 9 times more likely to contain SE than poultry houses with a lower rodent index.

In addition to rodents, flies have been shown to harbor SE within the poultry house environment. Several

Salmonella

species were found in houseflies and bronze dump flies collected at caged-layer facilities that produced eggs that were implicated as the food vehicle in two recent outbreaks of SE infections. SE was isolated from 2 of 15 pools of houseflies from these facilities (Ref. 49). Both flies and rodents are attracted to feed within the poultry house and, according to the Layers study, flies and rodents have access to feed troughs on nearly all farms.

These studies indicate that rodents and pests can harbor SE that can be transmitted to layers and possibly to their eggs, potentially resulting in SE illnesses from consumption of shell eggs. We tentatively have concluded that producers must develop and implement a program to control rodents, flies and other pests.

We are proposing to require, under § 118.4(c)(1), that you must monitor rodent populations through visual inspection and use of mechanical traps or glueboards or another appropriate method. The use of traps and glueboards is appropriate if placed at regular intervals throughout each poultry house, or wherever rodents are most likely to be caught (Ref. 46). Davison et al. (Ref. 46) recommend that 12 traps be set per poultry house, left for a week, and checked twice during that week. If no mouse is caught at the first check, the trap should be moved, but no more than 15 feet. One week of trapping gives

a good indication of the level of rodent infestation in a poultry house; this is called rodent indexing (Ref. 46). If 0 to 10 mice (less than 2 mice/day) are caught, the rodent index is low or equal to 1; if 11 to 25 mice are caught, the rodent index is moderate or equal to 2; if 26 or more mice are caught, the rodent index is high or equal to 3. A low rodent index indicates acceptable rodent control.

We are proposing to require that when monitoring indicates unacceptable rodent activity (a rodent index of 2 or higher as described in Davison et al. (Ref. 46)) within a poultry house, you must take appropriate action to reduce the rodent population. We are proposing that baiting and trapping are possible methods to reduce a rodent population, but may not be effective in all situations. Producers, aware of rodent situations in their individual poultry houses, should choose a method that will be effective in their houses. If rodenticides are used, you should take care to prevent chickens or other nonrodents from consuming the bait.

We also are proposing to require under § 118.4(c)(2) that you monitor for flies and other pests through spot cards, Scudder grills, sticky traps or some other appropriate method that indicates pest activity. Spot cards are index cards used to enumerate the number of flies that land within the card area by counting fly specks (Ref. 50). Sticky traps are used to count the number of flies stuck to the trap (Ref. 51). A Scudder grill or a fly grill is a wooden grill that is placed over natural fly concentrations. The number of flies that land on the grill in 30 seconds is counted (Ref. 52). Spot cards and sticky traps should be checked weekly, while Scudder grills give an instant measure of fly activity within a poultry house.

Axtell (Ref. 50) has suggested that 50 or fewer hits on a spot card or sticky trap per week indicates satisfactory fly control. A count of less than 20 on a Scudder grill likewise indicates satisfactory fly control (Ref. 52). If monitoring indicates pest infestation (i.e., levels that do not indicate satisfactory pest control, as described above) within a poultry house, producers must use appropriate methods to reduce the pest population within a poultry house.

You would be required, under proposed § 118.4(c)(3), to remove debris within a poultry house and vegetation and debris outside of a poultry house that may harbor rodents and pests. Maintenance of a section of crushed rock around the perimeter of a poultry house helps prevent rodents from burrowing near poultry house foundations. Where possible, poultry houses should be sealed against entrance by rodents and pests.

4. Cleaning and Disinfection

We are proposing in § 118.4(d) that you must develop procedures for cleaning and disinfection of a poultry house that include removal of visible manure, dry cleaning, followed by wet cleaning using disinfectants, and finally, disinfecting. Further, we are proposing to require that you clean and disinfect a positive poultry house prior to the addition of new laying hens to the house. It is important, once a poultry house has had an SE-positive environmental or egg test, that you make every effort to rid the environment of SE before new laying hens are placed into that house to prevent the SE problem from being perpetuated in the replacement flock. Schlosser et al. (Ref. 39) reported that 50 percent of the SE-positive houses that were cleaned and disinfected according to PEQAP specifications were SE-negative when subsequently sampled. PEQAP cleaning and disinfection procedures consist of dry cleaning, wet cleaning (soaking, washing, rinsing), disinfection, and possibly fumigation with formaldehyde (Ref. 39). In addition, the Layers study found that no poultry house tested positive for SE after wet cleaning (i.e., where cages, walls, and ceilings were washed) (Ref. 27). We tentatively have concluded that, if an environmental test or an egg test is positive for SE during the life of a group in a poultry house, producers must clean and disinfect that poultry house before new laying hens are added to the house.

You must develop procedures for cleaning and disinfection in case they should ever need to be implemented. The cleaning and disinfection must include removal of all visible manure from the poultry house. Manure is a reservoir of SE that has been shed by infected laying hens. You must begin the cleaning procedure with dry cleaning of the house to remove dust, feathers, and old feed. Then, you must wet clean the poultry house, including washing with detergents. Detergents must be used according to label instructions, followed by recommended rinsing procedures. Following cleaning, you must disinfect the poultry house with spray, aerosol, fumigation or another appropriate disinfection method.

We are aware of studies that indicate that wet cleaning may have a detrimental effect on the SE status of a poultry house. In the report by Schlosser et al. (Ref. 39) mentioned in the first paragraph of this section, it is noted that, while 50 percent of the houses went from SE-positive to SE-negative after wet cleaning, 28 percent of the houses went from SE-negative to SE-positive. It is not known whether this was a testing error or a result of the wet cleaning. In addition, a Danish study found a relationship between wet cleaning procedures and SE-positive pig herds (Ref. 53). The authors were unsure whether the cleaning procedures were actually contributing to the presence of SE in the pigs or if the study was biased. Because there is some evidence, though inconclusive, suggesting that wet cleaning may result in an SE-positive poultry house environment, we specifically request comment and data on this subject. Although we are requiring cleaning and disinfection only for houses that have had an environmental or egg test that was positive for SE, we recommend that you remove manure and dry clean poultry houses as a general management practice every time you depopulate a house, even when no SE was detected in the house or eggs.

5. Refrigeration of Shell Eggs Stored More Than 36 Hours

We are proposing in § 118.4(e) that you must store eggs at or below 45°F (7.2°C) ambient temperature if you hold them at the farm for more than 36 hours after laying. This proposed requirement is the only SE prevention measure that applies to all producers with 3,000 or more laying hens regardless of whether your eggs will receive a treatment.

As we described in the shell egg refrigeration and labeling proposed rule (64 FR 36492 at 36495, July 6, 1999), although fresh shell eggs provide an inhospitable environment for

Salmonella

and other microorganisms to multiply, the chemical and physical barriers against bacterial movement and growth in shell eggs degrade as a result of the time and temperature of holding. Consequently, as a result of degradation, SE, if present, has access to the nutrient rich yolk, which provides a favorable environment for growth of SE.

Studies have shown that SE, when inoculated into the albumen of whole shell eggs, multiplied to high numbers if the eggs were not properly refrigerated (Refs. 54, 55, and 56). One study investigated the effect of holding inoculated whole eggs at five different temperatures in the range of 4 °C (39 °F) to 27 °C (81 °F). The investigators found that the SE growth response was proportional to the temperature at which the inoculated eggs were held. The study demonstrated that SE inoculated in shell eggs can multiply to substantial levels if held at 10 °C (50 °F)

or higher for up to 30 days. The authors concluded that “because the number of SE present at the time an infected egg is laid is probably very low, egg storage at 4 °C (39 °F) could be expected to result in a smaller risk to the public health than higher storage temperatures” (Ref. 54). In studies by Humphrey (Ref. 55) and Bradshaw et al. (Ref. 56), no growth was observed in SE inoculated into whole shell eggs at 8 °C (46 °F) and 7 °C (45 °F), respectively. We find that the scientific evidence on the growth of SE in eggs shows that control of storage temperature of shell eggs can effectively prevent the multiplication of any SE present. We seek comment and data on the impact of refrigeration on eggs after they leave the farm, such as the possibility that the eggs may “sweat” when removed from refrigeration.

Although we believe that it is very important that eggs be placed into refrigerated storage as soon as possible after they are laid, we realize that this may not be practical for all producers. It may be several hours or longer after the eggs are laid before they are collected or picked up for transport. It may not be practical for producers to place eggs under refrigeration within several hours after they are laid. It would be reasonable, based on what we know about current practices and the risk of SE growth in unrefrigerated eggs, to establish a time limit for holding eggs under ambient temperature conditions. According to the Layers study (Ref. 26), almost half of the farm sites surveyed had egg pick-ups every 1 to 2 days. We believe that holding eggs under ambient temperature conditions for up to 36 hours would not result in excessive growth of any SE, if present (Ref. 54). If eggs will be held at the farm for more than 36 hours after they are laid, it is important to place them in an environment that will protect the yolk membrane from degradation and, thereby, prevent any SE that may be present from multiplying. We have tentatively concluded that if eggs will be stored for more than 36 hours after they are laid, producers, with 3,000 or more laying hens, must store them at an ambient temperature of 45 °F (7.2 °C) or lower.

We are soliciting comment and data on the 36-hour threshold that eggs may be held unrefrigerated at a farm. Is this time frame practical for producers with daily egg pickup? Is it practical to refrigerate eggs held at farms for less than 36 hours?

F. Indication of the Effectiveness of the SE Prevention Measures: Testing

In addition to implementing SE prevention measures in the poultry house environment, we have tentatively concluded it is also important that you do environmental testing as an indicator of whether your measures are working effectively.

1. Environmental Testing for SE

Under proposed § 118.1(a), § 118.5 would apply to you if you are a shell egg producer with 3,000 or more laying hens, you produce shell eggs for the table market but do not sell all of your eggs directly to consumers, and any of your eggs that are produced at a particular farm do not receive a treatment as defined in § 118.3. We are proposing in § 118.5 that you must conduct environmental testing for SE as an indicator of whether your SE prevention measures are working effectively. According to Schlosser et al. (Ref. 39), the Northeast Conference on Avian Diseases recommended that the poultry house environment (e.g., manure pits and egg machinery) be sampled by swabbing. This recommendation was made with the assumption that, if SE was found in the environment, there was a high probability that the laying hens in the house were infected. Sampling of manure in a poultry house is a simple screening method for determining if laying hens are shedding SE. Some studies have shown that manure sampling gives more consistent results than sampling of egg machinery (Ref. 39), although we recognize that sampling egg machinery may be preferable in certain poultry houses, and the Layers study identified almost one-half of environmental positives through sampling of egg machinery (Ref. 27). We tentatively have determined that environmental testing of the manure or egg machinery in a poultry house is an appropriate method for screening the environment for SE and should be used as one indicator of the effectiveness of your SE prevention measures.

Testing provides an opportunity for you to evaluate the SE status of your poultry houses and to take appropriate action if your measures are not preventing SE. Many of the comments we received in response to the public meetings in Columbus, OH, and Sacramento, CA, stated that environmental testing was an appropriate indicator of whether SE prevention measures are working effectively. In addition, most of the voluntary egg QA programs contain some level of environmental testing for SE to evaluate the effectiveness of the programs.

Information from an egg QA program with a testing protocol indicates that the highest numbers of positive environmental samples are found when laying hens are 40 to 45 weeks of age (Ref. 57). The Layers study (Ref. 27) found that flocks less than 60 weeks of age (younger flocks) were 5 times more likely to test positive for SE than older flocks. Accordingly, we are proposing in § 118.5(a) that environmental testing for SE be conducted for the flock in each poultry house when each group of laying hens making up that flock is 40 to 45 weeks of age. We are proposing in § 118.5(b) that environmental testing for SE also be conducted approximately 20 weeks after the end of any induced molting process. We propose to do this because the egg industry considers the time period approximately 20 weeks after the end of a molting process to be equivalent to the time period when layers are 40 to 45 weeks of age in an initial laying cycle.

An SE-positive environmental test at the 40 to 45 week time period notifies a producer that there is a problem with SE contamination. At this point, action can be taken to determine if there are SE-contaminated eggs and to keep SE-contaminated eggs produced by an SE-positive flock out of the table egg market. Additionally, a positive environmental test during the 40 to 45 week period (just after peak lay) gives a producer sufficient notice to make arrangements for cleaning and disinfection of the contaminated poultry house at depopulation. Therefore, we have tentatively concluded that you must perform environmental testing for SE on a poultry house when each group of laying hens in the flock in that house are 40 to 45 weeks of age and, if molted, approximately 20 weeks after the end of any molting process.

We tentatively have concluded in proposed § 118.5(a)(1) that, if an environmental test at 40 to 45 weeks for SE is negative, and your laying hens do not undergo induced molting, then you do not need to perform additional environmental testing on the poultry house, unless the flock in that poultry house contains multi-aged laying hens. If the flock contains multi-aged laying hens, you must test the environment of the poultry house when each group of hens in the flock is 40 to 45 weeks of age. We are establishing minimum testing requirements to serve as one indication of whether your SE prevention measures are working effectively, and we believe that one test per laying cycle is sufficient for that purpose. In addition, a representative

from the PEQAP program stated at a recent FDA/FSIS public meeting on egg safety (Washington, DC, July 31, 2000) that 75 percent of environmental positives will be caught with one environmental test (Ref. 58).

If an environmental test for SE is positive, we have tentatively concluded, under proposed § 118.5(a)(2), that you must review implementation of your SE prevention measures and begin egg testing within 24 hours of receiving notification of the positive environmental test, unless you divert eggs to treatment for the life of the flock in that poultry house. Review of the SE prevention measures is critical to ensure that they are being implemented properly and to eliminate improper implementation as a contributor to the SE-positive environment. We are proposing that you begin egg testing within 24 hours of receiving notification of an SE-positive environmental test in order to determine as quickly as possible whether SE-contaminated eggs are being marketed to consumers.

Further, we tentatively have concluded, in proposed § 118.5(b), that you must perform an environmental test for SE at approximately 20 weeks after the end of the molting process. Under proposed § 118.5(b)(1), if an environmental test is negative approximately 20 weeks after the end of a molting process, and your laying hens are not molted again, you do not need to perform additional environmental testing, for the reasons previously stated, on that poultry house, unless the flock in the poultry house contains multi-aged laying hens. If the flock contains multi-aged laying hens, the environment of the poultry house must be tested approximately 20 weeks after the end of the molting process of each group of hens in the flock in each poultry house.

Under proposed § 118.5(b)(2), if the environmental test for SE is positive at approximately 20 weeks after the end of a molting process, you must proceed in the same manner as described when the environmental test performed when laying hens are 40 to 45 weeks of age is positive for SE.

2. Egg Testing for SE

Under proposed § 118.1(a), § 118.6 would apply to you if you are a shell egg producer with 3,000 or more laying hens, you produce shell eggs for the table market but do not sell all of your eggs directly to consumers, and any of your eggs that are produced at a particular farm do not receive a treatment as defined in § 118.3. We are proposing in § 118.6 that if you have an environmental test that is positive for SE at any point during the life of a flock, you must perform egg testing for SE, unless you divert eggs to treatment as defined in § 118.3 for the life of the flock in the positive poultry house. If an environmental test is SE-positive, the flock in that environment may be producing SE-positive eggs. Studies have shown that infected laying hens that are shedding SE into the environment are not necessarily producing SE-contaminated eggs (Ref. 14). However, data from the SE Pilot Project (Ref. 39) showed that 50 percent of flocks with an SE-positive environment produced at least one positive egg in the time period studied. The prevalence of SE-positive eggs from flocks in SE-positive environments was estimated to be approximately 1 in 3,600 from data from the SE Pilot Project (Ref. 39). The SE Risk Assessment (Ref. 15) estimated the prevalence of contaminated eggs to be as high as 1 in 1,400 from “high risk” flocks with SE-positive environments. We have tentatively concluded that, in order to protect public health, you must begin testing eggs within 24 hours of receiving notification that you have an environmental test that is positive for SE, unless you choose to divert eggs to treatment as defined in § 118.3 for the life of the flock in the positive poultry house.

We are proposing in § 118.6(c) that you must conduct 4 egg tests on the positive poultry house; you must collect and test eggs as required by §§ 118.7 and 118.8, respectively, at 2-week intervals for a total of 4 tests. We are also proposing in § 118.6(c) that if all four tests are negative for SE, then you may continue to supply eggs to the table egg market. However, if any one of the four egg tests is positive for SE, we are proposing in § 118.6(d) that, upon receiving notification of an SE-positive egg test, you must divert all eggs from the positive flock for treatment as defined in § 118.3 until the provisions of § 118.6(c) are met. You may divert eggs from the positive flock to egg products processing or to a treatment that will achieve at least a 5-log destruction of SE for shell eggs. You may return to providing eggs to the table egg market if they have met the provisions of proposed § 118.6(c) (see discussion in section III.G.2 of this document) and continue to meet the provisions of proposed § 118.6(e), described in the following paragraph.

We are proposing in § 118.6(e) that, if you have had a positive egg test in a flock and later meet the number of negative egg tests required in § 118.6(c) and return to table egg production, you must conduct one egg test per month on that flock (see discussion in section III.G.2 of this document) for the life of that previously positive flock. Humphrey (Ref. 14) has suggested that laying hens that are infected with SE will produce SE-contaminated eggs sporadically. Therefore, we believe that it is important that a flock that previously has produced positive eggs be monitored throughout its life for production of SE-contaminated eggs. Under proposed § 118.6(e)(1), if the monthly egg test in paragraph (e) is negative for SE, you may continue to supply eggs to the table market. If any of the monthly egg tests in paragraph (e) are positive for SE, under proposed § 118.6(e)(2), you must divert eggs from the positive flock to treatment for the life of the flock or until the conditions in paragraph (c) of proposed § 118.6 are met.

The testing schemes described in the previous paragraphs could be the basis for a performance based regulatory scheme. We are soliciting comment and data on alternative regulatory schemes that would achieve the same public health protection as the set of measures we are currently proposing. One possibility is a requirement for a specified frequency of environmental testing for all producers, followed, if necessary, by egg testing and diversion. As long as producers were maintaining poultry houses that tested negative for SE, the SE prevention measures would be recommended but not required. However, some or all of the measures may be required of producers whose houses were contaminated with SE. We solicit comment on a testing-based regulatory scheme and combinations of the prevention measures that might achieve the same public health goals as the current proposal.

G. Sampling and Testing Methodology for SE

We are proposing in § 118.7 to require that you follow a scientifically valid sampling procedure when sampling for SE in the poultry house environment and in eggs. Your ability to accurately assess the SE status of a flock and its eggs is a factor of the sampling methodology used to detect SE in the environment and in eggs. To protect public health, it is important that when you perform environmental testing for SE, you take representative samples of the manure or other appropriate material in poultry houses and, when you perform egg testing, you randomly collect 1,000 eggs from a day's production.

1. Sampling of the Poultry House Environment

We are proposing in § 118.7(a) that you use a scientifically valid sampling procedure for conducting environmental sampling within each poultry house. Currently, drag swabbing methods are being used to sample manure in poultry houses in the voluntary State QA programs (Refs. 28, 29, 30, 31, and 32). Drag swabbing has been reported to be an effective and convenient method for determining the SE status of a flock in a poultry house (Ref. 59). Drag swabbing involves pulling a square gauze pad (approximately 4 x 4 inches) that has been moistened with canned, evaporated milk across the surface of manure. Information on drag swabbing generated for the CA Egg QA Program (CEQAP) indicates that a swab becomes saturated with manure after being dragged approximately 30 linear feet (Ref. 60) and, therefore, in that program an individual swab is only dragged for 30 feet. Most other State programs drag a single swab the entire length of a row of cages within a poultry house regardless of the length of that row (Refs. 28, 30, 31, and 32). As only the one CEQAP study has been done on saturation of a drag swab, there is very little information on this subject.

Currently, two different sampling plans are being used to drag swab manure in poultry houses among the voluntary State egg QA programs. CEQAP has developed a statistical sampling plan for drag swabbing a poultry house based on an assumed level of contamination within that house. Based on this assumed level of contamination, the number of swabs necessary to give a particular probability of detecting SE can be determined. For example, if 10 percent of the area of a poultry house is contaminated with SE, taking 32 swabs would give a 96 percent probability of detecting SE in that house. For the CEQAP program, the total area of a poultry house is divided into 30-foot sections (the distance that they have determined it is valid to drag a single swab) and, in our example, 32 of those 30-foot sections would be randomly selected to be drag swabbed for SE. In this sampling plan, the assumed area of contamination can be altered to fit the conditions in a particular poultry house with consequent changes in the number of swabs that must be taken to retain a 95 percent or better probability of detecting any SE that may be present.

Alternatively, many of the other voluntary egg QA programs drag swab the entire length of every row of cages within a poultry house. Rows or banks of cages typically have a right and left side. Each side of a row is dragged with a fresh swab until all the rows have been sampled. One swab is used per side regardless of the length of that row. The number of drag swabs taken per house equals twice the number of rows in that house. In addition, there are houses with cages that are stair-stepped and can be eight cages high with a large manure pit beneath them. In houses such as these, the manure belts are usually sampled. In houses where the floors are constantly flushed with water, the floor in general is swabbed.

We are aware of the differences in the types of poultry houses within the United States and the challenges involved in sampling all houses representatively and consistently. We are specifically soliciting comment on the appropriateness of different methods of drag swabbing, including manure belt and floor swabbing, and egg machinery swabbing. We would like comments on the distance an individual swab should be dragged and whether or not it is necessary to drag every row of every house. We would also like comments on alternative methods of sampling (e.g., sampling of the air in a poultry house to detect SE) that could be utilized more uniformly in different styles of poultry houses. Based on comments received, we will consider what poultry house environmental sampling methods should be required in any final rule.

2. Egg Sampling

In § 118.5(a)(2)(B) and (b)(2)(B), we are proposing to require that you begin egg testing within 24 hours of receiving notification of a single SE-positive environmental test unless you divert eggs to treatment for the life of the flock in the poultry house. In § 118.7(b)(1), we are proposing that, when you conduct an egg test required under § 118.6, you randomly collect and test 1,000 eggs from a day's production. The 1,000-egg sample must be tested according to proposed § 118.8. You must randomly collect and test 4 1,000-egg samples at 2-week intervals for a total test of 4,000 eggs over an 8-week period. With this sampling scheme, there is approximately a 95 percent probability that a positive egg will be detected from a flock that is producing SE-contaminated eggs with a prevalence of 1 in 1,400 (Ref. 61). As mentioned previously, data have indicated that an SE-contaminated flock may be producing SE-contaminated eggs with a prevalence of 1 in 1,400 (Ref. 15). We are proposing that eggs be tested in 2-week intervals because infected flocks shed SE intermittently (Ref. 14). However, the false negative rate of the sampling scheme is sensitive to the assumption regarding the prevalence of SE-contaminated eggs (Ref. 61). We are soliciting comment on this assumption, as well as other scientifically valid egg sampling procedures.

In proposed § 118.7(b)(2) we have tentatively concluded that 1,000 eggs from a day's production should be tested per month for the life of a flock that has had an SE-positive egg test and then met the provisions of § 118.6(c) and returned to table egg production. We are requiring this monthly egg test for the life of the flock because infected layers shed SE intermittently (Ref. 14).

H. Laboratory Methods for Testing for SE

We are proposing in § 118.8(a) that you must test for SE in environmental samples according to the method “Detection of

Salmonella

in Environmental Samples from Poultry Houses” and in § 118.8(b) that you must test for SE in egg samples according to the preenrichment method described by Valentin et al. (Ref. 62). These methods, which are incorporated by reference, are required unless you test for SE in environmental and egg samples using other methods that are at least equivalent in accuracy, precision, and sensitivity in detecting SE. In the future, we intend to place the specified methods in FDA's Bacteriological Analytical Manual. After publication of this proposed rule, the environmental sampling method will be available on FDA's Internet Web site at

www.cfsan.fda.gov

.

The method for detecting SE in the environment that we are specifically proposing to allow, “Detection of

Salmonella

in Environmental Samples from Poultry Houses,” is a pre-enrichment method followed by primary enrichment method. The basic procedure for culturing samples involves incubating pre-enriched samples in enrichment broth and then streaking samples of broth onto selective media. Following incubation of the samples on the selective media, any suspect colonies that have grown on the media are identified biologically and serologically. In general, this procedure should give results in 5 days following receipt of samples by the laboratory.

The method for detecting SE in egg samples that we are specifically proposing to allow is a pre-enrichment method. The basic procedure for culturing involves incubation of pools of 20 eggs, followed by enrichment in modified tryptic soy broth. Following incubation and enrichment, samples are subcultured and streaked onto media and any suspect colonies that have

grown on the media are identified biochemically and serologically. We specifically request comment on appropriate options for conducting and funding testing of SE detection methods through State and Federal programs.

I. Administration of the SE Prevention Measures

We are proposing in § 118.9 that one individual at each farm must be responsible for administration of the SE prevention measures. Oversight by one qualified individual is essential to the effective implementation of SE prevention measures for egg production. Because egg production operations tend to be small and may have frequent turnover in staff, it is particularly important that one individual have training equivalent to a standardized curriculum recognized by FDA (discussed in the following paragraphs) or be otherwise qualified through job experience to administer the SE prevention measures.

Proposed § 118.9 requires an individual to have the requisite training or experience to administer SE prevention measures. Training on SE prevention measures for egg production must be at least equivalent to that received under a standardized curriculum recognized by FDA. We anticipate that 2- or 3-day training sessions will be provided by an egg safety training alliance, modeled after the Seafood HACCP Alliance. The Seafood HACCP Alliance is a consortium consisting of representatives from Federal and State agencies, industry, and academia who have worked to create a uniform training program that will meet the requirements of the seafood HACCP regulations with minimal cost. It is our intention to develop an Egg Safety Alliance to create a core curriculum and training materials on SE prevention measures for egg production. It also is our intention to use the Egg Safety Alliance curriculum and materials as the standard against which other course curricula and materials may be judged.

We also are proposing in § 118.9 that job experience will qualify an individual to administer the SE prevention measures if such experience has provided knowledge at least equivalent to that provided through the standardized curriculum. We acknowledge that a course on SE prevention measures for egg production might not be necessary for an individual who has experience working on an egg farm and is well-versed in SE prevention during egg production. Where job experience has imparted a level of knowledge at least equivalent to what an individual would receive through the standardized curriculum, that individual would be considered qualified to administer the prevention measures under proposed § 118.9.

We are proposing in §§ 118.9(a) through (c) that the qualified individual designated under § 118.9 must develop and implement SE prevention measures for each farm, reassess and modify the prevention measures as necessary to ensure that the requirements of § 118.4 are met, and review all records created under § 118.10. We also are proposing that the individual does not need to have performed the monitoring or created the records being reviewed. We have tentatively concluded that the prevention measures need to be implemented and, if necessary, modified and reassessed by an individual who not only is knowledgeable about egg production but who also has been trained or is experienced specifically in SE prevention measures for egg production so that the individual will be able to recognize potential problems.

J. Recordkeeping Requirements for the SE Prevention Measures

We are proposing recordkeeping requirements related to environmental testing and egg testing for SE, diversion, and eggs going to treatment.

1. Records that Egg Producers Are Required to Maintain

Under proposed § 118.1(a), § 118.10 would apply to you if you are a shell egg producer with 3000 or more laying hens, you produce shell eggs for the table market but do not sell all of your eggs directly to consumers, and any of your eggs that are produced at a particular farm do not receive a treatment as defined in § 118.3. We are proposing in § 118.10(a)(1) that you must keep records indicating compliance with environmental and egg sampling performed under proposed § 118.7 and results of environmental and egg testing performed under proposed § 118.8 as required in proposed §§ 118.5 and 118.6. If applicable, you must also keep records indicating compliance with the egg diversion requirements of proposed § 118.6. These records may be handwritten logs, invoices, documents reporting laboratory results, or other appropriate records.

Maintenance of appropriate records is fundamental to evaluating the effectiveness of your SE prevention measures. As stated in section III.A of this document, the combined SE prevention measures, when implemented properly, have been shown to result in a decrease in the number of poultry houses with SE-positive environments (Ref. 39). We have tentatively concluded that in order for you and FDA to evaluate whether these measures are being effective, it is necessary for you to keep records documenting the results of environmental testing and, if applicable, egg testing. We are proposing in § 118.10(a)(2) that if egg testing reveals SE-positive eggs you must maintain records indicating compliance with the diversion requirements in § 118.6. Records of diversion will provide assurance to both you and FDA that eggs required to be diverted are not being marketed to consumers and, thereby, putting consumers at risk of illness from SE.

We are proposing in § 118.10(a)(3) that you must keep records indicating that all of the eggs at a particular farm will be given a treatment as defined in § 118.3, if you have 3,000 or more laying hens and you are not complying with the SE prevention measures other than refrigeration (i.e., you are a producer described in § 118.1(b)). These records may include a contract with an in-shell pasteurization facility or an egg-breaking facility. It is necessary that these records be maintained so that both you and FDA will have an assurance that the potential for SE contamination in eggs is being addressed through a treatment or through the SE prevention measures.

2. General Requirements for Records Maintained by Egg Producers

In proposed § 118.10(b), we describe general requirements for records that must be maintained. Proposed § 118.10(b)(1) and (b)(2) require that records contain your name, the location of your farm, and the date and time of the activity that the record reflects. Proposed § 118.10(b)(3) requires that the record include the signature or initials of the person performing the operation or creating the record. The record signing requirement will assure responsibility and accountability by the individual who performed the activity. Also, a signature or initials ensure that the source of the record will be known if any questions regarding the record arise.

Proposed § 118.10(b)(4) requires that data reflecting compliance activities be entered on a record by the person performing or observing the activity at the time it is performed or observed in order to increase accuracy. The record must contain the actual values observed, if applicable.

3. Length of Time Records Must Be Retained

Proposed § 118.10(c) requires you to maintain all records in accordance with proposed part 118 at your place of business, unless stored offsite under § 118.10(d), for 1 year after the flock to which the records pertain has been taken permanently out of production. You must maintain records for 1 year after a flock is no longer producing eggs for consumption to allow for annual inspection and to facilitate investigation if the eggs from that flock are implicated in an outbreak of a foodborne illness.

4. Offsite Storage of Records

Proposed § 118.10(d) allows for offsite storage of records 6 months after the date the records were created. This applies to all records required under proposed part 118. We recognize that, under the recordkeeping requirements of this part, there may be more records than available storage space in an egg production facility. Therefore, we are proposing that records may be stored offsite. You must be able to retrieve any records you store offsite and provide them at your place of business within 24 hours of a request for official review. We would consider electronic records to be onsite if they are available from an onsite computer, including records transmitted to that computer via a network connection.

5. Official Review of Records

Proposed § 118.10(e) requires you to have all records required by part 118 available for official review and copying at reasonable times. The agency's access to records required by proposed part 118 is essential to understand whether your SE prevention measures are working and whether you are complying with the regulations. Our authority to require these records, and to provide for agency access to them, is discussed elsewhere in this document.

6. Public Disclosure of Records

Proposed § 118.10(f) states that records required by proposed part 118 are subject to the disclosure requirements under 21 CFR part 20. In another FDA rulemaking that discussed public disclosure of required records (60 FR 65096 at 65139, December 15, 1995), we concluded:

[R]ecords and plans should be protected to the extent possible in order to promote the implementation of HACCP across the seafood industry. FDA has concluded that the public will benefit from the protection of records because it will actually strengthen the HACCP system. So long as the legitimate public need to be able to evaluate the system can be met through other means, the confidentiality of HACCP records and plans generally will foster the industry's acceptance of HACCP. Even though HACCP may be mandatory under these regulations, in order for it to succeed, processors must be committed to it because they see value in it for themselves. Fear of public disclosure of matters that have long been regarded as confidential business matters could significantly undermine that commitment. FDA concludes, therefore, that it is in the public interest to foster tailored HACCP plans that demonstrate understanding and thought, rather than promote the use of rote plans and minimally acceptable standards due to fear of public disclosure.

FDA understands that we cannot make promises of confidentiality that exceed the permissible boundaries established under FOIA, nor does the agency wish to do so in this case. The agency still does not expect that we will be in possession of a large volume of plans and records at any given moment. However, given the significant interest in this subject as conveyed by the comments, we have concluded that the final regulations should reflect the fact that the HACCP plans and records that do come into FDA's possession will generally meet the definition of either trade secret or commercial confidential materials* * *.

We are not aware of any circumstances that would warrant different consideration on issues related to disclosure of records for SE environmental and egg sampling and testing and for diversion of eggs than those required for seafood HACCP. Therefore, we intend to consider records that come into our possession under this rule as generally meeting the definition of either a trade secret or commercial confidential materials.

7. Comment Solicitation on Recordkeeping Measures

We are soliciting comment on whether we should require two additional recordkeeping measures beyond the proposed recordkeeping requirements for environmental and egg sampling and testing, and for diversion. This solicitation is being made to assess the importance of these additional recordkeeping measures for a comprehensive SE prevention plan, given their added costs. First, we are soliciting comment on whether we should require that you establish and maintain a written SE prevention plan. If required, this SE prevention plan would set forth a producer's plan to implement the regulation's prevention and testing measures, and the requirement for diversion if eggs test positive for SE. A written plan may aid in the planning and establishing of efficient, effective, and consistently implemented SE prevention measures by facility personnel.

A written SE prevention plan also would be helpful to FDA representatives who inspect an egg facility. A written copy of a plan specific to each farm would assist FDA in establishing a link between what agency representatives see during an inspection and the overall SE prevention measures used on that farm over a longer time period. SE prevention measures may be quite different among farms, given different facility design and size, and yet be equally effective in meeting FDA's requirements. Knowledge of the specific prevention measures taken on a farm, as discussed in an SE prevention plan, would assist FDA representatives in assessing compliance with the prevention measures.

The second recordkeeping measure about which we are soliciting comment relates to a requirement that you maintain records indicating performance and compliance in implementing your facility's specific SE prevention measures. In this document, we are specifically proposing to require records only for environmental and egg sampling and testing, and for diversion of eggs found to be SE positive. We are requesting comment on whether we should require other documents demonstrating your implementation of the SE prevention measures that could be considered by FDA in assessing your compliance efforts, particularly in light of an SE-positive environmental test. Such documents, for example, might include monitoring records and activity logs. In the absence of other records to demonstrate compliance with SE prevention measures, FDA representatives who inspect a facility will base their evaluation of compliance with the regulation on observations, your sampling, testing, and any diversion records, FDA testing, and any other relevant information.

FDA did not propose to require a written plan and monitoring and compliance records because of their added costs, which FDA estimates to be $14.7 million, an 18 percent increase in the rule's total costs. Considering the information in the previous paragraphs, we are soliciting comment on the cost-effectiveness of the inclusion of a recordkeeping provision for a written SE prevention plan and a provision requiring records demonstrating compliance with all SE prevention measures in any final rule based on this proposal.

We also are soliciting comment about whether we should consider requiring, in a final rule, that you register with FDA if you are a producer who must comply with all of the SE prevention measures, as described in proposed § 118.1(a). We would use the producer registration information to create a

database that we would use to efficiently conduct inspections and allocate inspection resources. When the provisions of this rule are finalized, FDA intends to conduct annual inspections of egg farms. Oversight through annual inspection is necessary to ensure that shell eggs are being produced under controls that will prevent SE contamination and reduce the likelihood that SE-contaminated eggs will cause foodborne illness. Therefore, we solicit comment on the efficacy of requiring that producers register the location and size of their business with FDA.

K. Enforcement of On-Farm SE Prevention Measures for Shell Eggs

As discussed in section III.L of this document, FDA is proposing these regulations under both the FFDCA and the PHS Act. Failure to comply with the on-farm requirements proposed in §§ 118.1 through 118.10 would subject a producer to the administrative remedies (i.e., diversion or destruction) in § 118.12 of the proposed rule. Further, we would consider a failure to comply with the SE prevention requirements in proposed §§ 118.1 through 118.9 to result in the shell eggs being adulterated under section 402(a)(4) of the FFDCA (21 U.S.C. 342(a)(4)). Causing the eggs to become adulterated would be a violation of section 301(b) of the FFDCA (21 U.S.C. 331(b)), which prohibits adulteration or causing adulteration of food in commerce. Also, the introduction or delivery for introduction of adulterated shell eggs into interstate commerce would be a prohibited act under section 301(a) of the FFDCA (21 U.S.C 331(a)). Enforcement of adulteration regulations under the FFDCA is conducted under sections 301, 302, 303, and 304 (21 U.S.C. 332, 333, and 334).

Section 361 of the PHS Act (42 U.S.C. 264) authorizes the Secretary of Health and Human Services (the Secretary), and by delegation FDA, to issue regulations that provide for the destruction of articles and for other measures that the Secretary determines are necessary to prevent the introduction, transmission, or spread of communicable diseases. FDA tentatively concludes that the SE on-farm prevention requirements can be efficiently and effectively enforced through administrative procedures under the PHS Act. Accordingly, FDA is proposing procedures in § 118.12 under which FDA or a State or locality may order the diversion or destruction of shell eggs that have been produced or held in violation of any of the regulations in §§ 118.1 through 118.10. Under proposed § 118.12, FDA or a State or locality may issue a written order to the person holding the shell eggs requiring that the eggs be diverted or destroyed.

The proposed regulations would provide for the diversion to a treatment that achieves at least a 5-log destruction of SE for shell eggs or for processing of the egg products in accordance with the EPIA. Because EPIA requires pasteurization of egg products, any

Salmonella

present would likely be eliminated, as it would if the eggs received a treatment that achieves at least a 5-log destruction of SE. The written order would identify the shell eggs that are affected, and the grounds for issuing the order. The written order would provide that, unless the order is appealed by either filing a written appeal or by requesting a hearing, the shell eggs must be diverted or destroyed within 10-working days of the receipt of the order.

The authority for the enforcement of section 361 of the PHS Act is provided, in part, by section 368 of the PHS Act (42 U.S.C. 271). Under section 368(a), any person who violates a regulation prescribed under section 361 of the PHS Act may be punished by imprisonment for up to 1 year and may be fined. Individuals violating a regulation issued under section 361 may be fined an amount up to $100,000 if death has not resulted from the violation or up to $250,000 if death has resulted (18 U.S.C. 3559 and 3571(c)). In addition, Federal district courts have authority to enjoin individuals and organizations from violating regulations implemented under section 361 of the PHS Act (

Califano

v.

Yamasaki

, 442 U.S. 682, 704-05 (1979);

United States

v.

Beatrice Foods Co.

, 493 F.2d 1259, 1271-72 (8th Cir. 1974),

cert. denied

, 420 U.S. 961 (1975)).

We are proposing to amend § 16.5 (21 CFR 16.5) by adding paragraph (a)(5) to clarify that the regulatory hearing procedures in 21 CFR part 16 do not apply to a hearing proposed under § 118.12 on an order for diversion or destruction of shell eggs under section 361 of the PHS Act. We intend for the administrative remedies in proposed § 118.12 to be the applicable informal hearing process for any order issued under such section.

Proposed § 118.12(b) requires that shell egg producers allow FDA representatives to inspect egg production establishments. FDA does not need to provide advance notice before an inspection, and an inspection may include, but is not limited to, egg and environmental sampling, review of records, and inspection of eggs and equipment.

Proposed § 118.12(c) provides that States and localities that are authorized to inspect or regulate egg production establishments may enforce proposed §§ 118.4 through 118.10 of the rule through inspections under § 118.12(b) and through the administrative remedies in § 118.12(a). Proposed § 118.12(c) also provides that those States or localities may follow the rule's hearing procedures, substituting, where necessary, the appropriate State or local officials for designated FDA officials. The State or local officials also may use comparable State or local hearing procedures as long as such procedures satisfy due process.

L. Legal Authority

FDA is proposing these regulations under the PHS Act and the FFDCA. FDA's legal authority under the PHS Act for the proposed regulations is derived from the provisions of sections 311, 361, and 368 (42 U.S.C. 243, 264, and 271) that relate to communicable disease. The PHS Act authorizes the Secretary to make and enforce such regulations as “are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States * * * or from one State * * * into any other State” (section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority from the Surgeon General to the Secretary; see 21 CFR 5.10(a)(4) for delegation from the Secretary to FDA.) This proposed rule would not be the first regulation issued by FDA that relied upon the authority of the PHS Act to prevent the transmission of communicable disease. For more than 60 years, FDA has used the PHS Act as its legal authority (in whole or in part) to issue the following regulations:

• Regulations to control the interstate shipment of Psittacine birds (21 CFR 1240.65);

• Regulations on the source and use of potable water (21 CFR 1240.80 to 1240.95);

• Regulations to control the interstate and intrastate commerce of turtles (21 CFR 1240.62);

• Regulations to control the interstate shipment of molluscan shellfish (21 CFR 1240.60);

• Regulations to require pasteurization of milk and milk products (21 CFR 1240.61);

• Regulations to require a safe handling statement on cartons of shell eggs that have not been treated to destroy

Salmonella

microorganisms and to require refrigeration of shell eggs held

for retail distribution (parts 16, 101, and 115 (21 CFR parts 16, 101, and 115));

• Regulations governing blood and tissue products in intrastate and interstate commerce (parts 606, 640, 1270, and 1271 (21 CFR parts 606, 640, 1270, and 1271));

• Regulations to require HACCP systems for juice in interstate and intrastate commerce (part 120 (21 CFR part 120); and

• Regulations to prevent the monkeypox virus from being established and spreading in the United States (21 CFR 1240.63).

Furthermore, at least one court has supported FDA's use of its PHS Act authority to issue regulations to control communicable disease.

State of Louisiana

v.

Mathews

, 427 F. Supp. 174 (E.D.La. 1977), involved an FDA regulation issued under the PHS Act banning the sale and distribution of small turtles. Plaintiffs argued that the PHS Act only provided FDA with authority to ban individual lots of infected turtles that were shown to be health hazards and did not provide authority for FDA's broad ban on all small turtles.

Id

. at 175. The court rejected this argument, observing that “Congress has granted broad, flexible powers to federal health authorities who must use their judgment in attempting to protect the public health against the spread of communicable disease.”

Id

. at 176. The court found that FDA's total ban was “permissible as necessary to prevent the spread of communicable disease.”

Id

.

Plaintiffs in the case also challenged FDA's authority under the PHS Act to promulgate a rule applicable to intrastate commerce.

Id

. FDA had concluded that controlling the spread of disease from contaminated turtles required extending the ban to intrastate sales.

Id

. Specifically, FDA reasoned that contaminated turtles may be purchased in one State for use as a pet in another and that, without prohibiting intrastate sales, unlawful interstate sales would be difficult or impossible to stop.

Id

. The court found that the intrastate ban “is not only authorized by law, but under modern conditions of transportation and commerce is clearly reasonable to prevent the interstate spread of disease.”

Id

.

In

Public Citizen

v.

Heckler

, 602 F. Supp. 611 (D.D.C. 1985), the court considered a request to compel the Department to act on a petition to ban all domestic sales of raw milk and raw milk products because of the risk of transmission of disease from such products. In ordering FDA to respond to the petition, the court found that the Department had authority to ban raw milk and milk products under the PHS Act: “Under both the [PHS] Act's authorization for regulations to control communicable diseases, and the [act's] provisions for the control of adulterated foods, the Secretary has both the authority and the heavy responsibility to act to protect the nation's health in situations such as this one.”

Id

. at 613. (internal citations omitted). See

Public Citizen

v.

Heckler

, 653 F. Supp. 1229, 1242 (D.D.C. 1987) (ordering FDA to publish a proposed rule banning the interstate sale of all raw milk and raw milk products).

In addition to the PHS Act, FDA's legal authority to require on-farm prevention measures under proposed §§ 118.1 through 118.9 derives from sections 402(a)(4) and 701(a) of the FFDCA (21 U.S.C. 371(a)). Under section 402(a)(4) of the FFDCA, a food is adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” Under section 701(a) of the FFDCA, FDA is authorized to issue regulations for the FFDCA's efficient enforcement. A regulation that requires measures to prevent food from being held under insanitary conditions whereby either of the proscribed results may occur allows for efficient enforcement of the FFDCA. See, e.g., regulations to require HACCP systems for fish and fishery products (21 CFR part 123) and juice (part 120) and regulations to require a safe handling statement on cartons of shell eggs that have not been treated to destroy

Salmonella

microorganisms and to require refrigeration of shell eggs held for retail distribution (parts 101 and 115).

Salmonellosis is a communicable disease that results from intestinal infection with

Salmonella

and is characterized by diarrhea, fever, abdominal cramps, headache, nausea, and vomiting. Contaminated shell eggs are the predominant identified food source of SE-related cases of salmonellosis in the United States. Lack of adequate on-farm prevention measures for the production of shell eggs can lead to the presence of SE in shell eggs and increase the likelihood of human illness if the eggs are not treated or thoroughly cooked. Infection may also be transmitted from person to person and animal-to-person. The provisions in the proposed rule are necessary to prevent SE from entering the farm and to prevent SE, if present, from cross contaminating the layers or eggs on the farm. We tentatively conclude that a regulation to require on-farm measures is necessary to prevent the spread of communicable disease and to prevent shell eggs from being prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.

Although the egg market is largely regional, it involves significant shipment of shell eggs from State to State. Moreover, shipment of SE contaminated eggs from one State to another has contributed to the geographical spread of disease outbreaks in the U.S. human population. For example, eggs from Pennsylvania were implicated in an outbreak of SE infection reported in Asbury Park, NJ, involving at least 47 persons (Ref. 63). Eggs from Maryland were implicated in an outbreak in Livonia, NY, where 12 patrons of a restaurant reported gastrointestinal illness linked to consumption of omelets made from pooled grade A eggs (

Id

.). Further, consumption of raw eggs was associated with an SE outbreak at a catered wedding reception in New York, where Caesar salad dressing was implicated as the cause of SE illnesses. The Caesar salad dressing, made with 18 raw shell eggs traced to a Pennsylvania producer, was left unrefrigerated for 2 hours at the catering establishment, held in an unrefrigerated truck until delivered, and served at the reception 4.5 hours later (Ref. 64).

If eggs are not produced using SE prevention measures, SE is more likely to be present in the shell eggs, thereby increasing the likelihood of human illness if the eggs are not treated or thoroughly cooked. We tentatively conclude that it is necessary for producers with 3,000 or more layers on a farm that do not sell all of their eggs directly to consumers and that produce for the table market shell eggs that do not all receive a treatment, to produce shell eggs using all of the proposed rule's measures to prevent the spread of communicable disease. We also tentatively conclude that only the refrigeration requirements of proposed § 118.4 would apply to producers that provide shell eggs to the table market but do not sell all of their eggs directly to consumers and have 3,000 or more layers at a farm, and whose eggs receive a treatment. We have previously explained, in section III.B of this document, why we are proposing to exempt producers who sell all of their eggs directly to consumers and who have fewer than 3,000 laying hens at a farm from the SE prevention measure requirements.

Activities that are intrastate in character, such as the production and final sale of shell eggs to a retail establishment or institution for ultimate consumption by the consumer within one State, are subject to regulation under section 361 of the PHS Act when intrastate regulation is necessary to prevent the interstate spread of disease (

State of Louisiana

v.

Mathews

, 427 F. Supp. 174, 176 (E.D.La. 1977)). We tentatively conclude that the on-farm SE prevention measures in proposed §§ 118.1 through 118.10 must also apply to producers of shell eggs who sell their eggs intrastate, other than directly to consumers. The record in this rulemaking demonstrates that shell eggs can function as a vehicle for transmitting foodborne illness caused by

Salmonella

(Refs. 7, 8, and 9). Similarly, the record (Ref. 65) demonstrates that consumers, including tourists and other travelers, are likely to purchase intrastate raw shell eggs or products made with them. These consumers subsequently take the eggs or products back to their home state where the eggs or products are consumed, or the consumers carry a communicable disease back to their home state as a result of such consumption, thereby creating the risk that foodborne illness may be spread from one State to another as a result of such consumption. Although producers do not ship such eggs across State lines, there have been interstate SE outbreaks associated with such eggs (Ref. 66).

We believe that a regulation to require on-farm SE prevention measures or shell eggs produced and sold within a State would reduce the risk of SE illness. We are concerned that if we do not require on-farm prevention measures for shell eggs that are produced and sold in one state, the regulations will not prevent the introduction of SE contaminated eggs into other states and, thus, will not prevent the introduction of salmonellosis from one State to another. We tentatively conclude that the spread of salmonellosis among states from SE-contaminated eggs cannot be adequately controlled without extending the on-farm requirements to producers of eggs whose eggs are shipped within one state.

We are proposing to use our authority under section 361 of the PHS Act to institute recordkeeping requirements. We have previously imposed recordkeeping requirements under section 361 of the PHS Act in regulations governing blood and tissue products (parts 606, 640, and 1270) and juice (part 120).

Regulations governing blood and blood components require that records be kept covering each step in the their collection, processing, compatibility testing, storage and distribution and documentation covering shipping temperature and donor information (examination results, tests, laboratory data, interviews, written consent, and health certification) (§§ 606.160 and 640.72).

Recordkeeping requirements are also included in FDA's Human Tissue Intended for Transplantation regulations in part 1270, which also include requirements that records be maintained relating to infectious disease tests, donors, and the receipt, distribution, and disposition of human tissue (§ 1270.35).

HACCP systems regulations for juice also require significant recordkeeping. The regulations generally require each juice processor with a food hazard that is reasonably likely to occur to maintain a written hazard analysis and HACCP plan (21 CFR 120.12). The regulations further require that such processors maintain records documenting the implementation of the sanitation standard operating procedures, the ongoing application of the HACCP plan, verification of the HACCP system, and validation of the HACCP plan or hazard analysis.

Id

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Section 361 of the PHS act provides FDA with authority to issue regulations necessary to prevent the introduction, transmission, or spread of communicable disease. Recordkeeping requirements are necessary for FDA to ensure that producers follow the sampling, testing, and, if necessary, diversion requirements under proposed part 118 for the production of shell eggs. We are proposing environmental testing as an indicator of whether a producer's SE prevention measures are effective. Testing would provide information on the SE status of a poultry house and indicate the need to take appropriate action if the measures were not preventing SE. Under the proposed rule, a positive environmental test would necessitate review of the implementation of SE prevention measures and testing of eggs (unless all eggs in the poultry house are subsequently diverted for the life of the flock). Testing would reduce the number of SE-positive eggs that reach consumers by: (1) Improving the effectiveness of SE prevention measures by indicating when prevention measures are ineffective and need to be modified and (2) triggering diversion to treatment of SE-positive eggs.

Records of SE testing are needed to allow FDA to determine whether SE prevention measures are being implemented in an effective manner over time. Furthermore, FDA personnel may not be present when producers perform environmental sampling and collect eggs for testing. Records would allow FDA to verify that sampling is done in a scientifically valid manner and that the required testing is conducted. Records would also allow FDA to confirm test results and that producers are taking appropriate actions based on the results (e.g., reassessment, additional testing, diversion). The records would provide assurance, to both the producer and FDA, that the risk of SE-contaminated eggs being provided to consumers is being minimized, either through an SE-negative poultry house or diversion of SE-contaminated eggs.

In addition to having the authority under the PHS Act to require recordkeeping, we believe we also have the authority to require access to the records. Because the on-farm sampling, testing, and diversion requirements are necessary to minimize the risk of communication of salmonellosis, access to records that demonstrate a farm has followed such requirements in part 118 is essential to confirm compliance and achieve the full benefits of the rule. We also have the authority, under section 361 of the PHS Act, to copy the records when necessary. We may consider it necessary to copy records when, for example, our investigator may need assistance in reviewing a certain record from relevant experts in headquarters. If we are unable to copy the records, we would have to rely solely on our investigators' notes and reports when drawing conclusions. In addition, copying records will facilitate followup regulatory actions. Therefore, we have tentatively concluded that the ability to access and copy records is necessary to enforce the rule and prevent the spread of communicable disease. A failure to comply with the rule's records provisions would subject the producer to the administrative procedures under proposed § 118.12. In other relevant sections of this document, we explain in more detail the recordkeeping provisions that we believe are necessary and, because they are limited to what is necessary, that we believe do not create an unreasonable recordkeeping burden.

Under the PHS Act, the Federal, State, and local governments have a long tradition of cooperation. The PHS Act specifically recognizes cooperation between the Federal, State, and local governments as an important tool for public health officials. Previously, in the area of food safety, FDA has used portions of the PHS Act (e.g., sections 310 and 311 (42 U.S.C. 242 and 243)) that focus on Federal assistance to the States. The Conference for Food

Protection (CFP) and the Food Code are a result of Federal, State, and local cooperation and Federal assistance to States and localities under the PHS Act. Section 311 of the PHS Act not only recognizes Federal assistance to the States, but it also recognizes that States and localities may be able to assist the Federal Government. This section provides in part: “The Secretary is authorized to accept from State and local authorities any assistance in the enforcement of quarantine regulations made pursuant to this Act which such authorities may be able and willing to provide.”

We believe that, under sections 311 and 361 of the PHS Act, there are several ways we could accept assistance from the States in the enforcement of the on-farm regulation. For example, FDA could accept State and local assistance in the inspection of shell egg farms and then use those inspections as the basis for detention and diversion or destruction under proposed § 118.12 (as discussed in section III.K of this document) or as the basis for an enforcement action under the FFDCA. Another option would be to authorize the States and localities to conduct inspections and enforce the on-farm requirements through the administrative enforcement remedies set out in proposed § 118.12, while FDA could hear appeals with judicial review available after FDA's decision. FDA also believes that sections 311 and 361 of the PHS Act authorize the agency to issue a regulation that would allow States and localities to enforce the SE prevention on-farm requirements themselves.

After examining these options, FDA has tentatively concluded that all except the last option (allowing States and localities to enforce the requirements themselves) would prove too cumbersome. FDA believes that a cooperative approach would be the most effective means to enforce the on-farm requirements. We are proposing a similar approach to the one chosen for the egg labeling and refrigeration regulations (parts 101 and 115). Specifically, FDA has tentatively decided to allow agencies of those States and localities that are able and willing to inspect or regulate shell egg producers, as authorized under sections 311 and 361 of the PHS Act, to enforce the SE prevention measures along with FDA. FDA recognizes that States and localities currently do this type of enforcement and has tentatively concluded that this option will be the most effective and efficient use of Federal, State, and local food safety resources. Accordingly, proposed § 118.12(c) provides that those States and localities that are able and willing are authorized under sections 311 and 361 of the PHS Act to enforce proposed §§ 118.1 through 118.10 using the administrative procedures in § 118.12, as set out in section III.K of this document. With respect to the hearing procedures, we recognize that many States and localities already have administrative procedures in place for hearings. The proposed regulation would allow them to use a similar hearing process as long as that process satisfies basic due process requirements.

FDA recognizes that some of these are new approaches to enforcement of food safety regulations, and is soliciting comments on this aspect of this proposed regulation. FDA is particularly interested in comments on how State, local, and Federal food safety authorities can best work together to ensure effective and efficient implementation and enforcement of food safety standards.

M. Response to Comments Related to On-Farm Prevention Measures

In this section, we are responding to comments that the agency received in response to the 1998 joint FDA/USDA ANPRM on

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Enteritidis in eggs and in response to the public meetings on egg safety that the agency sponsored with USDA in Columbus, OH (March 30, 2000), Sacramento, CA (April 6, 2000) and Washington, DC (July 31, 2000). FDA/USDA received approximately 73 letters to the 1998 ANPRM (Docket No. 97N-0322), each containing one or more comments. We received approximately 370 letters to Docket No. 00N-0504 for the public meetings on egg safety, each containing one or more comments. Comments on both the ANPRM and the public meetings were received from egg farmers, egg packers, trade associations, consumers, consumer interest groups, animal interest groups, academia, State government agencies, and foreign government agencies. We are responding to comments received to these dockets to the extent that they are relevant to this proposal.

(Comment 1) A few comments stated that it is not necessary to establish regulations for egg safety because the risk of illness from an SE-contaminated egg is low. Comments referenced the SE Risk Assessment in stating that the risk of an egg being contaminated with SE is 0.005 percent. In addition, 30 percent of the 3.3 million eggs that are contaminated annually are used for the production of egg products that are pasteurized and, therefore, do not result in illness. Comments maintained that the risk of illness from the remaining 2.3 million SE-contaminated eggs is less than the risk from consuming other high-protein foods and, therefore, is acceptable and does not warrant Federal regulatory action.

(Response) We do not agree with these comments. We believe that the current risk of illness from consuming SE-contaminated eggs is still too high, especially when there are cost-effective measures that can be taken that will reduce the risk. In 2001, the isolation rate of SE was 2.0 per 100,000 population and the contribution of SE (corrected for underreporting) to total salmonellosis

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