98-24309. Retained Water in Raw Meat and Poultry Products; Poultry Chilling Performance Standards  

  • [Federal Register Volume 63, Number 176 (Friday, September 11, 1998)]
    [Proposed Rules]
    [Pages 48961-48981]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-24309]
    
    
    
    Federal Register / Vol. 63, No. 176 / Friday, September 11, 1998 / 
    Proposed Rules
    
    [[Page 48961]]
    
    
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    DEPARTMENT OF AGRICULTURE
    
    Food Safety and Inspection Service
    
    9 CFR Parts 381 and 441
    
    [Docket No. 97-054P]
    RIN 0583-AC26
    
    
    Retained Water in Raw Meat and Poultry Products; Poultry Chilling 
    Performance Standards
    
    AGENCY: Food Safety and Inspection Service, USDA.
    ACTION: Proposed rule.
    
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    SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing 
    regulations to limit the amount of water retained by raw, single-
    ingredient, meat and poultry products as a result of post-evisceration 
    processing, such as carcass washing and chilling. Meat and poultry 
    carcasses and parts would not be permitted to contain water resulting 
    from post-evisceration processing unless the establishment demonstrates 
    that water retention is necessary to meet applicable food safety 
    requirements. In addition, the establishment would be required to 
    disclose on the label the maximum percentage of retained water in the 
    product. The proposed labeling statement would provide information to 
    consumers of raw meat and poultry products that would help them to make 
    purchasing decisions. Establishments having data demonstrating that 
    there is no retained water in their products could choose not to label 
    the products with the retained-water statement or to make a no-
    retained-water claim on the product label.
        FSIS is also proposing to revise the poultry chilling regulations 
    to improve consistency with the Pathogen Reduction/Hazard Analysis and 
    Critical Control Points (PR/HACCP) regulations, eliminate ``command-
    and-control'' features, and reflect current technological capabilities 
    and good manufacturing practices.
    
    DATES: Comments must be received on or before December 10, 1998.
    
    ADDRESSES: Submit one original and two copies of written comments to 
    Docket Clerk, U.S. Department of Agriculture, Food Safety and 
    Inspection Service, Room 102, 300 12th Street, SW., Washington, DC 
    20250-3700. Please refer to docket number 97-054P in your comments. All 
    comments submitted in response to this proposal, as well as research 
    and background information used by FSIS in developing this document, 
    will be available for public inspection in the Docket Clerk's Office 
    between 8:30 a.m. and 4:30 p.m., Monday through Friday.
    
    FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy 
    Administrator, Office of Policy, Program Development, and Evaluation, 
    Food Safety and Inspection Service, U.S. Department of Agriculture, 
    Washington, DC 20250-3700; (202) 205-0699.
    
    SUPPLEMENTARY INFORMATION:
    
    Background
    
        FSIS carries out the mandates of the Federal Meat Inspection Act 
    (FMIA; 21 U.S.C. 601 et seq.), the Poultry Products Inspection Act 
    (PPIA; 21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 
    U.S.C. 1031 to 1056) to ensure that meat, meat food, poultry, and egg 
    products in interstate and foreign commerce are wholesome, not 
    adulterated, and properly marked, labeled, and packaged. The Agency 
    maintains continuous inspection oversight of operations in meat and 
    poultry slaughtering and processing establishments and in egg product 
    processing plants. Among the requirements enforced by the Agency are 
    those having to do with the post-evisceration handling and storage of 
    carcasses and parts.
        Meat and poultry carcasses are handled in a manner intended to 
    yield wholesome, unadulterated products. After evisceration, raw meat 
    and poultry carcasses are subject to various processes, including 
    washing and chilling, to preserve the safety of the products. The 
    Agency is concerned about the potential for water absorption and 
    retention in the stages of processing after livestock and poultry 
    carcasses are eviscerated and trimmed. Because an eviscerated carcass 
    is open and exposed to water through the washing, chilling, and 
    spraying processes, it is likely to absorb and retain water under the 
    skin and in muscle tissue. There is a potential for product 
    adulteration due to excess water absorption and retention.
        In livestock slaughtering establishments, carcasses undergo a final 
    wash after slaughter and dressing to remove any adhering foreign matter 
    before being placed in the cooler. Historically, meat carcasses have 
    been air-chilled. Since the late 1970's, FSIS has permitted air 
    chilling in combination with a water spray to minimize carcass 
    shrinkage and promote rapid heat loss.
        Air chilling results in carcass weight loss from evaporation of the 
    natural water in the carcass during evaporative cooling. Spraying water 
    on livestock carcasses during air chilling either replaces the water 
    that would have evaporated during air chilling or prevents the water in 
    the carcass from evaporating. The result is that livestock carcasses 
    subjected to a water spray retain water, and consequently, weight, 
    which would have been lost as a result of air chilling. Water spray 
    systems must be operated in a manner that does not result in a shift's 
    production of meat carcasses from weighing, on average, more than their 
    pre-chilled weight. (FSIS Directive 6330.1) This directive recognizes 
    that it is technologically feasible and commercially practical to chill 
    livestock carcasses in a manner that, on average, does not result in an 
    increase in the carcass weight above the pre-chilled weight.
        Although livestock slaughter establishments are not prohibited from 
    using water immersion chilling methods, federally inspected 
    establishments in the United States do not use immersion chilling for 
    livestock carcasses. Immersion chilling is impractical because of the 
    size of livestock carcasses and the associated costs of equipment and 
    other resources.
        Processing and chilling methods used for some edible meat 
    byproducts and organ meats may result in water retention. For example, 
    cheek meat, meat from ears and tails, and organ meats are washed, 
    cleaned and chilled to preserve safety and wholesomeness before being 
    shipped. Tripe is bleached and scalded before being shipped. 
    Chitterlings (swine intestines) are washed and chilled before shipment 
    and are packaged with water. A few establishments chill beef cheek 
    meats in water, a process that may result in the absorption of water. 
    The product is labeled to indicate the maximum percentage added water 
    it may contain to alert buyers to the fact that the product may weigh 
    more because of the chilling process.
        Unlike livestock establishments, poultry processors have 
    traditionally chilled poultry using the water immersion chilling 
    method. Although air chilling is permitted, immersion chilling is more 
    rapid and cost efficient. The use of water immersion chilling is 
    limited to whole poultry carcasses or major carcass portions. Poultry 
    establishments are required to reduce the internal temperature of 
    water-chilled poultry carcasses to 40 degrees F. or less within 4 to 8 
    hours after slaughter, depending on the size of the carcass (9 CFR 
    381.66(b)).
        Water-immersion chilling is the preferred poultry chilling method 
    in the United States for several reasons. First, water is the most 
    effective and efficient conducting medium for removing animal heat.
    
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        Before the 1960's, poultry was chilled in layers of ice or immersed 
    in small tanks of ice water. The poultry was chilled using these 
    methods for a sufficient amount of time to reduce the temperature of 
    the poultry to 40 degrees F. or below, after which the tanks were 
    emptied. The use of small individual single-use tanks required 
    significant resources, including space, employees, and water or ice. 
    Because of these disadvantages, continuous immersion chillers were 
    developed. Continuous immersion chillers consist of one or more large 
    tanks where chilled water is continually replenished and poultry 
    carcasses continuously enter and exit. Modern chillers are equipped 
    with refrigeration units and systems for controlling water volume, 
    direction, and agitation. They are efficient, rapid, and economical.
        Chilling poultry carcasses in water-immersion chillers always 
    results in some absorption and retention of water, primarily in the 
    skin and the tissue immediately under the skin. Also, some water 
    becomes bound to the muscle tissue.
        FSIS has consistently required that the retention of water in meat 
    and in poultry products be minimized. FSIS is mandated to prevent the 
    distribution in commerce of meat and poultry products that are 
    adulterated or misbranded. A product is adulterated if, among other 
    circumstances, ``a substance has been added to or mixed with the 
    product to increase its bulk or weight or make it appear of greater 
    value than it is.'' (21 U.S.C. 601(m)(8), 453(g)(8)). Thus, a product 
    containing excessive water may be considered adulterated. Likewise, a 
    product containing excessive water may be considered misbranded. A 
    product is misbranded if, among other circumstances, its label is false 
    or misleading in any particular. (21 U.S.C. 601(n)(1), 453(h)(1)). 
    Immersion chilling of poultry could result in a product's becoming 
    misbranded or economically adulterated through the retention of 
    absorbed water. However, because immersion chilling is the most 
    efficient way to control bacterial growth in poultry products and to 
    ensure that establishments consistently meet applicable chilling time 
    and temperature requirements, FSIS has permitted the retention of some 
    water in poultry.
        FSIS has limited water retention to amounts that are considered 
    unavoidable while achieving applicable food safety requirements. The 
    regulations generally require water absorption and retention in poultry 
    products to be minimized (9 CFR 381.66(d)(1)). FSIS promulgated 
    regulations defining maximum water retention levels for classes of 
    poultry in 1959, 1960, and 1971 (24 FR 9566 (12/1/59); 26 FR 6471 (7/
    19/61); and 35 FR 739 (10/7/70)). Poultry products containing water in 
    excess of the regulatory limits are considered adulterated.
        To ensure that poultry products do not exceed maximum water 
    retention levels, inspectors sample carcasses each day from each 
    chilling system at a point before the poultry is washed and again 
    shortly after the poultry exits the chiller. If the water limits are 
    exceeded, the poultry is retained until enough water has drained to 
    bring the poultry into compliance with the limits. As a practical 
    matter, establishments maintain overall water absorption averages below 
    the maximum limitation to consistently comply with the regulatory 
    limits. However, some firms equip and operate their processing lines in 
    a manner that will enable them to control retained water to a level as 
    close as possible to the regulatory limits. Sometimes the regulatory 
    limits are exceeded. The poultry may then be held at the plant for a 
    longer time to permit excess water to drain, or it may be diverted to 
    operations, such as boning and cut-up, or other processing operations 
    in which excess water is lost.
    
    Concerns About Differences Between the Meat and the Poultry Regulations
    
        Early in 1996, FSIS received a petition from several national 
    livestock industry associations concerning perceived inequities between 
    the meat and poultry regulations. The petitioners argued that the 
    restriction on water absorption in meat carcasses is inequitable in 
    comparison to the absorption allowance for poultry and that, moreover, 
    poultry carcasses with weight added through water absorption are 
    economically adulterated. The petitioners requested that FSIS prohibit 
    the retention of any water absorbed by poultry carcasses during 
    immersion chilling. This request was among those the petitioners 
    reiterated in a February 7, 1997, letter to the Department. FSIS plans 
    to address elements of the petitioners' requests other than the 
    absorbed-water issue in future rulemaking documents.
        In 1994, a group of poultry consumers and red meat producers 
    brought an action against the Department in the United States District 
    Court for the Southern District of Iowa challenging several differences 
    in the regulatory requirements for meat and poultry, including the 
    contaminant removal methods, standards of identity, and water-
    retention. (Kenney, et al. v. Glickman.)
        Plaintiffs alleged that poultry products containing absorbed water 
    were both economically adulterated and misbranded within the meaning of 
    the PPIA. They also alleged that the regulations establishing maximum 
    levels for water retention violated the Administrative Procedure Act 
    because they were arbitrary and capricious when compared to the 
    regulatory prohibition on absorbed water in meat carcasses. The Court 
    found that poultry containing absorbed water was not economically 
    adulterated or misbranded under the PPIA. However, the Court also found 
    that the regulation specifying water absorption and retention limits 
    for ready-to-cook poultry that is to be frozen, cooked, or consumer-
    packaged as whole poultry (9 CFR 381.66(d)(2)) was arbitrary and 
    capricious because the Secretary did not explain in the rulemaking 
    record how he determined the particular water retention levels, why 
    water retention cannot be reduced below current levels, or why meat and 
    poultry should be treated differently.
        The Court left in place the general requirement at 9 CFR 
    381.66(d)(1) for establishments to minimize water absorption and 
    retention in poultry at the time of packaging. The Court also left 
    standing the regulations at 9 CFR 381.66(d)(3)-(6) controlling the 
    amount of retained water in chickens and turkeys that are to be cut up 
    or ice-packed.
        The American Meat Institute (AMI), a trade association representing 
    meat and poultry slaughtering and processing establishments, petitioned 
    the Department on October 2, 1997, to amend the regulations governing 
    water absorption and retention in certain raw meat and poultry 
    products. This petitioner requested five specific changes:
         Repealing regulations requiring poultry carcasses to be 
    chilled below 40  deg.F within a specified time
         Requiring water retention in meat and poultry products to 
    have been minimized at the time of packaging
         Allowing meat and poultry carcasses to absorb and retain 
    water that is incidental and unavoidable in chilling practices designed 
    to improve food protection
         Measuring weight gain from water retention as the 
    difference between the hot carcass weight and the weight of packaged, 
    finished products
         Requiring labeling of raw meat and poultry with retained 
    water above certain minimum absorption and retention levels FSIS 
    considered the petitioner's requests in developing this proposal.
    
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    Purpose for New Regulation
    
        In proposing new regulations governing water retention in raw meat 
    and poultry products, FSIS intends: (1) to provide consumers with 
    additional information to help them in making purchasing decisions; (2) 
    to eliminate certain differences between the meat and the poultry 
    inspection regulations; (3) to establish regulations that are 
    consistent with the objectives of regulatory reform and with the 
    Agency's ``Pathogen Reduction; Hazard Analysis and Critical Control 
    Points Systems (PR/HACCP)'' regulations (61 FR 38806; July 25, 1996); 
    and (4) to streamline the regulations.
        This proposal would respond to the District Court's findings that 
    the regulations the Court set aside were ``arbitrary and capricious'' 
    by providing: (1) that any water retention limits be established on the 
    basis of sound data; (2) that such limits be as low as technically 
    feasible in meeting food safety requirements; and (3) that, to the 
    extent possible, the same criteria for establishing water retention 
    limits apply both to meat and to poultry products.
        FSIS currently lacks information on which to base any water 
    retention limit, or to determine whether any limit currently in use can 
    be further reduced. The proposal would be intended, in part, to ensure 
    the availability of data demonstrating that water retention in affected 
    products is unavoidable and that any water retention limits the Agency 
    sets are the minimum feasible. The soundness of the data would be 
    ensured in large measure by its having been collected under protocols 
    approved by FSIS (see below).
        This proposal would respond, at least in part, to four of the five 
    requests in AMI's petition. It concerns water absorbed and retained in 
    product as a result of post-evisceration processing and, hence, the 
    difference between ``hot carcass'' and finished product weight. It 
    would require that water retention be minimized, that the processing 
    that resulted in water absorption have a food-safety purpose, and that 
    the amount of water retained be indicated on labels of affected 
    products.
        This proposal does not address the time and temperature 
    requirements for chilling poultry carcasses. FSIS intends to undertake 
    a separate rulemaking on this subject.
    
    Proposed Provisions To Limit Retained Water in Meat and Poultry
    
        FSIS is proposing new requirements in new Part 441 to address water 
    retention in single-ingredient raw meat and ready-to-cook poultry 
    products as a result of post-evisceration processing. The proposed 
    requirements would replace those set forth in 9 CFR Sec. 381.66(d)(3)-
    (8) as well as those in Sec. 381.66(d)(2). The intention is to 
    restrict, as much as feasible, the amount of water absorbed and 
    retained in meat and poultry products. The Agency would also require 
    product labels to state the maximum percentage of retained water the 
    products may contain.
        Some quantitative limit or measure is necessary to determine 
    whether water retention has been minimized. Until the decision in 
    Kenney v. Glickman, FSIS used the limits specified in Sec. 381.66(d)(2) 
    to determine whether poultry establishments were meeting the 
    requirement to minimize water absorption and retention in whole birds.
        The only currently available quantitative limit for determining 
    whether water retention in raw products has been minimized (other than 
    the limits for cut-up or ice-pack poultry in 9 CFR 381.66(d)(3)-(6)) is 
    zero percent. FSIS is aware that it may be difficult to eliminate water 
    retention for poultry and some meat products while continuing to meet 
    applicable food safety requirements. FSIS is therefore proposing an 
    alternative to a zero-percent retained-water requirement. 
    Establishments would be required to collect data, in accordance with a 
    protocol approved by FSIS, and demonstrate that water retention is an 
    unavoidable consequence of the process used to meet a food safety 
    requirement, such as the Salmonella performance standards or time/
    temperature chilling requirements. FSIS expects that, to determine that 
    any unavoidable water retention is the minimum feasible, the protocol 
    would provide for testing the process under alternative equipment 
    settings or other variables.
        FSIS would accept data generated from an approved protocol to 
    support water retention levels for multiple establishments using 
    similar post-evisceration processing techniques and equipment. 
    Depending on the design of the protocol and the adequacy of the data 
    collected under it, the data could be used to justify an industry-wide 
    water-retention limit, a limit applying to poultry products processed 
    by several establishments, or a limit applying only to a single 
    establishment's product. Establishments using an industry-wide or 
    multi-establishment limit would have to be able to demonstrate that the 
    conditions under which their products are processed match those assumed 
    or specified in the protocol used to justify the limit.
        FSIS requests comment on the advisability of accepting, during the 
    comment period on this proposed rule, protocols for gathering data that 
    would justify industry-wide or process-specific water retention limits. 
    FSIS also requests comment on whether the Agency should accept 
    protocols submitted by industry groups for individual establishments.
        In a recent Federal Register notice (62 FR 64767; December 9, 
    1997), FSIS requested comments on specifications for protocols to be 
    used for collecting data on chilled, ready-to-cook poultry products. 
    The suggested specifications for such a protocol included: a statement 
    of purpose; the type of washing or chilling system; a description of 
    the chiller system process, components, equipment, modifications, and 
    steps in the chilling process; the number of chillers in a series and 
    arrangements of components; the number of evisceration lines feeding 
    into a chiller; any pre-chilling steps; anti-microbial treatments, if 
    any; the length and velocity of dripping lines; any special apparatus 
    or procedure for removing excess water from birds; and a description of 
    chilling system factors affecting water absorption and retention, such 
    as the time of the birds in the chiller, the water temperature, and the 
    amount of chill water agitation.
        To date, FSIS has received two comments on the notice. Three 
    livestock producer associations submitted a comment stating that they 
    were not in a position to provide information regarding protocols or 
    specifications for protocols to collect water retention data. They 
    maintained that the poultry industry would be supplying most, if not 
    all, the data needed to support any added-water limitations. They also 
    expressed the suspicion that data collected by the poultry industry 
    would reflect a ``push'' in the direction of maximum retention rather 
    than the true capability of technology and processing procedures to 
    minimize water retention.
        The other comment was submitted by a trade association representing 
    turkey and other poultry producers and processors. The association 
    listed two principles and attendant considerations that, in its view, 
    should be observed in developing protocols. The first principle was 
    food safety: Considerations in achieving safety were rapid chilling of 
    carcasses and the efficiency of immersion chilling. The second 
    principle was product wholesomeness and quality. Attendant 
    considerations were restricting water absorption to the amount 
    necessary to achieve food safety, calculating water absorption from the 
    point of entry of carcasses into
    
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    the chilling medium, and recognizing that it is a documented fact that 
    water absorption is unavoidable in all poultry species. Additional 
    considerations presented in the comment were that water absorption is 
    not a food safety issue, and that water loss occurs during further 
    processing of carcasses.
        FSIS has considered these comments and will be interested in 
    further discussion of water-data protocols in the context of this 
    proposal. Regarding the livestock producer associations' comment on 
    possible bias in data submitted by the poultry industry, FSIS notes 
    that any data submitted would have to have been collected under 
    scientifically designed protocols approved by the Agency. FSIS now 
    expects protocols it will approve to be composed of the elements listed 
    in Appendix A of this document. Further, any water retention in a 
    single-ingredient, raw meat or poultry product would have to be 
    reflected on the product label. The discipline of the marketplace as 
    well as FSIS regulatory oversight would help ensure the accuracy of 
    label statements.
        Under proposed Sec. 441.10(a), meat or poultry products would have 
    to bear a label statement of the maximum percentage of water absorbed 
    and retained as a result of post-evisceration processes. A qualifying 
    statement accompanying the product name could read, ``may contain up to 
    __ percent absorbed water.'' The percentage would reflect the maximum 
    percentage of water that may be retained in the product. Alternatively, 
    the label could bear an accurate statement of the percentage of 
    retained water in the product. Establishments having data or 
    information to demonstrate that their products do not contain retained 
    water would not have to label the products and could include a no-
    retained-water claim on the product label. The labels would be 
    generically approved pursuant to 9 CFR 317.5(b)(2) or 381.133(b)(2).
        This proposed requirement, which is responsive, in part, to the AMI 
    petition discussed above, would ensure that accurate information 
    concerning the product is conveyed to the consumer in accordance with 
    the anti-misbranding provisions of the FMIA and the PPIA (especially 21 
    U.S.C. 601(n)(1), (6); 453(h)(1), (6)). It would ensure that the 
    product labeling is not misleading with respect to water retention in 
    the product. The placement of the required information on the label 
    would ensure that the information would be likely to be read and 
    understood by the ordinary individual under customary conditions of 
    purchase and use.
        The information to be required would be analogous to the 
    information conveyed to consumers on the labels of ``ham--water added'' 
    or fruit beverages labeled to indicate the actual percentage of juice 
    in the product. As a result, consumers would be able to determine 
    before they buy packaged raw meat or poultry products whether or not 
    the value of products with retained water was commensurate with prices 
    of alternatives in the meat case. The market will provide significant 
    incentives to plants to adopt new cost-effective technologies for 
    reducing retained water. FSIS requests comment on the usefulness to 
    consumers of the proposed labeling requirement.
        The proposed requirements would affect only single-ingredient, raw, 
    whole, cut-up, or ground meat and poultry carcasses and parts, 
    including edible organs and other edible meat and poultry byproducts. 
    It would not affect raw products that now bear complete labeling or 
    nutrition labeling, such as pre-basted frozen turkeys, or further 
    processed products, such as deli meats. This proposal also would not 
    cover cooked and cured pork products, such as those currently subject 
    to protein-fat-free requirements (9 CFR 318.19(a)(5), 319.104-.105, 
    327.23).
        FSIS personnel would verify an establishment's control of water 
    retention by checking the establishment records or by conducting in-
    plant or in-distribution tests of products by methods that the Agency 
    would develop. FSIS would also conduct independent tests of the 
    establishment's absorbed-water control as part of investigations if a 
    problem were suspected or in the course of special studies.
    
    Proposed Changes in Poultry Chilling Regulations
    
        FSIS is proposing to amend the chilling requirements for poultry. 
    Various prescriptive requirements and specifications, such as the 
    minimum amount of fresh water intake by continuous chillers for each 
    poultry carcass, would be removed. Establishments would be given the 
    flexibility to take advantage of the latest technologies and 
    procedures.
        This proposal would amend 9 CFR 381.65, which concerns general 
    operating procedures, by removing provisions that are redundant, 
    excessively detailed, or inconsistent with the PR/HACCP final rule. The 
    proposal would eliminate current paragraph (b), the prohibition on 
    handling and storing materials that could cause adulteration of poultry 
    products in any room where poultry products are processed, handled, or 
    stored. This provision will be unnecessary when HACCP plans are 
    implemented because each HACCP plan will specify the measures to be 
    taken to protect poultry products from physical, chemical, or 
    biological contamination. The requirements in current paragraphs (a) 
    and (c) of 9 CFR 381.65 would be retained as paragraphs (a) and (b) 
    because they set out general principles of good sanitation and 
    commercial practice that all establishments must observe.
        The requirements in paragraphs (h) and (j) of 9 CFR 381.65, 
    relating to poultry thawing and dressing techniques, would be replaced 
    with two performance standards. The first would require simply that 
    establishments use thawing procedures that will prevent adulteration 
    of, or net weight gain by, the product. The second would require that 
    water used in thawing be permitted to drain freely from the carcass. 
    Proposed paragraph (c)(1), which would replace paragraph (h), would 
    require that frozen poultry be thawed for further processing in a 
    manner that will prevent product adulteration but would not require 
    that any specific thawing method be used.
        The current thawing regulation does not prevent practices that may 
    constitute hazards to food safety. For example, it does not prevent re-
    exposure of thawed, or partially thawed, product to a thawing medium 
    that may have become contaminated by previous use and that may be too 
    warm to prevent microbial growth. The current paragraph (h)(1)(i) 
    specifies a maximum permitted thawing medium temperature of 70  deg.F., 
    which is too high to prevent microbial growth in product that is re-
    exposed to or held in the medium. The regulation conflicts with HACCP 
    because establishments should assess thawing processes when conducting 
    their hazard analysis. Establishments must be given the responsibility 
    and flexibility to choose thawing measures that are effective and do 
    not create food safety hazards.
        Proposed paragraph (c)(2) would replace the current paragraph (j), 
    which specifies the manner in which carcass wash water is to be 
    drained, with a performance standard requiring simply that the wash 
    water be permitted to drain freely from the carcass.
        Current paragraph (d), which contains a requirement to remove 
    kidneys from mature chickens and turkeys, would be eliminated. The 
    kidneys of mature chickens and turkeys are a source of cadmium, which 
    can accumulate in the human liver and kidneys and cause acute or 
    chronic health problems.
    
    [[Page 48965]]
    
    Kidneys with excess cadmium are a ``food safety hazard reasonably 
    likely to occur'' that establishments will identify in their hazard 
    analyses and control through their HACCP systems. Thus, current 
    paragraph (d) is redundant with the HACCP regulations. The requirement 
    to remove kidneys is referenced in the definition of ``ready-to-cook 
    poultry'' at Sec. 381.1(b)(44). Therefore, the Agency is proposing to 
    amend that definition. Commenters on this proposal may wish to address 
    the need for regulatory food safety performance standards to control 
    heavy metal residues in organ meats, given the fact that establishments 
    will be operating HACCP systems.
        Current paragraph (i), which specifies how poultry carcasses are to 
    be cut open for evisceration, would be removed. The regulation is 
    outdated, prescriptive, and may be an obstacle to improved product 
    safety. The current regulation is intended to ensure that opening cuts 
    are made without cutting the intestinal tract and without contaminating 
    the carcass. Unnecessary cuts are prohibited because they may result in 
    carcass contamination during evisceration or excessive water absorption 
    during chilling. The regulation is also intended to maximize the 
    viewing of the interior and viscera of the carcass by the postmortem 
    inspector.
        In recent years, the poultry industry has developed new methods of 
    poultry evisceration that do not result in adulteration. For example, 
    ultrasound techniques are available for use as a diagnostic aid to 
    detect malformities or other defects before the carcasses are opened. 
    Also, equipment is available that can remove the viscera intact, using 
    vacuum suction, without breakage or spillage of intestinal contents, 
    and other available evisceration systems require that the carcass be 
    opened by a longitudinal cut. The current regulation generally limits 
    the opening cut to the area around the vent (cloaca) to prevent birds 
    from carrying excess water under the skin that could cause water-
    control test failures. The new technologies can potentially improve 
    efficiency and product wholesomeness but are not likely to be 
    implemented unless the regulation is amended. The Agency believes that 
    establishments should have the flexibility to innovate and to implement 
    promising new technologies, consistent with their HACCP plans.
        The requirement in current paragraph (k) to adequately drain ready-
    to-cook poultry after chilling to remove ice and water before packaging 
    would be retained and the paragraph would be redesignated as paragraph 
    (d).
        Current paragraphs (l) through (p) would be removed. These 
    paragraphs include requirements concerning the chilling of poultry 
    parts, the removal from establishments of offal resulting from 
    evisceration, the cleanliness of containers, the sturdiness of 
    packaging materials, and the use of protective coverings. These are all 
    matters to be addressed by establishments in their HACCP plans.
        Finally, current paragraph (q), concerning the harvesting of 
    detached ova for human food, would be redesignated as paragraph (e) and 
    would be slightly revised to eliminate a command-and-control 
    requirement that the ova be identified past the point of inspection. 
    The requirement that ova may leave the official establishment only for 
    shipment to an egg products processing plant would remain.
        In 9 CFR 381.66, paragraph (a) would be revised. This paragraph 
    requires that poultry be chilled or frozen in a manner that promptly 
    removes animal heat from the carcasses and does not adulterate the 
    product. The second sentence of the current paragraph, a command-and-
    control requirement to file a description of the chilling or freezing 
    procedures with the inspector in charge, would be removed.
        The general chilling requirements for poultry, paragraph (b), would 
    remain the same. FSIS regards the chilling of poultry to a safe 
    internal temperature within a minimum number of hours as a useful food-
    safety precaution. However, as mentioned above, the Agency intends to 
    undertake rulemaking on this matter. The table of maximum times and 
    temperatures in paragraph (b) is based on the duration of the lag phase 
    of bacterial growth on the surfaces of dressed, ready-to-cook poultry 
    carcasses under plant conditions. Although interested persons are 
    encouraged to submit data that would justify a change in this 
    provision, amending the paragraph is outside the scope of the present 
    rulemaking.
        The numerous detailed, prescriptive, command-and-control 
    requirements in paragraph (c) would be removed. For example, proposed 
    paragraph (c)(2)(i) does not specify chilling media temperatures and 
    the use of recording thermometers, as does the current paragraph 
    (c)(2)(i). Proposed paragraph (c)(1) would continue to require the use 
    of potable water, and proposed paragraph (c)(2)(i) would continue to 
    require sufficient water for a continuous overflow from chilling system 
    sections. However, specific requirements (paragraphs (c)(2)(ii)-(iii) 
    and (c)(2)(v)) concerning the operation of continuous chilling systems, 
    including the minimum amount of fresh water intake per bird, would be 
    removed.
        Current paragraph (c)(2)(iv) would be redesignated as (c)(2)(ii). 
    This paragraph, which concerns the chilling of major portions of 
    poultry carcasses, is the subject of a final rule (proposed at 62 FR 
    31017; June 6, 1997) that appears elsewhere in this issue of the 
    Federal Register.
        Current paragraph (c)(2)(vi), the highly detailed and prescriptive 
    requirements concerning water reconditioning systems for poultry 
    chillers, including the requirement for prior approval of such systems 
    by FSIS, would be removed. Establishments subject to the poultry 
    products inspection regulations are not using these systems because 
    none have proven feasible in commercial operations.
        The requirements in paragraphs (c)(4)(i) and (c)(4)(ii), concerning 
    the holding of poultry in chilling tanks, would be removed, and in 
    paragraph (c)(5), the highly specific requirements concerning the use 
    of continuous chillers to chill giblets would be removed. 
    Establishments will address the food safety hazards associated with 
    these procedures in their HACCP plans. However, the requirement to 
    chill giblets to less than 40  deg.F. in under 2 hours would remain.
        Paragraph (d) of section 381.66 would be completely revised. The 
    general requirement to minimize water absorption by raw poultry, and 
    the requirement to furnish equipment necessary for water tests, would 
    remain. The tables setting water absorption and retention limits for 
    the various kinds and weight classes of poultry would be eliminated, as 
    would the requirements for daily water testing by FSIS inspectors. The 
    requirement to notify FSIS of any adjustments in washing, chilling, and 
    draining methods would be also be removed.
        FSIS is proposing to remove current paragraph (d)(10), which 
    specifies how poultry may be ice-packed in barrels and requires FSIS 
    approval for the use of alternative types of containers. Establishments 
    will address any food safety hazards associated with containers in 
    their HACCP plans.
        The Agency is likewise proposing to remove paragraph (d)(11), which 
    requires establishments to prevent free water from being included in 
    giblet packages. Among other things, the current regulation requires 
    use of a specific type of giblet wrapping material and incorporates by 
    reference the testing standards that must be met in evaluating the 
    material. This kind of detailed specification is no longer necessary 
    under the Agency's new regulatory
    
    [[Page 48966]]
    
    approach. Also, establishments must comply with the regulations on net 
    quantity of contents and net weight (9 CFR 317.18-.19, 381.121-121b). 
    This proposal would give establishments greater responsibility and 
    flexibility in choosing appropriate giblet packaging materials. By 
    complying with the proposed retained-water limitation requirements 
    (discussed below) and by appropriately labeling product, establishments 
    would be ensuring that water absorption is controlled and that 
    consumers are informed.
        Finally, paragraph (e), on air chilling, and paragraph (f), 
    governing the freezing of poultry, would be retained substantially in 
    their present form. Paragraph (f)(6), concerning immersion or spray 
    freezing compounds and equipment, would be removed because it is a 
    prior-approval requirement inconsistent with the HACCP regulations and 
    is duplicative of other inspection regulations.
        The removal of the current poultry chilling regulations would 
    eliminate prescriptive, command-and-control procedures for determining 
    product compliance and would encourage processors to use the most 
    efficient and effective methods of controlling microorganisms.
    
    Executive Order 12866 and Regulatory Flexibility Act
    
        This proposed rule has been determined to be economically 
    significant and was reviewed by the Office of Management and Budget 
    under Executive Order 12866. The full text of the PRIA is published as 
    Appendix B of this document.
    
    Summary: Preliminary Regulatory Impact Analysis
    
        The proposed rule resulted from an analysis of six alternative 
    regulatory approaches for addressing retained water in raw meat and 
    poultry products. The six alternatives include: (1) no limit on 
    retained water but mandatory labeling that identifies the percentage of 
    retained water in the product; (2) a requirement that all 
    establishments meet a water limit based on best available technology, 
    with mandatory labeling to indicate any retained water; (3) a moisture 
    limit based on best performance with existing equipment, with mandatory 
    labeling to show any retained water; (4) a standard of zero retained 
    moisture; (5) a requirement that no retained water could be included in 
    net weight; and (6) a requirement of zero retained water unless the 
    water retention is unavoidable in processes necessary to meet food 
    safety requirements, e.g., to reduce pathogens, with product labeling 
    to indicate the presence of retained moisture, where applicable. For 
    all alternatives where a limit on retained water is established, the 
    analysis assumed that the limits would be established by the regulated 
    industry associations or other groups.
        FSIS chose the last alternative. The selected option would not 
    allow retained water in an affected product unless it is an inevitable 
    consequence of the process or processes used to meet applicable food-
    safety requirements. Levels of unavoidable retained water would be 
    established by inspected establishments, associations, or other groups, 
    using acceptable protocols. Also, the maximum amount of retained water 
    that could be present would have to be indicated on the product label. 
    FSIS found that this option provides more benefits and fewer costs than 
    other options allowing retained water. By ``inevitable consequence'' 
    the Agency means an unavoidable and irreducible side effect. A food-
    safety requirement could be a regulatory prescription, such as the 
    temperature to which a product must be chilled and held. It could also 
    be a preventive measure taken at a CCP or a critical limit in the 
    establishment's HACCP plan. Given a food-safety requirement, an 
    establishment must choose a method for satisfying the requirement.
        FSIS understands that the choice of method is based on a judgment 
    of technical and economic feasibility. FSIS understands that product 
    quality and product acceptability to the consumer are also important 
    factors. The Agency requests comment on these matters.
        The method selected for meeting food safety requirements could have 
    side effects that cannot be eliminated. A side effect of an 
    antimicrobial treatment of carcasses or a carcass chilling method could 
    be an increase in the water content of carcasses and parts. FSIS is 
    proposing to require that the amount of water that might be retained in 
    carcasses and parts as a result of using such an antimicrobial or 
    chilling method be an unavoidable and irreducible side effect of using 
    that method.
        To be applicable to the raw products of an inspected establishment, 
    a non-zero retained-water limit would have to be based on supporting 
    data collected in accordance with an FSIS-approved protocol. The 
    proposal would allow a protocol to be developed and data-generating 
    studies following the protocol to be carried out by an individual 
    establishment, an industry trade association, or other group using the 
    same or similar processing techniques and equipment. Depending on the 
    design of the protocol, the data gathered could justify water-retention 
    limits for a single establishment, a group of establishments with 
    similar equipment processing similar classes of raw product, or all 
    such establishments in an industry. To establish a non-zero retained 
    water limit, an inspected establishment, industry trade association, or 
    other group would have to generate the necessary supporting data. The 
    labels of products would have to indicate the presence of retained 
    water in the products.
        This requirement would not appear to have a significant impact on 
    the meat industry because the meat industry is already achieving zero-
    percent retained water. This proposal would, however, provide an 
    alternative for establishments that are having or will have trouble 
    meeting the Salmonella performance standards. These establishments 
    could use a full range of antimicrobial rinses or hot-water rinses 
    without having to worry about meeting zero-percent retained water. If 
    they can demonstrate that they need a non-zero limit to meet the 
    Salmonella standards, they can use the flexibility provided by the 
    proposed rule and establish a new water limit as long as they state the 
    maximum percentage of water absorbed and retained on product labels.
        Immersion chilling is the process used by most poultry 
    establishments to meet the existing chilling requirements for poultry, 
    e.g., 9 CFR 381.66(b)(2) requires that poultry carcasses under 4 pounds 
    shall be chilled to 40  deg.F within 4 hours following evisceration. It 
    follows that, for most poultry establishments, the inevitable retained 
    water amount is the ``minimum'' level that can be reached with existing 
    immersion chiller equipment while still meeting the chilling 
    requirement. FSIS recognizes that this ``minimum'' must be established 
    within practical limits for operating parameters such as drip time and 
    chiller water temperature. The Agency believes that the industry 
    already has information concerning the chiller variable settings that 
    minimize water retention. FSIS, therefore, believes the poultry 
    industry can establish water retention limits for various chiller 
    systems with minimal costs. FSIS also recognizes that some poultry 
    establishments may require higher levels of retained water to meet the 
    Salmonella standards than they do to meet the existing chilling 
    requirements.
        The proposal does not provide specific guidance on options 
    available for poultry processors that are already operating far below 
    the existing standards for Salmonella, such as by permitting higher 
    retained water levels
    
    [[Page 48967]]
    
    if data showed further pathogen reductions would be achieved.
        The analysis estimates a range of costs the industry will incur to 
    meet this new regulatory requirement. If establishments are able to 
    demonstrate that current levels of retained water are necessary to 
    achieve applicable food safety standards, establishments would not 
    incur costs for reducing retained water. These establishments would 
    only incur costs for establishing limits and costs for labeling the 
    product. The costs of establishing limits for the poultry industry are 
    estimated to be $1.5 million. This estimate is based on each 
    establishment's conducting its own tests. The cost should be lower if 
    associations or other groups establish limits for different types of 
    chiller systems. Labeling costs are estimated to be $18.4 million if 
    all raw, single-ingredient poultry continues to retain water.
        To the extent that establishments cannot demonstrate that current 
    retained water levels are necessary for achieving applicable food 
    safety standards, significant costs could be incurred as establishments 
    modify processes to minimize retained water levels. Reducing retained 
    water could entail a wide range of processing modifications, depending 
    on the type of chilling equipment currently used and amount of retained 
    water that would have to be removed. The PRIA estimates that the cost 
    of removing a substantial portion of the existing retained water could 
    easily approach $100 million. The PRIA estimates that the average 
    retained water for chicken as a percentage of net weight is currently 
    in the 5.0 to 6.5 percent range. The corresponding level for turkey is 
    4.0 to 4.5 percent.
        The proposed rule should not have a significant impact on a large 
    number of small businesses. Almost half of all federally inspected 
    poultry slaughter establishments are large, based on the Small Business 
    Administration criterion of more than 500 employees. There are from 50 
    to 60 establishments that process under a million birds annually. Many 
    of these smaller operations do not use continuous immersion chillers. 
    They use ice or slush to meet the existing chilling requirements. Few, 
    if any, would have to reduce the current level of retained water. The 
    establishments most affected by this proposal are the firms operating 
    immersion chillers in a manner so as to target the maximum allowable 
    retained water.
        Because of the Court's decision, FSIS needs to develop new 
    regulatory requirements to carry out its responsibilities for 
    protecting the public from economic adulteration. Preventing economic 
    adulteration provides a consumer benefit. Consumers would also benefit 
    from the additional information that would be provided by the labeling 
    requirement. The information on retained water should lead to more 
    informed purchasing decisions. The proposal would also provide all 
    affected establishments with the flexibility and market incentives to 
    implement new procedures for meeting pathogen reduction performance 
    standards. In addition, by replacing command-and-control requirements 
    with HACCP-consistent performance standards, the proposal would 
    eliminate some recordkeeping and reporting burdens, provide for 
    increased flexibility and reduce the costs of HACCP implementation.
    
    Executive Order 12988
    
        This proposed rule has been reviewed under Executive Order 12988, 
    Civil Justice Reform. States and local jurisdictions are preempted by 
    the Federal Meat Inspection Act (FMIA) and the Poultry Products 
    Inspection Act (PPIA) from imposing any marking or packaging 
    requirements on federally inspected meat or poultry products that are 
    in addition to, or different than, those imposed under the FMIA and 
    PPIA. States and local jurisdictions may, however, exercise concurrent 
    jurisdiction over meat and poultry products that are outside official 
    establishments for the purpose of preventing the distribution of meat 
    or poultry products that are misbranded or adulterated under the FMIA 
    or PPIA, or, in the case of imported articles, which are not at such an 
    establishment, after their entry into the United States.
        This proposed rule is not intended to have retroactive effect.
        There are no applicable administrative procedures that must be 
    exhausted prior to any judicial challenge to the provisions of this 
    proposed rule. However, the administrative procedures specified in 9 
    CFR 381.35 must be exhausted prior to any judicial challenge of the 
    application of the provisions of this proposed rule, if the challenge 
    involves any decision of an FSIS employee relating to inspection 
    services provided under the FMIA or PPIA.
    
    Executive Order 12898
    
        Pursuant to Executive Order 12898 (59 FR 7629; February 16, 1994), 
    ``Federal Actions to Address Environmental Justice in Minority and Low-
    Income Populations,'' FSIS has considered potential impacts of this 
    proposed rule on environmental and health conditions in low-income and 
    minority communities.
        This proposed rule would provide new, uniform regulations limiting 
    the amount of water retained by raw, single-ingredient, meat and 
    poultry products as a result of post-evisceration processing, such as 
    carcass chilling, considered necessary to minimize pathogen growth on 
    the products. As explained in the economic impact analysis above, the 
    proposed regulations should generally benefit consumers of meat and 
    poultry products. The proposed regulations would not require or compel 
    meat or poultry establishments to relocate or alter their operations in 
    ways that could adversely affect the public health or environment in 
    low-income and minority communities. Further, this proposed rule would 
    not exclude any persons or populations from participation in FSIS 
    programs, deny any persons or populations the benefits of FSIS 
    programs, or subject any persons or populations to discrimination 
    because of their race, color, or national origin.
    
    Paperwork Requirements
    
        Title: Retained Water in Raw Meat and Poultry Products; Poultry 
    Chilling Performance Standards.
        Type of Collection: Labels and labeling records; data or 
    information supporting labeling statements.
        Abstract: Changes to product labels would be generically approved. 
    The paperwork and recordkeeping associated with such label approval is 
    approved under OMB control number 0583-0092. Slaughtering 
    establishments would have to have data to support percent-absorbed-
    water statements on product labels and to demonstrate that the amount 
    of absorbed water in the product is unavoidable under the 
    establishments' HACCP plans. The data would have to have been collected 
    under FSIS-approved protocols.
        This proposed rule would require an estimated 210,000 hours to 
    develop the data to support retained water levels above zero. All 300 
    federally inspected poultry establishments would need to conduct 
    studies to establish minimum retained water levels. The PRIA assumed 
    that the average establishment would conduct studies for two product 
    categories. The PRIA assumed that a reasonable study would examine 10 
    alternative chiller settings with four 50-bird water tests conducted 
    for each setting. Each test would require 2.5 hours. Thus, it would 
    take an estimated 200 hours for each of 300 poultry establishments, or 
    more than 30,000 hours.
    
    [[Page 48968]]
    
        The PRIA assumes that at most 500 meat establishments need to 
    develop non-zero water levels to meet the existing pathogen-reduction 
    performance standards. With larger carcasses, the recording time is 
    doubled to 200 hours per establishment. These 500 meat establishments 
    would also require 100 hours to collect microbial samples. Thus, the 
    information collection would be 300 hours for each of 500 
    establishments, or 150,000 hours.
        All 800 establishments with non-zero levels would also have to 
    develop new, generically approved labels.
        Estimate of Burden: Protocols for determining minimum feasible 
    water retention in product classes (3,000 hours); data supporting 
    absorbed-water label statements or the lack thereof (210,000 hours).
        Respondents: Meat and poultry product establishments or trade 
    associations.
        Estimated Number of Respondents: 800.
        Estimated Number of Responses per Respondent: 1.
        Estimated Total Annual Burden on Respondents: 213,000 hours.
        Copies of this information collection assessment can be obtained 
    from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection 
    Service, USDA, Cotton Annex Building, Room 107, Washington, DC 20250.
        Comments are invited on: (a) whether the proposed collection of 
    information is necessary for the proper performance of the functions of 
    the Agency, including whether the information will have practical 
    utility; (b) the accuracy of the Agency's estimate of the burden of the 
    proposed collection of information including the validity of the 
    methodology and assumptions used; (c) ways to enhance the quality, 
    utility, and clarity of the information to be collected; and (d) ways 
    to minimize the burden of the collection of information on those who 
    are to respond, including the use of appropriate automated, electronic, 
    mechanical, or other technological collection techniques or other forms 
    of information technology. Comments may be sent to Lee Puricelli, 
    Paperwork Specialist, see address above, and Desk Officer for 
    Agriculture, Office of Information and Regulatory Affairs, Office of 
    Management and Budget, Washington, DC 20253.
        Comments are requested by December 10, 1998. To be most effective, 
    comments should be sent to OMB within 30 days of the publication date 
    of this proposed rule.
    
    List of Subjects
    
    9 CFR Part 381
    
        Food labeling, Poultry and poultry products.
    
    9 CFR Part 441
    
        Consumer protection, Meat and meat products, Poultry and poultry 
    products.
    
        For the reasons discussed in the preamble, FSIS is proposing to 
    amend 9 CFR Chapter III, as follows:
    
    PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
    
        1. The authority citation for part 381 would continue to read as 
    follows:
    
        Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR 
    2.18, 2.53.
    
        2. Paragraph (b)(44) of Sec. 381.1 would be revised to read as 
    follows:
    
    
    Sec. 381.1  Definitions.
    
    * * * * *
        (b) * * *
        (44) Ready-to-cook poultry. ``Ready-to-cook poultry'' means any 
    slaughtered poultry free from protruding pinfeathers, vestigial 
    feathers (hair or down), and from which the head, feet, crop, oil 
    gland, trachea, esophagus, feet, crop, oil gland, reproductive organs, 
    and lungs have been removed, and mature poultry from which the kidneys 
    have been removed, and with or without the giblets, and which is 
    suitable for cooking without need of further processing. Ready-to-cook 
    poultry also means any cut-up or disjointed portion of poultry or other 
    parts of poultry, such as reproductive organs, head, or feet that are 
    suitable for cooking without need of further processing.
    * * * * *
        3. Section 381.65 would be revised to read as follows:
    
    
    Sec. 381.65  Operations and procedures, generally.
    
        (a) Operations and procedures involving the processing, other 
    handling, or storing of any poultry product shall be strictly in accord 
    with clean and sanitary practices and shall be conducted in such a 
    manner that will result in sanitary processing, proper inspection, and 
    the production of poultry and poultry products that are not 
    adulterated.
        (b) Poultry shall be slaughtered in accordance with good commercial 
    practices in a manner that will result in thorough bleeding of the 
    carcasses and assure that breathing has stopped prior to scalding. 
    Blood from the killing operation shall be confined to a relatively 
    small area.
        (c)(1) When thawing frozen ready-to-cook poultry in water, the 
    establishment shall use methods that prevent adulteration of, or net 
    weight gain by, the poultry.
        (2) The water used in washing the poultry shall be permitted to 
    drain freely from the body cavity.
        (d) Ready-to-cook poultry shall be adequately drained after 
    chilling, to remove ice and water before the poultry is packaged or 
    packed for shipping.
        (e)(1) Detached ova may be collected for human food in the official 
    establishment provided the collection is sanitary. Ova from condemned 
    carcasses shall be condemned and treated as required in Sec. 381.95. 
    Ova for human food must be cooled, packaged, and handled so as to be 
    fit for human food.
        (2) Detached ova harvested for human food may leave the official 
    establishment only for movement to an egg products processing plant for 
    processing as allowed in Sec. 59.440 of the regulations (7 CFR 59.440) 
    under the Egg Products Inspection Act, and when moved from the official 
    establishment shall bear labeling which indicates that the ova were 
    harvested under sanitary supervision of the Inspection Service.
        4. Section 381.66 would be amended by revising paragraphs (a), (c), 
    and (d) and removing paragraph (f)(6), to read as follows:
    
    
    Sec. 381.66  Temperatures and chilling and freezing procedures.
    
        (a) General. Temperatures and procedures which are necessary for 
    chilling and freezing ready-to-cook poultry, including all edible 
    portions thereof, shall be in accordance with operating procedures 
    which ensure the prompt removal of the animal heat and will preserve 
    the condition and wholesomeness of the poultry and assure that the 
    products are not adulterated.
        (b) * * *
        (c) Ice and water chilling. (1) Only ice produced from potable 
    water may be used for ice and water chilling. The ice shall be handled 
    and stored in a sanitary manner.
        (2)(i) Chillers must contain sufficient water or ice, or both, to 
    keep the chilling media clean and provide a continuous overflow from 
    each section of the chilling system. If there is no loss of water 
    between sections, multiple section chilling systems may be connected so 
    the overflow from subsequent sections serves as water intake for the 
    first section.
        (ii) Partial trimming and salvage of parts of poultry carcasses 
    often result in parts of major size, either front or rear portions, 
    wherein the major portion of
    
    [[Page 48969]]
    
    the poultry carcass remains intact. These portions may be chilled in 
    water and ice, including chilling in continuous chillers. Individual 
    parts from salvage operations, including but not limited to drumsticks, 
    thighs, split carcasses, and split breasts, shall not be cooled in 
    water and ice but may be cooled in the air, or ice, or under a spray of 
    water with continuous drainage.
        (3) Previously chilled poultry carcasses and major portions shall 
    be maintained constantly at 40  deg.F. or below until removed from the 
    vats or tanks prior to being cooled to 40  deg.F. or below, for 
    freezing or cooling in the official establishment. Such products shall 
    not be packed until after they have been chilled to 40  deg.F. or 
    below, except when the packaging will be followed immediately by 
    freezing at the official establishment.
        (4) Giblets shall be chilled to 40  deg.F. or below within 2 hours 
    from the time they are removed from the inedible viscera, except that 
    when they are cooled with the carcass, the requirements of paragraph 
    (b)(2) of this section shall apply. Any of the acceptable methods of 
    chilling the poultry carcass may be followed in cooling giblets.
        (d) Water absorption and retention. (1) Poultry washing, chilling, 
    and draining practices and procedures shall be such as will minimize 
    water absorption and retention at time of packaging.
        (2) The establishment shall provide scales, weights, identification 
    devices, and other supplies necessary to conduct water tests.
    * * * * *
        5. A new Part 441 would be added to subchapter E to read as 
    follows:
    
    PART 441--CONSUMER PROTECTION STANDARDS: RAW PRODUCTS
    
        Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-470, 601-695; 
    7 CFR 2.18, 2.53.
    
    
    Sec. 441.10  Retained water.
    
        Raw meat and poultry carcasses and parts shall not contain water 
    resulting from post-evisceration processing unless the establishment 
    preparing them demonstrates to the Administrator, with data collected 
    in accordance with an FSIS-approved protocol, that any water retained 
    is an inevitable consequence of the process used to meet applicable 
    food safety requirements. Raw meat and poultry carcasses and parts that 
    retain water must bear a statement on the label in prominent letters 
    and contiguous to the product name indicating the maximum percentage of 
    water that may be retained. Raw meat and poultry carcasses and parts 
    that retain no water may bear a statement indicating that no water is 
    retained.
    
        Done at Washington, DC on September 3, 1998.
    Thomas J. Billy,
    Administrator.
    
    Appendix A--Expected Elements of a Protocol for Gathering Water 
    Retention Data
    
        Purpose statement. The primary purpose of the protocol should be 
    to determine the amount or percentage of water absorption and 
    retention that is inevitable using a particular chilling system 
    while achieving the regulatory pathogen reduction performance 
    standard for Salmonella as set forth in the PR/HACCP regulations (9 
    CFR 310.25(b), 381.94(b)) and the time/temperature requirements set 
    forth in 9 CFR 381.66. Additional purposes that could be included 
    are determining chilling system efficiency and evaluating product 
    quality.
        Type of washing and chilling system used by the establishment. 
    Any post-evisceration washing or chilling processes that affect 
    water retention levels in and microbial loads on raw product should 
    be described. For poultry establishments, the main chiller types, 
    identified by the mechanism used to transport the birds through the 
    chiller or to agitate the water in the chiller, are the drag-
    through, the screw type, and the rocker-arm type.
        Configuration and any modifications of the chiller system 
    components. A description of chiller-system configurations and 
    modifications should be provided. The description should include the 
    number and type of chillers in a series and arrangements of chilling 
    system components, and the number of evisceration lines feeding into 
    a chiller system. If there is a pre-chilling step in the process, 
    its purpose and the type of equipment used should be accurately 
    described. Any mechanical or design changes made to the chilling 
    equipment should be described.
        Special features in the chilling process. Any special features 
    in the chilling process, such as antimicrobial treatments, should be 
    described. Also, the length and velocity of the dripping line should 
    be described, as well as the total time allowed for dripping. Any 
    special apparatus, such as a mechanism for squeezing excessive water 
    from chilled birds, should be explained.
        Description of variable factors in the chilling system. The 
    protocol should describe variable factors that affect water 
    absorption and retention. In poultry processing, such factors are 
    typically considered to be the time in chiller water, the water 
    temperature, and agitation. The protocol should consider air 
    agitation, where applicable.
        Additional factors that may affect water-absorption and 
    retention are scalding temperature and the pressure or amount of 
    buffeting applied to birds by feather removal machinery, and the 
    resultant loosening of the skin. Another factor that should be 
    considered is the method used to open the bird for evisceration.
        Standards to be met by the chilling system. For example, the 
    chilling system may be designed simply to achieve a reduction in 
    temperature of ready-to-cook poultry to less than 40  deg.F. within 
    the time limit specified by the regulations, or in less time. As to 
    the standard for pathogen minimization, the Salmonella pathogen 
    reduction standards, as set forth in the PR/HACCP final rule, have 
    been suggested. Although there is not yet an applicable Salmonella 
    standard for turkeys, commenters are free to suggest a practicable 
    standard for use in gathering data on turkeys under the protocols 
    here suggested. Additional microbiological targets, such as E. coli 
    or Campylobacter levels, or reductions in numbers of other 
    microorganisms, may also be used.
        Testing methods to be employed. The protocol should detail the 
    testing methods to be used both for measuring water absorption and 
    retention and for sampling and testing product for pathogen 
    reductions. The protocol should call for water retention and 
    pathogen reduction tests at various chilling equipment settings and 
    chilling time-and-temperature combinations. The method to be used in 
    calculating water absorption and retention should be reproducible 
    and statistically verifiable.
        With respect to the pathogen-reduction aspect of the testing, 
    FSIS recommends the methods used for E. coli and Salmonella testing 
    under the PR/HACCP regulations. The number of samples, the type of 
    samples, the sampling time period, and the type of testing or 
    measurement should be included in the protocol.
        Reporting of data evaluation of results. The protocol should 
    explain how data obtained are to be reported and summarized. The 
    criteria for evaluating the results and the basis for conclusions to 
    be drawn should be explained.
        Conclusions. The protocol should provide for a statement of what 
    the data obtained demonstrate and what conclusions were reached.
    
    Appendix B--Preliminary Regulatory Impact Analysis--Retained Water 
    in Meat and Poultry Products
    
    August 1998--U.S. Department of Agriculture, Food Safety and Inspection 
    Service
    
    Table of Contents
    
    Executive Summary
    I. Introduction
    II. Need for Regulatory Action
    III. Background
    IV. Description of Proposed Rule
    V. Analysis of Existing Data on Retained Water
    VI. Retained Water in Net Weight
    VII. Economic Analysis of Retained Water in Meat and Poultry
    VIII. Options Identified
    IX. Analysis of Options
    X. Cost of Proposed Rule
    XI. Benefits of Proposed Rule
    XII. Effect on Product Quality
    XIII. Aggregate Market Effects
    
    Executive Summary
    
        This analysis was conducted to meet the requirements of 
    Executive Order 12866 and
    
    [[Page 48970]]
    
    the Regulatory Flexibility Act. The proposed rule has been 
    designated economically significant because there is a potential 
    impact of $100 million or more. This Preliminary Regulatory Impact 
    Analysis (PRIA) shows that the rule could lead to a substantial 
    reduction in the amount of retained water in poultry which could 
    have a significant economic impact on the poultry industry. Under 
    the proposed rule, raw, single-ingredient meat and poultry products 
    would not be permitted to contain water resulting from post-
    evisceration processing unless the establishment demonstrates that 
    water retention is an inevitable consequence of the process or 
    processes used to meet applicable food safety requirements. There 
    are three types of costs associated with this proposed rule. There 
    are costs for conducting the tests necessary to establish retained 
    water levels. There are also costs associated with reducing retained 
    water to such levels. Finally, there are costs for revising product 
    labels to indicate the presence of retained water. Product labels 
    would indicate the percentage of net weight represented by retained 
    water. This information could be used by consumers in making product 
    choices. The market could provide incentives to firms to invest in 
    new technologies that would reduce retained water.
        Most of the cost of this proposed rule would be experienced by 
    the poultry industry. Most, if not all, raw poultry products now 
    contain retained water whereas only a few meat byproducts or organ 
    meats may now contain retained water. Most costs experienced by the 
    meat industry would be associated with voluntary decisions to use 
    new or different processes to meet food safety requirements that 
    would result in some level of unavoidable retained water.
        This analysis estimates a range of costs the poultry industry 
    would incur to meet this new regulatory requirement. If 
    establishments are able to demonstrate that current levels of 
    retained water levels are an inevitable consequence of the processes 
    used to meet applicable food safety standards, establishments would 
    not incur costs for reducing retained water. These establishments 
    would incur costs for justifying existing retained water levels and 
    costs for revising product labels. The costs of establishing limits 
    for the poultry industry are estimated to be $1.5 million. Label 
    revision costs are estimated to be $18.4 million if all raw, single-
    ingredient poultry continues to contain retained water.
        To the extent that poultry establishments cannot demonstrate 
    that current retained water levels are necessary for achieving 
    applicable food safety standards, significant costs could be 
    incurred as establishments modify processes to reduce retained water 
    levels. Reducing retained water could entail a wide range of 
    processing modifications, depending on the type of chilling 
    equipment currently used and the amount of retained water that would 
    have to be removed. The analysis estimates that the average retained 
    water for chicken as a percentage of net weight is probably in the 
    5.0 to 6.5 percent range. The average retained water for turkey as a 
    percentage of net weight is probably in the 4.0 to 4.5 percent 
    range.
        If this proposed rule would require removing a substantial 
    portion of the existing retained water, then the costs to the 
    poultry industry could exceed $100 million. FSIS' retained water 
    tests on whole broilers show that retained water varies considerably 
    from establishment to establishment. For 13 establishments operating 
    under the 8 percent regulatory limit for whole broilers, the average 
    retained water at the end of the drip line ranged from 4.72 to 7.32 
    percent. FSIS believes that the establishments operating at the 
    higher end of this spectrum are targeting the regulatory limit and 
    establishments operating at the lower end of this spectrum are, most 
    likely, operating at or near the minimum necessary to meet existing 
    chilling requirements which are food safety standards. For this 
    reason, FSIS does not expect to see costs approaching the $100 
    million level. However, FSIS also recognizes that the retained water 
    levels at the lower end of the spectrum could be tied to purchase 
    specifications or other factors and may not be true minimum levels. 
    Therefore, this analysis has estimated the cost of removing a 
    substantial portion of the current levels of retained water from all 
    poultry establishments.
        This PRIA estimates that using additional drain time to reduce 
    retained water in poultry by 4 to 5 percentage points in all 
    establishments could cost up to $94 million in one-time fixed costs. 
    Annual recurring costs are estimated at $10 million. These cost 
    estimates are based on situations where inspected establishments 
    were required to drain retained water that exceeded regulatory 
    limits. FSIS program personnel do not believe it is feasible to 
    eliminate all retained water from immersion-chilled poultry. Thus, 
    if establishments must eliminate a substantial portion of retained 
    water, they would incur the costs of minimizing the water plus the 
    costs of establishing the minimum or minimums and labeling costs. 
    The costs of the proposed rule, however, are highly dependent on the 
    level of retained water that is necessary to meet existing food 
    safety requirements. That level will remain unknown until 
    established by well-designed studies. However, as discussed above, 
    FSIS predicts that only those poultry establishments operating at 
    the higher end of the retained water spectrum would have to 
    substantially reduce their retained water levels. This prediction is 
    based on data showing that establishments can control retained water 
    and data showing that some are controlling retained water so as to 
    be at or near the applicable regulatory limit.
        This proposal fills a regulatory void created by the U.S. 
    District Court decision to set aside the water retention limits for 
    whole birds. The regulatory limits that the Court set aside were not 
    based on adequate analytical support. Regulatory limits are 
    necessary to protect the public from economic adulteration. 
    Preventing economic adulteration provides a consumer benefit. 
    Consumers would also benefit from the additional information that 
    would be provided by the labeling requirement. The information on 
    retained water should lead to more informed purchasing decisions.
        The proposal would also provide affected establishments with the 
    flexibility they need to choose the most appropriate means for 
    implementing HACCP plans for assuring the safety of raw product. For 
    example, under the proposed rule, both meat and poultry carcasses 
    would be allowed to retain absorbed water if data showed that such 
    water was unavoidable in order to assure compliance with the 
    pathogen reduction performance standards for Salmonella. In 
    addition, by replacing certain existing command-and-control 
    requirements with HACCP-consistent performance standards, the 
    proposal would allow increased flexibility which should reduce the 
    costs for HACCP implementation. This analysis does not attempt to 
    quantify the benefits of the increased flexibility that results from 
    eliminating command-and-control requirements. The proposal would 
    also remove certain recordkeeping and reporting requirements.
        In terms of aggregate market effects, the analysis concludes 
    that, when compared to the present situation, the proposed rule 
    could result in higher prices for both poultry and meat, with less 
    poultry consumed and more meat consumed. However, when estimated 
    costs are compared with aggregate consumer expenditures, the 
    analysis shows that costs are very small compared with current 
    expenditures. Maximum first year cost estimates for the poultry 
    industry represent 0.36 percent of aggregate consumer expenditures 
    on poultry. Recurring costs to the poultry industry represent only 
    0.03 percent of consumer expenditures and 0.04 cents per pound.
    
    I. Introduction
    
        FSIS is proposing regulations limiting the amount of retained 
    water raw meat and poultry products may contain. The proposed 
    rulemaking would, among other things, amend the meat and poultry 
    inspection regulations governing water retained by carcasses and 
    parts of carcasses as a result of post-evisceration washing and 
    chilling necessary to ensure product safety and wholesomeness. The 
    amended regulations would apply the same retained-water standard to 
    both red meat and poultry. Meat and poultry carcasses and parts 
    would not be permitted to contain water resulting from post-
    evisceration processing unless the establishment demonstrates that 
    water retention is an unavoidable consequence of the processing used 
    to meet existing food safety requirements. Under the proposal, raw 
    meat and poultry products that retain water would have to be labeled 
    indicating the maximum amount of retained water that may be present 
    as a percentage of product weight.
        In addition to revising the regulations controlling retained 
    water, FSIS is also proposing to revise the poultry regulations 
    covering thawing procedures, water use and reconditioning, and 
    certain other operating procedures. These other regulations are 
    being revised to improve consistency with the Pathogen Reduction/
    Hazard Analysis and Critical Control Points (PR/HACCP) regulations, 
    eliminate ``command-and-control'' features, and reflect current 
    technological capabilities and good manufacturing practices. By 
    replacing command-and-control requirements with
    
    [[Page 48971]]
    
    HACCP-consistent performance standards, the proposal would allow 
    increased flexibility and should reduce costs for HACCP 
    implementation. Removing some command-and-control regulations would 
    also eliminate some existing recordkeeping and reporting burdens. 
    This analysis does not attempt to quantify the benefits of the 
    increased flexibility that results from eliminating command-and-
    control requirements.
    
    II. Need for Regulatory Action
    
    Respond to Court Decision
    
        The regulations controlling retained water in poultry carcasses 
    have consisted of three major components: (1) a performance standard 
    requiring washing, chilling, and draining practices that will 
    minimize water absorption and retention at time of packaging, (2) 
    limits for maximum retained water in birds that will be packaged as 
    whole carcasses, and (3) limits for maximum retained water in birds 
    that will be ice-packed or cut up prior to packaging. The 
    performance standard is interpreted as minimizing the water that is 
    absorbed and subsequently retained, i.e., it is not interpreted as 
    requiring minimization of both water absorption and water retention. 
    In implementing the standard, FSIS concludes that the performance 
    standard is met when retained water is under the maximum limits.
        Until the Court case referred to below, the maximum retained 
    water for most whole chickens (those 4.25 pounds or under) was 8 
    percent. The maximum retained water for chicken that will be ice-
    packed or subsequently cut up into parts is 12 percent. The 12 
    percent limit is based on the premise that chicken parts from whole 
    birds with water levels between 8 and 12 percent will reach the 8 
    percent level by the time the parts are packaged. The analogous 
    limits for turkey are similar but include unique limits for 12 
    different carcass weight categories. The maximum retained water 
    limits for whole turkey range from 4.3 to 8.0 percent depending on 
    weight. The corresponding limits for cut-up turkey range from 5.3 to 
    9.0 percent. The maximum retained water for whole ducks, geese and 
    guineas was 6 percent, the same limit that applied to chickens over 
    4.25 pounds.
        The U.S. District Court, in the matter of Kenney v. Glickman, 
    set aside the water retention limits for whole birds. The Court 
    found that the analytical support for the existing limits was 
    insufficient. Thus, there are currently no regulatory criteria to 
    determine whether retained water has been minimized in chilled or 
    frozen whole birds. FSIS is mandated to prevent the distribution in 
    commerce of meat or poultry products that are adulterated or 
    misbranded. Under the meat and poultry statutes, a product is 
    adulterated if, among other circumstances, a substance has been 
    added to or mixed with the product to increase its bulk or weight or 
    make it appear of greater value than it is. Thus, if water has not 
    been minimized, the product may be considered adulterated. Such 
    product may also be considered misbranded. Without limits on 
    retained water, FSIS cannot adequately protect consumers from 
    adulteration and misbranding due to excessive retained water in 
    whole birds.
    
    Eliminate Inconsistency
    
        In addition to the situation created by the July 1997 Court 
    decision, FSIS sees additional need for regulatory action. With 
    respect to the regulation of retained water, there are differences 
    or inconsistencies both between the livestock and poultry industries 
    and within the existing regulatory framework for poultry. FSIS 
    allows poultry to retain water absorbed during processing as an 
    unavoidable result of traditional chilling practices. There is no 
    comparable allowance for meat. The regulatory definitions for 
    economic adulteration ``by substances added so as to increase bulk 
    or weight or make a product appear better or of greater value than 
    it is'' are identical for meat and poultry. Although the Secretary 
    of Agriculture has the authority to apply the adulteration 
    provisions differently, FSIS believes there can be more consistency 
    between the livestock and poultry industries in how the adulteration 
    provisions are applied to retained water in raw products. The 
    traditional differences in chilling practices have led to a 
    situation where the weight of a meat carcass usually decreases 
    during chilling while the weight of a poultry carcass increases.
        The Department promulgated regulations limiting water absorption 
    in poultry in 1959, 1961, and 1970 (December 1, 1959, 24 FR 9566; 
    July 19, 1961, 26 FR 6471; October 7, 1970, 35 FR 739). The existing 
    regulations contain a standard of performance that calls for 
    minimization and maximum retained water limits for poultry carcasses 
    based on carcass weight and intended use. Under the existing 
    regulatory enforcement framework, a poultry establishment is 
    ``minimizing'' retained water when it is operating within the 
    existing limits. FSIS is aware that not all establishments are 
    really minimizing retained water. Data analyzed for this PRIA show 
    that some poultry establishments have been controlling their 
    processes to retain the maximum allowed water. While this is 
    considered acceptable in the sense that product is not adulterated, 
    it is not consistent with a regulatory intent to minimize. However, 
    it may be consistent with food safety objectives to reduce 
    pathogens.
        The existence of the 12 percent limit for cut-up chicken is in 
    itself inconsistent with the concept of minimization. Many 
    establishments pack both whole and cut-up chicken. In meeting the 8 
    percent limit for whole birds, they demonstrate that their minimum 
    is below 8 percent. The 12 percent limit serves as an opportunity to 
    maintain water levels in cut-up poultry. The 12 percent limit is 
    also available as default when the 8 percent limit is not achieved. 
    An establishment can divert birds to cut-up operations when they 
    fail the whole bird limit.
    
    III. Background
    
        There are no existing meat regulations that address retained 
    water in raw meat products. Without any regulatory limits, FSIS has 
    enforced the adulteration provision of the FMIA to mean that any 
    level of retained water is adulteration. FSIS has allowed cold water 
    spray chilling systems as a supplement to air chilling of beef and 
    hog carcasses under the conditions outlined in FSIS Directive 
    6330.1. That document requires that establishments develop quality 
    control systems and inspectors monitor these quality control 
    programs to make sure that the total weight of a group of spray-
    chilled carcasses is not greater than the total pre-wash weight of 
    the same carcasses. Thus, while an individual carcass may show a 
    weight gain, FSIS enforces a standard of zero-retained water for 
    groups of beef or pork carcasses for spray chilling systems. In 
    contrast, FSIS has not required establishments to closely monitor 
    water when using pathogen reduction methods on the kill floor, such 
    as pre-evisceration carcass sprays or steam vacuum processes.
        FSIS implements an extensive program to assure compliance with 
    existing limits for retained water in poultry. Retained water can 
    result from both carcass washing and carcass chilling, i.e., the 
    post-evisceration washing and chilling processes. The existing 
    procedures for conducting retained water tests for poultry are 
    outlined in Part 10 of the Meat and Poultry Inspection Manual. The 
    standard procedures instruct the inspector to tag and weigh a sample 
    of 10 birds from the eviscerating line before the final carcass 
    wash. The final carcass wash occurs before birds enter the chiller. 
    The same 10 birds are then weighed after the chiller at a point 
    specified in the establishment's water control procedures as 
    outlined on FSIS Form 528. The most common point is the end of the 
    drip line or the last accessible point on the drip line. The test 
    procedures are the same regardless of whether the whole bird or cut-
    up limits apply.
        Under standard procedures, inspectors conduct one test each 
    shift. Today, many establishments are tested once each week based on 
    history of compliance. The standard procedures state that test birds 
    must not be allowed extra draining, i.e., they must reflect the 
    production lot. The standard water procedures may specify that the 
    test birds are drained for a specific time if production is all 
    drained for the same time. For example, one establishment specifies 
    that test birds are to be drained four (4) hours before being 
    weighed. When water limits are exceeded, product is retained.
        Violations do occasionally occur and appear to be a function of 
    how close to the regulatory limit an establishment is operating. 
    Existing data indicate that some establishments control their 
    process way below the limits and never come close to a violation. 
    Based on the data reviewed for this analysis, most establishments do 
    not have water violations or rarely exceed existing limits. A few, 
    however, appear to target the limit and frequently experience 
    retained product as an extra operating expense. In the data examined 
    for this analysis, retained product required additional drain times 
    ranging from 3 minutes to 12 hours.
        FSIS' existing retained water control program is a relatively 
    resource intensive effort. In a poultry establishment with two 
    shifts and two chiller systems, FSIS may be conducting four 10-bird 
    tests each day. Each test takes from 40 to 60 minutes for selecting, 
    tagging, and weighing birds and then recording results and making 
    necessary calculations. Even with reduced testing in
    
    [[Page 48972]]
    
    many establishments, it appears reasonable to estimate that FSIS 
    conducts between 300 and 400 retained water tests each day. Assuming 
    a 260-day work year, FSIS conducts from 78,000 to 104,000 tests 
    annually. At 40 to 60 minutes each, the annual testing represents 
    from 25 to 50 staff years of 2,080 hours each. The Agency also 
    expends an estimated 560 staff-hours each year reviewing changes in 
    establishment washing, chilling, and draining procedures. These 
    estimates do not include the cost of addressing violations.
        FSIS intends to pursue a new water control program that can 
    incorporate wholesale or retail sampling to identify establishments 
    that may be exceeding water limits and then target resources to 
    conduct follow-up testing to confirm compliance or noncompliance. 
    FSIS is aware of a retail testing method that has been developed and 
    used in European Union member States. The method involves measuring 
    drippage from sampled products against what is considered the 
    natural water content of the product.
        In its 1980 net weight proposal, FSIS considered a ``building-
    block'' approach to net weight compliance that was then being 
    reviewed by the Codex Alimentarius Commission. This approach, as 
    described in the 1980 notice, ``would be modeled on a statistical 
    limits of variance technique developed by Switzerland for 
    application to imported, prepackaged foods. Inspectors would make 
    limited inspections for compliance at retail. If the sampling 
    technique indicates a noncompliance problem, additional inspection 
    of the same product would be made at retail and further back in the 
    marketing chain, including at processing plants. If the problem 
    continues following notification of the producers, a more precise 
    enforcement test would be applied.'' An alternative that lends 
    itself to this type of approach will rate high on the criterion for 
    an efficient, equitable enforcement system.
    
    IV. Description of Proposed Rule
    
        The proposed rule would establish a single retained water 
    standard for all raw, single ingredient meat and poultry products. 
    This standard would allow retained water only if that water was an 
    inevitable consequence of the process or processes used to assure 
    compliance with existing food safety requirements. The presence of 
    any retained water would, however, have to be identified on product 
    labeling.
        The proposed requirements would affect only single-ingredient, 
    raw, whole, cut-up, or ground meat and poultry carcasses and parts, 
    including edible organs and other edible meat and poultry 
    byproducts. It would not affect raw products with labeling that 
    includes a list of ingredients or nutrition labeling, such as pre-
    basted frozen turkeys or individually quick frozen (IQF) poultry 
    parts labeled to indicate the addition of basting solutions.
        The proposal would also modify other existing regulations 
    related to water use and chilling requirements. For example, the 
    proposal would remove a requirement that establishments must file a 
    description of chilling and freezing procedures with the inspector-
    in-charge (IIC). At the same time, the proposal would remove the 
    requirements that the establishment submit written notice of any 
    adjustments to washing, chilling, and draining methods before any 
    changes are made and provide FSIS data showing the adjustments are 
    effective in meeting existing water limits. These modifications 
    would reduce recordkeeping and reporting burdens.
        The proposal would also remove specific requirements concerning 
    the amount of fresh water intake required in the first section of a 
    continuous chilling system. The existing regulations require a 
    minimum of one-half gallon per frying chicken and proportionately 
    more for other classes of poultry, including not less than one 
    gallon per turkey. The potential for lowering water costs is 
    unknown. The general requirements for using potable water and 
    continuous overflow from one section of the chiller to the next will 
    remain. The requirement for continuous overflow would appear to 
    limit the opportunity for reduced water usage.
        The regulations concerning water intake were established at a 
    time when FSIS assumed responsibility for controlling pathogen 
    levels and frequently did so with design requirements. In 1978, the 
    Department published a proposal (43 FR 14043, April 4, 1978) that 
    would reduce water intake requirements by 50 percent when chlorine 
    levels in the incoming water were at least 20 parts per million. The 
    proposal was subsequently withdrawn. Of concern during the 
    rulemaking were studies by USDA and the Virginia Polytechnic 
    Institute and State University (VPI) that showed that bacteria 
    levels increased as intake water was reduced. While the relationship 
    of water intake and pathogen levels remains a public health concern, 
    FSIS is no longer attempting to design protection using command and 
    control regulations. Under the Pathogen Reduction/HACCP final rule, 
    establishments are required to meet pathogen reduction performance 
    standards. This current proposal is a performance-based standard 
    that will lead to retained water levels that are necessary to meet 
    pathogen reduction requirements and other food safety standards. The 
    current proposal is consistent with FSIS objectives of setting 
    performance standards and moving away from design requirements, such 
    as the minimum of one-half gallon of fresh water intake per chicken. 
    It is now industry's responsibility to establish how water intake 
    relates to both retained water and pathogen levels.
        The proposal would also remove prescriptive requirements for 
    water reconditioning systems for poultry chillers. This change would 
    not have an impact because reconditioning systems have not proven 
    feasible in commercial operations.
        FSIS intends to retain the existing requirements mandating that 
    the internal temperature of poultry carcasses be lowered to 40 
    deg.F. or less within a specified time. The Agency also will 
    continue to require that each establishment provide scales, weights, 
    identification devices, and other supplies necessary to conduct 
    water tests. While the Agency envisions a compliance-sampling 
    program using the deviation from an expected level of total water 
    content as a screening system, the Agency will still use the 
    existing sampling system to confirm potential compliance problems.
        The poultry regulations discussed above concerning water use, 
    chilling requirements and water retention are all contained in 9 CFR 
    381.66 (Temperatures and chilling and freezing procedures). This 
    proposal would also remove several existing regulations from 9 CFR 
    381.65 that now address general operating procedures, many of which 
    are not related to water use or chilling procedures. Operating 
    procedure requirements that would be removed or revised under this 
    proposal include the following:
         Specific requirements that prescribe the nature of 
    opening cuts for evisceration,
         The requirement to remove kidneys from mature poultry,
         Requirements pertaining to the handling and storage of 
    materials that could adulterate product,
         Requirements for containers, packaging, and covering 
    materials,
         Requirements on removing offal from establishments,
         Requirements prescribing how to thaw frozen poultry and 
    drain ready-to-cook poultry,
         Requirements on how establishments can chill parts of 
    carcasses, and
         Requirements related to harvesting detached ova.
        The regulations that would be eliminated are either regulations 
    that are overly prescriptive command and control regulations, such 
    as those defining opening cuts or regulations that are now redundant 
    with HACCP, e.g., the removal of kidneys. The reason for removing 
    the kidneys of mature chickens and turkeys is that they are a source 
    of cadmium, which can accumulate in the human liver and kidneys and 
    cause acute or chronic health problems. This is a ``food safety 
    hazard reasonably likely to occur'' that establishments will 
    identify in their hazard analyses and control through their HACCP 
    systems. Thus, a regulatory requirement for their removal would be 
    redundant with the HACCP regulations.
    
    V. Analysis of Existing Data on Retained Water
    
        As discussed above, most raw, single-ingredient meat products 
    are not currently allowed to contain any retained water. This 
    analysis assumes that these meat products will continue to be 
    produced without retained water. Products that are packed in water 
    or may retain water are already labeled to indicate such 
    information. Chitterlings (swine intestines) are washed and chilled 
    before shipment and are packaged with water. Certain organ meats and 
    meat from ears and tails are also washed and chilled using water. A 
    few establishments chill beef cheek meats in water, a process that 
    may result in the absorption of water. The product is labeled to 
    indicate the maximum percentage added water it may contain to alert 
    buyers to the fact that the product may weigh more because of the 
    chilling process. The Agency does not have data on the volume of 
    meat products with retained water or data on the current levels of 
    retained water. These products do not, however,
    
    [[Page 48973]]
    
    represent a major portion of the meat industry.
        In order to estimate the current level of retained water, in 
    early 1997, the Agency's headquarters staff informally requested 
    field offices to forward readily available water data from poultry 
    plants. The material assembled varied from region-to-region and 
    plant-to-plant. The field offices did not use a standard method to 
    summarize available data. In some cases, the individual 
    establishments were identified; in other instances, all plant 
    identification was removed. The allowable water, i.e., the 
    applicable regulatory limit, was not always readily discernible. The 
    data covered the period of January through May 1997. Most of the 
    data was included on the Daily Moisture Records (FSIS Form 549 or 
    its replacement Form 6310-1). These records record the pre-wash and 
    post-chill weight of each individual bird for each 10-bird test. 
    Five 10-bird tests are recorded on each record.
        While the data assembled was not systematically collected, it 
    has a degree of randomness and provides a preliminary estimate of 
    the amount of water currently absorbed and retained during the 
    washing and chilling process as measured by existing FSIS water test 
    procedures. An analysis was conducted using all the data that met 
    the following criteria for establishments slaughtering young 
    chickens.
    
    {time}  Minimum of twenty 10-bird tests (200 birds).
    {time}  Existing regulatory limit available.
    {time}  All available test data collected under a single applicable 
    limit.
    {time}  All results clearly legible.
    {time}  Establishment identified (to connect water data with 
    production).
    
        The data from 33 establishments slaughtering young chickens met 
    the above criteria. These 33 establishments represented 17.5 percent 
    of FY 1996 production. Within the 33, 19 establishments were 
    operating under the 12 percent water limit that was applicable to 
    cut-up and ice-pack poultry. These 19 establishments accounted for 
    9.11 percent of the total FY 1996 production and 52 percent of the 
    production within the 33 establishments.
        Thirteen establishments were operating under an 8 percent water 
    absorption limit during the period the data was collected. The 8 
    percent limit applies to whole carcass pack chickens or frozen 
    chickens that are 4.25 pounds or less. The 13 establishments 
    represented 7.95 percent of FY 1996 production. One establishment 
    was operating under the 6 percent limit for whole chickens over 4.25 
    pounds.
        Among the 33 establishments, 48 percent of the young chickens 
    were being processed under the water limits for whole birds. Today, 
    the National Broiler Council estimates that only 10 percent of 
    broilers are ``marketed'' as whole birds. Two factors explain this 
    difference. First, if any birds in a production shift are to be 
    shipped whole, the entire shift is subject to the whole bird limit. 
    Second, some birds are shipped whole and then cut up in a second 
    establishment conducting further processing. The 10 percent 
    ``marketed'' as whole birds refers to retail and food service 
    destinations.
        The 13 establishments operating under the 8 percent limit had an 
    average absorbed water level of 5.81 percent and a production based 
    weighted average of 5.68 percent. Individual establishment averages 
    ranged from 4.72 to 7.32 percent. These percentages represent 
    percentage gain relative to the carcass weight prior to the final 
    carcass wash. The individual plant averages were calculated by 
    combining all available water tests from all shifts and all washer/
    chiller systems. Averaging all water test results in this manner 
    assumes that each test represents an equal amount of production. 
    Many plants have more than one chiller system and multiple shifts. 
    Production may not be equally distributed across all shift-chiller 
    combinations.
        The 19 establishments operating under the 12 percent limit had 
    an average absorbed water level of 9.11 and a weighted average of 
    9.02 percent. As above, these percentages represent percentage gain 
    relative to the carcass weight prior to the final carcass wash. 
    While 18 of these establishments had absorbed water levels close to 
    8 percent or above, one establishment had an average water level of 
    5.37 based on sixty 10-bird tests (600 birds) conducted from January 
    through April 1997. The establishment operates two systems, one 
    averaged 5.61 percent, the other 5.14. All the daily records were 
    checked to indicate the establishment was producing cut-up poultry.
        In addition to the data analyzed above (33 establishments), the 
    1997 data included water tests from three young chicken 
    establishments that processed both whole birds under the 8 percent 
    limit and cut-up chickens under the 12 percent limit. For these 3 
    plants, there were at least 20 tests at each level.
        The results are shown in the following table:
    
    ------------------------------------------------------------------------
                                        8 percent    12 percent             
              Establishment               limit        Limit      Difference
    ------------------------------------------------------------------------
    A................................         6.42         7.67         1.25
    B................................         5.26         6.15         0.89
    C................................         5.94         7.30         1.36
    ------------------------------------------------------------------------
    
    An analysis of variance procedure indicated that, after accounting 
    for variability between plants, there is a statistically significant 
    difference (confidence greater than 99%) between the percentages of 
    water gain at the two regulatory limits. It follows that these 
    establishments are not really minimizing retained water when 
    operating under the 12 percent limit because they have lower 
    retained water when processing whole birds. The difference does not, 
    however, approach 4 percent.
    
        Because there are 12 different water limits for different sizes 
    of turkeys, the approach to analyzing existing data had to be 
    different. It's common to see three different water limits for a 
    five-test series recorded on the Daily Moisture Records. The data 
    from turkey establishments was sorted using the following two 
    criteria:
         Minimum of ten 10-bird tests conducted under limits 
    applicable to turkeys packaged as whole birds.
         Establishment identified.
        A review of the existing data identified six establishments that 
    were operating under the limits for whole carcass packing 
    procedures. These six establishments represented 12.7 percent of 
    federally inspected turkeys in FY 1966. An estimated 40 percent of 
    all turkeys are marketed as whole birds. Because of the 12 different 
    limits for whole turkeys depending on weight, this analysis did not 
    attempt to estimate absorbed water for different sizes of birds.
        The six turkey plants had an average absorbed water level of 
    4.39 percent and a weighted average of 4.74 percent. Individual 
    plant averages ranged from 1.91 to 5.53 percent. This analysis did 
    not attempt to estimate water levels for cut-up or ice-packed 
    turkeys.
        The review of Daily Moisture Records identified a couple of 
    potential issues that should be addressed by comments. First, some 
    of the highest water results occurred when line speeds were running 
    too slow for the established water control procedures. Since slowing 
    line speeds may be a response to higher pathogen levels there is 
    some indication that water pick up and pathogen levels may be 
    inversely related under some conditions. In one case, a company 
    conceded that it could not pass the 8 percent whole bird water 
    limits at certain lower speeds and agreed to divert birds to cut-up 
    operations when the line speed dropped to a certain level. By 
    diverting the birds to cut-up, the establishment avoided the process 
    of conducting a 50-bird test to establish the necessary drain time 
    to meet the 8 percent limit. Another plant noted that slower speeds 
    resulted in insufficient numbers of birds for proper travel through 
    their chiller system with rocker arms.
        As a second issue, the data indicate that more problems arise 
    with very small birds, i.e., broilers in the 2\1/2\ to 3-pound 
    range. Individual birds would show water pick-up in the 20 to 24 
    percent ranges. FSIS staff notes that eviscerating equipment 
    sometimes causes extra large openings on small carcasses that lead 
    to pockets of water under the skin. These birds are informally 
    referred to as ``water bags.'' The water test is rather meaningless 
    for these birds if they are headed to cut-up operations because the 
    water in
    
    [[Page 48974]]
    
    these pockets drains quickly and easily at the cut-up operation.
    
    VI. Retained Water in Net Weight
    
        The proposed rule would require that product labels indicate the 
    percentage of net weight represented by retained water. All the data 
    presented in the previous section refers to retained water as a 
    percentage gain from the carcass weight prior to the final carcass 
    wash. The same volume of retained water expressed as a percentage of 
    net weight will be somewhat lower because net weight includes the 
    pre-wash carcass weight plus any absorbed water.
        A second difference occurs because FSIS water tests normally 
    occur at the end of the drip line. The exact relationship between 
    the volume of retained water as recorded by FSIS tests and the 
    volume of retained water in finished packaged product is unknown. 
    Retained water in finished packaged product will be lower for 
    several reasons. First, an establishment's handling procedures will 
    lead to some water loss before the product is packaged and weighed. 
    Today, only 10 percent of broilers are ``marketed'' as whole birds. 
    Thus, a lot of broilers produced under whole bird limits are being 
    cut up in the originating establishment or in a subsequent 
    establishment before being packed as finished product. Second, any 
    product that exceeds existing limits is required to drain for a 
    specific time as determined by program personnel. Third, the 
    establishment may implement draining procedures to meet a customer's 
    purchase specifications. In these cases, the retained water included 
    in net weight could be far less than the retained water measured by 
    FSIS tests.
        It is also difficult to compare the water data for whole birds 
    with the data on cut-up poultry. As discussed above, available data 
    showed whole young chickens to average 5.68 percent while cut-up 
    young chickens averaged 9.02 percent on a production-based weighted 
    average. The 12 percent limit on cut-up chickens was based on a 
    premise that if poultry for cut-up averages less than 12 percent at 
    the time of water test, it would drain to less than 8 percent during 
    the remaining handling prior to final packaging. This does not mean 
    that poultry destined for cut-up will drain 4 percent. It seems 
    reasonable to assume, however, that the level of 9.02 percent will 
    approach the whole bird level of 5.68 percent, probably ending up 
    somewhere between 6.0 and 7.0 percent.
        Allowing for some drain in the whole bird packaging process and 
    considering the conversion to percentage of net weight, it seems 
    likely that the average retained water for chicken as a percentage 
    of net weight is probably in the 5.0 to 6.5 percent range. This 
    estimate is consistent with findings published in a study \1\ 
    conducted in 1979 by the Economics, Statistics, and Cooperatives 
    Service (ESCS (now ERS)). That study, hereafter referred to as the 
    1979 ERS study, estimated that average water pickup for six 
    processors at the time of packaging was 5 to 6 percent. Because some 
    product undergoes further cut-up and packaging in other 
    establishments, the average water level leaving originating 
    establishments is not the same as the level in customer packages.
    ---------------------------------------------------------------------------
    
        \1\ Assessment of Proposed Net Weight Labeling Regulations, 
    Staff Report, Prepared by the Economics, Statistics, and 
    Cooperatives Service for the Food Safety and Quality Service, USDA, 
    August 1979.
    ---------------------------------------------------------------------------
    
        The whole bird data on turkeys, i.e., 4.74 percent retained 
    water, is a better estimate for packaged turkey since 40 percent are 
    marketed as whole birds. One would expect some additional drainage 
    before the birds are packaged. The average retained water level for 
    turkey as a percentage of net weight is probably somewhere in the 
    range of 4 to 4.5 percent.
    
    VII. Economic Analysis of Retained Water in Meat and Poultry
    
        This chapter examines the economic issues associated with 
    retained water in poultry. For analytical purposes, this chapter 
    assumes that the average retained water for all chicken is 5 percent 
    of net weight and the average for turkeys is 4 percent of net 
    weight. The analysis in Sections 4 and 5 concluded that the averaged 
    retained water for chicken is probably between 5.0 and 6.5 percent 
    and the average retained water for turkey is probably between 4.0 
    and 4.5 percent.
        In FY 96, there were 7.67 billion chickens slaughtered under 
    Federal inspection. Based on an estimated average carcass weight of 
    3.36 pounds, the total weight of ready-to-cook chicken was 25.8 
    billion pounds. If the average retained water was 5 percent, then 
    one can view the total as 24.5 billion pounds of chicken and 1.3 
    billion pounds of retained water. Since the wholesale price of whole 
    broilers was $.6124 per pound,\2\ the chicken had an estimated whole 
    bird, wholesale value of $15.8 billion.
    ---------------------------------------------------------------------------
    
        \2\ Livestock, Diary and Poultry Situation and Outlook, LDP-M-
    44, ERS, USDA, August 15, 1997.
    ---------------------------------------------------------------------------
    
        In FY 96, there were 289.6 million turkeys slaughtered under 
    Federal inspection. Using an average carcass weight of 17.9 pounds, 
    the production was 5.18 billion pounds. The average FY 1996 
    wholesale price was $.665 per pound resulting in a total wholesale 
    value of $3.4 billion. Using an estimated average retained water 
    level of 4 percent, one could view the production as 4.97 billion 
    pounds of turkey and 0.21 billion pounds of retained water.
        There are two ways of looking at the current situation. One is 
    the perspective that customers are paying $15.0 billion for the 
    chicken and $789.4 million for the retained water and $3.3 billion 
    for turkey and $136 million for retained water. The other is that 
    the water has no effect on the value of the poultry. In this case, 
    the value of the chicken is $15.8 billion and the value of the 
    turkey is $3.4 billion. The customer is simply not being informed 
    that the true wholesale price of the chicken on a ``zero added 
    water'' basis is $.6446 per pound and not $.6124. Similarly, the 
    customer is not being informed that the true wholesale value of 
    turkey is $.684 per pound and not $.665.
        While the 1979 ERS study was focused on analyzing alternative 
    net weight regulations, the study addressed essentially the same 
    issue as retained water when it considered drained weight labeling. 
    The ERS study used an ``added water in chicken'' example to 
    illustrate the retail price effects of dry tare versus drained 
    weight labeling of packaged chicken. The example was a package of 
    chicken breasts selling for $1.20 per pound with a labeled weight of 
    3 pounds using a dry tare system. The tare is the weight of any 
    container, or wrapper, or other material not included in the stated 
    weight of a package. This package would cost the consumer $3.60. If 
    this package undergoes a water loss of 4 percent, and assuming the 
    net weight was exact under the dry tare system, the consumer 
    selecting this package would be receiving 2.88 pounds of drained 
    weight chicken and the real price per pound of chicken is $1.25 
    ($3.602.88 pounds).
        Under a drained weight system, assuming exact measurements, the 
    package would show a net weight of 2.88 pounds and a price per pound 
    of $1.25. The cost of the package would remain $3.60. The ERS study 
    used this example to illustrate that changing net weight 
    methodology, by itself, only changes the information a consumer 
    receives but not the real cost of the product. After analyzing the 
    ``water in chicken'' issue, the 1979 ERS study concluded:
    
    Whether consumers pay chicken prices for water is not clear simply 
    because a dry tare labeling weight is allowed. If $3.60 is the 
    competitive cost for a package of chicken breasts of that quality, 
    then the consumer is not paying $1.20/lb. for 0.12 lb. of water and 
    juices. The consumer is simply not being informed that the true 
    price of chicken at the retail level on a drained weight basis is 
    $1.25/lb. not $1.20. Consumers may well be paying more for chicken 
    or other meat and poultry products than can be justified. But to 
    verify such an assertion would require an extensive study of the 
    industrial organization of the industry and data on firm costs, 
    revenues, and profits. Answering that question is beyond the scope 
    of this study.
    
        The economic issue raised by the retained water issue is whether 
    labels reflecting the price of poultry on a ``green weight'' basis 
    would have enough of an effect on the demand for poultry that 
    consumers would purchase less poultry and more product that competes 
    with poultry. This analysis, like the earlier ERS study, has not 
    attempted to predict the shifts in supply and demand that might 
    occur if product labels included the ``true'' price of poultry. The 
    marketplace issues are more complex than just pounds and cents. 
    Discussions with retail industry personnel indicate that they 
    believe many consumers object to free liquid in packages and that 
    ``dry'' looking packages would have a positive impact on demand. 
    They also noted that labeling of water is not necessarily a 
    detraction. They point to the rapidly growing market for 
    Individually Quick Frozen (IQF) Ice-Glazed poultry. This product 
    sometimes includes labeling indicating the addition of basting 
    solutions to enhance flavor and juiciness. IQF Ice-Glazed and 
    marinated products are marketed based on convenience.
    
    VIII. Options Identified
    
        FSIS identified six options for regulating retained water in raw 
    meat and poultry products. These six options are:
    
    [[Page 48975]]
    
         No limits on retained water as long as the product 
    label indicated the amount of retained water.
         A standard requiring zero retained water for all raw, 
    single-ingredient products.
         A requirement that there could be no retained water in 
    the stated weight of the product.
         A standard that would set limits for retained water 
    based on best available technology within traditional production 
    practices. This option would also require that retained water be 
    identified on product labels.
         A standard that would set limits for retained water 
    based on optimum use of existing equipment. This option would also 
    require that retained water be identified on product labels.
         A standard that would require an establishment to 
    demonstrate that any retained water is an inevitable consequence of 
    the process used to meet applicable food safety requirements. This 
    option would also require that retained water be identified on 
    product labels.
    
    IX. Analysis of Options
    
        This section provides an assessment of the six regulatory 
    options identified. The six options fit into three categories. The 
    first category is represented by Option 1 and can be characterized 
    as the option where there would be no limits on retained water for 
    any raw product as long as the label indicated the presence of that 
    water. The second category covers options where no retained water 
    would be allowed. This analysis discusses two variations, one 
    (Option 2) where no retained water would be allowed in the product 
    and another (Option 3) where no retained water could be included in 
    the product weight. Options 4, 5, and 6 are all similar in that they 
    would permit limited water retention and they would require that any 
    retained water be identified on product labels. These last three 
    options differ in the basis for establishing the limits for water 
    retention. The three options consider limits based on best available 
    technology, limits based on best performance with existing 
    equipment, and limits based on the retained water necessary to meet 
    existing food safety requirements. Setting new limits based on any 
    of these three criteria would have to meet the Court's requirement 
    that the rulemaking record explain how particular water retention 
    levels are set.
        All six options provide consumers with improved information on 
    the ``true'' price of poultry. Improved information results from 
    either labeling the level of retained water, eliminating all 
    retained water, or a combination of labeling and limiting the amount 
    of retained water. Improved information provides a consumer benefit 
    in that it allows consumers to make more informed purchasing 
    decisions. The analysis that follows does not quantify the consumer 
    benefits of each option. FSIS recognizes that removing all retained 
    water informs consumers of the ``true'' price of poultry; no further 
    calculation balancing water content and label price would be 
    necessary. A combination of labeling with a limit on retained water 
    may have greater consumer benefits than labeling alone because the 
    labeled product price would provide improved information to those 
    consumers that would not use the retained water information.
    
    Option 1--Labeling of Percentage Retained Water
    
        Under this option, there would be no limit on retained water as 
    long as the amount, i.e., percentage of product weight, was 
    indicated on the product label. The same requirement would apply to 
    both meat and poultry products. To assure prominent notification, 
    the product name on the labeling of an affected product would be 
    accompanied by a statement, such as ``may contain up to __ percent 
    retained water'' or ``contains __ percent retained water.''
        After identifying this option, the department concluded that 
    this regulatory option would not be consistent with the existing 
    adulteration provisions discussed earlier. In other words, unlimited 
    retained water would constitute economic adulteration, even if 
    identified through labeling. While this conclusion eliminates this 
    option, this analysis uses the option as a vehicle to discuss the 
    costs and benefits of using labels to inform consumers about 
    retained water.
        The cost analysis presented later in Section X concludes that 
    all poultry labels could be revised at a cost of $18.4 million. This 
    cost would be an up-front, nonrecurring cost. The label revision 
    costs of $18.4 million are an estimate for the cost of revising 
    labels for raw poultry shipped from federally inspected poultry 
    establishments that both slaughter and further process raw poultry. 
    The estimate of $18.4 million does not include potential label 
    revision costs for product that is produced in one of the slaughter/
    processing establishments and then further processed in a second 
    inspected establishment that does not slaughter poultry. To 
    illustrate, there are inspected establishments that purchase whole 
    birds and further process these carcasses into parts of carcasses 
    and other establishments that purchase parts of carcasses and 
    further process these parts. The inspected establishments purchasing 
    product that has ``percentage retained water labeling'' would have 
    to label their further processed, single-ingredient, raw products 
    unless they had data showing that the further processing they 
    conduct removes all the retained water. Presumably, the percentage 
    of retained water would decrease during further processing. The 
    further processing establishments would have to label their products 
    to indicate the presence of any remaining retained water. FSIS does 
    not have information on the number of establishments or labels that 
    could potentially be affected.
        There are two other situations where revised labels could be 
    required. While most raw poultry sold in retail stores is packaged 
    and labeled in federally inspected establishments, some raw product 
    is repackaged and labeled at the retail level. Retail stores would 
    have to label their single-ingredient, raw products unless they had 
    data showing that the processing and repackaging they conduct 
    removes all retained water. Thus, there would be some cost for 
    labeling retained water at the retail level. Finally, there may also 
    be a few meat labels that need to be revised since some byproducts 
    and organ meats are now washed in water before being shipped.
        There would also be the cost of establishing the level of 
    retained water. As discussed earlier, FSIS now employs from 25 to 50 
    staff years measuring retained water. Inspected establishments could 
    utilize FSIS test results or conduct there own retained water tests. 
    If such tests are conducted by Quality Control (QC) technicians 
    making $35,000 annually, the cost of 25 to 50 staff years represents 
    from $875,000 to $1.75 million, annually. This option would not 
    require any reduction in the current levels of retained water. Thus, 
    there would be no costs for modifying production practices. The cost 
    analysis in Section X addresses the cost of establishing a minimum 
    which is a different task than establishing the level.
        The labeling of product to identify retained water benefits 
    consumers. The information provided has value because it allows 
    consumers to make better decisions. In the terminology of the 1979 
    ERS study, the labeling of retained water would help consumers 
    establish the ``true'' price of poultry.
        The extent of the labeling benefit, i.e., the value of labeling 
    information to consumers, is affected by several factors. These 
    include the type of label that will eventually be required, the 
    number of different labels present in the marketplace and the 
    variation in retained water within a specific production lot. The 
    first factor affecting the value of the labeling information is the 
    type of label statement. If the label statement indicates ``up to 
    ____ percent retained water,'' the consumer cannot use the 
    information to calculate a true price per pound because the label 
    would not specify the actual amount of retained water. The ``up to 
    ____ percent'' type of label would provide consumers with general 
    information indicating that some level of added water was present. 
    This type of label does not provide the same incentive to minimize 
    added water as a label indicating a specific percentage, i.e., 
    ``contains ____ percent added water.''
        The second factor affecting the value of labeling is the number 
    of different labels present in the marketplace. If different 
    establishments have different labels for different levels of 
    retained water, consumers could be faced with a multitude of 
    different labels making price comparisons very difficult. It is not 
    unusual for a large supermarket to stock raw poultry from more than 
    10 different federally inspected establishments. While it appears 
    reasonable to assume that a company or an establishment would prefer 
    to use a single retained water statement for all raw product labels, 
    it is possible that some establishments would develop alternative 
    labels for each product, each indicating a different level of 
    retained water. Added water content could be established on a day-
    to-day or production-shift basis.
        A third factor affecting the value of labeling is the variation 
    in retained water within a specific production lot. Natural
    
    [[Page 48976]]
    
    variation is a component of all food attribute labeling. Variation 
    does appear, however, to present a greater than usual concern with 
    retained water. Based on the 10-bird tests conducted by FSIS, the 
    package-to-package variation could be relatively high for whole 
    birds. In a randomly selected 10-bird test for whole broilers 
    (average ``green weight'', i.e., carcass weight prior to any water 
    absorption, was 3.6 pounds), the average retained water was 6.57 
    percent. The range was from less than 1.0 percent (0.95) to 14.6 
    percent. Only five birds were within 2.0 percent of the 
    average 6.57 percent. Two individual birds exceeded the 8.0 percent 
    limit. In a second 10-bird test of 3.2-pound broilers averaging 6.92 
    percent retained water, 6 of 10 were within  2.0 
    percent. Three individual birds exceeded the 8.0 percent limit. This 
    data raises an issue concerning how a percentage labeling option 
    would be implemented, i.e., what level would be required to appear 
    on product labels? Would it be the average or would it be a level 
    that included 90 or 95 percent of the individual birds?
        The amount of retained water appears to vary less for turkeys. 
    In one randomly selected 10-bird test of smaller turkeys (regulatory 
    limit of 6.0 percent), 9 of 10 were within 1.0 percent 
    of an average retained water level of 5.45 percent. In a 10-bird 
    test of larger birds (regulatory limit 5.3 percent), 7 of 10 were 
    within 1.0 percent. One bird exceeded the regulatory 
    limit.
        While the variation rate affects the value of the labeling 
    benefit, it does not eliminate the benefit. For an individual 
    purchase, purchasing a product labeled ``2% retained water'' does 
    not guarantee more useable product than purchasing a product labeled 
    ``4% retained water.'' When averaged over several purchases, 
    however, the product labeled to indicate less retained water should 
    result in more useable product. In addition, a large portion of raw 
    poultry is now marketed as packages of thighs, wings, breast 
    quarters, leg quarters, and boneless, skinless breast meat, etc. For 
    these types of packages, the bird-to-bird variation is less of a 
    concern.
    
    Option 2--Zero Retained Water
    
        The Agency could establish a standard of zero retained water for 
    all raw, single-ingredient meat and poultry products. In theory, 
    given sufficient drip time or drain time or drying time, all raw, 
    single-ingredient products can be returned to a ``green weight.'' 
    However, available data suggests that returning immersion-chilled 
    poultry to ``green weight'' may not be feasible. The 1979 ERS study 
    included data that supports the conclusion that water retained 
    during washing and chilling does not completely drain from poultry 
    by the time the product reaches the consumer. For the study, ERS, in 
    conjunction with ten local weights and measures agencies, measured 
    the percent drain in 297 retail packages of chicken from five 
    poultry processors. All packages were whole cut-up chicken packed at 
    establishments using immersion chilling. All brands had an average 
    water pickup of 5 to 6 percent at the time of packaging. For the 297 
    packages the average drain as a percentage of labeled net weight was 
    3.42 percent. Assuming the product started at an average of 5.5 
    percent, the product was still retaining approximately 2.0 percent 
    absorbed water when sampled at retail. The study did not indicate 
    how many days the product had been in distribution. One processor 
    was shipping to retail stores on both the east and west coast. Thus, 
    in some cases, there was considerable transportation time involved.
        There was a second \3\ study that showed that the water loss 
    that occurs in the plant from the time the poultry is placed in the 
    package to the time it leaves the plant is substantially less than 
    total retained water. During the development of the 1989 Net Weight 
    Proposal (54 FR 9370, March 6, 1989), FSIS, in cooperation with the 
    National Broiler Council and the National Conference on Weights and 
    Measures, conducted a study on water loss. Data collected from ten 
    chicken processors showed that the average water loss occurring in 
    the plant after packaging was 1.8 percent. The study did not, 
    however, include data on the length of time the product stayed in 
    the plant after initial packing.
    ---------------------------------------------------------------------------
    
        \3\ U.S. Department of Commerce, National Institute of Standards 
    and Technology (NIST), Report of the 73rd National Conference on 
    Weights and Measures, NIST Special Publication 750, 1988.
    ---------------------------------------------------------------------------
    
        FSIS technical personnel believe that a zero standard would 
    require the poultry industry to abandon immersion chilling because 
    attaining zero-retained water with immersion chilling is not 
    technically feasible. Installing air chilling or air chilling/spray 
    systems would require major reconstruction costs for the poultry 
    industry. There is also a potential cost associated with possible 
    increases in pathogen levels. Studies have shown that immersion 
    chilling reduces overall pathogen levels on poultry. If this option 
    would force the poultry industry to abandon immersion chilling and 
    pathogen levels increased, then there could be additional social 
    costs associated with increases in foodborne illness. With this 
    option there would be no need to revise product labels.
        Under this option, consumers would benefit by being fully 
    informed as to the ``true'' price of both meat and poultry products. 
    No balancing of water content and label price would be necessary. 
    However, because the benefits of better informed consumers from a 
    zero-retained water standard are unlikely to surpass the costs, this 
    option was eliminated.
    
    Option 3--``Green Weight'' Labeling
    
        A variation on the concept of zero-retained water is the option 
    where there could be no retained water in the stated weight of the 
    product. Establishments would be required to establish a retained 
    water level for each ``lot'' or shift. Scales would then have to be 
    adjusted to account for retained water. The weight indicated on 
    product labels would be an estimate of the ``green weight'' prior to 
    the final carcass wash.
        The only direct cost is the cost of establishing the amount of 
    retained water in order to adjust scales. There would be no need to 
    revise product labels or modify chilling practices. The major impact 
    would be a reduction in the labeled volume of poultry production by 
    an estimated 1.5 billion pounds. To maintain the current level of 
    sales in dollars, the poultry industry would have to raise the 
    wholesale price per pound by an average of 5.1 percent. Retail 
    prices would also increase. Consumers would, most likely, perceive 
    an increase in poultry prices. As the 1979 ERS study noted, however, 
    changing net weight methodology, by itself, only changes that 
    information a consumer receives but not the real cost of the 
    product. Consumers would, however, be fully informed as to the 
    ``true'' price of poultry.
        A disadvantage of this option would be that the labeled weight 
    would only be an estimate of the ``green weight.'' The package-to-
    package variation would now be an issue for the accuracy of the net 
    weight statement rather than the accuracy of a qualifying statement. 
    There could also be considerable differences between labeled weight 
    and packaged weight. This option would require the Agency to revise 
    the overall system for regulating net weight accuracy.
        If this option were selected, FSIS would have to reopen the net 
    weight regulations. In 1990, after four proposals and almost two 
    decades, FSIS published final rules for net weight labeling of meat 
    and poultry products (55 FR 49826, November 30, 1990). In the final 
    net weight rule, FSIS established a regulatory framework that for 
    all compliance testing in federally inspected establishments, the 
    net weight of raw chicken would be established using a dry tare 
    system. In a dry tare system, both free liquid and liquid absorbed 
    by packaging material would be included in the net weight of the 
    product. At the same time, the rule recognized that a few State and 
    local weights and measures authorities still prefer to conduct wet-
    tare compliance testing. Under a wet-tare system, the free liquid 
    and liquid absorbed by packaging material are not counted in 
    measuring the product weight. The final rule established a 3 percent 
    ``gray area'' where if fresh poultry minus any liquids (free liquid 
    plus liquid absorbed by any packaging material) is within 3 percent 
    of the labeled weight, further information is sought before any 
    determination is made. The 3 percent ``gray area'' applies only in 
    localities using wet-tare testing. The task force that recommended 
    the 3 percent gray area for raw poultry noted \4\ that the 
    recommended level would require over pack by manufacturers supplying 
    wet-tare localities to compensate for water lost.
    ---------------------------------------------------------------------------
    
        \4\ U.S. Department of Commerce, National Institute of Standards 
    and Technology (NIST), Report of the 73rd National Conference on 
    Weights and Measures, NIST Special Publication 750, 1988.
    ---------------------------------------------------------------------------
    
        Enforcement of net weight requirements is an area where Federal, 
    State, and local authorities share responsibility and must 
    cooperate. The enforcement procedures, as adopted by the National 
    Conference on Weights and Measures, are published in NIST Handbook 
    133, Third Edition, Supplement, ``Checking the Net Contents of 
    Packaged Goods.'' FSIS' net weight regulations incorporate Handbook 
    133 by reference. The National Institute of Standards and Technology 
    (NIST) has a statutory responsibility for ``cooperation with the
    
    [[Page 48977]]
    
    States in securing uniformity of weights and measures laws and 
    methods of inspection.'' At the same time, the FMIA and PPIA do not 
    allow State and local jurisdictions to impose any standards that 
    differ from those published by FSIS. In publishing the final net 
    weight regulations in 1990, FSIS stated that the ``rule is designed 
    to enhance the ability of Federal, State, and local agencies to 
    enhance the industry-wide use of strict net weight standards at the 
    packing, warehouse and retail level.'' Although this option would 
    enable FSIS to address economic adulteration, it was eliminated 
    because (1) the benefits in the form of consumer information do not 
    appear to outweigh the costs of adjusting scales and labels to show 
    green weight, and (2) because of the need to maintain uniformity in 
    weights and measures laws and methods of inspection.
    
    Option 4--Retained Water Limits Based on Best Available Technology 
    Within Traditional Production Practices
    
        Under this option, FSIS would require all establishments to meet 
    water limits based on the lowest levels that are currently being 
    achieved by those establishments using the best available water-
    immersion chilling technology. The limit for retained water in 
    carcass beef, pork, lamb, and goat would remain at zero. There might 
    be some costs associated with establishing limits for the byproducts 
    and organ meats that are now processed separately from carcasses.
        FSIS recognizes that, for the poultry industry, the concept of a 
    ``minimum'' cannot be separated from some definition of standard 
    manufacturing practices that would include a reasonable drip or 
    drain time and some reasonable minimum temperature for chiller 
    water. Longer drip lines and lower chiller water temperatures are 
    both factors that would increase the cost of chilling poultry.
        Under this option, it is envisioned that the new limits would be 
    established based on data from the establishments using the best 
    technology. There would be costs for collecting and analyzing the 
    data and costs from modifying processes to reduce water retention. 
    This option could impose considerable costs on those establishments 
    that do not currently have the best available technology.
        The maximum allowed water level could actually be a series of 
    levels for different types and weights of meat and poultry products. 
    Under this option, products could not contain more than the 
    established limits and all products containing retained water would 
    have to be labeled indicating the presence of retained water. The 
    costs of labeling the percentage retained water would be similar to 
    those described under Option 1. The factors affecting the value of 
    labeling information would still exist, but there should be fewer 
    different labels because the range of permissible retained water 
    levels would be reduced.
        Operating the best technology so as to minimize retained water 
    may not be consistent with minimizing pathogens. Thus, there is a 
    potential cost associated with increased pathogen levels and 
    increased foodborne illness.
        This option would enable FSIS to effectively address economic 
    adulteration and would provide consumers information. However, 
    because the costs to industry to acquire the best available 
    technology would be large and would outweigh consumer benefits, this 
    option was eliminated. Furthermore, the option has the effect of a 
    design standard.
    
    Option 5--Water Limits Based on Existing Equipment
    
        This option would require all establishments to operate their 
    existing equipment so as to minimize retained water. As discussed in 
    the previous option, minimums would have to be based on some 
    reasonable limits for operating parameters. The retained water 
    requirement for carcass meat would remain at zero since meat 
    establishments are already operating at zero.
        As with the previous option, new retained water limits are 
    required for this option. Data would have to be collected and 
    analyzed to establish minimum water levels for different types of 
    equipment. There would be costs for collecting and analyzing this 
    data, most likely greater than for the previous option. However, no 
    establishment would have to replace equipment, as all minimums would 
    be based on existing equipment. This option would presumably lead to 
    a larger number of retained water requirements. FSIS technical 
    staffs believe retained water is related to variables such as type 
    of chiller, water temperature, time in chiller and type and level of 
    agitation.
        Retained water would have to be identified on product labels. 
    The costs of labeling retained water would be similar to those under 
    Options 1 and 4. The factors affecting the value of labeling would 
    still exist. Having different minimums for different equipment would 
    probably lead to a greater number of labeling variations.
        Minimizing retained water may not be consistent with processes 
    that minimize pathogens. Thus, there is a potential cost associated 
    with increased pathogen levels and increased foodborne illness.
        Option 5 is superior to Option 4 in that no establishment would 
    have to replace existing equipment or processes. This factor 
    outweighs the potentially higher cost of establishing limits and the 
    potential decrease in the value of labeling information due to a 
    greater number of labeling variations. Option 5 is deemed inferior 
    to the preferred option which follows because it does not provide 
    flexibility to the meat industry and does not integrate food safety 
    requirements. Options 4 and 5 may lead to increased pathogen levels 
    and increased costs of foodborne illness.
    
    Option 6--Retained Water Limits Established by Processes Necessary 
    To Meet Food Safety Requirements
    
        Under this option, all establishments would be expected to meet 
    a zero-retained water standard (i.e., Option 2) unless data 
    demonstrate that another level is necessary to meet existing food 
    safety standards using existing washing, chilling, and draining 
    systems (i.e., by introducing food safety objectives to Options 4 
    and 5). FSIS envisions that such data could be established on an 
    industry-wide basis, for a specific industry sector using similar 
    processes, or on an establishment-by-establishment basis. The data 
    could be collected and analyzed by individual establishments or by 
    trade associations or other groups.
        There would be costs for collecting and analyzing data. For the 
    previous option, the data would be collected to establish a minimum. 
    For this option, the data would be collected to establish a minimum 
    while still meeting the existing chilling requirements. Thus, the 
    poultry industry costs for establishing the limits should be 
    essentially the same as the costs for the previous option. The meat 
    industry would establish limits for retained water only if they 
    viewed it as a new lower cost option for meeting pathogen reduction 
    performance standards. Any retained water would have to be 
    identified on product labels. The limits on retained water would, 
    most likely, be a series of levels for different types and weights 
    of meat and poultry products. The costs of labeling retained water 
    would be similar to those under Options 1, 4 and 5. The value or 
    usefulness of the labeling will depend on the number of different 
    limits and whether those limits are established on an industry-wide 
    basis or on an establishment-by-establishment basis.
        The actual retained water limits for this option would be based 
    on the inevitable consequence of meeting food safety requirements 
    with existing processes. The necessity of meeting food safety 
    requirements would lead to equal or higher retained water levels 
    than those based on best available technology (Option 4) or best use 
    of existing equipment (Option 5). Since the costs of modifying 
    production processes decrease as the level of allowed retained water 
    increases, costs are the same or lower for this option than those 
    for Options 4 and 5. The costs for establishing the retained water 
    limits should be similar to those for Options 4 and 5. The labeling 
    costs are essentially the same. For this option, there are no 
    potential costs associated with increases in pathogen levels and 
    foodborne illness. Thus, since the labeling benefits are essentially 
    the same, this option is expected to have the greatest net benefits 
    of the three options that permit limited retained water. This option 
    was selected as the proposed rule.
    
    X. Cost of Proposed Rule
    
        The purpose of this section is to estimate the costs of proposed 
    rule. The proposed rule would create three types of costs: (1) the 
    costs for establishing water levels necessary to meet food safety 
    requirements, (2) the costs associated with reducing retained water 
    to such levels, and (3) the costs of revising product labels to 
    indicate the presence of retained water. Most of the potential cost 
    impact falls on the poultry establishments using water-immersion 
    chiller systems. There are approximately 300 federally inspected and 
    an estimated 65 State-inspected poultry slaughter establishments. 
    There will also be some impact on livestock slaughter establishments 
    and on retail stores that re-pack and re-label raw, single 
    ingredient meat and poultry products.
    
    [[Page 48978]]
    
    Cost of Establishing Water Limits
    
        The proposed rule would prohibit retained water in raw meat and 
    poultry products unless the water is an inevitable consequence of 
    the process or processes used to meet applicable food safety 
    requirements. To establish a non-zero retained water limit, an 
    inspected establishment or trade association or other group would 
    have to generate supporting data. The proposal would allow such data 
    generating studies to be conducted for an individual establishment 
    or for an industry sector using the same or similar processing 
    techniques and equipment.
        This requirement would not appear to have a significant impact 
    on the meat industry because the meat industry is already achieving 
    zero retained water. This proposal would, however, provide an 
    alternative for establishments that are having or will have trouble 
    meeting the Salmonella performance standards. These establishments 
    could utilize a full range of approved antimicrobial rinses or hot 
    water rinses without having to worry about achieving zero retained 
    water. If establishments can demonstrate that they need a non-zero 
    limit to meet the Salmonella standards, they can utilize the 
    flexibility provided by this rule and establish a new retained water 
    limit as long as they indicate the presence of retained water on 
    product labels.
        It is assumed that 500 meat establishments (10% of the 5,000 
    affected meat establishments) would conclude that they cannot meet 
    the new pathogen reduction standards without using a process that 
    results in some level of retained water. The 10% estimate is from 
    the Final RIA published with the final PR/HACCP rule (see Federal 
    Register Vol. 61, No. 144, July 25, 1966, pages 38976-38977). In 
    that analysis, FSIS referred to historical data showing control 
    problems in from 5 to 10 percent of inspected establishments. The 
    estimated 500 establishments having difficulty meeting pathogen 
    reduction standards would be required to conduct water tests to 
    establish unavoidable levels and possibly some additional Salmonella 
    tests. The analysis assumes 200 hours per establishment for water 
    tests and 100 hours to collect a sample set for Salmonella. The 
    total cost would be 150,000 hours or $3.75 million for labor and 
    another $1.2 million for 35,000 sample analyses. These estimates are 
    based on cost factors from the FRIA for the PR/HACCP rule, i.e., $25 
    an hour for a quality control manager and $34 for a laboratory 
    analysis for Salmonella. The average sample set for meat is 
    approximately 70 samples considering 82 for steer or heifer 
    carcasses and 55 for swine carcasses. The total cost for the meat 
    establishments would be an estimated $5 million. The costs for 
    Salmonella testing and the costs of using alternative processes such 
    as carcass washing systems have already been addressed in the FRIA 
    for the PR/HACCP rule in the discussion of compliance costs for 
    meeting the Salmonella standards (Federal Register reference noted 
    above). The cost of establishing water limits (100,000 hours or $2.5 
    million) would be additional costs. In return, this rule provides an 
    alternative that doesn't currently exist.
        FSIS does not consider air chilling an economically feasible 
    alternative for chilling poultry. Thus, it seems reasonable to 
    assume that the poultry industry would conclude that immersion 
    chilling is necessary to meet the existing chilling requirements for 
    poultry, e.g., 9 CFR 381.66(b)(2) requires that poultry carcasses 
    under 4 pounds shall be chilled to 40 deg. F. within 4 hours 
    following evisceration. It follows that the retained water necessary 
    to meet food safety requirements is the minimum level that can be 
    reached with existing equipment and still be in compliance with 
    chilling requirements. There is also the possibility that the 
    retained water necessary to meet the pathogen reduction performance 
    standards for Salmonella would be higher than the level necessary to 
    meet chilling requirements. The following discussion, however, 
    assumes that the unavoidable retained water levels are driven by the 
    chilling requirements.
        The Agency believes that the industry already has considerable 
    information concerning the chiller variable settings that minimize 
    water retention. The variables of concern are chiller water 
    temperature, water intake, total time in chiller and level of 
    agitation. FSIS, therefore, believes the poultry industry can 
    establish water limits for various chiller systems with minimal 
    costs. Under current regulations (9 CFR 381.66(d)), establishments 
    must conduct a 50-bird test to demonstrate that any change in 
    chilling procedures does not affect compliance with existing 
    requirements. This analysis assumes that poultry establishments 
    could establish minimum retained water levels by conducting four 10-
    bird tests at ten different chiller settings for each product 
    category. It is assumed that the average establishments would have 
    two product categories, e.g., light hens versus heavy toms. Each 
    test would take an estimated 2.5 hours to select birds, tag and 
    weigh birds, and reweigh birds after chilling. (The FSIS 10-bird 
    test takes from 40 to 60 minutes.) Time required between tests would 
    not be considered a cost. Thus, testing would cost each plant 200 
    hours or $5,000 using a quality control manager making $25 per hour. 
    The cost to 300 inspected establishments would be 60,000 hours or 
    $1.5 million. Some smaller federally inspected establishments and 
    presumably more State inspected establishments do not use immersion 
    chilling. They chill using ice and slush on processing tables/
    counters and have retained water levels below 2 percent. In the data 
    collected from the field, two chicken establishments with annual 
    production under 200,000 birds had retained water levels of 1.58% 
    and 1.7%. It is assumed these smaller establishments are at a 
    minimum level and would incur no additional cost to establish a 
    minimum. These establishments do not appear to have any variables 
    that could be studied during a water test.
        The proposal doesn't provide specific guidance on options 
    available for poultry processors that are already operating far 
    below the existing standards for Salmonella. As an illustrative 
    example, consider what options are available for a broiler slaughter 
    establishment that has an unavoidable retained water level of 5 
    percent (due to immersion chilling for time/temperature) and is 
    consistently achieving Salmonella positive levels of around 10 
    percent, well below the existing standard of 20 percent. Should this 
    establishment be able to operate at a higher retained water level if 
    data showed that the establishment could then achieve an even lower 
    level of Salmonella? Should the Agency's food safety objectives lead 
    to a solution where any level of water would be allowed if data 
    demonstrated a reduction in pathogens? While the current proposal 
    does not allow such flexibility, the Agency is requesting comment on 
    this aspect of the proposal. Under the current proposal, if FSIS 
    lowers the pathogen reduction standards as stated in the preamble to 
    the PR/HACCP rule, inspected establishments would have the option of 
    increasing retained water if appropriate tests showed that such 
    increases were unavoidable in meeting revised food safety standards.
    
    Costs of Reducing Retained Water
    
        If establishments are able to demonstrate that current levels of 
    retained water are necessary to meet food safety standards, 
    establishments would not incur costs for reducing retained water. 
    However, to the extent that establishments cannot demonstrate that 
    current retained water levels are necessary for meeting applicable 
    food safety standards, significant costs could be incurred as 
    establishments modify processes to minimize retained water levels. 
    Reducing retained water could entail a wide range of processing 
    modifications, depending on the type of chilling equipment currently 
    used and amount of retained water that would have to be removed.
        The Economic Research Service (ERS) conducted some preliminary 
    analyses to begin to establish estimates of what it might cost to 
    significantly reduce the amount of retained water in raw poultry. 
    There are three ways to reduce retained water. The first involves 
    holding poultry in refrigerated rooms until excess water has drained 
    off the birds. The second involves making adjustments in the 
    chilling process to reduce water absorption. The third involves a 
    change in the chilling system, i.e., a move to air chilling or air 
    chilling in combination with a water spray. As noted elsewhere in 
    this PRIA, FSIS does not consider requirements that would mandate 
    air chilling to be economically feasible. The existing regulations 
    for air chilling (9 CFR 381.66(e)) require the internal temperature 
    of the carcass to be reduced to 40  deg.F or less within 16 hours. 
    There are limited data on costs of air chilling. Both reconstruction 
    costs and operating costs would be high. The 1979 ERS study included 
    an estimate from an industry source that air chilling uses more 
    energy and costs about 4 cents per pound more than immersion 
    chilling. The ERS study noted that there was only one major U.S. 
    poultry processor using air chilling in 1979. A draft Impact 
    Analysis Statement conducted for the 1978 proposal to reduce water 
    use requirements for chilling stated that retail prices for air 
    chilled birds were running approximately 20 percent higher than 
    water chilled birds. That analysis attributed the higher retail 
    prices to the higher capital cost and higher operating expenses.
    
    [[Page 48979]]
    
        The simplest way of viewing the cost of reducing retained water 
    is to consider the incremental operating costs under the conditions, 
    e.g., chiller temperature, that established the minimum unavoidable 
    water. Such conditions could also involve optimizing water 
    temperature and flow through the chillers, reducing the amount of 
    agitation of the chilling medium, and reducing the ``dwell time'' of 
    poultry in the chillers. If, as some believe, lower water 
    temperature reduces water absorption, the response to tighter 
    retained water requirements will be the installation of new or 
    heavier compressors to lower the temperature in the chiller units. 
    An installed additional compressor would cost an estimated $150,000 
    per establishment, or an estimated $45 million for all 300 federally 
    inspected establishments.
        FSIS does not have a method for estimating a cost for operating 
    at conditions that establish a non-zero level of retained water 
    necessary to meet food safety requirements. As an alternative, this 
    PRIA estimates the cost of removing a substantial portion of the 
    existing water using an extended draining or dripping process. One 
    can view the estimated draining costs as an upper bound on the cost 
    of removing water. An establishment would only use draining under 
    conditions where the cost of draining was less than the incremental 
    operating costs.
        To extend draining or dripping time, many establishments would 
    have to add refrigerated facilities, purchase vats for storing birds 
    being drained, hire additional personnel, and purchase additional 
    stock handling equipment. There would be inventory costs due to 
    holding birds off the market for a longer time before shipment. 
    Holding birds at inspected establishments would also reduce the 
    corresponding retail shelf life.
        The ERS staff developed some cost estimates for holding poultry 
    based on the following industry input:
         One common method of draining uses stainless steel vats 
    at a cost of $1,000 each.
         Vats hold approximately 500 chickens or 100 turkeys.
         Cooler space costs $125 per square foot.
         Vats can be stacked two high.
         Stacked vats with aisles require 12 square feet of 
    space per vat.
         Forklifts to move vats cost $24,000 each.
    
    With the above factors in mind, one can address the questions of: 
    ``What are the fixed costs of draining a substantial amount of 
    absorbed water from poultry?''
    
        The Daily Moisture Records sometime include a record of the 
    additional drain time required. The time varies considerably 
    probably depending on the initial water level, the drain 
    configuration, and the location of the excess water, i.e., under 
    skin versus between muscle tissue or within muscle tissue. The 
    available data, for cases where young chickens were more than 1 
    percent over the limit, indicates that it can take from \1/2\ to 
    3\1/2\ hours to drain one percent. In two cases where broilers 
    exceeded the 12 percent regulatory limit by more than 4 percent, the 
    required drain time was approximately 12 hours. Program personnel 
    estimate that the drain time per percent increases as the birds 
    approach ``green weight,'' i.e., it takes longer to drain from 8 to 
    4 percent than it does from 12 to 8 percent. Thus, it seems 
    reasonable to conclude that a 12-hour drain would be the minimum 
    time required to remove most of the retained water from chickens.
        Most of the drain times for turkeys ranged from \1/2\ to 1 hour 
    on an ``hour per percentage reduction'' basis. However, two cases 
    showed drain times in the 10 to 11 hours per percentage reduction 
    range. All of the turkey violations noted were less than 1 percent 
    above the existing limit whereas some of the chickens started at 
    water levels 4 to 5 percentage points above existing limits.
        The existing data from water control efforts indicates that it 
    could take at least 12 hours to remove a substantial portion of the 
    retained water in chickens. The 12-hour estimate is based on 
    starting at a relatively high percentage and lowering the level by 4 
    to 5 percentage points. Thus, a 12-hour drain would reduce the 
    existing level from 5 to 6.5 percent by an amount less than 4 to 5 
    percentage points. To drain chickens for 12 hours is somewhat 
    equivalent to saying the industry would need to add the extra 
    capacity to drain half a day's production, since most chicken is 
    processed in establishments running two shifts.
        Since average chicken production is 29.5 million birds per day 
    (assuming a 260-day work year), half a day's production is 14.75 
    million birds. Using the above factors, this would require 29,510 
    vats at $29.5 million; 354,120 square feet of cooler space at $44.3 
    million; and $4.8 million of forklifts assuming the largest 200 
    chicken establishments would each require an additional forklift. In 
    this 12-hour case, the total fixed costs would be $78.6 million.
        Similarly, half a day's production for turkeys is 557,000 birds 
    requiring 5,570 vats at a cost of $5.57 million and cooler space at 
    a cost of $8.36 million. Assuming that the largest 70 turkey 
    establishments would require an additional forklift at a total cost 
    of $1.68 million, the total fixed costs for draining all turkeys for 
    12 hours would be $15.6 million. Thus, total fixed costs for a 12-
    hour drain for chickens and turkeys are estimated at $94.3 million.
        One can argue that large plants already have the capacity to 
    store a shift's production. This occurs today when limits are 
    exceeded. The MPI Manual provides, as an alternative to calculated 
    drain time, a 24-hour continuous drain at 40 deg. F. or below before 
    shipping. The data reviewed for this analysis included two such 
    cases. Today's excess capacity can also be viewed as a contingency 
    capacity that would still be required over and above any additional 
    capacity needed to achieve an overall water reduction.
        This analysis has not attempted to estimate the complete 
    variable costs of holding poultry to drain. Variable costs would 
    include increased labor costs, increased utility costs, increased 
    overhead, and the cost of carrying additional inventory. Holding 
    half a day's production is equivalent to continually storing a 
    wholesale value of $37 million in poultry ($19.2 billion divided by 
    520 shifts). At a 10 percent interest rate, the annual cost of 
    draining poultry for 12 hours would be $3.7 million.
        It would also seem reasonable to assume a minimum average of one 
    additional employee per establishment. Three hundred employees at 
    $21,500 per year (average wage in chicken slaughter establishments 
    of $10.34 per hour) would result in an annual operating cost of $6.4 
    million. Thus, FSIS estimates the minimum variable costs at $10.1 
    million ($3.7 million plus $6.4 million) per year if the response is 
    to drain poultry.
        The above analysis has provided an estimate of the cost of 
    reducing retained water by a ``substantial'' amount, i.e., an amount 
    that can be equaled to a 12-hour drain. Available data indicates 
    that a 12-hour drain could reduce overall water by an amount 
    somewhat less than 4 to 5 percentage points at an estimated first 
    year cost of $104.3 million ($94.2 plus $10.1 million) and recurring 
    annual costs of at least $10.1 million.
    
    Cost of Revising Labels
    
        The cost of revising labels is a relatively easy cost to 
    quantify. For previous rulemakings, FSIS has collected survey data 
    on the costs of label revisions. Labeling changes have been the 
    subject of several rulemakings in recent years.
        The proposed rule would entail a one-time change in affected raw 
    meat and poultry product labels to add a statement of the percentage 
    of retained water in the product next to the product name. 
    Establishments would have to prepare or order new product labels to 
    comply with this requirement. FSIS would allow establishments to run 
    out their stocks of existing product labels before the proposed 
    labeling requirements would take effect. The establishments would, 
    therefore, not incur costs of discarding existing label inventories.
        The cost of revising a label varies widely depending on the type 
    of label, the number of colors affected, and the printing process 
    used. Adding a water content statement is the lowest cost type of 
    modification because it involves single color printing and no 
    graphic art. The cost of revising labels is an up-front, 
    nonrecurring cost. This analysis uses an average cost of $1,000 for 
    each product label that must be modified. The cost can vary widely, 
    however. Discussions with turkey industry personnel indicate that it 
    can cost from $1,500 to $2,000 to change a label for one of the 
    opaque plastic bags used to package whole turkeys. In contrast, a 
    1992 survey conducted in conjunction with nutrition labeling 
    regulations found that many small firms use simplified labels that 
    can be revised for less than $200 per label.
        The primary impact will be on the approximately 300 federally 
    inspected and 65 State inspected establishments that slaughter and 
    pack raw poultry. Currently, 135 of the federally inspected 
    establishments are considered large entities, according to Small 
    Business Administration (SBA) criteria (establishments having more 
    than 500 employees). The cost to these ``large'' establishments of 
    changing labels is estimated at approximately $12.5 million. There 
    are another 168 federally inspected poultry establishments that 
    slaughter and
    
    [[Page 48980]]
    
    pack raw poultry. The estimated labeling cost for these 
    establishments is $5.9 million. The method for estimating these 
    costs is illustrated in Table 2.
    
      Table 2.--Costs of Revising Product Labels for Poultry Establishments 
    ------------------------------------------------------------------------
                                                                   Cost at  
                                       Number of      Average     $1,000 per
        Establishment category      establishments   number of      label   
                                                       labels       ($000)  
    ------------------------------------------------------------------------
    Large Chicken.................            115         a 100      $11,500
    Large Turkey..................             20            50        1,000
    Small Poultry.................            168            35        5,880
                                   -----------------------------------------
        Total.....................            303   ...........       18,380
    ------------------------------------------------------------------------
    a Available information indicates large chicken plants have more unique 
      labels, but many are modified by changing a retail chain specific     
      sticker on a base label. A single modification to a base label in     
      effect revises many labels.                                           
    
        There may be some labeling costs to the meat industry. Some 
    edible meat byproducts and organ meats are washed and cleaned before 
    being shipped in commerce and may be chilled or packed in water to 
    preserve their safety and wholesomeness. Tripe, for example, is 
    bleached and scalded before being shipped. Some organ meats, such as 
    chitterlings (swine intestines), are chilled and packed in water. 
    The Agency does not have any data to estimate the number of 
    establishments or number of labels affected. Similarly, the analysis 
    has not accounted for separate packaging of poultry giblets. Poultry 
    giblets, including livers, hearts, and gizzards (and necks, though 
    strictly speaking, necks are not giblets) are washed and chilled in 
    water before being packaged and shipped.
        There will also be some labeling cost to retail stores that 
    repackage raw products. They would have to apply some form of label, 
    most likely a sticker, to store packaged product that has retained 
    water. Today, most raw poultry sold from retail meat counters is 
    packaged under Federal inspection. Thus, the overall retail impact 
    should be minimal. Many large supermarkets also prepare fried 
    chicken or rotisserie chicken that is marketed through their deli 
    departments. Obviously, if they prepare the product as ready-to-eat 
    product, it would no longer have to be labeled. The same would be 
    true for products that are marinated or otherwise seasoned and 
    marketed as convenience ready-to-cook products.
    
    XI. Benefits of Proposed Rule
    
        The proposed rule provides FSIS with the necessary regulatory 
    limits to prevent economic adulteration and misbranding due to 
    excessive retained water. Preventing economic adulteration provides 
    a consumer benefit. Quantifying that benefit is beyond the scope of 
    this analysis. Another consumer benefit results from the additional 
    labeling information that would be available to household consumers 
    and other customers to help them in their purchasing decisions. As 
    noted in Section VII, customers are currently not being informed as 
    to the true price of poultry. Customers would benefit from having 
    improved knowledge of product quality, in terms of meat or poultry 
    meat content.
        The proposed rule would provide the meat industry with 
    additional flexibility for meeting pathogen reduction performance 
    standards. Meat processors would be able to utilize pathogen 
    reduction techniques without having to be concerned about meeting 
    the existing zero retained water requirement.
        This proposed rule would also provide affected establishments 
    with increased flexibility to choose the most appropriate means for 
    implementing HACCP plans for protecting the safety of raw product 
    while minimizing the potential for economic adulteration. By 
    removing certain command-and-control requirements and providing 
    increased flexibility for HACCP implementation, this proposal could 
    reduce HACCP implementation costs.
        As discussed in the background section, this proposal would 
    eliminate many requirements, including the following:
         The requirement that poultry establishments must 
    provide FSIS with a description of all chilling and freezing 
    procedures.
         The requirement that poultry establishments must notify 
    FSIS before any changes in chilling procedures are implemented and 
    provide FSIS with test results demonstrating the effectiveness of 
    any such changes.
         The existing requirements that meat carcasses cannot 
    show any weight gain resulting from the use of carcass spray 
    systems.
         The existing water intake requirements.
    
    Retail stores could benefit from reduced water. While discussions 
    with retailers indicate a primary concern with packaging that 
    doesn't leak, reduced water should help prevent leakage which leads 
    to costs of cleaning retail counters.
    
    XII. Effect on Product Quality
    
        FSIS is aware that a substantial change in retained water could 
    have an effect on product quality and performance. Certainly, 
    consumers have become accustomed to purchasing fresh poultry that is 
    very moist and presumably could have a lot less retained water and 
    still have a moist surface. FSIS is not aware of any studies 
    concerning how water level affects cooking properties, flavor, shelf 
    life, or visual attributes. Discussions with officials in the retail 
    industry indicate that they do frequently hear consumer complaints 
    concerning excess water in packages. FSIS is interested in comments 
    providing any information as to whether poultry without retained 
    water would be too dry after cooking or whether consumers would 
    select packages if the product appeared less moist or if lower water 
    would be perceived as being less fresh. Since most meat products do 
    not currently have retained water, FSIS assumes that industry would 
    conduct marketing studies that would demonstrate the viability of 
    product with added water before any production practices were 
    changed.
    
    XIII. Aggregate Market Effects
    
        Comparative statics analysis provides insight into the 
    qualitative impacts of the proposed rule on the poultry and meat 
    markets. Focusing first on the unambiguous effects on costs of 
    production it is assumed that for the moment the rule has no direct 
    effect on consumer demand. The analysis also assumes that there will 
    be no direct effect on the meat market. The rule will increase the 
    cost of production for poultry. At a minimum there will be cost 
    increases resulting from developing and conducting the protocols and 
    from adding information on water levels to the product label. Costs 
    of production will increase more if poultry plants have to undertake 
    steps to reduce water by adding new equipment, constructing 
    facilities to drain poultry or operating existing equipment at 
    higher costs. In a comparative statics analysis, higher costs of 
    production would be represented by a decrease in the supply of 
    poultry. The result in the poultry market would be a new equilibrium 
    price that would be higher and a new equilibrium quantity that would 
    be lower. There would be an effect on the meat market because meat 
    is a substitute for poultry. Higher poultry prices would lead to an 
    increased demand for meat with the result that both the new 
    equilibrium price and equilibrium quantity consumed of meat would be 
    higher. Thus, compared to the present situation, the proposed rule 
    would result in higher prices for both poultry and meat, with less 
    poultry consumed and more meat consumed.
        Consider now the direct effect of the proposed rule on demand 
    for poultry. There are two effects which may affect demand for 
    poultry. First, the rule is expected to result in drier poultry 
    being sold, that is, on average, the retained water in poultry will 
    be lower. Second, labels on retail packages of poultry will inform 
    consumers as to the
    
    [[Page 48981]]
    
    maximum retained water permitted in the plant from which the poultry 
    in a retail package was shipped. If consumers consider drier poultry 
    a desirable product quality, this would increase the demand for 
    poultry. This would lead to a higher equilibrium price for poultry. 
    However, the new equilibrium quantity consumed would be 
    indeterminate because of the simultaneous decrease in supply 
    described earlier. Again, the expected higher equilibrium price for 
    poultry will lead to new higher equilibrium price and quantity 
    consumed in the meat market.
        The effect of label information on consumer demand for poultry 
    is unclear. Consumers could react to label information showing the 
    percentage retained water by reducing demand for poultry. The 
    reasoning being that consumers will perceive the product as less 
    desirable. If this is the consumer reaction, it would work against 
    the demand increasing effect of drier poultry. In such cases 
    comparative statics analysis cannot predict unambiguously the new 
    equilibrium price and quantity consumed of poultry nor the effect on 
    the meat market. However, consumers might react to label information 
    by increasing poultry demand. An argument for this reaction is that 
    consumers have greater assurance that the package of poultry they 
    purchase is of an acceptable water level. Currently, unless 
    consumers are aware of FSIS water regulations, they have no 
    objective measure of the amount of retained water. For example, 
    consumers who perceived poultry as high in water say, 12 percent, 
    might react favorably to label information reporting a 6 percent 
    maximum and increase demand for poultry. It seems likely that 
    consumers will use label information to select among poultry 
    supplied from plants with different water limits.
        The analysis of costs considered the possibility that some meat 
    plants would not be able to meet the new pathogen reduction 
    standards without using a process that results in some level of 
    retained water. A comparative statics analysis of the meat market 
    would parallel what has been presented for poultry.
        Comparative statics analysis can provide insights into the 
    qualitative effects of changes that affect supply and demand. 
    Insights into the magnitude of these effects would require 
    quantitative specifications of supply and demand relationships that 
    incorporate the variables of interest. FSIS is not aware of 
    empirical specifications that would be applicable to analyzing this 
    rule.
        Data on the aggregate supply and use can provide additional 
    insight into the effects of this rule on the poultry and meat 
    markets. It was estimated that the cost of the proposed rule for 
    poultry was $1.5 million for establishing water limits, $104.3 
    million if plants had to reduce water, and $18.4 million for 
    revising labels. Total first year cost could be as high as $124.2 
    million. This compares to an estimated $34.5 billion spent by U.S. 
    consumers on poultry in 1997. In percentage terms, first year costs 
    would represent 0.36 percent of aggregate consumer expenditures on 
    poultry or about one half cent per pound of retail weight. In 
    subsequent years, recurring costs are $10.1 million, corresponding 
    to 0.03 percent of consumer expenditures and 0.04 cents per pound.
        Estimated costs of the rule for meat were $2.5 million for 
    establishing water levels. No quantitative estimates are provided 
    for reducing water or for labeling but these are expected to be 
    quite small. Aggregate consumer expenditures on meat are estimated 
    at $80.3 billion dollars in 1997. The quantity consumed on a retail 
    weight basis was about 30.8 billion pounds.
        The proposal is not expected to have significant impacts on 
    international trade. Like consumers, trading partners would benefit 
    from additional information that would facilitate purchasing 
    decisions. Countries exporting poultry to the United States would 
    have to have equivalent systems. Currently, annual poultry imports 
    are about 5 million pounds. Any imports containing retained water 
    would have to have product labeling indicating the presence of that 
    water.
        Foreign buyers can develop their own purchase specifications in 
    the area of retained water. FSIS is aware that one large domestic 
    customer requires that product weight be adjusted downward based on 
    the results of a 48 hour drain. In other words, if a sample of birds 
    drains ``x'' percent in 48 hours, the product weight must be reduced 
    by ``x'' percent.
    
    [FR Doc. 98-24309 Filed 9-8-98; 12:22 pm]
    BILLING CODE 3410-DM-P
    
    
    

Document Information

Published:
09/11/1998
Department:
Food Safety and Inspection Service
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
98-24309
Dates:
Comments must be received on or before December 10, 1998.
Pages:
48961-48981 (21 pages)
Docket Numbers:
Docket No. 97-054P
RINs:
0583-AC26: Retained Water in Raw Meat and Poultry Products; Poultry-Chilling Performance Standards
RIN Links:
https://www.federalregister.gov/regulations/0583-AC26/retained-water-in-raw-meat-and-poultry-products-poultry-chilling-performance-standards
PDF File:
98-24309.pdf
CFR: (3)
9 CFR 381.1
9 CFR 381.65
9 CFR 381.66