Federal Register: January 9, 2001 (Volume 66, Number 6)]
[Rules and Regulations]               
[Page 1749-1772]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja01-19]                         


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Part III

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 381 and 441

[Docket No. 97-054F]

RIN 0583-AC26

 
Retained Water in Raw Meat and Poultry Products; Poultry Chilling 
Requirements

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is issuing 
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. Raw livestock and 
poultry carcasses and parts will not be permitted to retain water 
resulting from post-evisceration processing unless the establishment 
preparing those carcasses and parts demonstrates to FSIS, with data 
collected in accordance with a written protocol, that any water 
retained in the carcasses and parts is an inevitable consequence of the 
process used to meet applicable food safety requirements. In addition, 
the establishment will be required to disclose on the labeling of the 
meat or poultry products the maximum percentage of retained water in 
the raw product. The required labeling statement will help consumers of 
raw meat and poultry products to make informed purchasing decisions. 
Establishments having data demonstrating that there is no retained 
water in their products can 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 revising 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: Effective Date: This rule is effective on January 9, 2002. 
Establishments wishing to implement the provisions of this final rule 
prior to the effective date should contact the appropriate FSIS 
District Office. FSIS will provide instructions to its inspection 
program personnel for facilitating early implementation.
    Comments: Comments on the guidance material published in Appendix A 
should be received by April 9, 2001. Comments responding to information 
requested in the preamble to this final rule should be received by FSIS 
by April 9, 2001.

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 97-054F in your comments. All 
comments submitted on this rule, as well as the 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. The final regulatory impact 
analysis referred to in this document and summarized in the section 
discussing the Agency's compliance with Executive Order 12866 is 
available for viewing on the Agency's Internet homepage located at 
``http://www.fsis.usda.gov''.

FOR FURTHER INFORMATION CONTACT: Ms. 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 prepared for distribution in commerce are wholesome, not 
adulterated, and properly marked, labeled, and packaged. The FMIA and 
PPIA prohibit anyone from selling, transporting, offering for sale or 
transportation, or receiving for transportation in commerce, of any 
adulterated or misbranded meat or poultry product (21 U.S.C. 610, 458).
    Under the Acts (21 U.S.C. 601(m)(8); 453(g)(8)), a product is 
adulterated if, among other circumstances in which it might be 
adulterated, ``any substance has been added thereto or mixed or packed 
therewith so as to increase its bulk or weight, or reduce its quality 
or strength, or make it appear better or of greater value than it is.'' 
Under the same Acts (21 U.S.C. 601(n)(1), (12) and 21 U.S.C. 453(h)(1), 
(12)) a product is misbranded if, among other circumstances in which it 
might be misbranded, ``its labeling is false or misleading in any 
particular.''
    FSIS provides continuous inspection in meat and poultry 
slaughtering and processing establishments and in egg product 
processing plants to ensure that the establishments sell in commerce 
only products that are not adulterated or misbranded. At meat and 
poultry slaughtering establishments, FSIS enforces requirements 
intended to prevent the adulteration of carcasses and parts during 
post-evisceration processing, handling, and storage. Some of these 
requirements concern the washing and chilling of the carcasses and 
parts.
    After evisceration, raw livestock and poultry carcasses are subject 
to various processes, including washing and chilling, to ensure the 
safety of the products. In livestock slaughtering establishments, air 
chilling causes 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 do not lose weight through evaporation. 
Establishments should operate water spray systems in a manner that does 
not result in an increase in the average weight of a group of livestock 
carcasses produced during a scheduled period of operations over the 
carcasses' pre-chilled weight. FSIS Directive 6330.1, which describes 
the Agency's policies on the spray-chilling of carcasses, 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.
    However, the 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. 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.

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    Unlike meat packers, 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  deg.F or less within 4 to 8 hours after slaughter, 
depending on the size of the carcass (9 CFR 381.66(b)).
    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 poultry products be minimized. FSIS is mandated to prevent the 
distribution in commerce of meat, meat food and poultry products that 
are adulterated or misbranded.
    Immersion chilling of poultry could result in a product becoming 
misbranded or economically adulterated through the retention of 
absorbed water. Nonetheless, since immersion chilling is an 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 products. The Agency requires, however, that retained 
water amounts be minimized (9 CFR 381.66(d)(1)) and has set limits on 
the amount of water a poultry product may retain (9 CFR 381.66(d)(2)-
(4)).
    The Agency promulgated regulations limiting water absorption and 
retention in poultry products in 1959, 1961, and 1970 (24 FR 9566, 
December 1, 1959; 26 FR 6471, July 19, 1961; 35 FR 15739, October 7, 
1970). The retained-water limits were based on carcass weight and 
intended use of the product. For example, higher limits were provided 
for birds that were to be cut-up than for those to be sold as whole 
birds because, when the birds are cut up, water retained at or near 
those higher limits declines below the regulatory limits for whole 
birds. If water has not been minimized, the product may be considered 
adulterated. Such product may also be considered misbranded if its 
labeling does not disclose the presence of retained water at levels 
higher than the required limits. Until a Federal court set aside the 
regulatory limits on retained water in poultry products, public 
knowledge of the limits obviated the need for a requirement for 
retained water to be disclosed on a product label. Without published 
limits on retained water, FSIS cannot adequately protect consumers from 
adulteration and misbranding due to excessive retained water in whole 
birds.
    FSIS, however, lacks information on which to decide what level, if 
any, of retained water would not constitute adulteration, or to 
determine whether the limits that are in use do not result in 
adulteration.

Provisions To Limit Retained Water in Raw Meat and Poultry Products

    On September 11, 1998, FSIS proposed regulations that would limit 
the amount of water retained by raw carcasses and parts of livestock 
and poultry as a result of post-evisceration processing, such as 
carcass washing and chilling. Under the proposal, meat and poultry 
carcasses and parts could not retain water from such processing unless 
the establishment preparing the carcasses and parts demonstrated that 
water retention is an unavoidable consequence of procedures necessary 
to meet applicable food safety requirements. FSIS also proposed to 
require that the establishment disclose on the product labeling the 
maximum percentage of retained water in the product. The labeling 
statement would provide information that would be helpful to consumers 
in making purchasing decisions. An establishment having data 
demonstrating that there is no retained water in the 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. The proposed 
requirements were intended to replace those set forth in 9 CFR 
381.66(d)(2)-(8). The purpose of the proposed requirements was to 
restrict, as much as feasible, the amount of water absorbed and 
retained in raw meat and poultry products.
    The proposed rule was prompted by longstanding industry petitions 
and by the Agency's need to reform its regulations to make them more 
consistent with its Pathogen Reduction/Hazard Analysis and Critical 
Control Point System (PR/HACCP) regulations, in accordance with its 
regulatory reform agenda. The rulemaking gained further impetus in the 
wake of a July 23, 1997, Federal court decision in Kenney v. Glickman 
vacating the regulations in 9 CFR 381.66(d)(2) that contain the water-
retention tables for poultry.
    As explained above, FSIS has consistently required that the 
retention of water in meat and poultry be minimized and has considered 
product with too much retained water to be adulterated. FSIS used the 
retained water limits specified in Sec. 381.66(d)(2) to determine 
whether poultry establishments were meeting the requirement to minimize 
water absorption and absorption and retention in whole birds. The 
decision in Kenney v. Glickman, however, removed this regulation 
because its basis was inadequate, and left the Agency without a 
regulatory limit, greater than zero percent, at or below which it could 
consider retained water in whole poultry to have been minimized. The 
limits for cut-up or ice-pack poultry in 9 CFR 381.66(d)(3)-(6)) were 
unaffected by the Court decision. This final rule replaces retained 
water limits that have been set out in the regulations with a 
requirement that products not retain water unless establishments 
demonstrate that the retained water is an unavoidable consequence of 
meeting food safety requirements.
    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. Even in operations that yield raw product 
with zero-percent retained water, there is a certain amount of process 
variability. FSIS therefore proposed 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 expected 
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 said in the proposal that it 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 Agency stated that 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

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are processed match those specified in the protocol used to justify the 
limit.

Comments

    FSIS received 252 letters commenting on the proposed rule. Most 
were from members of the regulated industry. Sixty-one were from 
companies, company officials, or other individuals associated with the 
meat industry, or trade associations representing the industry, 
including both producers and packers. One hundred and sixty-nine were 
from companies, company officials or other individuals associated with 
the poultry industry, or from trade associations representing the 
industry, including both producers and processors. The rest were sent 
in by consumer-advocacy groups and other consumer-oriented 
organizations (3), individual consumers (7), weights and measures 
officials (7), a trade association not exclusively concerned with meat 
and poultry (1), technology firms (3), and the European Union. 
Consumers, consumer groups, and commenters representing livestock 
producer and meat packing interests tended to favor the proposal or to 
criticize it for not going far enough in restricting water retention. 
Poultry interests tended to oppose the proposal or to favor extensive 
modifications. Technology firms were divided on the merits of the 
proposal and on processes for improving food safety.
    Comment summaries (each termed ``Comment'') by topic and Agency 
responses follow:

Alleged Inequitable Regulatory Treatment

    Comment: Meat industry groups said that FSIS must eliminate the 
substantial inequity in the regulatory treatment of meat, compared with 
the treatment of poultry. They said that requirements for chilling meat 
and poultry products must be the same. The ``equity'' issue, they said, 
remains unresolved by the proposal, and that FSIS is maintaining the 
status quo without offering compelling food safety reasons for doing 
so. Poultry chilling, they said, should be subject to the same 
``rigorous requirements'' as those that apply to the chilling of meat. 
The rule should be science-based, equitable, and HACCP-consistent.
    On the other side, poultry groups said that the proposal does not 
treat poultry equitably with meat. They said that the meat industry 
uses spray chilling and does not have to adhere to chilling time/
temperature requirements as does the poultry industry. Moreover, they 
said, organ meats are chilled in water without regulatory limitation.
    Poultry groups also suggested that the proposed regulations may not 
apply equally to livestock and poultry parts. They said that ``parts'' 
in the meat regulations has a connotation different from that of 
``parts'' in the poultry regulations. They asserted that there are few 
proposed changes that would affect the chilling and labeling of meats.
    Response: FSIS disagrees that it is not resolving the ``equity'' 
issue. This rulemaking clearly applies to both meat and poultry 
products. Both meat and poultry establishments must abide by the 
retained-water minimization requirements of this final rule. Also, the 
retained-water labeling requirement will make both meat and poultry 
product establishments accountable to consumers for water retention.
    The point of the poultry industry commenters with respect to the 
spray chilling of meat carcasses is well taken, and it is true that 
meat carcasses do not have to meet chilling time/temperature 
requirements as do poultry carcasses.
    FSIS acknowledges the need to address the issue involving the 
chilling time and temperature requirements for poultry that were raised 
in both the American Meat Institute's 1997 petition and industry 
comments on this rulemaking. However, as the Agency indicated in the 
preamble to the proposed rule (63 FR 48963, 48965), FSIS did not intend 
to address this issue in this but in a future rulemaking.
    FSIS does not agree with the poultry industry statement about the 
meaning of ``parts'' in the meat and poultry regulations, nor does the 
Agency see the relevance of the point to this rule. Raw, single-
ingredient meat and poultry products, including parts of either meat or 
poultry carcasses, are covered. Some products of the meat industry that 
previously have not been covered by a retained-water regulation, e.g. 
livestock organs and offal, are now covered by this rule--a fact to 
which members of the meat industry have objected.
    If applying ``the same rigorous requirements'' to poultry as to 
meat means requiring the poultry industry to adopt non-immersion-
chilling methods, this final rule will not accomplish that objective. 
The food safety rationale for mandating the use of a particular 
technology has not been demonstrated.
    Comment: FSIS is biased in favor of the poultry industry when it 
states that immersion chilling reduces overall pathogen levels. There 
are other ways to reduce pathogens. The Agency is particularly biased 
in stating that installing air chilling or air-spray systems in the 
poultry industry would be economically infeasible.
    Response: FSIS acknowledges that pre-chill treatments can be 
advantageous in controlling bacteria and in achieving the objectives of 
the rulemaking. FSIS has never suggested, however, that the purpose of 
immersion chilling is to remove pathogens, but has stated that chilling 
reduces the temperature of the carcass and thus inhibits the growth of 
pathogens and other bacteria. FSIS stated in the Preliminary Regulatory 
Impact Analysis (PRIA) that requiring the poultry industry to install 
air chilling or air-spray chilling systems would entail major 
construction costs (63 FR 48976). FSIS does not consider this 
conclusion of its analysis to be evidence of bias.
    Comment: Poultry has been immersion-chilled for decades. The 
poultry and meat industries are different and should be regulated 
differently.
    Response: Different technologies may be needed to produce safe 
products from different species. FSIS is not banning or discouraging 
the use of immersion-chilling technologies to produce safe poultry 
products. The Agency is obligated, however, to take the same regulatory 
approach to meat as to poultry products, unless it finds, based on the 
available record, that different approaches are necessary.

Technology of Chilling and Bacterial Control

    Comment: FSIS should encourage investment in technology adjustments 
that prevent water retention in poultry. The meat industry uses steam 
vacuum and steam-and-hot-water pasteurization without adding water 
weight via water retention in carcasses.
    Response: By requiring establishments to justify unavoidable 
retained water in food safety terms and to apply retained-water 
labeling to their products, the final rule will provide an incentive 
for technological adjustments that minimize water retention in 
carcasses.
    Comment: Consumer groups and meat industry commenters asserted that 
FSIS has failed to consider the most recent information on the 
effectiveness of chilling technologies other than immersion chilling. 
They said FSIS seemed to dismiss air chilling because it could result 
in product discoloration. Some noted that European processors use air 
chilling, which does not have the cross-contamination risks of chiller 
baths.
    Response: In framing the proposed regulation, FSIS did not assume 
that immersion chilling will be the technology of choice for either the 
meat or the poultry product industry.

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    FSIS has taken no position on the safety or quality of air-chilled 
product but has limited data on the effectiveness of air chilling, 
especially in large-scale operations of the kind that supply most of 
the poultry products sold in the United States.
    Comment: Immersion chilling is the best way to prevent potential 
food safety problems. Using chilled water is the most efficient, 
effective way to remove carcass heat and is the best way to achieve the 
purposes of HACCP. One company reported data on post-chill compared 
with pre-chill carcasses that show a 73-percent reduction in pathogenic 
organisms and an 85-percent reduction in generic E. coli. After a 
trisodium phosphate (TSP) carcass-rinse treatment, the incidence of 
Salmonella and E. coli is 0 percent. (Carcasses not rinsed with TSP 
show 96 percent and 30 percent, respectively. Campylobacter was found 
in 78 percent of untreated carcasses, and in 46 percent after TSP 
treatment.) The company maintained that air-chilling methods are not so 
effective, but that immersion chilling is an effective and economical 
way to meet the USDA time/temperature requirement.
    Response: FSIS appreciates the food safety accomplishments of firms 
using any post-evisceration processes, but consumer protections other 
than food safety must also be ensured. Although immersion chilling can 
be effective in controlling microbial growth, products exposed to the 
process will retain water. This final rule is intended to address this 
problem.
    Comment: A poultry processor who uses air chilling stated that air 
chilling is economically feasible. Analysis of retail prices shows air-
chilled poultry yields 7 to 8 percent more poultry meat to the consumer 
than does water-chilled poultry.
    Response: FSIS is not endorsing the use by the regulated industry 
of a particular technology.
    Comment: Consumer groups cited recent studies, including a 1987 
conference paper by C.J. Thomas, et al., and a 1997 paper by M. Ristic, 
as evidence of the advantages of air-chilling technology.
    Response: The paper by C.J. Thomas et al. refers only in passing, 
in a question-and-answer section, to an increasing use of air-chilling 
processes. The paper is not really about air chilling.
    The Ristic (1997) paper cited by the commenters and other studies 
by the same author have consistently shown air-spray chilling to have 
certain advantages over other methods. The studies do not compare the 
feasibility of air-spray chilling with that of other chilling 
technologies in an industry with a production volume as high as that in 
the United States, nor do they provide a basis for regulatory action 
with respect to one or another technology.
    Comment: A European Union official asked if there are scientific 
studies that support immersion chilling, rather than air-spray 
chilling, of livestock carcasses.
    Response: FSIS is not aware of any peer-reviewed study on the 
water-immersion chilling of whole livestock carcasses. Among studies on 
the efficacy of livestock-carcass spray chilling, including systems 
using anti-microbial solutions, are:
    Gill, C.O., and T. Jones, 1992. Assessment of the hygienic 
efficiencies of two commercial processes for cooling pig carcasses. 
Food Microbiology 9(4):335-343.
    Gill, C.O., and J. Bryant, 1997. Assessment of the hygienic 
performances of two beef carcass cooling processes from product 
temperature history data or enumeration of bacteria on carcass 
surfaces, 1997. Food Microbiology 14(6):593-602.
    Gill, C.O., and T. Jones, 1997. Assessment of the hygienic 
performance of an air-cooling process for lamb carcasses and a spray-
cooling process for pig carcasses. International Journal of Food 
Microbiology, 38(\2/3\):85-93.
    Grier, G.G., and B.D. Dills, 1988. Bacteriology and retail case 
life of spray-chilled pork. Canadian Institute of Food Science and 
Technology journal 21:295-299.
    Hamby, P.L., J.W. Savell, G.R. Acuff, C. Vanderzant, and H.R. 
Cross, 1987. Spray-chilling and carcass decontamination systems using 
lactic and acetic acid. Meat Science 21:1-14.
    Jericho, K.W.F., G. O'Laney, and G.C. Kozub, 1998. Verification of 
the hygienic adequacy of beef carcass cooling processes by 
microbiological culture and the temperature-function integration 
technique. Journal of Food Protection 61(10):1347-1351.
    Stevenson, K.E., R.A. Merkel, and H.C. Lee, 1978. Effects of 
chilling rate, carcass fatness, and chlorine spray on microbiological 
quality and case-life of beef. Journal of Food Science 43:849-852.
    Comment: The ozonation process achieves significant E. coli 
reductions on carcasses sampled at post-chill. Any rule permitting 
immersion chillers to use ozonation should be supported.
    Response: If it is true that ozonation reduces generic E. coli 
populations, establishments may find the process useful in meeting 
requirements of the PR/HACCP regulations. The FSIS regulations do not 
prohibit use of ozonation equipment with immersion chillers. However, 
the Food and Drug Administration must approve the use of ozone for food 
processing purposes before FSIS can allow it.

Time/Temperature Chilling Requirement for Poultry

    Comment: Some commenters disputed the FSIS statement 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 (for poultry to 
reach a temperature 40  deg.F or below within a specified number of 
hours).'' They stated that the poultry chilling requirement (9 CFR 
381.66(b)(2)) is a command-and-control regulation that the final rule 
should eliminate. Commenters favoring both the meat-industry and the 
poultry-industry sides of the water-retention issue argued for 
immediate repeal of the poultry chilling requirement. Some even thought 
the proposal was premature and should be withdrawn because it did not 
address this matter.
    Response: FSIS views the poultry time/temperature 40  deg.F 
chilling requirement as a food safety performance-standard issue that 
would best be addressed in a separate notice-and-comment rulemaking, 
which the Agency plans to conduct. The Agency believes that any 
performance standard that might replace the 40  deg.F requirement 
should be science-based, HACCP-consistent, and applicable to all 
species subject to mandatory inspection. The Agency is continuing to 
study this matter and hopes to be able to propose regulatory amendments 
in the coming months. In the meantime, FSIS will permit establishments 
to vary the parameters of their chilling or other processing operations 
as necessary to meet the objectives of their data collection protocols.

Product Quality Argument ``Arbitrary and Capricious''

    Comment: The product-quality-based water-weight allowance is 
arbitrary and capricious, claimed the plaintiffs in the Kenney case. 
Quality is no problem in Europe, where poultry is air-chilled or air-
spray-chilled. Adding water is adding an ingredient to make a multi-
ingredient product. The product should be labeled to show the amount of 
retained water that is necessary for food safety purposes and the 
amount that is necessary for food-quality purposes.
    Response: The commenters' criticism is unwarranted. This rule is 
primarily

[[Page 1754]]

intended to limit water retention resulting from processing to the 
amount that is unavoidable to achieve a food safety objective. However, 
FSIS has stated that, in their data collection protocols, 
establishments may specify determining product quality as a secondary 
or tertiary purpose of the data collection activity. This rulemaking 
does not provide for an additional retained-water amount that an 
establishment may consider necessary to maintain product quality.
    Ready-to-cook poultry in Europe is dryer than ready-to-cook poultry 
in the United States. Whether United States consumers will eventually 
demand poultry that is similar to the European product is a question 
that can be answered by the market.
    FSIS does not agree with the statement that water should be 
considered an ingredient in immersion-chilled poultry products. Water 
is not added to the products being chilled to create new products.

Zero Retained Water

    Comment: Various commenters supported a zero-retained-water 
standard for both meat and poultry products. They said FSIS was wrong 
to reject, as a reason for a zero-retained-water standard, the argument 
that the information benefit to consumers is unlikely to exceed costs.
    Consumer groups commented that FSIS's own figures show consumers 
pay almost $1 billion/year for retained water in poultry. They said 
FSIS should be proposing zero retained water, and that neither meat nor 
poultry products should be allowed to gain water. The proposal falls 
well short of what is needed, they said, strongly preferring Option 2 
(zero retained water) in the regulatory analysis to Option 6 (retained 
water limits established by processes necessary to meet food safety 
requirements--the selected option). They said FSIS should reconsider 
Options 2 and 4 (retained water limits based on best available 
technology within traditional production practices).
    Response: Mandating zero water retention for the poultry industry 
would be tantamount to requiring the re-tooling of the industry on an 
economically prohibitive scale. FSIS calculated that the resulting 
benefit to consumers, an informational benefit, would be slight in 
comparison to the impact on the national economy. The Agency calculated 
that consumers could receive a desirable informational benefit at a 
lower cost to society.
    The proposal did not specify any acceptable amount of retained 
water, only that any amount that is retained be no greater than the 
unavoidable amount resulting from post-evisceration processing to 
achieve regulatory food safety requirements.
    In the PRIA, FSIS suggested that the value of poultry production 
could be viewed as the production of poultry and the production of 
water. The Agency also said that another view was that the water has no 
effect on the price of poultry meat, but that the consumer is simply 
not being informed of the wholesale-price of poultry or turkey on a 
zero-added-water basis. The Agency's concern in much of the PRIA was 
the effect of full disclosure of retained water on consumer purchasing. 
The Agency concluded that this effect was unclear, though beneficial. 
The Agency did not take the position that water is literally being sold 
at poultry prices.
    In the FRIA, the Agency has not attempted to quantify the overall 
benefits of the rule. However, FSIS rejected Option 2 and Option 4 
because the costs to industry would be substantially disproportionate 
to consumer benefits.
    This rule will ensure that water retention is limited to the amount 
unavoidable for food safety reasons, and that consumers are informed 
about this water retention. In establishing zero water retention as the 
default requirement, the rule compels the industry to justify 
scientifically any amount of water retention in raw, single-ingredient, 
meat or poultry product. Water in excess of the amount that is 
scientifically justified will adulterate the product.
    Comment: Individual commenters generally supported the proposal on 
the ground that consumers would not purchase meat containing too much 
water. Some even thought the Agency should permit zero-percent retained 
water. Commenters said they do not know the exact water weight of 
poultry product because it is not labeled. Some said that added water 
in curing or other processing is a consumer rip-off. One commenter said 
immersion-chilling water is a ``fecal soup'' in which poultry are 
marinated.
    Response: FSIS appreciates commenters' support for the general 
direction of this rulemaking. The Agency disagrees with the 
characterization of poultry chillers because the chillers efficiently 
reduce carcass temperatures and slow microbial growth. FSIS also 
disagrees that this rule should impose an unconditional limit of zero-
percent retained water in raw meat and poultry products. Regarding 
added water in cured products, curing is outside the scope of the 
rulemaking. In any event, if a product that contains a curing solution 
weighs more than it did in the untreated state, that fact must be 
reflected on the product label.
    Comment: A commenter with a veterinary background claimed that 
continuous chillers are insanitary common baths to which there are 
economically feasible alternatives. These alternatives--chilling 
tunnels, chill-spray conveyor lines, immersion-chilled vacuum-packaged 
product--should be explored, said the commenter. Other alternatives are 
unsatisfactory. Radiation treatments are not wholly effective.
    The commenter stated that irradiation at doses lower than those 
resulting in off-odors yields spore formers like C. botulinum Type C. 
Irradiation kills spoilage bacteria that can be indicators of 
unwholesomeness.
    As for antimicrobial interventions used with immersion chillers, 
chlorination of chiller water is not entirely effective and forms toxic 
organochlorine compounds that have environmental impacts. Phosphates 
used in post-chill dips facilitate water retention.
    Eliminating retained water in poultry would ``correct a consumer 
fraud and [an] advantage poultry has over other parts of the food 
industry.'' The result of imposing regulatory limits on water retention 
after continuous chillers were introduced was to allow the poultry 
industry to sell ``legally adulterated product.''
    Response: Studies do not bear out the feasibility of using 
technologies other than immersion chilling that would achieve the same 
food safety benefit on the same scale. FSIS is not aware of any 
technology other than food irradiation that is 100-percent effective in 
eliminating pathogens on raw meat or poultry products. Irradiated 
product generally is not shelf-stable. Through proper control, 
sufficient numbers of spoilage organisms remain to successfully compete 
against outgrowth of C. botulinum.
    Regarding chlorination, FSIS agrees that organochloride compounds 
form in chlorinated poultry chill water. Nevertheless, FSIS considers 
the potential food safety benefits of chlorination to outweigh the 
risks.
    The adulteration hazard of phosphates (extra water pick-up) that 
are used on raw products is exaggerated for two reasons. First, some 
phosphate compounds, such as orthophosphate dips, have been approved 
for use on raw products but are not in general use. Second, the 
treatment of raw products with such anti-microbial phosphate solutions 
as TSP should not be equated

[[Page 1755]]

with the addition of phosphate compounds to pickle-cured meat products 
to reduce the amount of cooked out juices. Such food additives become 
components of the products and do cause the products to hold water.
    On the charge that regulatory water retention limits constitute 
legalized adulteration and a fraud, the Agency points out that the 
water retention that it is allowing would have to be disclosed on the 
label. Therefore, there would be no fraud. The Agency also believes 
that in appropriate circumstances, it could determine that some water 
retention is necessary, is unavoidable, and would not need to be 
disclosed. However, those circumstances have not been established in 
this rulemaking.

Data-Collection Protocol Requirement

    Comment: Requiring an establishment-generated data-collection 
protocol for determining minimum unavoidable retained moisture would be 
arbitrary and capricious. FSIS has failed to articulate uniform 
criteria for such a protocol or a process for review of protocols.
    Response: FSIS does not have the data necessary to set a regulatory 
limit on the amount of moisture a raw, single-ingredient product may 
retain. FSIS has put the burden of developing data to justify a level 
of retained water other than zero on official establishments because 
they are in the best position to determine what they have to do 
simultaneously to meet food safety requirements and to minimize 
retained water in their products. FSIS published suggested protocol 
specifications for comment on December 9, 1997 (62 FR 64767), and a 
list of expected elements of protocols with the proposed rule. The 
Agency received few comments on the expected protocol elements. These 
elements of protocol design give industry flexibility in collecting 
data that will be useful in determining water-retention limits on an 
establishment-by-establishment or industry-wide basis.
    Regarding protocol review procedures, as discussed below, in 
response to comments, the Agency has decided not to pre-approve the 
data collection protocols establishments will use because to do so 
would contradict its regulatory policy which is opposed to command-and-
control regulation.
    Comment: The proposal, with its requirement for data-collection 
protocols to be pre-approved by FSIS, represents a return to command-
and-control regulation.
    Response: FSIS proposed that it review the data-collection 
protocols because of the need to ensure a degree of uniformity in and 
scientific validity of data-collection procedures for establishing the 
amount of unavoidable water retention. FSIS agrees with the commenter, 
however, that the proposed pre-approval of protocols would be a 
command-and-control requirement. The Agency, therefore, will not be 
pre-approving such protocols. FSIS is requiring, however, that an 
establishment notify the Agency as soon as the protocol is available 
for review. FSIS will then have 30 days in which it may object to or 
require changes in the protocol.
    Comment: A poultry industry association opposed ``pre-clearance of 
retained water after pre-clearance of data protocols.''
    Response: As stated in the preamble of the proposal (at 63 FR 
48964), the labels with the retained-water statements will be 
generically approved pursuant to 9 CFR 317.5(b)(2) and 381.133(b)(2). 
Generically approved labels may be used without being submitted to the 
Agency for approval provided that they show all mandatory features and 
are not false or misleading. FSIS samples generically approved labels 
at establishments to determine their compliance with labeling 
requirements. With respect to labels with retained-water statements, 
the Agency may, from time to time, examine the data collected by 
establishments to ensure that the basis for label statements is sound. 
The Agency, however, will not pre-approve either the data or the water-
retention limits the data are purported to justify.

Protocol Approval Process

    Comment: A European Union official suggested that FSIS clarify the 
protocol approval process: Would the establishment, after it is 
recognized as eligible, have to ``submit systematically a dossier'' on 
final treatment of livestock and poultry carcasses and parts?
    Response: Foreign establishments recognized as eligible to export 
to the United States will not have to submit a dossier to FSIS on water 
retention. However, they will have to maintain a file containing data 
that demonstrate either that the product they ship contains no retained 
water, or that it contains no more than the amount that is stated on 
the product label and that such amount is no greater than the amount 
that is unavoidable in achieving food safety objectives. The data must 
be collected under a protocol that is acceptable to the foreign 
government.

Process for Determining Amount of Unavoidable Retained Water

    Comment: FSIS should more fully describe the process for 
demonstrating that retained water is unavoidable.
    Response: FSIS is not prescribing a method for determining the 
unavoidable amount of retained water. Each establishment should be able 
to choose the method that is most appropriate for its processing 
situation. However, a slaughtering establishment should consider 
varying its process in whatever manner seems most likely to reduce 
carcass microbial counts and maintain them at a low level. The 
establishment should then measure the water retention amounts 
corresponding to the respective microbial reductions. A series of 
trials to achieve pathogen reduction by running chilling equipment at 
different settings, making other process changes, and plotting the 
microbial and water-retention data, should show what the retained water 
levels in the product were when any observed increase or decrease in 
microbial counts occurred.
    The establishment might consider plotting available E. coli 
process-control data, or Salmonella or other microbial data that it has 
collected, on a time chart with water-retention data collected on the 
same product on the same dates. It should then be possible to observe 
the retained-water levels corresponding to microbial counts on the same 
products. From this information, an establishment should be able to 
determine what is the unavoidable level of retained water that 
corresponds to the lowest microbial counts.
    FSIS is not prescribing any particular method for establishments to 
use to determine the amount of retained water in their products. A 
number of chemical and physical methods are available for determining 
the amount of moisture in foods, such as the method described in 
Appendix A of this document.

Retained-Water Limits

    Comment: There is no connection between water retention and HACCP.
    Response: Although this rulemaking is intended to establish a basis 
for controlling retained water in raw meat and poultry products, it is 
understood that retained water is an unavoidable consequence of certain 
processes commonly used to achieve food safety objectives, such as 
immersing chickens as a means of lowering the temperature of carcasses 
while limiting the opportunity for pathogen growth. This objective 
derives from the need to meet the pathogen reduction performance 
standard, a food safety requirement that must be met (63 FR 48963). 
While the

[[Page 1756]]

Agency does not prescribe the critical control points or critical 
limits that establishments must include in their HACCP plans, the 
failure by an establishment to meet the pathogen-reduction performance 
standards constitutes failure to maintain an adequate HACCP plan (9 CFR 
310.25(b)(3)(iii), 381.94(b)(3)(iii)). Thus, there is a relationship 
between this rule and HACCP.
    Comment: It is difficult to predict with precision the amount of 
water that may be retained. It would be difficult for the industry to 
devise protocols and guidelines necessary to comply with the proposed 
rule. Changes in systems would require changes in protocols, which 
would have to be resubmitted for approval to the Agency. This 
requirement would be burdensome to the industry and the Agency.
    Response: Under this final rule, FSIS may review, but will not pre-
approve, data-collection protocols developed by establishments. FSIS 
does not expect the development and use of a data-collection protocol 
for determining unavoidable water retention to be continuous. In most 
cases, protocol development will be largely a one-time-only expense. 
FSIS is taking a flexible approach toward the data-collection 
protocols. FSIS understands that there are many factors that determine 
water retention. If variables in the model used in a protocol changed, 
FSIS would not necessarily expect a whole new protocol to be developed. 
The Agency is mainly interested in knowing that the protocols are 
scientifically valid, that the data collected under them will reflect 
water-retention amounts that are unavoidable, and that the data support 
the water-retention statements on product labeling. For this reason, 
FSIS is requiring that an establishment make its new or revised 
protocol available for review by the Agency, but FSIS will not be pre-
approving the protocol.
    Comment: The proposed requirements for limiting water retention and 
labeling the amount of retained water are redundant. If there is a 
labeling requirement, there should be no requirement for industry to 
limit water retention. If there is a water-retention requirement, there 
is no need for a labeling requirement.
    Response: The retained water minimization and labeling requirements 
are not redundant but address two different legal prohibitions--
adulteration and misbranding. This rule is intended to prevent 
adulteration and misbranding of raw meat and poultry products by 
ensuring that water retention in the products is minimized and by 
improving the availability of information on water retention. The 
retained-water minimization requirement stems from the Agency's long-
held view that excessive water retention is a form of product 
adulteration. The labeling requirement is intended to help prevent 
misbranding. It is intended to help prevent potential buyers from being 
misled about a characteristic of the product--retained water--by 
providing them with information about the characteristic. Product 
labeling is one of the most useful ways to provide such information. 
The labeling requirement is especially necessary in the wake of the 
U.S. Court decision in Kenney which, by setting aside the regulations 
that prescribed limits for water retention in ready-to-cook whole 
poultry, left consumers without any information that retained water was 
being held below a certain maximum percentage.
    Simply imposing a regulation that limited water retention would not 
inform consumers of the retained water content of products unless 
specific water retention limits were clearly presented in the 
regulation. For reasons discussed elsewhere in this document, FSIS has 
found that it is not in a position to impose such a regulation. On the 
other hand, simply requiring labeling would not be consistent with the 
adulteration provisions of the FMIA and PPIA. Unlimited retained water 
would constitute economic adulteration even if identified through 
labeling.
    If an outcome of this rule were that no raw, single-ingredient meat 
or poultry product retained any water from processing, a labeling 
requirement might eventually be unnecessary.
    Comment: A weights and measures official said, regarding FSIS's 
view that ``excessive'' water retention may constitute adulteration, 
that the proposal did not limit water in raw, single-ingredient 
products but only required a more technical justification.
    Response: The final rule clearly does limit water retention. The 
rule does not flatly mandate zero-percent water retention, but requires 
a demonstration that any water retention is unavoidable. Any retained-
water percentage greater than zero percent will be considered excessive 
unless the percentage is justified by data collected under a valid 
protocol.

Food Safety Requirements

    Comment: FSIS must identify the food safety requirements to be met 
in the post-evisceration or chilling process.
    Response: In the PR/HACCP regulations, FSIS has identified process-
control criteria and pathogen-reduction performance standards that 
establishments must meet. In the expected elements published with the 
proposed rule on retained water, FSIS stated its preference concerning 
the purpose of a data-collection protocol: To determine the amount or 
percentage of moisture absorption and retention that is unavoidable 
using a particular chilling system while achieving the pathogen-
reduction performance standard for Salmonella. In conducting hazard 
analyses and developing their HACCP plans, establishments may identify 
additional or other food safety objectives. It has been unnecessary in 
this rulemaking to set out further food safety requirements.

Retained-Water Labeling

    Comment: Poultry industry commenters suggested that the retained-
water labeling requirement was a punishment for using the most 
effective techniques. Some thought the retained-water labeling 
provision might decrease consumer demand for the labeled products.
    Response: FSIS has an obligation to balance the interests in any 
situation. While it is true that any water that will be declared on the 
label will be the unavoidable result of an effective process, it is 
also true that the misbranding and economic adulteration provisions of 
the FMIA and PPIA make clear the obligation of producers raw meat or 
poultry products not to mislead consumers. FSIS thinks that if they 
market as meat or poultry a product that contains something other than 
meat or poultry, that fact should be disclosed. Comments received in 
response to the proposal are inconclusive on how consumers will regard 
product with labeled retained-water amounts, although consumer advocacy 
groups and some individual commenters favored the labeling proposal.
    Comment: Plaintiffs in Kenney opposed the proposed labeling 
provision, saying it would only be sanctioning the reporting of illegal 
water retention.
    Response: FSIS disagrees. The Court in the Kenney case held that, 
under the PPIA, the Secretary of Agriculture had the authority to 
require labeling of the amount of retained water in and to define a 
poultry product. (Kenney v. Glickman, No. 4-94-CV-10402 (S.D. Iowa, 
Jul. 23, 1997) (order granting plaintiff and respondent motions for 
summary judgment) at pp.12, 13.)
    Comment: A turkey processor said that the proposal would create a 
bag-printing headache for the poultry industry because turkey 
processors ship many products under private-label brands.

[[Page 1757]]

    Response: FSIS does not foresee a problem in this regard. The 
purchasing specifications provided by firms for which processed birds 
are prepared cannot be lower than the minimum water retention of which 
the processor's technology is capable. The processor should be able to 
order or produce bags labeled with a retained-water statement that 
routinely complies with the regulation.
    Comment: Industry groups suggested that if labeling is needed, a 
percent-retained-water statement could be either in the product name or 
in the ingredient statement, or the retained moisture could be 
reflected in nutrition labeling of the product.
    Response: Placing the retained-water statement in an ingredient 
statement would imply that the product is fabricated of more than one 
ingredient. This implication would be misleading, because the water 
that would be listed in the ingredient statement is retained from 
processing and not literally added to the product to create a new meat 
or poultry product.
    FSIS also does not agree that nutrition labeling can be used. 
First, assuming that retained water could be regarded as part of the 
product, and that the nutrition labeling were accurate, few consumers 
would notice changes in the percentages of protein, fat, or other 
nutrients resulting from a change in the percentage of retained water 
in the product. Also, a retained water statement in a nutrition facts 
panel would not be as conspicuous as one on the principal display 
panel. Moreover, because nutrition labeling of single-ingredient 
products is still voluntary, relatively few consumers of such products 
would have the advantage of even the limited amount of information on 
water retention that nutrition labels could convey.
    Comment: A local weights and measures agency stated that percent-
retained-water labeling should be standardized and placed in a uniform 
location on the package.
    Response: FSIS wants to be as flexible as possible, consistent with 
the objective of informing the consumer of the amount and presence of 
retained water in affected product. The Agency is requiring that the 
retained water statement be contiguous to the product name or elsewhere 
on the principal display panel of the label.
    Comment: Several companies and groups wrote that if FSIS insists on 
a labeling requirement, it should apply only to processor-packaged 
product intended for sale to consumers at retail. The final rule should 
exempt from the labeling requirement products intended for export, 
products shipped in bulk for further processing, and product to be sold 
to institutions and food-service operations.
    Response: The commenters appear to be alluding to exemptions in the 
FSIS nutrition labeling regulations for products intended for further 
processing, certain products that are not for sale to consumers, 
products intended for export, certain products sold at retail stores, 
and items on restaurant menus (9 CFR 317.400(a)(2), (3), (6), (7); 
381.500(a)(2), (3), (6), (7)). Those regulations were intended to be 
consistent with the aim of the Nutrition Labeling and Education Act and 
regulations implemented by the Food and Drug Administration, to assist 
consumers in maintaining healthy dietary practices. The preamble to the 
FSIS nutrition labeling final rule states the Agency's goal of 
providing consumers with more accurate and complete nutritional 
information (58 FR 635; January 3, 1993). In response to comments on 
its nutrition labeling proposed rule, FSIS did provide exemptions in 
the final rule of the sort the commenter refers to, on the ground that 
there was little value in requiring nutrition information where the 
consumer will not see it (58 FR 639).
    However, unlike the nutrition labeling regulations, this final rule 
is intended to provide information directly both to household consumers 
and to large purchasers of meat and poultry products. Product shipped 
in bulk should be labeled accurately to ensure accurate formulation of 
further-processed products. Also, product shipped to institutions and 
food-service operations should be labeled with the same accuracy as 
product shipped to household consumers.
    On the matter of exported product, the industry does not produce, 
and FSIS does not regulate, a separate class of raw, single-ingredient, 
meat or poultry product for export to which this rule would not 
appropriately be applicable. Thus, FSIS disagrees that export product 
should be subject to retained-water labeling requirements different 
from those to which product for domestic sale is subject.
    Comment: The proposed retained-water labeling requirement should be 
adopted immediately.
    Response: FSIS appreciates the support for the labeling provision 
of the proposal. The Agency, however, is setting the effective date of 
the final rule at 1 year following publication of the rule in the 
Federal Register to mitigate the effects of the rule on 
establishments--particularly those that are considered small businesses 
under Small Business Administration criteria--that may have to consider 
changing or updating their chilling processes and equipment.
    This 1-year pre-implementation period will enable FSIS to prepare 
sampling, testing, and document review procedures; train Agency 
personnel in the new procedures; and develop a new national reference 
database on the natural moisture content of raw products in the various 
meat and poultry product classes. However, establishments can 
voluntarily implement the provisions of this rule in advance of the 
effective date.
    Comment: A local weights and measures official commented that the 
labeled water retention amount on poultry products should not be based 
on an average but should be applicable to 95 percent of individual 
birds.
    Response: FSIS notes that this comment was based on the analysis in 
the PRIA of rulemaking Option 1--to allow any percentage of retained 
water so long as the percentage amount is on the product label. FSIS 
will expect establishment data collection protocols (see 
Sec. 441.10(d)) to include the sampling and testing methods for 
determining that food safety requirements (pathogen reductions) are 
being met and the testing methods for determining water retention. FSIS 
will also expect the protocols to explain how water retention data are 
to be reported and evaluated. The data collected by the establishment 
should show with reasonable confidence--i.e., 95-percent statistical 
confidence--that a given package retains no more water than is 
unavoidable, and no more than the label states.

Labeling Format

    Comment: Rather than the statement ``up to X% retained water'' or 
``less than X% retained water,'' the label of affected products should 
state, ``contains X% added water.'' The ``up to X%'' statement prevents 
the consumer from calculating the true price per pound without added 
water weight. A ``contains X%'' statement would be consistent with the 
ban on qualifying terms in the Fair Packaging and Labeling Act.
    Response: Current production practices yield product with varying 
levels of water retention. It is therefore difficult for an 
establishment to target an exact water-retention percentage for all its 
products of a certain class. FSIS has taken this fact into 
consideration and has framed the labeling requirements of this final 
rule in a way that will minimize inadvertent industry noncompliance.

[[Page 1758]]

    It is true that a consumer may not be able to compute the exact 
percentage of retained water in a product labeled ``with up to X% 
retained water.'' The establishment that prepared the product, however, 
will have had to determine a water-retention range based on the data 
used to determine the amount of retained water that is unavoidable in 
the product. The establishment will be free to label its product with 
the water-retention amount that reliably represents the amount that is 
in the packaged product.
    Consumers of the product will have available more information on 
water retention than they have had in the past.

Retained-Water Labeling and Product Tare

    Comment: If FSIS insists on a labeling requirement, product tare 
should be addressed. For example, if product labeled as having 4-
percent retained water that loses 2 percent of the water is sold in a 
wet-tare jurisdiction, how would the product be labeled? How would the 
regulation be applied?
    Response: Compliance with net-weight regulations is determined by 
following the wet-tare and dry-tare procedures in National Institute of 
Standards and Technology (NIST) Handbook 133, which is incorporated by 
reference in the FSIS regulations at 9 CFR 317.19 and 381.121b. The 
actual net weight of the product, as determined on a lot-average basis 
by these procedures, is compared with the labeled net weight of the 
product.
    The commenter did not say whether the 2-percent moisture loss was 
additional to or part of the 4-percent retained-water amount 
represented on the label. FSIS assumes that the 2-percent loss is from 
the 4-percent amount. Thus, in the example presented by the commenter, 
the retained-water statement should reflect that the product contains 
at least 2 percent or as much as 4 percent water from processing.
    Using the 3-pound dry-tare chicken example presented in the PRIA 
and FRIA, the product net weight in a wet-tare jurisdiction would be as 
much as 2.94 lb. or as little as 2.88 lb. The labeled net weight 
corresponding to a ``2-percent'' retained-water statement would be 2.94 
lb. The loss to the product, labeled with this net weight, of an 
additional 2 percent in water weight would raise the issue of short 
weighting. The actual net weight of the package would enter the ``gray 
area'' provided in the NIST Handbook 133 procedures for determining 
net-weight compliance in wet-tare jurisdictions. FSIS and local weights 
and measures authorities would then follow the procedures provided for 
gray-area product. Depending on the wording of the retained-water 
statement, this loss of additional moisture could mean that the 
statement is inaccurate, and the product misbranded for that reason.
    If a company has had difficulty in determining the unavoidable 
amount of retained water in the product, the company should recheck the 
data on which its determination of ``unavoidable'' is based, its data-
collection protocol, and its processing procedures.
    If the company knows that the product will lose 2 percent of net 
weight because of water loss while in distribution channels, the 
company should adjust the retained-water statement to account for the 
fact. If the company knows that a retained-water product will continue 
to retain a certain percentage when it is sold in the wet-tare 
jurisdiction, the retained water statement must account for that 
percentage of water retention.

National Standard for Retained Water

    Comment: Several commenters said that if FSIS proceeds with the 
rulemaking, the Agency should develop national standards for 
``unavoidable moisture retention.'' Products should be able to exceed 
the national standard if labeled. Some argued that, based on 
information in the PRIA at 63 FR 48978, water retention could be held 
to 2-5% with appropriate technology. Others suggested that the Agency 
could simply justify scientifically the water retention limits in the 
regulations that were set aside.
    Response: To be valid, a national standard such as envisioned by 
the commenters would have to be applicable to homogeneous products 
produced under similar conditions.
    The currently available data on water retention provide an 
inadequate basis for setting any retained-water standard because the 
data that could be applied to the industry are based on industry 
practices that conformed to the regulations that the U.S. District 
Court set aside in Kenney v. Glickman. The Court set the regulations 
aside, in part, because USDA had not adequately explained how the 
particular water retention limits in the regulations were determined or 
why water retention could not be reduced below those levels.
    FSIS would have to have new data, collected under new protocols and 
criteria that meet the concerns expressed in the Court decision in 
Kenney to be able to revive the previous regulations, including updated 
tables listing the water retention limits for poultry. In other words, 
the Agency would have to be able adequately to explain how the 
particular water retention limits were determined and why they could 
not be further reduced. Moreover, the Agency would have to be able to 
explain adequately how such regulations would apply to meat and 
poultry. Commenters did not state how this could be done.
    FSIS agrees with the commenter who cited the analysis in the PRIA 
of available water retention data. This analysis indicates that water 
retention can be held at substantially below the regulatory limits that 
were set aside by the United States District Court in Kenney v. 
Glickman. It thus seems unlikely that new data would support the limits 
in the regulations that were set aside.
    Comment: Even with supporting data, an industry-wide water-
retention standard could still be ``arbitrary and capricious.''
    Response: Depending on the design of the protocol and the adequacy 
of the data collected, a limit applying to the products of one or more 
establishments could be scientifically justified and not be arbitrary 
and capricious.

Costs of Rule

    Comment: Compliance to ensure labeling accuracy should not result 
in added costs.
    Response: The data-collection and labeling requirements will be 
minimal for meat establishments whose products do not gain water. 
Poultry establishments will have to collect data to determine the 
minimum water-retention levels in their products and will have to be 
able to verify on a continuing basis the accuracy of their product 
labels. Establishments will not necessarily have to conduct more tests 
or collect more data than they have been collecting under the 
regulations that this rule replaces. Thus, day-to-day costs of 
complying with the requirements for labeling accuracy will not be 
greater than past costs of complying with water-retention requirements.

Measuring Retained Water

    Comment: The water retention amount should be measured as the 
difference between the ``hot carcass weight'' and finished package 
weight of the product. The second amount should be measured at the 
point of packaging.
    Response: Establishments may use in-plant methods, such as weighing 
carcasses before and after washing or chilling procedures, as a means 
of controlling water retention. However, FSIS emphasizes that 
compliance with

[[Page 1759]]

this final rule will primarily depend on whether the retained-water 
amount of the product in distribution channels, i.e. the retained water 
weight of the product at the time it enters commerce, is no greater 
than the amount that is demonstrably unavoidable. FSIS intends to 
subject product samples collected in-distribution to an oven-drying 
test (described in Appendix A of this document) to determine the amount 
of water in the samples. Those amounts will be compared with the amount 
of naturally occurring water in the products to determine compliance 
with labeling and the retained-water-minimization provisions of the 
final rule. FSIS will, however, conduct in-plant verification of 
establishment process controls, and this verification may occasionally 
involve comparing hot carcasses weights with the weights of carcasses 
after spray chilling.

Compliance, Oversight and Control

    Comment: FSIS must explain how compliance with the regulation is to 
be determined. A European Union official requested information on 
methods currently used to detect water content. One company suggested 
that moisture gain be determined at the last possible point before 
consumer packaging. Another observed that the poultry industry views 
retained water as the amount in the product to be lost over time as the 
product is en route to the consumer.
    Response: Until now, FSIS and official establishments have measured 
water content by sampling and weighing carcasses before the carcass 
wash and after chilling. In poultry slaughtering establishments, 
carcasses are sampled and weighed before and after immersion chilling. 
In livestock slaughtering establishments, sampled carcasses are weighed 
after slaughter before and after being subject to spray-chilling 
processes. These traditional in-plant methods for determining the 
effectiveness of retained water controls continue to be available to 
the Agency and industry.
    Under this final rule, though, FSIS will be verifying compliance 
with the retained-water limitation and labeling requirements primarily 
by reviewing establishment water-retention data collected under the 
required data-collection protocol. The Agency also plans to conduct in-
plant and in-distribution tests of the moisture content of products 
using the oven-drying method described in the Agency's Chemistry 
Laboratory Guidebook and in Appendix A of this document. FSIS will not 
be dictating to industry the in-plant sites for measuring and 
controlling retained water.
    Establishments must be aware that the Agency will be most concerned 
with the amount of retained water in product that has entered commerce.
    Comment: The proposed rule has no provision for compliance 
oversight in distribution channels and at retail or food-service 
operations.
    Response: The regulation clearly applies to products in 
distribution channels, although it does not specify how the Agency will 
enforce regulatory requirements outside official establishments. 
Official slaughtering establishments will be primarily responsible for 
minimizing water retention, subject to meeting the food safety 
objectives of their HACCP plans and of the PR/HACCP and other 
regulations. FSIS will conduct in-plant and in-distribution activities 
to verify labeling accuracy and retained-water minimization.
    Comment: Correction of the water-adulteration problem at retail 
would trigger costly recalls and reduce consumer confidence in 
regulatory bodies.
    Response: If a recall is necessary to prevent the sale of 
adulterated product, the Agency will expect the industry to take the 
necessary action.

Weights and Measures Checks

    Comment: ``Weights and Measures officials generally inspect 
prepackaged meat and poultry at the retail level. Any changes * * * 
should either have no effect on point-of-sale package weight inspection 
procedures or, even better, simplify them.''
    Response: Net-weight compliance procedures will be largely 
unaffected by this rulemaking. FSIS will be following NIST Handbook 133 
procedures for determining whether or not product is misbranded with 
respect to net weight. These procedures are used by State and local 
weights and measures officials, so there will be no difference between 
the procedures followed by the Federal Government and the States with 
respect to net weight.

Offal Products

    Comment: From companies and associations representing the meat 
industry: Offal products should be exempt from the rule because they 
are not considered meat products. Moreover, FSIS Standards and Labeling 
Division policy covers ``purge'' from organ products.
    Response: In the interests of equitable regulation, offal products 
and other products of the meat industry and any poultry products with 
which there is a water-retention issue are subject to the present rule. 
This final rule supersedes current policy notices and directives 
affecting water retention; as appropriate, the Agency will revise or 
cancel those documents.

FSIS Priorities

    Comment: The proposal is a misapplication of FSIS resources, which 
should be focused on food safety concerns. Consumers are more 
interested in knowing about product safety than retained water.
    Response: While the Agency's primary concern is food safety, the 
FMIA and PPIA provide other consumer protections as well, including 
that consumers have the right to be apprised of what they are buying.

Consumer Situation

    Comment: Some commenters asserted that FSIS offered no data showing 
consumers are misled about retained water in poultry products.
    Response: It is true that FSIS has not gathered survey data showing 
that consumers are being misled about retained water, but from 
inquiries it has received over the years, the Agency is aware of 
consumer concerns about water in packaged poultry. Although consumers 
did not petition the Agency for a retained-water-labeling requirement, 
a number of individuals and consumer advocates who commented on the 
proposal regarded informing consumers about retained water as an 
important purpose of the rule. Some requested immediate implementation 
of the labeling requirement.
    Comment: The proposed rule could adversely affect industry and 
consumers. Product quality could be adversely affected. The proposal 
itself (at 63 FR 48980) suggests that retained-water labeling, by 
inducing a reduction in retained water in raw products, would actually 
be harmful to consumers who may prefer a moist product.
    Response: The information on consumer receptiveness to poultry 
products that might be less moist is inconclusive. The Agency 
acknowledged in the PRIA, to which the commenter refers, that consumers 
in the United States have become accustomed to purchasing fresh poultry 
that is very moist. FSIS requested comment on whether consumers would 
be more or less likely to purchase a package of meat or poultry that 
appeared less moist but received little information on this matter in 
response.

[[Page 1760]]

FSIS Response to Kenney Case Decision

    Comment: The proposal is not justified by the limited scope of the 
decision in Kenney. FSIS misinterpreted the decision, in which the 
Court found poultry with retained water not to be adulterated and 
recommended science-based limits.
    Also, the decision in the Kenney case does not require the Agency 
to mandate retained-water labeling.
    Response: The Agency does not agree with the commenter's view that 
the Agency misinterpreted the District Court decision in the Kenney 
case, nor does the Agency infer from the decision that it is not 
warranted to proceed with this rulemaking. The Court affirmed the 
Agency's right to define a poultry product to include poultry product 
with retained water. Although the Court did not specifically instruct 
the Agency to revise the retained water regulations that the Court set 
aside, the Court clearly affirmed the Agency's authority to regulate 
the amount of retained water in poultry products. This final rule will 
limit the amount of retained water in raw meat and poultry products and 
FSIS believes the retained water limitation will be scientifically 
based.
    Regarding the labeling requirement in the final rule, it will 
prevent misbranding of products subject to the rule.
    Comment: Poultry industry commenters argued that FSIS is responding 
to competitive, not consumer, concerns and to lobbying by the meat 
industry. The Agency is responding to ``perceived inequity'' rather 
than to food safety concerns.
    Response: FSIS took seriously the determination by the Court that 
the basis for its regulation of retained water in poultry was 
inadequate. As a result of the decision, the Agency believed it was 
necessary to re-examine the basis for regulation and determine the most 
appropriate, science-based approach for regulating retained water in 
poultry. The Agency's response on this issue was grounded in its 
obligation to ensure that consumers are protected from adulterated and 
misbranded product.
    Comment: According to some poultry industry commenters, the rule is 
arbitrary and capricious in that it makes unjustified sweeping changes 
to the Agency's long-established policy of not requiring that meat or 
poultry be labeled to show retained-water content. The rule could be 
invalidated under the ``arbitrary and capricious'' standard applied by 
the Supreme Court (in Automobile Manufacturers Assn. v. State Farm) to 
the Department of Transportation's rescission of a rule requiring the 
installation of passive restraints in new cars. Simply requiring that 
meat and poultry establishments justify retained water in their 
products would fully satisfy the mandate of the U.S. District Court in 
Kenney v. Glickman.
    Response: FSIS disagrees that, in requiring labeling of raw, 
single-ingredient meat and poultry products to state the retained-water 
content of the products, it is making ``arbitrary and capricious'' 
sweeping policy changes. Rather, FSIS is attempting to carry out its 
statutory obligation to prevent the distribution of products that are 
adulterated or misbranded under circumstances in which a regulation 
intended to prevent adulteration or misbranding of poultry products has 
been invalidated.
    With respect to the labeling issue, FSIS thinks that the State Farm 
case is inapposite. FSIS is willing to concede that it had a policy not 
to require labeling of poultry products for retained water. However, 
the Kenney decision represents a change in circumstances that requires 
that the Agency rethink its policies and change them if it is unable to 
justify them within the legal context established by the Court's 
decision. The case has left the Agency without a published, regulatory 
limit on retained water to prevent adulteration. Because there is no 
longer such a limit, the case has also left the public without access 
to information about the characteristics of poultry products. In the 
absence of a specific level of retained water that is unavoidable in 
the production of a safe product, FSIS finds that the level of retained 
water is a fact that is material in that the product is being 
represented as meat or poultry. Failure to disclose this fact would 
misbrand the product.
    Therefore, FSIS is requiring that meat and poultry products be 
labeled to show the maximum amount of water they may retain. In the 
absence of data, the Agency is taking the most logical and reasonable 
course of action available to it.
    Regarding the U.S. District Court decision in the Kenney case, the 
Court agreed with the Department's contention that the PPIA (21 U.S.C. 
457(b)(2)) gives the Secretary the authority to determine that the 
composition of a poultry product includes a limited amount of water 
retained from processing. The Court also stated that, given the 
deference that must be shown the Secretary on this matter, ``the 
Secretary did not abuse his discretion or act contrary to law by 
failing to conclude that a label that does not disclose the retained 
water in a poultry product was false or misleading.'' The Court further 
held that, notwithstanding the quantity-of-contents labeling provisions 
of the PPIA, the Secretary was within his discretion in not finding 
poultry with retained water to be misbranded.
    However, the Court found that the Secretary acted arbitrarily and 
capriciously in not adequately explaining the reasons for the water 
retention limits for poultry products and in not explaining why water 
retention could not be further reduced. In other words, the Secretary 
did not provide a basis for determining whether and what amount of 
water retention should be permitted or could be considered non-
adulterative, or what amount of water retention is unavoidable in a 
poultry product. Put another way, the Secretary did not provide a basis 
for distinguishing a poultry product with permissible retained water 
from such a product adulterated by excessive retained water. The Court 
also found the Secretary to have acted arbitrarily and capriciously in 
not according the same regulatory treatment to meat and to poultry. The 
Court therefore set aside the regulation that provided the water 
retention limits for poultry products (9 CFR 381.66(d)(2)).
    Thus, this situation is distinguishable from that in State Farm. 
FSIS is not simply abandoning a long-held, well-justified position. 
When asked to justify its position on retained water in poultry, the 
Agency could find no basis for it in the record compiled when the 
position was adopted. Thus, the Court in Kenney found that FSIS water 
retention levels for poultry were not sustainable. When FSIS sought a 
reliable basis for arriving at a new level, it could find no evidence 
that would justify any water retention in poultry. In view of this, and 
the Agency's obligation, in the absence of evidence that justifies a 
contrary approach, to treat meat and poultry products the same way in 
its regulations, FSIS is left with little choice but to insist that 
meat and poultry products contain no retained water unless there is a 
substantial justification for permitting some water retention.
    FSIS is not stating in this final rule what the justification for 
retained water should be beyond stating that it must be an unavoidable 
consequence of processing to meet food safety requirements. This is the 
only justification FSIS can find for the presence of retained water in 
a livestock or poultry carcass.
    As stated previously in this document, the Agency has consistently 
required that establishments minimize retained water in meat and 
poultry

[[Page 1761]]

products, but the Agency no longer has a quantitative limit or measure 
other than zero-percent retained water by which to determine that 
retained water has been minimized. For this reason, and because the 
Court found that the Agency did not have a basis for determining 
unavoidable retained water in a product, the Agency must insist that, 
in addition to justifying the presence of retained water, 
establishments also substantiate the amount of retained water that is 
unavoidable.
    In order to determine whether or not a poultry product is 
economically adulterated by retained water, the Agency must have 
available to it data that show what the amount of unavoidable retained 
water is and the amount that the product retains. Hence, the 
requirement that establishments collect such data according to written 
protocols.

Effect on Pathogens

    Comment: Increasing water retention in achieving non-required 
Salmonella levels (i.e., reducing Salmonella levels below the pathogen 
reduction performance standards) would defeat the purpose and goal of 
the rule.
    Response: FSIS encourages establishment efforts to improve the 
safety of meat and poultry products by reducing the incidence of 
Salmonella below the prescribed performance standards. We recognize 
that achieving such results may cause the product to have increased 
retained water that would be required to be labeled on the package. 
However, we feel that the requirement to label a product to indicate 
the maximum amount of water that may be retained in the product is 
necessary to reflect the material fact that water has been retained.
    Comment: The proposal (at 63 FR 48977) suggested the possibility 
that pathogens on product could increase with decreased retained water, 
and that efforts to reduce the retained-water level would harm 
consumers.
    Response: The commenter misinterpreted the proposal. The commenter 
took out of context a step in the Agency's reasoning on the potential 
costs of a rejected option: that of establishing retained water limits 
based solely on the capabilities of existing equipment. In fact, this 
rule is based on the chosen option of limiting water retention to the 
amount that is unavoidable in meeting food safety requirements.
    Comment: A consumer group commented that FSIS has paid insufficient 
attention to Lillard (1990), who reports a significant increase in the 
incidence of Salmonella on post-chill poultry carcasses.
    Response: The Lillard (1990) paper cited by the commenter did 
indeed show that Salmonella incidence increased on post-chill as 
compared with pre-chill poultry. The study identified immersion 
chilling as the most significant point of cross contamination in modern 
commercial poultry processing. However, the study also confirmed that 
the immersion chilling process has a washing effect, and that even 
though Salmonella incidence may have increased on the birds, the 
microbiological quality of the poultry carcasses, as determined by 
enumeration of aerobic bacteria and Enterobacteriaceae, improved. In 
other words, though bacteria might be spread from bird to bird during 
the process, the overall level of bacteria on the birds decreased.
    Comment: A consumer group said that FSIS should determine the 
pathogen levels in poultry package liquid and the relationship between 
these levels and the risk of cross-contamination in the kitchen. FSIS 
should compare the benefits in lower social and medical costs from 
contaminated poultry, compared with increased costs to the poultry 
industry and consumers from eliminating all retained water.
    Response: As explained in the FRIA, FSIS has assumed as an indirect 
benefit of the final rule the possible health effects from reducing 
retained water. However, to determine the relationship between pathogen 
levels in poultry and the risk of cross contamination in the consumer's 
home, and to compare the increased costs to the poultry industry of 
this rule with the possible health benefits to society from reducing 
retained water, would require a lengthy study. If such a study were a 
prerequisite for this final rule, the rule and its beneficial effects 
would be delayed.

Apparent Inconsistency in Proposed Rule

    Comment: There is, apparently, an inconsistency between the 
preamble use of the term ``raw, single-ingredient, meat, meat products, 
and poultry products'' and the term ``carcasses and parts'' in the 
proposed regulation concerning products to be covered by the labeling 
requirement.
    Response: ``Raw, single-ingredient meat, meat products and poultry 
products'' are broadly comprised of ``carcasses and parts,'' whether of 
livestock or of poultry. The term ``carcass'' in the FSIS regulations 
denotes ``all parts, including viscera, of any slaughtered livestock'' 
(9 CFR 301.2(p)) and in the poultry products regulations ``all parts, 
including viscera, of any slaughtered poultry'' (9 CFR 381.1(b)(9). By 
the term ``carcasses and parts,'' FSIS means a class of product 
included in the terms ``meat and meat food product'' and ``poultry 
product,'' namely, raw, single-ingredient products that have been 
subject to no more than minimal processing, such as cutting or 
grinding, before being sold in commerce. The current regulatory 
definitions for ``meat food product'' and for ``poultry product'' 
include product made partly or wholly from carcasses and parts of 
livestock or poultry for use as human food. Thus, FSIS finds no 
inconsistency between the use of terms in the preamble of the proposed 
rule and the proposed regulatory text.

Time and Flexibility for Final Rule Implementation

    Comment: If FSIS proceeds to a final rule, the Agency should give 
industry time and flexibility to minimize cost impacts. The industry 
should have flexibility similar to that provided in the sausage casings 
notice (FSIS Docket No. 96-020N: 61 FR 39853; July 31, 1996).
    Response: FSIS believes that the commenter is referring to the 
labeling options that would be available to establishments subject to 
the proposed rule on sausage casings, ``Labeling of Natural or 
Regenerated Collagen Sausage Casings'' (FSIS Docket No. 96-020N: 62 FR 
38220; July 17, 1997). Under that proposal, the labels of sausages in 
natural casings made from livestock or poultry viscera or regenerated 
collagen casings would have to identify the type of livestock or 
poultry from which the casings are derived, if different from the 
livestock or poultry meat component of the sausage. The casing 
identification could be on the principal display panel or in the 
ingredient statement. Establishments producing, manufacturing, or using 
natural or regenerated collagen casings would have to keep records on 
the livestock or poultry source of the casings.
    FSIS is trying to minimize the cost impacts of the labeling 
requirements of this final rule by providing ample time for 
implementation and allowing the industry to use existing stocks of 
labels until they are exhausted. FSIS also is providing a degree of 
flexibility by permitting establishments to place the required retained 
water statement either contiguous to the product name or elsewhere on 
the principal display panel of the label.

[[Page 1762]]

Recommendations for Various Technical Changes

    Comment: The qualifier ``mature'' should be restored to the term 
``reproductive organs'' in Sec. 381.1(b)(44).
    Response: As discussed in the proposal, FSIS is revising the 
definition of ``ready-to-cook poultry'' to account for the elimination 
of the requirement to remove kidneys from mature birds. The qualifier 
``mature'' was inadvertently dropped from the term ``mature 
reproductive organs'' in the proposed regulatory text and is restored 
in this final rule. The verb phrase expressing the action taken with 
respect to mature reproductive organs and kidneys is changed from 
``have been removed'' to ``may have been removed'' (in 
Sec. 381.1(b)(44)) to reflect the fact that the decision to remove 
these organs is HACCP-based. Some establishments, in operating their 
HACCP systems, have shown that they can determine when poultry kidneys 
constitute a hazard (e.g., when they contain cadmium) and when they do 
not.
    Comment: The phrase ``feet, crop and oil glands'' appears twice in 
proposed Sec. 381.1(b)(44).
    Response: FSIS is correcting this typographical error.
    Comment: Remove Sec. 381.65(a) and (b). These are covered by HACCP 
or Sanitation SOP.
    Response: FSIS agrees that sanitary handling and processing of 
poultry and the protection of poultry products from adulterants ought 
to be covered by establishment Sanitation SOP's and HACCP plans. FSIS 
is removing paragraph (b) of 9 CFR 381.65 for that reason, as proposed, 
but retaining paragraph (a). The paragraph requires establishments to 
conduct operations and procedures in a manner that will ensure sanitary 
processing, proper inspection, and products that are not adulterated. 
These are basic performance objectives for any official establishment. 
The requirement to ensure proper inspection is especially pertinent to 
poultry processing and is not duplicated by the SSOP and HACCP 
regulations. Paragraph (c) is being re-designated as paragraph (b). 
FSIS will review the requirements in these and other paragraphs for 
further streamlining.
    Comment: Remove Sec. 381.65(d) because it is redundant with 
proposed Sec. 441.10.
    Response: Proposed Sec. 381.65(d) is a re-designation of 
Sec. 381.65(k), which requires ready-to-cook poultry to be adequately 
drained after chilling to remove ice and free water before packaging or 
packing. FSIS agrees that it is redundant with the new 9 CFR 441.10 and 
is removing it.
    Comment: Paragraph (d)(8) in Sec. 381.66 requiring the plant to 
notify the inspector of changes in washing, chilling, and draining 
procedures should be removed.
    Response: FSIS is removing 9 CFR 381.66(d)(8) as proposed.
    Comment: Proposed Sec. 381.66(c)(2)(i), restricting how plants 
operate chillers, should be revised to eliminate prescriptive 
requirements for the continuous overflow of water between chiller 
sections and references to the design of multi-section chillers. The 
paragraph should only require that the chiller be operated in a manner 
consistent with meeting pathogen reduction performance standards.
    Response: FSIS agrees in principle with the suggested change and is 
revising the paragraph. The Agency is removing the prescriptive design 
requirements for chillers and replacing them with a performance 
standard requirement that is consistent with the PR/HACCP regulations.
    Comment: Proposed Sec. 381.66(c)(2)(ii) should be revised to refer 
to split carcasses as defined in Sec. 381.170(b)(22). FSIS should 
revise the second sentence, the chilling method to be applied to 
individual poultry parts, because it is not consistent with HACCP.
    Response: FSIS agrees that the wording of proposed 
Sec. 381.66(c)(2)(ii) should be modified as suggested by the commenter.
    FSIS is removing the second sentence of the paragraph, which 
prohibits the chilling in water and ice of individual parts from 
salvage operations. While the purpose of this prohibition, to prevent 
the marketing of parts that retain too much water, coincides with some 
of the objectives of this final rule, it is a command-and-control 
requirement that is inconsistent both with HACCP and with the basic 
thrust of this final rule. FSIS published the retained-water proposal 
in the same issue of the Federal Register as the final rule permitting 
the continuous chilling of transversely split carcasses (63 FR 48957; 
September 11, 1998). The split-carcass-chilling final rule left 
unchanged the prohibition against the chilling in water and ice of 
individual parts.
    This final rule, however, applies to transversely split carcasses 
and other portions and parts of poultry. It applies to all raw, single-
ingredient, poultry products. This final rule makes redundant the 
requirements concerning the specific chilling method applied to these 
parts or portions of poultry. Therefore, the Agency is removing these 
requirements.
    Comment: Delete the proposed Sec. 381.66(d)(1) and (2) as redundant 
with Sec. 441.10.
    Response: While 9 CFR 381.66(d)(1), which requires that poultry 
washing, chilling, and draining practices minimize water absorption and 
retention, may appear to some to be redundant with 9 CFR 441.10, it 
articulates a general principle with which the Agency agrees 
irrespective of the present rulemaking: Retained water should be 
minimized. 9 CFR 381.66(d)(1) does not, however, present a measurable 
criterion for judging minimization, as 9 CFR 441.10 does. Therefore, 
FSIS finds it appropriate to adopt both provisions.
    FSIS finds that the proposed 9 CFR 381.66(d)(2), requiring the 
establishment to supply measuring devices or scales for use in 
measuring retained water, should be retained to ensure that both the 
establishment and the Agency can conduct in-plant checks for compliance 
with this final rule.
    Comment: Delete 9 CFR 381.66(f)(3), a prior-approval requirement 
for FSIS approval for off-premises freezing of ready-to-cook poultry. 
This prescriptive requirement is inconsistent with HACCP.
    Response: The commenter's suggestion is beyond the scope of the 
present rulemaking. FSIS regards the procedures for freezing poultry as 
encompassing a separate set of issues that are peripheral to the 
concerns of this rulemaking, which are focused on the chilling of 
poultry.

Effect on International Trade

    Comment: The proposal could distort international trade because the 
only establishments that will be considered eligible to export to the 
United States will be those that are able to demonstrate that 
``residual water content is due to the final decontamination of the 
products and not to the chilling process.''
    Response: The final rule does not identify any specific post-
evisceration process that an establishment must use for any purpose. 
Further, the rule is not expected to have significant impacts on 
international trade. Any imports containing retained water will have to 
be appropriately labeled, and poultry products are likely to be more 
affected than meats. Only six countries, however, Canada, France, Great 
Britain, Hong Kong, Israel, and Mexico, are listed as eligible to ship 
poultry products to the United States. Currently, about 5 million 
pounds of poultry imports enter the United States

[[Page 1763]]

annually. This is a relatively small amount of trade.

Provisions of the Final Rule

    Under Sec. 441.10(a), raw livestock and poultry carcasses and parts 
may not retain any amount of water resulting from post-evisceration 
processing, absent a demonstration, with data, by the establishment 
preparing them that such water is the unavoidable consequence of a 
process used to meet applicable food safety requirements. The data must 
have been collected according to a written protocol.
    Under Sec. 441.10(c)(1), the establishment must keep this protocol 
on file and available to FSIS personnel. The protocol must explain how 
the data will be collected and used in making the required 
demonstration for the product the protocol covers. Under 
Sec. 441.10(c)(2), the establishment must notify FSIS as soon as its 
data-collection protocol--whether new or revised--is available to the 
Agency. Within 30 days after receipt of this notification, FSIS may 
object to or require the establishment to make specified changes in the 
protocol. FSIS will take this action if it determines that the protocol 
is not valid, or that the data collected under it will not be 
sufficient to demonstrate that the amount of water retained in the 
product is an unavoidable consequence of the process used to meet 
applicable food safety requirements.
    FSIS is including in Sec. 441.10(d) the expected elements of a 
protocol for gathering water retention data. These protocol elements 
were published for comment as Appendix A of the September 11, 1998, 
proposal.
    Under Sec. 441.10(b), meat or poultry products will 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 must reflect the maximum 
percentage of water that may be retained in the product. Alternatively, 
the label may simply 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 will not have to label the products and could include a no 
retained water claim on the product label. The labels will be 
generically approved pursuant to 9 CFR 317.5(b)(2) or 381.133(b)(2).
    This 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 misbranding 
provisions of the FMIA and the PPIA (especially 21 U.S.C. 601(n)(1), 
(6); 453(h)(1), (6)). It will ensure that the product labeling is not 
misleading with respect to water retained by the product.
    FSIS had proposed that the retained-water statement be contiguous 
to the product name on the product label. In response to comments, the 
Agency is providing some flexibility in this matter by also permitting 
the statement to appear either contiguous to the product name or 
elsewhere on the principal display panel of the label. The placement of 
the required information on the label will ensure that the information 
will be likely to be read and understood by the ordinary individual 
under customary conditions of purchase and use.
    With the required labeling information, consumers will be in a 
better position to compare packaged raw meat or poultry products 
containing retained water with alternatives in the meat case. The 
market will provide incentives to plants to adopt new, cost-effective 
technologies for reducing retained water. The rule will 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 final rule also will not cover cooked and cured pork 
products, such as those subject to protein-fat-free requirements (9 CFR 
318.19(a)(5), 319.104-.105, 327.23).
    As stated elsewhere in this document, the Agency's concern in this 
rule is to ensure that products in commerce will not be adulterated or 
misbranded. To alleviate some confusion on this point that was 
expressed in a number of the comments received, the labeling provision 
in new Sec. 441.10(b) has been more precisely phrased than in the 
proposal.

Changes in Poultry Chilling Regulations

    FSIS is amending the chilling requirements for poultry by removing 
various prescriptive requirements and specifications, such as the 
minimum amount of fresh water intake by continuous chillers for each 
poultry carcass. The removal of those requirements should encourage 
processors to use the most efficient and effective methods of 
controlling microorganisms. Establishments will have the flexibility to 
take advantage of the latest technologies and procedures.
    This final rule amends 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 
final rule eliminates 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 is unnecessary because HACCP plans have been 
implemented in every affected establishment and because each HACCP plan 
must specify the measures to be taken to protect poultry products from 
physical, chemical, or biological contamination. The requirements in 
paragraphs (a) and (c) of 9 CFR 381.65 will be retained as paragraph 
(a) and (b) because they set out general principles of sanitation and 
commercial practice to which all establishments must adhere.
    The requirements in paragraphs (h) and (j) of 9 CFR 381.65, 
relating to poultry thawing and dressing techniques, are being replaced 
with two performance standards. The first requires simply that 
establishments use thawing procedures that will prevent adulteration 
of, or net weight gain by, the product. The second requires that water 
used in washing ready-to-cook poultry be permitted to drain freely from 
the carcass. A new paragraph (c), which replaces paragraph (h), 
requires 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 thawing regulation that is being replaced 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. 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 analyses. Establishments must be given the responsibility 
and flexibility to choose thawing measures that are effective and that 
do not create food safety hazards.
    A new paragraph (d) replaces 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.
    Paragraph (d), which contains a requirement to remove kidneys from

[[Page 1764]]

mature chickens and turkeys, is being 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. 
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, paragraph (d) 
is redundant with the HACCP regulations. The requirement to remove 
kidneys is referenced in the definition of ``ready-to-cook poultry'' at 
9 CFR 381.1(b)(44). Therefore, the Agency is amending that definition.
    Paragraph (i), which specifies how poultry carcasses are to be cut 
open for evisceration, is being removed. The regulation is outdated and 
prescriptive and may be an obstacle to improved product safety. The 
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 during the postmortem 
inspection.
    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 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 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. 
Because of this limitation, the new technologies, which can improve 
efficiency and product wholesomeness, are not likely to be implemented. 
Establishments, however, should have the flexibility to innovate and to 
implement promising new technologies, consistent with their HACCP 
plans.
    Paragraph (k), a requirement to adequately drain ready-to-cook 
poultry after chilling to remove ice and water before packaging, is 
redundant because of new part 441, and FSIS is removing it.
    Paragraphs (l) through (p) are also being 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 that are to be 
addressed by establishments in their Sanitation SOP's and HACCP plan.
    Finally, paragraph (q), concerning the harvesting of detached ova 
for human food, is being re-designated as paragraph (e) and revised to 
reduce duplication with requirements in Sec. 590.440 for handling ova 
and to eliminate a command-and-control requirement to identify the ova 
past the point of inspection. Also, the reference to a section of the 
egg products inspection regulations has been amended to account for the 
recent redesignation (63 FR 72353) of those regulations to Title 9, 
CFR.
    In 9 CFR 381.66, paragraph (a) is being revised. This paragraph 
requires poultry to 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 paragraph, a command-and-control 
requirement to file a description of the chilling or freezing 
procedures with the inspector in charge, is being removed.
    The general chilling requirements for poultry, paragraph (b), 
remain the same. FSIS has long regarded 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) are being removed. For example, the 
amended paragraph (c)(2)(i) does not specify chilling media 
temperatures or the use of recording thermometers. New paragraph (c)(1) 
requires that potable water be used, and new paragraph (c)(2)(i) 
requires that sufficient water be used to maintain the sanitation of 
chilling media. 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, 
are being removed.
    Paragraph (c)(2)(iv) is being re-designated as (c)(2)(ii) and 
revised as discussed above in the response to comments. This paragraph, 
which concerns the chilling of major portions of poultry carcasses, was 
the subject of a September 18, 1999, final rule (63 FR 48958; proposed 
at 62 FR 31017; June 6, 1997).
    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, is being removed. Establishments subject to the poultry 
product 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, are being removed, and in 
paragraph (c)(5), the highly specific requirements concerning the use 
of continuous chillers to chill giblets are also being 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 will remain at 
this time.
    Paragraph (d) of Sec. 381.66 is being completely revised. The 
general requirement to minimize water absorption by raw poultry, and 
the requirement to furnish equipment necessary for water tests, will 
remain. The tables setting water absorption and retention limits for 
the various kinds and weight classes of poultry are being eliminated, 
as are the requirements for daily water testing by FSIS inspectors. The 
requirement to notify FSIS of any adjustments in washing, chilling, and 
draining methods is also being removed.
    FSIS is removing 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 ordinarily have 
procedures for determining appropriate containers for a product. If, in 
their hazard analyses, they determine that there are food safety 
hazards reasonably likely to occur that are associated with containers, 
they will address these hazards in their HACCP plans.
    The Agency is likewise removing paragraph (d)(11), which requires 
establishments to prevent free water from being included in giblet 
packages. Among other things, paragraph (d)(11) requires use of a 
specific type of giblet wrapping material and incorporates by

[[Page 1765]]

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 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 provision will give 
establishments flexibility in choosing giblet packaging materials, but 
also the responsibility to ensure that their choice is suitable, as 
well as safe, for this use. By complying with the retained-water 
limitation requirements (discussed below) and by appropriately labeling 
product, establishments will be ensuring that water absorption is 
controlled as well as ensuring that consumers are appropriately 
informed.
    Finally, paragraph (e), on air chilling, and paragraph (f), 
governing the freezing of poultry, are being retained substantially in 
their present form. Paragraph (f)(6), concerning immersion or spray 
freezing compounds and equipment, will be removed because it is a 
prior-approval requirement inconsistent with the HACCP regulations and 
is duplicative of other inspection regulations.

Implementation of the Final Rule

    FSIS foresees little difficulty in implementing the revised poultry 
chilling regulations, which relieve poultry establishments of certain 
burdens without raising misbranding or adulteration issues. FSIS will 
ensure compliance with the revised regulations through normal 
inspection.
    To implement the retained-water provisions of this final rule, on 
the other hand, both the Agency and the regulated industry will have to 
adopt new procedures. FSIS personnel will verify an establishment's 
control of water retention by checking establishment records or by 
conducting in-plant or in-distribution tests of sampled products. FSIS 
intends to sample product in distribution channels and in official 
establishments, using the oven-drying method described in Appendix A to 
determine the amount of moisture in product samples. At poultry 
processing establishments, the traditional method of weighing birds 
before and after chilling to determine moisture pick-up will continue 
to be available to both the Agency and the establishments as a process 
control check.
    FSIS also will conduct independent tests of the establishment's 
retained-water control as part of investigations of suspected problems 
or in the course of special studies. The overall focus of the Agency's 
activities will be to ensure that raw products that enter commerce do 
not contain water in excess of the amount that is unavoidable in 
achieving food safety objectives.
    FSIS is providing a full year from the publication date for 
implementation of this final rule to mitigate the effects of the rule 
on establishments that may have to consider changing or updating their 
chilling processes and equipment. The extended implementation period 
should be especially helpful to establishments that meet the small-
business-entity size criteria defined by the Small Business 
Administration.
    During the period before the effective date, FSIS will provide its 
field inspection personnel with the instructions they will need to 
carry out their review of protocols and verify that establishment data 
demonstrate the amount of water retention that is unavoidable and 
support product labeling statements. The Agency will prepare sampling, 
testing, and document review procedures for Agency use; train Agency 
personnel in the new procedures; and develop a new national reference 
database on the natural moisture content of raw products in the various 
meat and poultry product classes with which this rule is concerned.
    To develop this national database on natural moisture content, FSIS 
will test product samples drawn at official establishments. The Agency 
will use a common, analogous point of reference in livestock carcass 
and poultry product preparation at which to determine the naturally 
occurring percentage of moisture in meat products and poultry products, 
namely, the point at which the calculated yield weight is determined. 
(Calculated yield weight of a carcass is its predicted ``green 
weight''--the weight of the carcass after dressing and before any 
additional in-plant processing.) In poultry plants, this point is at 
the re-hanging operation (after de-feathering and hock removal). The 
analogous point in livestock slaughtering establishments is before the 
pre-evisceration carcass wash. FSIS has chosen these common reference 
points to reduce the possibility of measurement errors caused by 
various carcass-washing procedures.
    To determine the moisture content of a product sample, the Agency 
plans to rely on the oven-drying method described in its Chemistry 
Laboratory Guidebook and in Appendix A of this document. This method 
involves weighing, before and after drying, a dish containing a 
homogenized meat or poultry product sample. The method can be applied 
to products at any point in processing or distribution. Similar oven-
drying methods for determining the amount of moisture in meat, meat 
products, and poultry products are described in the Official Analytical 
Methods of the Association of Official Analytical Chemists and in ISO 
1442, published by the International Organization for Standardization.
    After developing sufficient information on the natural water 
content of raw meat or poultry products, FSIS will be in a better 
position to verify that the establishment is complying with the 
requirement to minimize retained-water amounts when the final rule 
becomes effective. To determine whether an establishment is complying 
with the regulations, the Agency will verify the establishment's 
protocol documentation and the data collected under the protocol, 
including data on retained-water minimization and pathogen reduction. 
FSIS also will verify compliance with the requirement that product 
labels display retained-water amounts, and that the actual retained 
water in the products corresponds to the labeled amount.
    Usually, the verification will consist only of a document check. 
However, the Agency will occasionally test products for moisture 
content to verify the establishment's findings.
    FSIS will randomly sample raw meat and poultry products both in-
plant and in-distribution and will test the products for retained water 
content. FSIS will collect and run tests on product samples and 
statistically analyze the results of the tests.
    The Agency will directly measure the moisture content of the raw 
products sampled in-plant at pre-shipment using its oven-drying method. 
The Agency will compare the results of these tests with the naturally 
occurring amounts of water in the national reference database and with 
the retained-water statements on the product labels to determine 
whether the products are in compliance with the requirement to minimize 
retained water, and whether they are correctly labeled with a retained-
water statement.
    To measure the amount of retained water and determine compliance 
with the final rule in in-plant situations when using the weighing 
method, FSIS will compare product weights taken after chilling, but 
before the product leaves the establishment, to the pre-final-wash 
weight or (in poultry plants) the calculated yield weight. In livestock 
slaughtering plants, the Agency expects to be comparing pre-final wash 
or ``hot'' carcass weights with the ``cold weights'' taken after spray 
chilling in establishments using the spray-chill process.

[[Page 1766]]

    The Agency does not expect to use calculated yield weight data as a 
basis for comparing hot and cold livestock carcass weights because such 
data are not available for most livestock establishments. The great 
majority of such establishments do not weigh carcasses after de-hiding 
or de-hairing and before the pre-evisceration wash. FSIS is aware that 
there may be a slight, measurable gain in carcass weight immediately 
after the pre-evisceration wash. However, this gain is usually more 
than offset by moisture loss on the kill floor. Thus, the ``hot'' 
carcass weight does not include a moisture gain resulting from the pre-
evisceration wash.
    FSIS is not prescribing any particular method that official 
establishments must use to measure the amount of retained water in 
their products. Establishments are free to use any scientifically valid 
method for this purpose. Establishments may want to use the food 
chemistry method described in Appendix A and used by FSIS to determine 
the moisture content of their products. Because of the destructive 
nature of the method and the delay in getting results, establishments 
may find it more convenient on a day-to-day basis to compare the 
weights of carcasses and parts before and after they are exposed to 
washes, sprays, or immersion chilling. The data from such checks would 
have to be available to FSIS to verify. As mentioned, poultry 
establishments will continue to be able to use the traditional method 
involving the weighing of birds before and after chilling as a check on 
water retention controls.
    FSIS also will conduct surveys of products in plants and in 
distribution channels to obtain an overview of national compliance with 
the regulations and to update the national reference database on the 
moisture content of meat and poultry products. The Agency will compare 
the results of these surveys with the information in its database to 
determine whether any adjustments in its enforcement of the regulations 
are necessary. Comments are requested on sampling and survey methods 
that the Agency should consider using both for initially building the 
national reference database and for the on-going compliance overview.
    FSIS will continue to verify that products are in compliance with 
the net-weight requirements for meat and poultry products. As stated 
elsewhere in this document, neither the net-weight requirements nor the 
obligation of an establishment to comply with them is affected by this 
final rule.
    FSIS expects there to be requests for adding water solutions to 
meat and poultry manufacturing trimmings in an effort to reduce the 
pathogen levels on product. Such applications may or may not result in 
retained water, as well as chemical residues. FSIS expects such 
applications to adhere to the same criteria as other applications 
resulting in retained water. FSIS will allow establishments to 
implement the provisions of this final rule in advance of the effective 
date provided the establishment informs the appropriate District Office 
in order that inspection program personnel are provided with the 
necessary instructional materials. FSIS expects to provide instructions 
regarding early implementation of the final rule.

Executive Order 12866 and Regulatory Flexibility Act

Current Practices in the Poultry Industry

    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 
to minimize 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 Kenney case, argued in U.S. District Court and referred 
to earlier in this document, various limits on maximum retained water 
applied to the various weight classes of whole chickens and turkeys. 
For example, the maximum retained water for most whole chickens 
weighing 4.25 pounds or less was 8 percent. The maximum retained water 
for chicken that is ice-packed or subsequently cut up into parts has 
been 12 percent. In its July 1997 decision, the U.S. District Court 
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 was arbitrary and capricious because 
the Secretary of Agriculture did not explain in the rulemaking record 
how he determined the particular water retention levels, why water 
retention cannot be reduced below those levels, or why meat and poultry 
should be treated differently with respect to water retention. The 
Court therefore set aside the water retention limits for poultry to be 
consumer packaged, frozen, or cooked as whole poultry. In the wake of 
the decision, there have been no regulatory criteria by which to 
determine whether retained water has been minimized in chilled or 
frozen whole birds.
    As discussed previously, FSIS is mandated by the FMIA and PPIA to 
prevent the distribution in commerce of meat or poultry products that 
are adulterated or misbranded. Without limits on retained water, FSIS 
cannot adequately protect consumers from adulteration and misbranding 
due to excessive retained water in whole birds. Hence, the Agency is 
establishing a new regulatory basis for minimizing retained water.
    FSIS is replacing the regulations under which poultry establishment 
was considered to be ``minimizing'' retained water when it was 
operating within the regulatory limits. FSIS is aware that not all 
establishments have really been minimizing retained water. Data 
analyzed for this FRIA show that some poultry establishments have been 
controlling their processes to retain the maximum allowed amount of 
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.
    With this final rule, FSIS also is addressing the issue of 
inconsistent treatment of meat and poultry in its regulations because, 
under the final rule, both meat and poultry products will be subject to 
the same requirements.

Need for the Rule

    The FMIA and PPIA, which the Agency administers, make clear the

[[Page 1767]]

obligation of producers of raw meat or poultry products not to mislead 
consumers. FSIS thinks that if they market as meat or poultry a product 
that contains something other than meat or poultry, that fact should be 
disclosed. It has been the consistent policy of FSIS to ensure that 
information that accurately discloses the contents of meat or poultry 
products is made available to consumers of those products.
    As noted earlier in this document, a 1997 U.S. District Court 
decision set aside the regulatory limits on retained water in poultry 
products. The District Court found that the Agency had not presented 
the basis for its retained water levels, why water retention could not 
be reduced below those levels, or why meat and poultry should be 
regulated differently with respect to water retention.
    The District Court ruling left FSIS without regulatory criteria for 
determining whether retained water had been minimized or what levels 
constituted adulteration. The Agency also no longer had available 
published retained water limits that it could enforce in an effort to 
protect consumers from misbranded product.

Analysis of Alternatives

    This rule resulted from an analysis of six alternative regulatory 
approaches for addressing retained water in raw meat and poultry 
products. The six alternatives are as follows:

    1. No limit on retained water but mandatory labeling that 
identifies the percentage of retained water in the product. FSIS did 
not recommend this alternative for adoption because it would not 
reduce retained water so that economic adulteration would continue 
to persist. It would, however, be advantageous to consumers because 
it would enable them to compare alternative packages of poultry with 
varying quantities of retained water and prices and select the 
package to suit their budgets.
    2. A requirement that all establishments meet a water limit 
based on best available technology, with mandatory labeling to 
indicate any retained water. FSIS did not propose this option 
because the adoption of the best available technology would be a 
step backward into a regime of command and control. It would also 
impose considerable costs on plants that are currently not employing 
such a technology without a corresponding improvement in food 
safety. For example, if the best available technology is determined 
to be the continuous chillers, there are several small and medium 
size plants that do not employ this technology. The economic impact 
of such an option would be significant on these plants. In the 
current environment of regulatory reform, FSIS is moving away from 
command and control to incentive-based performance standards. Such 
standards permit plants to reduce their retained water levels 
irrespective of the technology they employ. A moisture limit based 
on the best performance achievable with existing equipment, with 
mandatory labeling to show any retained water. FSIS did not adopt 
this option because, beyond stating that water retention should be 
minimized consistent with maximizing the safety of the product, it 
would be difficult, if not impossible, for FSIS to define the best 
performance achievable. This option would also encourage 
establishments to continue to use existing equipment, perhaps beyond 
the economic life of the equipment.
    3. A standard of zero retained moisture. FSIS did not recommend 
this option because the costs of this option might exceed the 
benefits. Finally, some minimum amount of retained water might be 
necessary for reducing pathogens.
    4. A requirement that no retained water could be included in net 
weight. FSIS did not recommend this option for adoption because it 
would require establishments to adjust their scales to account for 
retained water. The costs of adjusting these scales could be 
excessive. Moreover, enforcement of net weight requirements is an 
area where Federal, State and local authorities share responsibility 
and must cooperate. The enforcement procedure, 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''. The National Institute of Standards and 
Technology (NIST) has a statutory responsibility for ``cooperation 
with the states in securing uniformity of weights and measures laws 
and methods of inspection.
    5. 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. FSIS 
recommended this option because it prioritizes food safety above 
retained water. It also includes the provision of labeling the 
retained water to help consumers decide amongst alternative packages 
with different levels of retained water and prices.

    FSIS chose the last alternative. The selected option does not allow 
retained water in an affected product unless it is an unavoidable 
consequence of the process or processes used to meet applicable food 
safety requirements. By ``unavoidable consequence'' the Agency means an 
unavoidable and irreducible side effect. Under this option, inspected 
establishments, associations, or other groups, using acceptable 
protocols must establish levels of unavoidable retained water. Also, 
the maximum amount of retained water that can be present must be stated 
on the product label. FSIS has found that this option is likely to 
provide greater benefits than other options because it is more flexible 
and likely to prove less costly than some of the proposed alternatives. 
A food safety requirement can be a regulatory prescription, such as the 
temperature to which a product must be chilled and held. It can also be 
a preventive measure taken at a CCP or a critical limit in the 
establishment's HACCP plan. For example, the proposed rule might 
increase human handling for transferring products from the chillers to 
the freezer, thereby increasing cross contamination. A critical control 
point at such handling could reduce, if not eliminate, cross 
contamination. Given a food safety requirement, an establishment must 
choose a method for satisfying the requirement.
    The method selected for meeting food safety requirements may have 
unintended consequences that cannot be eliminated. A consequence of an 
antimicrobial treatment of carcasses or a carcass chilling method may 
be an increase in the water content of carcasses and parts. FSIS is 
requiring that the amount of water that might be retained in carcasses 
and parts as a result of using such an anti-microbial or chilling 
method be an unavoidable and irreducible 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 a written protocol that has been 
subject to review by FSIS. This final rule will allow an individual 
establishment or industry trade association or other group using the 
same or similar processing techniques to develop a protocol and carry 
out data-generating studies according to the protocol. 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 state the presence of retained water 
in the products.

Cost Estimates

    The analysis estimates a range of costs the poultry industry will 
incur to meet this new regulatory requirement. If establishments are 
able to demonstrate that current levels of retained water are 
unavoidable in achieving applicable food safety standards, 
establishments will not incur additional costs for reducing retained 
water. These establishments would only incur costs for establishing 
limits and costs for labeling the product. The costs of

[[Page 1768]]

establishing limits for the poultry industry are estimated to be $1.5 
million (in 1998 dollars). This estimate is based on each establishment 
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 (in 1998 dollars) if 
all raw, single-ingredient poultry continues to retain water.
    To the extent that establishments cannot demonstrate that current 
retained water levels are unavoidable in achieving applicable food 
safety standards, significant costs could be incurred as establishments 
modify processes to minimize retained water levels. FSIS 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. Reducing retained water could entail 
a wide range of process modifications, depending on the type of 
chilling equipment currently used and amount of retained water that 
would have to be removed. FSIS estimates that, if extensive 
modifications to chilling systems were needed throughout the industry, 
the fixed costs associated with removing a substantial portion of the 
existing retained water could run to well over $100 million. The 
substantial portion was defined in the PRIA, viz., that it would take 
12 hours to drain substantial portion of the retained water in 
chickens. The 12-hour drain would reduce the existing level range from 
5-6.5 percent, by 4 to 5 percentage points, i.e., to 1-1.5 percentage 
range, or by about 80 percent. The fixed costs estimates of these 
extensive modifications were taken from USDA/ERS study, discussed in 
the PRIA, and are summarized below.
    The drip-dry process for chicken requires production workers to 
remove chickens from a production line, place the chickens in vats, 
place the vats in a cool room for 12 hours, and return the chickens to 
the poultry line. Besides labor, this process requires cooling space, 
stainless steel vats that hold up to 500 chickens, and a forklift to 
transfer chickens from a production line to a storage room and then 
back to the line after the drip-dry process is complete.
    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:
    1. One common method of draining uses stainless steel vats at a 
cost of $1,000 each.
    2. Vats hold approximately 500 chickens or 100 turkeys.
    3. Cooler space costs $125 per square foot.
    4. Vats can be stacked two high.
    5. Stacked vats with aisles require 12 square feet of space per 
vat.
    6. Forklifts to move vats cost $24,000 each.
    The Daily Moisture Records sometimes include a record of the 
additional drain time required. The time varies with the initial water 
level, the drain configuration and the location of the excess water, 
i.e., under skin versus between muscle tissues or within muscle 
tissues. Based on the violations data, it was determined that a 12-hour 
drain would be the minimum time required to remove most of the retained 
water from chickens.
    Most of the drain time for turkeys ranged from \1/2\ to 1 hour on 
an ``hour per percentage reduction'' basis. 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 the existing limits.
    To drain chickens for 12 hours is equivalent to saying the industry 
would need to add 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; 354.12 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 ($29.5 + 44.3 + 
4.8).
    In addition, half a day's turkey production at 557,000 birds 
requiring 5,570 vats would cost $5.57 million and cooler space would 
cost $8.36 million. Assuming that the largest 70 turkey establishments 
would require an additional forklift at a cost of $1.68 million, the 
total fixed costs for draining all turkeys for 12 hours would be $15.61 
million ($5.57 + 8.36 + 1.68).
    In short, the total fixed costs for a 12-hour draining of chickens 
and turkeys would be $94.2 million ($$78.6 + $15.61). Since these costs 
were estimated in 1997, updating them with to the year 2000 would 
amount to about $100 million.
    Variable costs of holding poultry to drain would include increased 
labor costs, higher utility costs, increased overheads, and the cost of 
carrying additional inventory. Holding half a day's production is 
equivalent to continually storing a wholesale value of $37 million 
poultry ($19.2 billion divided by 520 shifts/year). At a 5 percent 
interest rate, the annual cost of draining poultry for 12 hours would 
be $1.85 million.
    It would be conservative to assume a minimum average of one 
additional employee per establishment. Since there are 300 
establishments, the cost at $21,500 per employee per year would result 
in an annual labor cost of $6.4 million ($21,500 x 300). The total 
variable costs of $8.25 million ($1.85 + $6.4) would increase to about 
$10 million in the year 2000 when updated by an increase in Employment 
Cost Index.
    To sum up, the first year costs of draining poultry would amount to 
$110 million ($100 m + $10 m). These are the costs of reducing retained 
water in the range of 1-1\1/2 \percent. Since the retained water is not 
reduced to zero, these are merely the lower bounds. The upper bound 
costs would be the costs of reducing retained water to zero percent.
    However, if extensive modifications were not needed, the industry 
would only incur the costs of establishing retained water limits and 
meeting the labeling requirements of the final rule.

Benefits of Final Rule

    Because of longstanding industry petitions and the decision in the 
Kenney case, FSIS has had to develop new regulatory requirements to 
carry out its responsibilities for protecting the public from economic 
adulteration. Prevention of economic adulteration is a consumer 
benefit. Consumers also will benefit from the additional information on 
retained water that will be provided as a result of the labeling 
requirement. The information on retained water should contribute to a 
sounder basis for purchasing decisions. Consumers are currently not 
being informed about the amount of retained water. Consumers will 
benefit from having improved knowledge of product quantity in terms of 
meat or poultry meat content.
    The final rule will provide the meat industry with additional 
flexibility for meeting the pathogen reduction performance standards. 
Meat processors will be able to use pathogen reduction techniques 
without having to be

[[Page 1769]]

concerned about meeting the existing zero retained water requirement. 
Of course, if their single-ingredient raw products retain water, the 
products will have to be labeled to indicate how much water may be 
retained.
    This final rule also will provide affected establishments with 
increased flexibility to choose the most appropriate means for 
implementing HACCP plans for protecting the safety or raw product while 
minimizing the potential for economic adulteration. By removing certain 
command-and-control requirements and providing increased flexibility 
for HACCP implementation, this final rule may reduce the costs of HACCP 
implementation.
    As discussed in the preamble, this final rule eliminates many 
requirements, including the following:
    1. The requirement that poultry establishments provide FSIS with a 
description of all chilling and freezing procedures.
    2. The requirement that poultry establishments notify FSIS before 
any changes in chilling procedures are implemented and provide FSIS 
with test results demonstrating the effectiveness of the changes.
    3. The requirements that meat carcasses cannot show any weight gain 
resulting from the use of carcass spray systems.
    4. Elimination of minimum water intake requirements for immersion 
chillers.
    Finally, the rule will 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 final rule will eliminate some recordkeeping 
and reporting burdens, provide for increased flexibility, and reduce 
the costs of HACCP implementation.

Impact on Small Entities

    The final 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 business entities, based on 
the Small Business Administration size criterion of more than 500 
employees.
    These establishments, and indeed most poultry establishments, use 
immersion chilling to meet the existing chilling requirements for 
poultry, e.g., 9 CFR 381.66(b)(2) requires that poultry carcasses under 
4 pounds must be chilled to 40  deg.F within 4 hours following 
evisceration. It follows that, for most poultry establishments, the 
unavoidable 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 industry already has 
information concerning the chiller variable settings that minimize 
water retention. Therefore, the poultry industry can establish water 
retention limits for various chiller systems with minimal costs. FSIS 
also recognizes the possibility that some poultry establishments may 
have to use anti-microbial interventions that result in higher levels 
of retained water to meet the Salmonella standards than they do to meet 
the existing chilling requirements.
    Fifty to 60 poultry slaughter establishments 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 final rule are the firms operating immersion chillers in a manner 
that targets the maximum allowable retained water.
    This final rule should not have a significant impact on the meat 
industry because that industry is already achieving zero-percent 
retained water. This final rule, however, provides an alternative for 
establishments that are having or will have trouble meeting the 
Salmonella performance standards. These establishments could use a full 
range of anti-microbial rinses or hot-water rinses without having to 
worry about meeting a zero-percent retained-water limit. If they can 
demonstrate that they need a non-zero limit to meet the Salmonella 
standards, they can use the flexibility provided by the final rule and 
establish a new water limit as long as they state the maximum 
percentage of water absorbed and retained on product labels. Of the 
meat products affected by this final rule, edible organs prepared in 
slaughtering plants are most likely to retain water. Of the 1,200 
establishments that prepare these products, about 85 percent are small. 
Most of these establishments will have to label their products to 
indicate the maximum retained-water percentage in the products.

Executive Order 12988

    This final 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 and meat products 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. States and local jurisdictions also 
may exercise concurrent jurisdiction, for the same purpose, over 
imported meat and poultry products that are not at an official 
establishment after the entry of such imported articles into the United 
States.
    This final 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 
final rule. However, the administrative procedures specified in 9 CFR 
306.5 and 381.35 must be exhausted prior to any judicial challenge of 
the application of the provisions of this final 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 
final rule on environmental and health conditions in low-income and 
minority communities.
    This final rule will 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, the regulations 
should generally benefit consumers of meat, meat products, and poultry 
products. The regulations will 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 final rule will not exclude

[[Page 1770]]

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.
    FSIS estimates that as many as 4 percent of meat and poultry 
establishments under Federal and State inspection are owned by women or 
members of non-white minority groups. Therefore, of the establishments 
affected by this rule, as many as 4 percent of the establishments may 
be under female or minority ownership. FSIS has no reason for 
supposing, however, that the effects of this rule, whether adverse or 
beneficial, on such establishments would be disproportionate.

Additional Public Notification

    Public awareness of all stages of rulemaking and policy development 
is important. Consequently, in an effort to better ensure that 
minorities, women, and persons with disabilities are aware of this 
final rule, FSIS will announce it and provide copies of this Federal 
Register publication of this final rule in the weekly FSIS Constituent 
Update. The FSIS Constituent Update is communicated via fax to over 300 
organizations and individuals. In addition, the update is available on 
line through the FSIS web page located at ``http://www.fsis.usda.gov''. 
The update is used to provide information regarding FSIS policies, 
procedures, regulations, Federal Register notices, FSIS public 
meetings, recalls, and any other types of information that could affect 
or would be of interest to the Agency's constituents/stakeholders. The 
constituent fax list consists of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals who have requested to be included. 
Through these various channels, FSIS is able to provide information to 
a much broader, more diverse audience. For more information and to be 
added to the constituent fax list, readers of this document may fax 
their requests to the Congressional and Public Affairs Office, at (202) 
720-5704.

Paperwork Requirements

    Title: Retained Water in Raw Meat and Poultry Products; Poultry 
Chilling.
    Type of Collection: Labels and labeling records; data or 
information supporting labeling statements.
    Abstract: 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 written protocols.
    This final rule will require an estimated 210,000 hours to develop 
the data to support retained water levels above zero. All 300 federally 
inspected poultry establishments will need to conduct studies to 
establish minimum retained water levels. The FRIA assumed that the 
average establishment would conduct studies for two product categories. 
The FRIA 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.
    The FRIA assumed 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). 
Changes to product labels would be generically approved and, therefore, 
establishments would not incur a burden from label submission.
    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, 112 Annex, 300 12th SW., 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 through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology.
    Specifically, FSIS is interested in comments regarding the label 
requirements. Some commenters expressed concern about the usefulness, 
or ``practical utility,'' of the information on the maximum percentage 
of retained water that must be disclosed on the label. FSIS welcomes 
any information and data to support this requirement or that presents 
alternatives. FSIS will fully address any comments in its information 
collection request that it will submit to the Office of Management 
Budget 60 days after publication of this rule.
    Comments may be sent to Lee Puricelli, see address above, and the 
Desk Officer for Agriculture, Office of Information and Regulatory 
Affairs, Office of Management and Budget, Washington DC 20253.
    Comments are requested by March 12, 2001. To be most effective, 
comments should be sent to OMB within 30 days of the publication date.

List of Subjects

9 CFR Part 381

    Food labeling, Poultry and poultry products.

9 CFR Part 441

    Consumer protection standards, Meat and meat products, Poultry 
products.


    For the reasons discussed in the preamble, FSIS is amending 9 CFR 
Chapter III, as follows:

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    1. The authority citation for part 381 continues 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) of Sec. 381.1 is amended by revising the 
definition of Ready-to-cook poultry to read as follows:


Sec. 381.1  Definitions.

* * * * *
    (b) * * *
    (44) Ready-to-cook poultry. ``Ready-to-cook poultry'' means any 
slaughtered

[[Page 1771]]

poultry free from protruding pinfeathers and vestigial feathers (hair 
or down), from which the head, feet, crop, oil gland, trachea, 
esophagus, entrails, and lungs have been removed, and from which the 
mature reproductive organs and kidneys may 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 is 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 must be strictly in accord 
with clean and sanitary practices and must be conducted in a manner 
that will result in sanitary processing, proper inspection, and the 
production of poultry and poultry products that are not adulterated.
    (b) Poultry must be slaughtered in accordance with good commercial 
practices in a manner that will result in thorough bleeding of the 
carcasses and ensure that breathing has stopped prior to scalding. 
Blood from the killing operation must be confined to a relatively small 
area.
    (c) When thawing frozen ready-to-cook poultry in water, the 
establishment must use methods that prevent adulteration of, or net 
weight gain by, the poultry.
    (d) The water used in washing the poultry must be permitted to 
drain freely from the body cavity.
    (e) Detached ova may be collected for human food and handled only 
in accordance with 9 CFR 590.440 and may leave the establishment only 
to be moved to an official egg product processing plant for processing. 
Ova from condemned carcasses must be condemned and treated as required 
in Sec. 381.95.

    4. Section 381.66 is 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 that are necessary for 
chilling and freezing ready-to-cook poultry, including all edible 
portions thereof, must be in accordance with operating procedures that 
ensure the prompt removal of the animal heat, preserve the condition 
and wholesomeness of the poultry, and assure that the products are not 
adulterated.
* * * * *
    (c) Ice and water chilling. (1) Only ice produced from potable 
water may be used for ice and water chilling. The ice must be handled 
and stored in a sanitary manner.
    (2)(i) Poultry chilling equipment must be operated in a manner 
consistent with meeting the applicable pathogen reduction performance 
standards for raw poultry products as set forth in Sec. 381.94 and the 
provisions of the establishment's HACCP plan.
    (ii) Major portions of poultry carcasses, as defined in 
Sec. 381.170(b)(22), may be chilled in water and ice.
    (3) Previously chilled poultry carcasses and major portions must be 
maintained constantly at 40  deg.F or below until removed from the vats 
or tanks for immediate packaging. Such products may be 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 must 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 must 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 must 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 must be such as will minimize 
water absorption and retention at time of packaging.
    (2) The establishment must provide scales, weights, identification 
devices, and other supplies necessary to conduct water tests.
* * * * *
    (f) * * *
    (6) [Removed]

    5. A new Part 441 is added to subchapter E to read as follows:

PART 441--CONSUMER PROTECTION STANDARDS: RAW PRODUCTS

    Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906; 
7 CFR 2.18, 2.53.


Sec. 441.10  Retained water.

    (a) Raw livestock and poultry carcasses and parts will not be 
permitted to retain water resulting from post-evisceration processing 
unless the establishment preparing those carcasses and parts 
demonstrates to FSIS, with data collected in accordance with a written 
protocol, that any water retained in the carcasses or parts is an 
unavoidable consequence of the process used to meet applicable food 
safety requirements.
    (b) Raw livestock and poultry carcasses and parts that retain water 
from post-evisceration processing and that are sold, transported, 
offered for sale or transportation, or received for transportation, in 
commerce, must bear a statement on the label in prominent letters and 
contiguous to the product name or elsewhere on the principal display 
panel of the label stating the maximum percentage of water that may be 
retained (e.g., ``up to X% retained water,'' ``less than X% retained 
water,'' ``up to X% water added from processing''). The percent water 
statement need not accompany the product name on other parts of the 
label. Raw livestock and poultry carcasses and parts that retain no 
water may bear a statement that no water is retained.
    (c)(1) An establishment subject to paragraph (a) of this section 
must maintain on file and available to FSIS its written data-collection 
protocol. The protocol must explain how data will be collected and used 
to demonstrate the amount of retained water in the product covered by 
the protocol that is an unavoidable consequence of the process used to 
meet specified food safety requirements.
    (2) The establishment must notify FSIS as soon as it has a new or 
revised protocol available for review by the Agency. Within 30 days 
after receipt of this notification, FSIS may object to or require the 
establishment to make changes in the protocol.
    (d) Expected elements of a protocol for gathering water retention 
data:
    (1) Purpose statement. The primary purpose of the protocol should 
be to determine the amount or percentage of water absorption and 
retention that is unavoidable 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.

[[Page 1772]]

    (2) 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 products 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.
    (3) 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.
    (4) 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.
    (5) 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.
    (6) 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, establishments are free to adopt practicable criteria 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.
    (7) 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.
    (8) Reporting of data and 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.
    (9) Conclusions. The protocol should provide for a statement of 
what the data obtained demonstrate and what conclusions were reached.

    Done at Washington, DC: January 3, 2001.
Thomas J. Billy,
Administrator.

    Note: Appendix A will not be codified in Title 9 of the Code of 
Federal Regulations.

Appendix A--Method for Determining Moisture in Meat and Meat Products 
and Poultry Products

A. Introduction

    Theory: In this determination, a weighed sample is heated, 
cooled, and then re-weighed. The loss in weight is calculated as 
moisture content.

B. Equipment

    Apparatus:
    a. Covered aluminum dish. At least 50 mm. diameter and not 
greater than 40 mm. deep, containing a paddle.
    b. Mechanical convection oven, preferably one equipped with a 
booster heater.
    c. Food chopper with plate openings  \1/8\" (3 mm.), 
or Robot Coupe or equivalent food processor.

C. [Reserved.]

D. [Reserved.]

E. Sample Preparation Procedure for Fresh Meat or Poultry

    For accurate and reliable measurement, the raw meat or poultry 
sample should be finely ground to a homogeneous consistency.

F. Analytical Procedure

    a. Accurately weigh sample (representing approximately 2 g. of 
dry material) into an aluminum dish.
    i. Weigh the sample as rapidly as possible to minimize loss of 
moisture.
    ii. The weight of the pan should include the paddle, which is 
used in spreading the sample across the bottom of the pan, thereby 
presenting a greater sample surface area, which is beneficial to 
moisture removal.
    iii. If the sample is relatively dry when received, a small 
quantity of distilled water may be added to the pan only after the 
sample weight is obtained. This quantity of water will be helpful in 
spreading the sample across the bottom of the pan, and will 
introduce no error since it will be evaporated when the sample is 
oven-dried.
    b. Dry, with cover removed, for 16-18 hours at 100-102  deg.C, 
or for 4 hours at 125  deg.C in mechanical convection oven.
    Do not overload the drying oven or sample may be insufficiently 
dried and give low results. Drying time will start when the original 
temperature has been reached. Use the oven's booster heater, if the 
oven is so equipped, to minimize this recovery time.

G. Calculations

1. Procedure
[GRAPHIC] [TIFF OMITTED] TR09JA01.000

A = sample weight
B = weight of dish + sample before drying
C = weight of dish + sample after drying

    Note: If laboratory is not air-conditioned, and humidity is 
high, dishes should be desiccated before the initial and final 
weighings.

    Reference: Official Methods of Analysis of the Association of 
Official Analytical Chemists, 16th Edition, 950.46.
[FR Doc. 01-460 Filed 1-4-01; 10:35 am]
BILLING CODE 3410-DM-P