DEPARTMENT OF AGRICULTURE

THE FOLLOWING IS A PRE-PUBLICATION COPY OF THE FSIS FINAL RULE ”RETAINED WATER IN RAW MEAT AND POULTRY PRODUCTS; POULTRY CHILLING REQUIREMENTS.” IT MAY NOT BE EXACTLY THE SAME AS THE VERSION THAT WILL APPEAR IN THE FEDERAL REGISTER.

BILLING CODE 3410-DM-P
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.

ACTION:  Final rule.

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 [Insert date 1 year after date 
of publication].  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 [Insert date 3 months after date of publication].  Comments 
responding to information requested in the preamble to this final rule should be 
received by FSIS by [Insert date 3 months after date of publication].

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.

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 NF 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 §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 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. 

      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 °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 NF 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 °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 
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 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 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.

      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 §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.  

      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 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.

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 
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. 

Recommendations for Various Technical Changes

      Comment:  The qualifier "mature" should be restored to the term 
"reproductive organs" in §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 §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 
§381.1(b)(44).

      Response:  FSIS is correcting this typographical error.

      Comment:  Remove §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 §381.65(d) because it is redundant with proposed §441.10. 

      Response:  Proposed paragraph 381.65(d) is a re-designation of paragraph 
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 §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 §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 §381.66(c)(2)(ii) should be revised to refer to split 
carcasses as defined in § 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 §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 §381.66(d)(1) and (2) as redundant with 
§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 paragraph 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 annually.  
This is a relatively small amount of trade.

Provisions of the Final Rule

      Under § 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 § 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 §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 §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 § 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 § 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 °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 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 §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 °F in under 2 hours will remain at 
this time.

Paragraph (d) of section 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 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.
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 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 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 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 °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), AFederal 
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 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 [insert 60 days from the date of publication in the 
Federal Register].  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 ' 381.1 is amended by revising the definition of 
ready-to-cook poultry to read as follows:

§ 381.1  Definitions.

*  *  *  *  *

(b) *  *  *

(44) Ready-to-cook poultry.  AReady-to-cook poultry@ means any slaughtered 
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:

§ 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 § 381.95. 

4. Section 381.66 is amended by revising paragraphs (a), (c), and (d) and 
removing paragraph (f)(6), to read as follows:
§ 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 § 381.94 and the provisions of the establishment's 
HACCP plan.

(ii) Major portions of poultry carcasses, as defined in § 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 °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 °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 °F or 
below, except when the packaging will be followed immediately by freezing at the 
official establishment.

(4) Giblets must be chilled to 40 °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.
§ 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.

(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 1F 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:
 
 
__________________________________
Thomas J. Billy,
 
Administrator. 


Note:  The following appendix will not appear in 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 NC, or for 4 hours at 
125 NC 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

     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.

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