[Federal Register Volume 66, Number 6 (Tuesday, January 9, 2001)]
[Rules and Regulations]
[Pages 1750-1772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-460]
[[Page 1749]]
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Part III
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 381 and 441
Retained Water in Raw Meat and Poultry Products; Poultry Chilling
Requirements; Final Rule
Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules
and Regulations
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 381 and 441
[Docket No. 97-054F]
RIN 0583-AC26
Retained Water in Raw Meat and Poultry Products; Poultry Chilling
Requirements
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is issuing
regulations to limit the amount of water retained by raw, single-
ingredient, meat and poultry products as a result of post-evisceration
processing, such as carcass washing and chilling. Raw livestock and
poultry carcasses and parts will not be permitted to retain water
resulting from post-evisceration processing unless the establishment
preparing those carcasses and parts demonstrates to FSIS, with data
collected in accordance with a written protocol, that any water
retained in the carcasses and parts is an inevitable consequence of the
process used to meet applicable food safety requirements. In addition,
the establishment will be required to disclose on the labeling of the
meat or poultry products the maximum percentage of retained water in
the raw product. The required labeling statement will help consumers of
raw meat and poultry products to make informed purchasing decisions.
Establishments having data demonstrating that there is no retained
water in their products can choose not to label the products with the
retained-water statement or to make a no-retained-water claim on the
product label.
FSIS is also revising the poultry chilling regulations to improve
consistency with the Pathogen Reduction/Hazard Analysis and Critical
Control Points (PR/HACCP) regulations, eliminate ``command-and-
control'' features, and reflect current technological capabilities and
good manufacturing practices.
DATES: Effective Date: This rule is effective on January 9, 2002.
Establishments wishing to implement the provisions of this final rule
prior to the effective date should contact the appropriate FSIS
District Office. FSIS will provide instructions to its inspection
program personnel for facilitating early implementation.
Comments: Comments on the guidance material published in Appendix A
should be received by April 9, 2001. Comments responding to information
requested in the preamble to this final rule should be received by FSIS
by April 9, 2001.
ADDRESSES: Submit one original and two copies of written comments to
Docket Clerk, U.S. Department of Agriculture, Food Safety and
Inspection Service, Room 102, 300 12th Street, SW., Washington, DC
20250-3700. Please refer to docket number 97-054F in your comments. All
comments submitted on this rule, as well as the research and background
information used by FSIS in developing this document, will be available
for public inspection in the Docket Clerk's Office between 8:30 a.m.
and 4:30 p.m., Monday through Friday. The final regulatory impact
analysis referred to in this document and summarized in the section
discussing the Agency's compliance with Executive Order 12866 is
available for viewing on the Agency's Internet homepage located at
``http://www.fsis.usda.gov''.
FOR FURTHER INFORMATION CONTACT: Ms. Patricia F. Stolfa, Assistant
Deputy Administrator, Office of Policy, Program Development and
Evaluation, Food Safety and Inspection Service, U.S. Department of
Agriculture, Washington, DC 20250-3700; (202) 205-0699.
SUPPLEMENTARY INFORMATION:
Background
FSIS carries out the mandates of the Federal Meat Inspection Act
(FMIA; 21 U.S.C. 601 et seq.), the Poultry Products Inspection Act
(PPIA; 21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21
U.S.C. 1031 to 1056) to ensure that meat, meat food, poultry, and egg
products prepared for distribution in commerce are wholesome, not
adulterated, and properly marked, labeled, and packaged. The FMIA and
PPIA prohibit anyone from selling, transporting, offering for sale or
transportation, or receiving for transportation in commerce, of any
adulterated or misbranded meat or poultry product (21 U.S.C. 610, 458).
Under the Acts (21 U.S.C. 601(m)(8); 453(g)(8)), a product is
adulterated if, among other circumstances in which it might be
adulterated, ``any substance has been added thereto or mixed or packed
therewith so as to increase its bulk or weight, or reduce its quality
or strength, or make it appear better or of greater value than it is.''
Under the same Acts (21 U.S.C. 601(n)(1), (12) and 21 U.S.C. 453(h)(1),
(12)) a product is misbranded if, among other circumstances in which it
might be misbranded, ``its labeling is false or misleading in any
particular.''
FSIS provides continuous inspection in meat and poultry
slaughtering and processing establishments and in egg product
processing plants to ensure that the establishments sell in commerce
only products that are not adulterated or misbranded. At meat and
poultry slaughtering establishments, FSIS enforces requirements
intended to prevent the adulteration of carcasses and parts during
post-evisceration processing, handling, and storage. Some of these
requirements concern the washing and chilling of the carcasses and
parts.
After evisceration, raw livestock and poultry carcasses are subject
to various processes, including washing and chilling, to ensure the
safety of the products. In livestock slaughtering establishments, air
chilling causes carcass weight loss from evaporation of the natural
water in the carcass during evaporative cooling. Spraying water on
livestock carcasses during air chilling either replaces the water that
would have evaporated during air chilling or prevents the water in the
carcass from evaporating. The result is that livestock carcasses
subjected to a water spray do not lose weight through evaporation.
Establishments should operate water spray systems in a manner that does
not result in an increase in the average weight of a group of livestock
carcasses produced during a scheduled period of operations over the
carcasses' pre-chilled weight. FSIS Directive 6330.1, which describes
the Agency's policies on the spray-chilling of carcasses, recognizes
that it is technologically feasible and commercially practical to chill
livestock carcasses in a manner that, on average, does not result in an
increase in the carcass weight above the pre-chilled weight.
However, the processing and chilling methods used for some edible
meat byproducts and organ meats may result in water retention. For
example, cheek meat, meat from ears and tails, and organ meats are
washed, cleaned, and chilled to preserve safety and wholesomeness
before being shipped. Chitterlings (swine intestines) are washed and
chilled before shipment and are packaged with water. A few
establishments chill beef cheek meats in water, a process that may
result in the absorption of water. The product is labeled to indicate
the maximum percentage added water it may contain to alert buyers to
the fact that the product may weigh more because of the chilling
process.
[[Page 1751]]
Unlike meat packers, poultry processors have traditionally chilled
poultry using the water-immersion chilling method. Although air
chilling is permitted, immersion chilling is more rapid and cost
efficient. The use of water immersion chilling is limited to whole
poultry carcasses or major carcass portions. Poultry establishments are
required to reduce the internal temperature of water-chilled poultry
carcasses to 40 deg.F or less within 4 to 8 hours after slaughter,
depending on the size of the carcass (9 CFR 381.66(b)).
Chilling poultry carcasses in water-immersion chillers always
results in some absorption and retention of water, primarily in the
skin and the tissue immediately under the skin. Also, some water
becomes bound to the muscle tissue.
FSIS has consistently required that the retention of water in meat
and poultry products be minimized. FSIS is mandated to prevent the
distribution in commerce of meat, meat food and poultry products that
are adulterated or misbranded.
Immersion chilling of poultry could result in a product becoming
misbranded or economically adulterated through the retention of
absorbed water. Nonetheless, since immersion chilling is an efficient
way to control bacterial growth in poultry products and to ensure that
establishments consistently meet applicable chilling time and
temperature requirements, FSIS has permitted the retention of some
water in poultry products. The Agency requires, however, that retained
water amounts be minimized (9 CFR 381.66(d)(1)) and has set limits on
the amount of water a poultry product may retain (9 CFR 381.66(d)(2)-
(4)).
The Agency promulgated regulations limiting water absorption and
retention in poultry products in 1959, 1961, and 1970 (24 FR 9566,
December 1, 1959; 26 FR 6471, July 19, 1961; 35 FR 15739, October 7,
1970). The retained-water limits were based on carcass weight and
intended use of the product. For example, higher limits were provided
for birds that were to be cut-up than for those to be sold as whole
birds because, when the birds are cut up, water retained at or near
those higher limits declines below the regulatory limits for whole
birds. If water has not been minimized, the product may be considered
adulterated. Such product may also be considered misbranded if its
labeling does not disclose the presence of retained water at levels
higher than the required limits. Until a Federal court set aside the
regulatory limits on retained water in poultry products, public
knowledge of the limits obviated the need for a requirement for
retained water to be disclosed on a product label. Without published
limits on retained water, FSIS cannot adequately protect consumers from
adulteration and misbranding due to excessive retained water in whole
birds.
FSIS, however, lacks information on which to decide what level, if
any, of retained water would not constitute adulteration, or to
determine whether the limits that are in use do not result in
adulteration.
Provisions To Limit Retained Water in Raw Meat and Poultry Products
On September 11, 1998, FSIS proposed regulations that would limit
the amount of water retained by raw carcasses and parts of livestock
and poultry as a result of post-evisceration processing, such as
carcass washing and chilling. Under the proposal, meat and poultry
carcasses and parts could not retain water from such processing unless
the establishment preparing the carcasses and parts demonstrated that
water retention is an unavoidable consequence of procedures necessary
to meet applicable food safety requirements. FSIS also proposed to
require that the establishment disclose on the product labeling the
maximum percentage of retained water in the product. The labeling
statement would provide information that would be helpful to consumers
in making purchasing decisions. An establishment having data
demonstrating that there is no retained water in the products could
choose not to label the products with the retained-water statement or
to make a no-retained-water claim on the product label. The proposed
requirements were intended to replace those set forth in 9 CFR
381.66(d)(2)-(8). The purpose of the proposed requirements was to
restrict, as much as feasible, the amount of water absorbed and
retained in raw meat and poultry products.
The proposed rule was prompted by longstanding industry petitions
and by the Agency's need to reform its regulations to make them more
consistent with its Pathogen Reduction/Hazard Analysis and Critical
Control Point System (PR/HACCP) regulations, in accordance with its
regulatory reform agenda. The rulemaking gained further impetus in the
wake of a July 23, 1997, Federal court decision in Kenney v. Glickman
vacating the regulations in 9 CFR 381.66(d)(2) that contain the water-
retention tables for poultry.
As explained above, FSIS has consistently required that the
retention of water in meat and poultry be minimized and has considered
product with too much retained water to be adulterated. FSIS used the
retained water limits specified in Sec. 381.66(d)(2) to determine
whether poultry establishments were meeting the requirement to minimize
water absorption and absorption and retention in whole birds. The
decision in Kenney v. Glickman, however, removed this regulation
because its basis was inadequate, and left the Agency without a
regulatory limit, greater than zero percent, at or below which it could
consider retained water in whole poultry to have been minimized. The
limits for cut-up or ice-pack poultry in 9 CFR 381.66(d)(3)-(6)) were
unaffected by the Court decision. This final rule replaces retained
water limits that have been set out in the regulations with a
requirement that products not retain water unless establishments
demonstrate that the retained water is an unavoidable consequence of
meeting food safety requirements.
FSIS is aware that it may be difficult to eliminate water retention
for poultry and some meat products while continuing to meet applicable
food safety requirements. Even in operations that yield raw product
with zero-percent retained water, there is a certain amount of process
variability. FSIS therefore proposed an alternative to a zero-percent
retained-water requirement. Establishments would be required to collect
data, in accordance with a protocol approved by FSIS, and demonstrate
that water retention is an unavoidable consequence of the process used
to meet a food safety requirement, such as the Salmonella performance
standards or time/temperature chilling requirements. FSIS expected
that, to determine that any unavoidable water retention is the minimum
feasible, the protocol would provide for testing the process under
alternative equipment settings or other variables.
FSIS said in the proposal that it would accept data generated from
an approved protocol to support water retention levels for multiple
establishments using similar post-evisceration processing techniques
and equipment. Depending on the design of the protocol and the adequacy
of the data collected under it, the Agency stated that the data could
be used to justify an industry-wide water-retention limit, a limit
applying to poultry products processed by several establishments, or a
limit applying only to a single establishment's product. Establishments
using an industry-wide or multi-establishment limit would have to be
able to demonstrate that the conditions under which their products
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are processed match those specified in the protocol used to justify the
limit.
Comments
FSIS received 252 letters commenting on the proposed rule. Most
were from members of the regulated industry. Sixty-one were from
companies, company officials, or other individuals associated with the
meat industry, or trade associations representing the industry,
including both producers and packers. One hundred and sixty-nine were
from companies, company officials or other individuals associated with
the poultry industry, or from trade associations representing the
industry, including both producers and processors. The rest were sent
in by consumer-advocacy groups and other consumer-oriented
organizations (3), individual consumers (7), weights and measures
officials (7), a trade association not exclusively concerned with meat
and poultry (1), technology firms (3), and the European Union.
Consumers, consumer groups, and commenters representing livestock
producer and meat packing interests tended to favor the proposal or to
criticize it for not going far enough in restricting water retention.
Poultry interests tended to oppose the proposal or to favor extensive
modifications. Technology firms were divided on the merits of the
proposal and on processes for improving food safety.
Comment summaries (each termed ``Comment'') by topic and Agency
responses follow:
Alleged Inequitable Regulatory Treatment
Comment: Meat industry groups said that FSIS must eliminate the
substantial inequity in the regulatory treatment of meat, compared with
the treatment of poultry. They said that requirements for chilling meat
and poultry products must be the same. The ``equity'' issue, they said,
remains unresolved by the proposal, and that FSIS is maintaining the
status quo without offering compelling food safety reasons for doing
so. Poultry chilling, they said, should be subject to the same
``rigorous requirements'' as those that apply to the chilling of meat.
The rule should be science-based, equitable, and HACCP-consistent.
On the other side, poultry groups said that the proposal does not
treat poultry equitably with meat. They said that the meat industry
uses spray chilling and does not have to adhere to chilling time/
temperature requirements as does the poultry industry. Moreover, they
said, organ meats are chilled in water without regulatory limitation.
Poultry groups also suggested that the proposed regulations may not
apply equally to livestock and poultry parts. They said that ``parts''
in the meat regulations has a connotation different from that of
``parts'' in the poultry regulations. They asserted that there are few
proposed changes that would affect the chilling and labeling of meats.
Response: FSIS disagrees that it is not resolving the ``equity''
issue. This rulemaking clearly applies to both meat and poultry
products. Both meat and poultry establishments must abide by the
retained-water minimization requirements of this final rule. Also, the
retained-water labeling requirement will make both meat and poultry
product establishments accountable to consumers for water retention.
The point of the poultry industry commenters with respect to the
spray chilling of meat carcasses is well taken, and it is true that
meat carcasses do not have to meet chilling time/temperature
requirements as do poultry carcasses.
FSIS acknowledges the need to address the issue involving the
chilling time and temperature requirements for poultry that were raised
in both the American Meat Institute's 1997 petition and industry
comments on this rulemaking. However, as the Agency indicated in the
preamble to the proposed rule (63 FR 48963, 48965), FSIS did not intend
to address this issue in this but in a future rulemaking.
FSIS does not agree with the poultry industry statement about the
meaning of ``parts'' in the meat and poultry regulations, nor does the
Agency see the relevance of the point to this rule. Raw, single-
ingredient meat and poultry products, including parts of either meat or
poultry carcasses, are covered. Some products of the meat industry that
previously have not been covered by a retained-water regulation, e.g.
livestock organs and offal, are now covered by this rule--a fact to
which members of the meat industry have objected.
If applying ``the same rigorous requirements'' to poultry as to
meat means requiring the poultry industry to adopt non-immersion-
chilling methods, this final rule will not accomplish that objective.
The food safety rationale for mandating the use of a particular
technology has not been demonstrated.
Comment: FSIS is biased in favor of the poultry industry when it
states that immersion chilling reduces overall pathogen levels. There
are other ways to reduce pathogens. The Agency is particularly biased
in stating that installing air chilling or air-spray systems in the
poultry industry would be economically infeasible.
Response: FSIS acknowledges that pre-chill treatments can be
advantageous in controlling bacteria and in achieving the objectives of
the rulemaking. FSIS has never suggested, however, that the purpose of
immersion chilling is to remove pathogens, but has stated that chilling
reduces the temperature of the carcass and thus inhibits the growth of
pathogens and other bacteria. FSIS stated in the Preliminary Regulatory
Impact Analysis (PRIA) that requiring the poultry industry to install
air chilling or air-spray chilling systems would entail major
construction costs (63 FR 48976). FSIS does not consider this
conclusion of its analysis to be evidence of bias.
Comment: Poultry has been immersion-chilled for decades. The
poultry and meat industries are different and should be regulated
differently.
Response: Different technologies may be needed to produce safe
products from different species. FSIS is not banning or discouraging
the use of immersion-chilling technologies to produce safe poultry
products. The Agency is obligated, however, to take the same regulatory
approach to meat as to poultry products, unless it finds, based on the
available record, that different approaches are necessary.
Technology of Chilling and Bacterial Control
Comment: FSIS should encourage investment in technology adjustments
that prevent water retention in poultry. The meat industry uses steam
vacuum and steam-and-hot-water pasteurization without adding water
weight via water retention in carcasses.
Response: By requiring establishments to justify unavoidable
retained water in food safety terms and to apply retained-water
labeling to their products, the final rule will provide an incentive
for technological adjustments that minimize water retention in
carcasses.
Comment: Consumer groups and meat industry commenters asserted that
FSIS has failed to consider the most recent information on the
effectiveness of chilling technologies other than immersion chilling.
They said FSIS seemed to dismiss air chilling because it could result
in product discoloration. Some noted that European processors use air
chilling, which does not have the cross-contamination risks of chiller
baths.
Response: In framing the proposed regulation, FSIS did not assume
that immersion chilling will be the technology of choice for either the
meat or the poultry product industry.
[[Page 1753]]
FSIS has taken no position on the safety or quality of air-chilled
product but has limited data on the effectiveness of air chilling,
especially in large-scale operations of the kind that supply most of
the poultry products sold in the United States.
Comment: Immersion chilling is the best way to prevent potential
food safety problems. Using chilled water is the most efficient,
effective way to remove carcass heat and is the best way to achieve the
purposes of HACCP. One company reported data on post-chill compared
with pre-chill carcasses that show a 73-percent reduction in pathogenic
organisms and an 85-percent reduction in generic E. coli. After a
trisodium phosphate (TSP) carcass-rinse treatment, the incidence of
Salmonella and E. coli is 0 percent. (Carcasses not rinsed with TSP
show 96 percent and 30 percent, respectively. Campylobacter was found
in 78 percent of untreated carcasses, and in 46 percent after TSP
treatment.) The company maintained that air-chilling methods are not so
effective, but that immersion chilling is an effective and economical
way to meet the USDA time/temperature requirement.
Response: FSIS appreciates the food safety accomplishments of firms
using any post-evisceration processes, but consumer protections other
than food safety must also be ensured. Although immersion chilling can
be effective in controlling microbial growth, products exposed to the
process will retain water. This final rule is intended to address this
problem.
Comment: A poultry processor who uses air chilling stated that air
chilling is economically feasible. Analysis of retail prices shows air-
chilled poultry yields 7 to 8 percent more poultry meat to the consumer
than does water-chilled poultry.
Response: FSIS is not endorsing the use by the regulated industry
of a particular technology.
Comment: Consumer groups cited recent studies, including a 1987
conference paper by C.J. Thomas, et al., and a 1997 paper by M. Ristic,
as evidence of the advantages of air-chilling technology.
Response: The paper by C.J. Thomas et al. refers only in passing,
in a question-and-answer section, to an increasing use of air-chilling
processes. The paper is not really about air chilling.
The Ristic (1997) paper cited by the commenters and other studies
by the same author have consistently shown air-spray chilling to have
certain advantages over other methods. The studies do not compare the
feasibility of air-spray chilling with that of other chilling
technologies in an industry with a production volume as high as that in
the United States, nor do they provide a basis for regulatory action
with respect to one or another technology.
Comment: A European Union official asked if there are scientific
studies that support immersion chilling, rather than air-spray
chilling, of livestock carcasses.
Response: FSIS is not aware of any peer-reviewed study on the
water-immersion chilling of whole livestock carcasses. Among studies on
the efficacy of livestock-carcass spray chilling, including systems
using anti-microbial solutions, are:
Gill, C.O., and T. Jones, 1992. Assessment of the hygienic
efficiencies of two commercial processes for cooling pig carcasses.
Food Microbiology 9(4):335-343.
Gill, C.O., and J. Bryant, 1997. Assessment of the hygienic
performances of two beef carcass cooling processes from product
temperature history data or enumeration of bacteria on carcass
surfaces, 1997. Food Microbiology 14(6):593-602.
Gill, C.O., and T. Jones, 1997. Assessment of the hygienic
performance of an air-cooling process for lamb carcasses and a spray-
cooling process for pig carcasses. International Journal of Food
Microbiology, 38(\2/3\):85-93.
Grier, G.G., and B.D. Dills, 1988. Bacteriology and retail case
life of spray-chilled pork. Canadian Institute of Food Science and
Technology journal 21:295-299.
Hamby, P.L., J.W. Savell, G.R. Acuff, C. Vanderzant, and H.R.
Cross, 1987. Spray-chilling and carcass decontamination systems using
lactic and acetic acid. Meat Science 21:1-14.
Jericho, K.W.F., G. O'Laney, and G.C. Kozub, 1998. Verification of
the hygienic adequacy of beef carcass cooling processes by
microbiological culture and the temperature-function integration
technique. Journal of Food Protection 61(10):1347-1351.
Stevenson, K.E., R.A. Merkel, and H.C. Lee, 1978. Effects of
chilling rate, carcass fatness, and chlorine spray on microbiological
quality and case-life of beef. Journal of Food Science 43:849-852.
Comment: The ozonation process achieves significant E. coli
reductions on carcasses sampled at post-chill. Any rule permitting
immersion chillers to use ozonation should be supported.
Response: If it is true that ozonation reduces generic E. coli
populations, establishments may find the process useful in meeting
requirements of the PR/HACCP regulations. The FSIS regulations do not
prohibit use of ozonation equipment with immersion chillers. However,
the Food and Drug Administration must approve the use of ozone for food
processing purposes before FSIS can allow it.
Time/Temperature Chilling Requirement for Poultry
Comment: Some commenters disputed the FSIS statement that ``for
most poultry establishments, the inevitable retained-water amount is
the `minimum' level that can be reached with existing immersion chiller
equipment while still meeting the chilling requirement (for poultry to
reach a temperature 40 deg.F or below within a specified number of
hours).'' They stated that the poultry chilling requirement (9 CFR
381.66(b)(2)) is a command-and-control regulation that the final rule
should eliminate. Commenters favoring both the meat-industry and the
poultry-industry sides of the water-retention issue argued for
immediate repeal of the poultry chilling requirement. Some even thought
the proposal was premature and should be withdrawn because it did not
address this matter.
Response: FSIS views the poultry time/temperature 40 deg.F
chilling requirement as a food safety performance-standard issue that
would best be addressed in a separate notice-and-comment rulemaking,
which the Agency plans to conduct. The Agency believes that any
performance standard that might replace the 40 deg.F requirement
should be science-based, HACCP-consistent, and applicable to all
species subject to mandatory inspection. The Agency is continuing to
study this matter and hopes to be able to propose regulatory amendments
in the coming months. In the meantime, FSIS will permit establishments
to vary the parameters of their chilling or other processing operations
as necessary to meet the objectives of their data collection protocols.
Product Quality Argument ``Arbitrary and Capricious''
Comment: The product-quality-based water-weight allowance is
arbitrary and capricious, claimed the plaintiffs in the Kenney case.
Quality is no problem in Europe, where poultry is air-chilled or air-
spray-chilled. Adding water is adding an ingredient to make a multi-
ingredient product. The product should be labeled to show the amount of
retained water that is necessary for food safety purposes and the
amount that is necessary for food-quality purposes.
Response: The commenters' criticism is unwarranted. This rule is
primarily
[[Page 1754]]
intended to limit water retention resulting from processing to the
amount that is unavoidable to achieve a food safety objective. However,
FSIS has stated that, in their data collection protocols,
establishments may specify determining product quality as a secondary
or tertiary purpose of the data collection activity. This rulemaking
does not provide for an additional retained-water amount that an
establishment may consider necessary to maintain product quality.
Ready-to-cook poultry in Europe is dryer than ready-to-cook poultry
in the United States. Whether United States consumers will eventually
demand poultry that is similar to the European product is a question
that can be answered by the market.
FSIS does not agree with the statement that water should be
considered an ingredient in immersion-chilled poultry products. Water
is not added to the products being chilled to create new products.
Zero Retained Water
Comment: Various commenters supported a zero-retained-water
standard for both meat and poultry products. They said FSIS was wrong
to reject, as a reason for a zero-retained-water standard, the argument
that the information benefit to consumers is unlikely to exceed costs.
Consumer groups commented that FSIS's own figures show consumers
pay almost $1 billion/year for retained water in poultry. They said
FSIS should be proposing zero retained water, and that neither meat nor
poultry products should be allowed to gain water. The proposal falls
well short of what is needed, they said, strongly preferring Option 2
(zero retained water) in the regulatory analysis to Option 6 (retained
water limits established by processes necessary to meet food safety
requirements--the selected option). They said FSIS should reconsider
Options 2 and 4 (retained water limits based on best available
technology within traditional production practices).
Response: Mandating zero water retention for the poultry industry
would be tantamount to requiring the re-tooling of the industry on an
economically prohibitive scale. FSIS calculated that the resulting
benefit to consumers, an informational benefit, would be slight in
comparison to the impact on the national economy. The Agency calculated
that consumers could receive a desirable informational benefit at a
lower cost to society.
The proposal did not specify any acceptable amount of retained
water, only that any amount that is retained be no greater than the
unavoidable amount resulting from post-evisceration processing to
achieve regulatory food safety requirements.
In the PRIA, FSIS suggested that the value of poultry production
could be viewed as the production of poultry and the production of
water. The Agency also said that another view was that the water has no
effect on the price of poultry meat, but that the consumer is simply
not being informed of the wholesale-price of poultry or turkey on a
zero-added-water basis. The Agency's concern in much of the PRIA was
the effect of full disclosure of retained water on consumer purchasing.
The Agency concluded that this effect was unclear, though beneficial.
The Agency did not take the position that water is literally being sold
at poultry prices.
In the FRIA, the Agency has not attempted to quantify the overall
benefits of the rule. However, FSIS rejected Option 2 and Option 4
because the costs to industry would be substantially disproportionate
to consumer benefits.
This rule will ensure that water retention is limited to the amount
unavoidable for food safety reasons, and that consumers are informed
about this water retention. In establishing zero water retention as the
default requirement, the rule compels the industry to justify
scientifically any amount of water retention in raw, single-ingredient,
meat or poultry product. Water in excess of the amount that is
scientifically justified will adulterate the product.
Comment: Individual commenters generally supported the proposal on
the ground that consumers would not purchase meat containing too much
water. Some even thought the Agency should permit zero-percent retained
water. Commenters said they do not know the exact water weight of
poultry product because it is not labeled. Some said that added water
in curing or other processing is a consumer rip-off. One commenter said
immersion-chilling water is a ``fecal soup'' in which poultry are
marinated.
Response: FSIS appreciates commenters' support for the general
direction of this rulemaking. The Agency disagrees with the
characterization of poultry chillers because the chillers efficiently
reduce carcass temperatures and slow microbial growth. FSIS also
disagrees that this rule should impose an unconditional limit of zero-
percent retained water in raw meat and poultry products. Regarding
added water in cured products, curing is outside the scope of the
rulemaking. In any event, if a product that contains a curing solution
weighs more than it did in the untreated state, that fact must be
reflected on the product label.
Comment: A commenter with a veterinary background claimed that
continuous chillers are insanitary common baths to which there are
economically feasible alternatives. These alternatives--chilling
tunnels, chill-spray conveyor lines, immersion-chilled vacuum-packaged
product--should be explored, said the commenter. Other alternatives are
unsatisfactory. Radiation treatments are not wholly effective.
The commenter stated that irradiation at doses lower than those
resulting in off-odors yields spore formers like C. botulinum Type C.
Irradiation kills spoilage bacteria that can be indicators of
unwholesomeness.
As for antimicrobial interventions used with immersion chillers,
chlorination of chiller water is not entirely effective and forms toxic
organochlorine compounds that have environmental impacts. Phosphates
used in post-chill dips facilitate water retention.
Eliminating retained water in poultry would ``correct a consumer
fraud and [an] advantage poultry has over other parts of the food
industry.'' The result of imposing regulatory limits on water retention
after continuous chillers were introduced was to allow the poultry
industry to sell ``legally adulterated product.''
Response: Studies do not bear out the feasibility of using
technologies other than immersion chilling that would achieve the same
food safety benefit on the same scale. FSIS is not aware of any
technology other than food irradiation that is 100-percent effective in
eliminating pathogens on raw meat or poultry products. Irradiated
product generally is not shelf-stable. Through proper control,
sufficient numbers of spoilage organisms remain to successfully compete
against outgrowth of C. botulinum.
Regarding chlorination, FSIS agrees that organochloride compounds
form in chlorinated poultry chill water. Nevertheless, FSIS considers
the potential food safety benefits of chlorination to outweigh the
risks.
The adulteration hazard of phosphates (extra water pick-up) that
are used on raw products is exaggerated for two reasons. First, some
phosphate compounds, such as orthophosphate dips, have been approved
for use on raw products but are not in general use. Second, the
treatment of raw products with such anti-microbial phosphate solutions
as TSP should not be equated
[[Page 1755]]
with the addition of phosphate compounds to pickle-cured meat products
to reduce the amount of cooked out juices. Such food additives become
components of the products and do cause the products to hold water.
On the charge that regulatory water retention limits constitute
legalized adulteration and a fraud, the Agency points out that the
water retention that it is allowing would have to be disclosed on the
label. Therefore, there would be no fraud. The Agency also believes
that in appropriate circumstances, it could determine that some water
retention is necessary, is unavoidable, and would not need to be
disclosed. However, those circumstances have not been established in
this rulemaking.
Data-Collection Protocol Requirement
Comment: Requiring an establishment-generated data-collection
protocol for determining minimum unavoidable retained moisture would be
arbitrary and capricious. FSIS has failed to articulate uniform
criteria for such a protocol or a process for review of protocols.
Response: FSIS does not have the data necessary to set a regulatory
limit on the amount of moisture a raw, single-ingredient product may
retain. FSIS has put the burden of developing data to justify a level
of retained water other than zero on official establishments because
they are in the best position to determine what they have to do
simultaneously to meet food safety requirements and to minimize
retained water in their products. FSIS published suggested protocol
specifications for comment on December 9, 1997 (62 FR 64767), and a
list of expected elements of protocols with the proposed rule. The
Agency received few comments on the expected protocol elements. These
elements of protocol design give industry flexibility in collecting
data that will be useful in determining water-retention limits on an
establishment-by-establishment or industry-wide basis.
Regarding protocol review procedures, as discussed below, in
response to comments, the Agency has decided not to pre-approve the
data collection protocols establishments will use because to do so
would contradict its regulatory policy which is opposed to command-and-
control regulation.
Comment: The proposal, with its requirement for data-collection
protocols to be pre-approved by FSIS, represents a return to command-
and-control regulation.
Response: FSIS proposed that it review the data-collection
protocols because of the need to ensure a degree of uniformity in and
scientific validity of data-collection procedures for establishing the
amount of unavoidable water retention. FSIS agrees with the commenter,
however, that the proposed pre-approval of protocols would be a
command-and-control requirement. The Agency, therefore, will not be
pre-approving such protocols. FSIS is requiring, however, that an
establishment notify the Agency as soon as the protocol is available
for review. FSIS will then have 30 days in which it may object to or
require changes in the protocol.
Comment: A poultry industry association opposed ``pre-clearance of
retained water after pre-clearance of data protocols.''
Response: As stated in the preamble of the proposal (at 63 FR
48964), the labels with the retained-water statements will be
generically approved pursuant to 9 CFR 317.5(b)(2) and 381.133(b)(2).
Generically approved labels may be used without being submitted to the
Agency for approval provided that they show all mandatory features and
are not false or misleading. FSIS samples generically approved labels
at establishments to determine their compliance with labeling
requirements. With respect to labels with retained-water statements,
the Agency may, from time to time, examine the data collected by
establishments to ensure that the basis for label statements is sound.
The Agency, however, will not pre-approve either the data or the water-
retention limits the data are purported to justify.
Protocol Approval Process
Comment: A European Union official suggested that FSIS clarify the
protocol approval process: Would the establishment, after it is
recognized as eligible, have to ``submit systematically a dossier'' on
final treatment of livestock and poultry carcasses and parts?
Response: Foreign establishments recognized as eligible to export
to the United States will not have to submit a dossier to FSIS on water
retention. However, they will have to maintain a file containing data
that demonstrate either that the product they ship contains no retained
water, or that it contains no more than the amount that is stated on
the product label and that such amount is no greater than the amount
that is unavoidable in achieving food safety objectives. The data must
be collected under a protocol that is acceptable to the foreign
government.
Process for Determining Amount of Unavoidable Retained Water
Comment: FSIS should more fully describe the process for
demonstrating that retained water is unavoidable.
Response: FSIS is not prescribing a method for determining the
unavoidable amount of retained water. Each establishment should be able
to choose the method that is most appropriate for its processing
situation. However, a slaughtering establishment should consider
varying its process in whatever manner seems most likely to reduce
carcass microbial counts and maintain them at a low level. The
establishment should then measure the water retention amounts
corresponding to the respective microbial reductions. A series of
trials to achieve pathogen reduction by running chilling equipment at
different settings, making other process changes, and plotting the
microbial and water-retention data, should show what the retained water
levels in the product were when any observed increase or decrease in
microbial counts occurred.
The establishment might consider plotting available E. coli
process-control data, or Salmonella or other microbial data that it has
collected, on a time chart with water-retention data collected on the
same product on the same dates. It should then be possible to observe
the retained-water levels corresponding to microbial counts on the same
products. From this information, an establishment should be able to
determine what is the unavoidable level of retained water that
corresponds to the lowest microbial counts.
FSIS is not prescribing any particular method for establishments to
use to determine the amount of retained water in their products. A
number of chemical and physical methods are available for determining
the amount of moisture in foods, such as the method described in
Appendix A of this document.
Retained-Water Limits
Comment: There is no connection between water retention and HACCP.
Response: Although this rulemaking is intended to establish a basis
for controlling retained water in raw meat and poultry products, it is
understood that retained water is an unavoidable consequence of certain
processes commonly used to achieve food safety objectives, such as
immersing chickens as a means of lowering the temperature of carcasses
while limiting the opportunity for pathogen growth. This objective
derives from the need to meet the pathogen reduction performance
standard, a food safety requirement that must be met (63 FR 48963).
While the
[[Page 1756]]
Agency does not prescribe the critical control points or critical
limits that establishments must include in their HACCP plans, the
failure by an establishment to meet the pathogen-reduction performance
standards constitutes failure to maintain an adequate HACCP plan (9 CFR
310.25(b)(3)(iii), 381.94(b)(3)(iii)). Thus, there is a relationship
between this rule and HACCP.
Comment: It is difficult to predict with precision the amount of
water that may be retained. It would be difficult for the industry to
devise protocols and guidelines necessary to comply with the proposed
rule. Changes in systems would require changes in protocols, which
would have to be resubmitted for approval to the Agency. This
requirement would be burdensome to the industry and the Agency.
Response: Under this final rule, FSIS may review, but will not pre-
approve, data-collection protocols developed by establishments. FSIS
does not expect the development and use of a data-collection protocol
for determining unavoidable water retention to be continuous. In most
cases, protocol development will be largely a one-time-only expense.
FSIS is taking a flexible approach toward the data-collection
protocols. FSIS understands that there are many factors that determine
water retention. If variables in the model used in a protocol changed,
FSIS would not necessarily expect a whole new protocol to be developed.
The Agency is mainly interested in knowing that the protocols are
scientifically valid, that the data collected under them will reflect
water-retention amounts that are unavoidable, and that the data support
the water-retention statements on product labeling. For this reason,
FSIS is requiring that an establishment make its new or revised
protocol available for review by the Agency, but FSIS will not be pre-
approving the protocol.
Comment: The proposed requirements for limiting water retention and
labeling the amount of retained water are redundant. If there is a
labeling requirement, there should be no requirement for industry to
limit water retention. If there is a water-retention requirement, there
is no need for a labeling requirement.
Response: The retained water minimization and labeling requirements
are not redundant but address two different legal prohibitions--
adulteration and misbranding. This rule is intended to prevent
adulteration and misbranding of raw meat and poultry products by
ensuring that water retention in the products is minimized and by
improving the availability of information on water retention. The
retained-water minimization requirement stems from the Agency's long-
held view that excessive water retention is a form of product
adulteration. The labeling requirement is intended to help prevent
misbranding. It is intended to help prevent potential buyers from being
misled about a characteristic of the product--retained water--by
providing them with information about the characteristic. Product
labeling is one of the most useful ways to provide such information.
The labeling requirement is especially necessary in the wake of the
U.S. Court decision in Kenney which, by setting aside the regulations
that prescribed limits for water retention in ready-to-cook whole
poultry, left consumers without any information that retained water was
being held below a certain maximum percentage.
Simply imposing a regulation that limited water retention would not
inform consumers of the retained water content of products unless
specific water retention limits were clearly presented in the
regulation. For reasons discussed elsewhere in this document, FSIS has
found that it is not in a position to impose such a regulation. On the
other hand, simply requiring labeling would not be consistent with the
adulteration provisions of the FMIA and PPIA. Unlimited retained water
would constitute economic adulteration even if identified through
labeling.
If an outcome of this rule were that no raw, single-ingredient meat
or poultry product retained any water from processing, a labeling
requirement might eventually be unnecessary.
Comment: A weights and measures official said, regarding FSIS's
view that ``excessive'' water retention may constitute adulteration,
that the proposal did not limit water in raw, single-ingredient
products but only required a more technical justification.
Response: The final rule clearly does limit water retention. The
rule does not flatly mandate zero-percent water retention, but requires
a demonstration that any water retention is unavoidable. Any retained-
water percentage greater than zero percent will be considered excessive
unless the percentage is justified by data collected under a valid
protocol.
Food Safety Requirements
Comment: FSIS must identify the food safety requirements to be met
in the post-evisceration or chilling process.
Response: In the PR/HACCP regulations, FSIS has identified process-
control criteria and pathogen-reduction performance standards that
establishments must meet. In the expected elements published with the
proposed rule on retained water, FSIS stated its preference concerning
the purpose of a data-collection protocol: To determine the amount or
percentage of moisture absorption and retention that is unavoidable
using a particular chilling system while achieving the pathogen-
reduction performance standard for Salmonella. In conducting hazard
analyses and developing their HACCP plans, establishments may identify
additional or other food safety objectives. It has been unnecessary in
this rulemaking to set out further food safety requirements.
Retained-Water Labeling
Comment: Poultry industry commenters suggested that the retained-
water labeling requirement was a punishment for using the most
effective techniques. Some thought the retained-water labeling
provision might decrease consumer demand for the labeled products.
Response: FSIS has an obligation to balance the interests in any
situation. While it is true that any water that will be declared on the
label will be the unavoidable result of an effective process, it is
also true that the misbranding and economic adulteration provisions of
the FMIA and PPIA make clear the obligation of producers raw meat or
poultry products not to mislead consumers. FSIS thinks that if they
market as meat or poultry a product that contains something other than
meat or poultry, that fact should be disclosed. Comments received in
response to the proposal are inconclusive on how consumers will regard
product with labeled retained-water amounts, although consumer advocacy
groups and some individual commenters favored the labeling proposal.
Comment: Plaintiffs in Kenney opposed the proposed labeling
provision, saying it would only be sanctioning the reporting of illegal
water retention.
Response: FSIS disagrees. The Court in the Kenney case held that,
under the PPIA, the Secretary of Agriculture had the authority to
require labeling of the amount of retained water in and to define a
poultry product. (Kenney v. Glickman, No. 4-94-CV-10402 (S.D. Iowa,
Jul. 23, 1997) (order granting plaintiff and respondent motions for
summary judgment) at pp.12, 13.)
Comment: A turkey processor said that the proposal would create a
bag-printing headache for the poultry industry because turkey
processors ship many products under private-label brands.
[[Page 1757]]
Response: FSIS does not foresee a problem in this regard. The
purchasing specifications provided by firms for which processed birds
are prepared cannot be lower than the minimum water retention of which
the processor's technology is capable. The processor should be able to
order or produce bags labeled with a retained-water statement that
routinely complies with the regulation.
Comment: Industry groups suggested that if labeling is needed, a
percent-retained-water statement could be either in the product name or
in the ingredient statement, or the retained moisture could be
reflected in nutrition labeling of the product.
Response: Placing the retained-water statement in an ingredient
statement would imply that the product is fabricated of more than one
ingredient. This implication would be misleading, because the water
that would be listed in the ingredient statement is retained from
processing and not literally added to the product to create a new meat
or poultry product.
FSIS also does not agree that nutrition labeling can be used.
First, assuming that retained water could be regarded as part of the
product, and that the nutrition labeling were accurate, few consumers
would notice changes in the percentages of protein, fat, or other
nutrients resulting from a change in the percentage of retained water
in the product. Also, a retained water statement in a nutrition facts
panel would not be as conspicuous as one on the principal display
panel. Moreover, because nutrition labeling of single-ingredient
products is still voluntary, relatively few consumers of such products
would have the advantage of even the limited amount of information on
water retention that nutrition labels could convey.
Comment: A local weights and measures agency stated that percent-
retained-water labeling should be standardized and placed in a uniform
location on the package.
Response: FSIS wants to be as flexible as possible, consistent with
the objective of informing the consumer of the amount and presence of
retained water in affected product. The Agency is requiring that the
retained water statement be contiguous to the product name or elsewhere
on the principal display panel of the label.
Comment: Several companies and groups wrote that if FSIS insists on
a labeling requirement, it should apply only to processor-packaged
product intended for sale to consumers at retail. The final rule should
exempt from the labeling requirement products intended for export,
products shipped in bulk for further processing, and product to be sold
to institutions and food-service operations.
Response: The commenters appear to be alluding to exemptions in the
FSIS nutrition labeling regulations for products intended for further
processing, certain products that are not for sale to consumers,
products intended for export, certain products sold at retail stores,
and items on restaurant menus (9 CFR 317.400(a)(2), (3), (6), (7);
381.500(a)(2), (3), (6), (7)). Those regulations were intended to be
consistent with the aim of the Nutrition Labeling and Education Act and
regulations implemented by the Food and Drug Administration, to assist
consumers in maintaining healthy dietary practices. The preamble to the
FSIS nutrition labeling final rule states the Agency's goal of
providing consumers with more accurate and complete nutritional
information (58 FR 635; January 3, 1993). In response to comments on
its nutrition labeling proposed rule, FSIS did provide exemptions in
the final rule of the sort the commenter refers to, on the ground that
there was little value in requiring nutrition information where the
consumer will not see it (58 FR 639).
However, unlike the nutrition labeling regulations, this final rule
is intended to provide information directly both to household consumers
and to large purchasers of meat and poultry products. Product shipped
in bulk should be labeled accurately to ensure accurate formulation of
further-processed products. Also, product shipped to institutions and
food-service operations should be labeled with the same accuracy as
product shipped to household consumers.
On the matter of exported product, the industry does not produce,
and FSIS does not regulate, a separate class of raw, single-ingredient,
meat or poultry product for export to which this rule would not
appropriately be applicable. Thus, FSIS disagrees that export product
should be subject to retained-water labeling requirements different
from those to which product for domestic sale is subject.
Comment: The proposed retained-water labeling requirement should be
adopted immediately.
Response: FSIS appreciates the support for the labeling provision
of the proposal. The Agency, however, is setting the effective date of
the final rule at 1 year following publication of the rule in the
Federal Register to mitigate the effects of the rule on
establishments--particularly those that are considered small businesses
under Small Business Administration criteria--that may have to consider
changing or updating their chilling processes and equipment.
This 1-year pre-implementation period will enable FSIS to prepare
sampling, testing, and document review procedures; train Agency
personnel in the new procedures; and develop a new national reference
database on the natural moisture content of raw products in the various
meat and poultry product classes. However, establishments can
voluntarily implement the provisions of this rule in advance of the
effective date.
Comment: A local weights and measures official commented that the
labeled water retention amount on poultry products should not be based
on an average but should be applicable to 95 percent of individual
birds.
Response: FSIS notes that this comment was based on the analysis in
the PRIA of rulemaking Option 1--to allow any percentage of retained
water so long as the percentage amount is on the product label. FSIS
will expect establishment data collection protocols (see
Sec. 441.10(d)) to include the sampling and testing methods for
determining that food safety requirements (pathogen reductions) are
being met and the testing methods for determining water retention. FSIS
will also expect the protocols to explain how water retention data are
to be reported and evaluated. The data collected by the establishment
should show with reasonable confidence--i.e., 95-percent statistical
confidence--that a given package retains no more water than is
unavoidable, and no more than the label states.
Labeling Format
Comment: Rather than the statement ``up to X% retained water'' or
``less than X% retained water,'' the label of affected products should
state, ``contains X% added water.'' The ``up to X%'' statement prevents
the consumer from calculating the true price per pound without added
water weight. A ``contains X%'' statement would be consistent with the
ban on qualifying terms in the Fair Packaging and Labeling Act.
Response: Current production practices yield product with varying
levels of water retention. It is therefore difficult for an
establishment to target an exact water-retention percentage for all its
products of a certain class. FSIS has taken this fact into
consideration and has framed the labeling requirements of this final
rule in a way that will minimize inadvertent industry noncompliance.
[[Page 1758]]
It is true that a consumer may not be able to compute the exact
percentage of retained water in a product labeled ``with up to X%
retained water.'' The establishment that prepared the product, however,
will have had to determine a water-retention range based on the data
used to determine the amount of retained water that is unavoidable in
the product. The establishment will be free to label its product with
the water-retention amount that reliably represents the amount that is
in the packaged product.
Consumers of the product will have available more information on
water retention than they have had in the past.
Retained-Water Labeling and Product Tare
Comment: If FSIS insists on a labeling requirement, product tare
should be addressed. For example, if product labeled as having 4-
percent retained water that loses 2 percent of the water is sold in a
wet-tare jurisdiction, how would the product be labeled? How would the
regulation be applied?
Response: Compliance with net-weight regulations is determined by
following the wet-tare and dry-tare procedures in National Institute of
Standards and Technology (NIST) Handbook 133, which is incorporated by
reference in the FSIS regulations at 9 CFR 317.19 and 381.121b. The
actual net weight of the product, as determined on a lot-average basis
by these procedures, is compared with the labeled net weight of the
product.
The commenter did not say whether the 2-percent moisture loss was
additional to or part of the 4-percent retained-water amount
represented on the label. FSIS assumes that the 2-percent loss is from
the 4-percent amount. Thus, in the example presented by the commenter,
the retained-water statement should reflect that the product contains
at least 2 percent or as much as 4 percent water from processing.
Using the 3-pound dry-tare chicken example presented in the PRIA
and FRIA, the product net weight in a wet-tare jurisdiction would be as
much as 2.94 lb. or as little as 2.88 lb. The labeled net weight
corresponding to a ``2-percent'' retained-water statement would be 2.94
lb. The loss to the product, labeled with this net weight, of an
additional 2 percent in water weight would raise the issue of short
weighting. The actual net weight of the package would enter the ``gray
area'' provided in the NIST Handbook 133 procedures for determining
net-weight compliance in wet-tare jurisdictions. FSIS and local weights
and measures authorities would then follow the procedures provided for
gray-area product. Depending on the wording of the retained-water
statement, this loss of additional moisture could mean that the
statement is inaccurate, and the product misbranded for that reason.
If a company has had difficulty in determining the unavoidable
amount of retained water in the product, the company should recheck the
data on which its determination of ``unavoidable'' is based, its data-
collection protocol, and its processing procedures.
If the company knows that the product will lose 2 percent of net
weight because of water loss while in distribution channels, the
company should adjust the retained-water statement to account for the
fact. If the company knows that a retained-water product will continue
to retain a certain percentage when it is sold in the wet-tare
jurisdiction, the retained water statement must account for that
percentage of water retention.
National Standard for Retained Water
Comment: Several commenters said that if FSIS proceeds with the
rulemaking, the Agency should develop national standards for
``unavoidable moisture retention.'' Products should be able to exceed
the national standard if labeled. Some argued that, based on
information in the PRIA at 63 FR 48978, water retention could be held
to 2-5% with appropriate technology. Others suggested that the Agency
could simply justify scientifically the water retention limits in the
regulations that were set aside.
Response: To be valid, a national standard such as envisioned by
the commenters would have to be applicable to homogeneous products
produced under similar conditions.
The currently available data on water retention provide an
inadequate basis for setting any retained-water standard because the
data that could be applied to the industry are based on industry
practices that conformed to the regulations that the U.S. District
Court set aside in Kenney v. Glickman. The Court set the regulations
aside, in part, because USDA had not adequately explained how the
particular water retention limits in the regulations were determined or
why water retention could not be reduced below those levels.
FSIS would have to have new data, collected under new protocols and
criteria that meet the concerns expressed in the Court decision in
Kenney to be able to revive the previous regulations, including updated
tables listing the water retention limits for poultry. In other words,
the Agency would have to be able adequately to explain how the
particular water retention limits were determined and why they could
not be further reduced. Moreover, the Agency would have to be able to
explain adequately how such regulations would apply to meat and
poultry. Commenters did not state how this could be done.
FSIS agrees with the commenter who cited the analysis in the PRIA
of available water retention data. This analysis indicates that water
retention can be held at substantially below the regulatory limits that
were set aside by the United States District Court in Kenney v.
Glickman. It thus seems unlikely that new data would support the limits
in the regulations that were set aside.
Comment: Even with supporting data, an industry-wide water-
retention standard could still be ``arbitrary and capricious.''
Response: Depending on the design of the protocol and the adequacy
of the data collected, a limit applying to the products of one or more
establishments could be scientifically justified and not be arbitrary
and capricious.
Costs of Rule
Comment: Compliance to ensure labeling accuracy should not result
in added costs.
Response: The data-collection and labeling requirements will be
minimal for meat establishments whose products do not gain water.
Poultry establishments will have to collect data to determine the
minimum water-retention levels in their products and will have to be
able to verify on a continuing basis the accuracy of their product
labels. Establishments will not necessarily have to conduct more tests
or collect more data than they have been collecting under the
regulations that this rule replaces. Thus, day-to-day costs of
complying with the requirements for labeling accuracy will not be
greater than past costs of complying with water-retention requirements.
Measuring Retained Water
Comment: The water retention amount should be measured as the
difference between the ``hot carcass weight'' and finished package
weight of the product. The second amount should be measured at the
point of packaging.
Response: Establishments may use in-plant methods, such as weighing
carcasses before and after washing or chilling procedures, as a means
of controlling water retention. However, FSIS emphasizes that
compliance with
[[Page 1759]]
this final rule will primarily depend on whether the retained-water
amount of the product in distribution channels, i.e. the retained water
weight of the product at the time it enters commerce, is no greater
than the amount that is demonstrably unavoidable. FSIS intends to
subject product samples collected in-distribution to an oven-drying
test (described in Appendix A of this document) to determine the amount
of water in the samples. Those amounts will be compared with the amount
of naturally occurring water in the products to determine compliance
with labeling and the retained-water-minimization provisions of the
final rule. FSIS will, however, conduct in-plant verification of
establishment process controls, and this verification may occasionally
involve comparing hot carcasses weights with the weights of carcasses
after spray chilling.
Compliance, Oversight and Control
Comment: FSIS must explain how compliance with the regulation is to
be determined. A European Union official requested information on
methods currently used to detect water content. One company suggested
that moisture gain be determined at the last possible point before
consumer packaging. Another observed that the poultry industry views
retained water as the amount in the product to be lost over time as the
product is en route to the consumer.
Response: Until now, FSIS and official establishments have measured
water content by sampling and weighing carcasses before the carcass
wash and after chilling. In poultry slaughtering establishments,
carcasses are sampled and weighed before and after immersion chilling.
In livestock slaughtering establishments, sampled carcasses are weighed
after slaughter before and after being subject to spray-chilling
processes. These traditional in-plant methods for determining the
effectiveness of retained water controls continue to be available to
the Agency and industry.
Under this final rule, though, FSIS will be verifying compliance
with the retained-water limitation and labeling requirements primarily
by reviewing establishment water-retention data collected under the
required data-collection protocol. The Agency also plans to conduct in-
plant and in-distribution tests of the moisture content of products
using the oven-drying method described in the Agency's Chemistry
Laboratory Guidebook and in Appendix A of this document. FSIS will not
be dictating to industry the in-plant sites for measuring and
controlling retained water.
Establishments must be aware that the Agency will be most concerned
with the amount of retained water in product that has entered commerce.
Comment: The proposed rule has no provision for compliance
oversight in distribution channels and at retail or food-service
operations.
Response: The regulation clearly applies to products in
distribution channels, although it does not specify how the Agency will
enforce regulatory requirements outside official establishments.
Official slaughtering establishments will be primarily responsible for
minimizing water retention, subject to meeting the food safety
objectives of their HACCP plans and of the PR/HACCP and other
regulations. FSIS will conduct in-plant and in-distribution activities
to verify labeling accuracy and retained-water minimization.
Comment: Correction of the water-adulteration problem at retail
would trigger costly recalls and reduce consumer confidence in
regulatory bodies.
Response: If a recall is necessary to prevent the sale of
adulterated product, the Agency will expect the industry to take the
necessary action.
Weights and Measures Checks
Comment: ``Weights and Measures officials generally inspect
prepackaged meat and poultry at the retail level. Any changes * * *
should either have no effect on point-of-sale package weight inspection
procedures or, even better, simplify them.''
Response: Net-weight compliance procedures will be largely
unaffected by this rulemaking. FSIS will be following NIST Handbook 133
procedures for determining whether or not product is misbranded with
respect to net weight. These procedures are used by State and local
weights and measures officials, so there will be no difference between
the procedures followed by the Federal Government and the States with
respect to net weight.
Offal Products
Comment: From companies and associations representing the meat
industry: Offal products should be exempt from the rule because they
are not considered meat products. Moreover, FSIS Standards and Labeling
Division policy covers ``purge'' from organ products.
Response: In the interests of equitable regulation, offal products
and other products of the meat industry and any poultry products with
which there is a water-retention issue are subject to the present rule.
This final rule supersedes current policy notices and directives
affecting water retention; as appropriate, the Agency will revise or
cancel those documents.
FSIS Priorities
Comment: The proposal is a misapplication of FSIS resources, which
should be focused on food safety concerns. Consumers are more
interested in knowing about product safety than retained water.
Response: While the Agency's primary concern is food safety, the
FMIA and PPIA provide other consumer protections as well, including
that consumers have the right to be apprised of what they are buying.
Consumer Situation
Comment: Some commenters asserted that FSIS offered no data showing
consumers are misled about retained water in poultry products.
Response: It is true that FSIS has not gathered survey data showing
that consumers are being misled about retained water, but from
inquiries it has received over the years, the Agency is aware of
consumer concerns about water in packaged poultry. Although consumers
did not petition the Agency for a retained-water-labeling requirement,
a number of individuals and consumer advocates who commented on the
proposal regarded informing consumers about retained water as an
important purpose of the rule. Some requested immediate implementation
of the labeling requirement.
Comment: The proposed rule could adversely affect industry and
consumers. Product quality could be adversely affected. The proposal
itself (at 63 FR 48980) suggests that retained-water labeling, by
inducing a reduction in retained water in raw products, would actually
be harmful to consumers who may prefer a moist product.
Response: The information on consumer receptiveness to poultry
products that might be less moist is inconclusive. The Agency
acknowledged in the PRIA, to which the commenter refers, that consumers
in the United States have become accustomed to purchasing fresh poultry
that is very moist. FSIS requested comment on whether consumers would
be more or less likely to purchase a package of meat or poultry that
appeared less moist but received little information on this matter in
response.
[[Page 1760]]
FSIS Response to Kenney Case Decision
Comment: The proposal is not justified by the limited scope of the
decision in Kenney. FSIS misinterpreted the decision, in which the
Court found poultry with retained water not to be adulterated and
recommended science-based limits.
Also, the decision in the Kenney case does not require the Agency
to mandate retained-water labeling.
Response: The Agency does not agree with the commenter's view that
the Agency misinterpreted the District Court decision in the Kenney
case, nor does the Agency infer from the decision that it is not
warranted to proceed with this rulemaking. The Court affirmed the
Agency's right to define a poultry product to include poultry product
with retained water. Although the Court did not specifically instruct
the Agency to revise the retained water regulations that the Court set
aside, the Court clearly affirmed the Agency's authority to regulate
the amount of retained water in poultry products. This final rule will
limit the amount of retained water in raw meat and poultry products and
FSIS believes the retained water limitation will be scientifically
based.
Regarding the labeling requirement in the final rule, it will
prevent misbranding of products subject to the rule.
Comment: Poultry industry commenters argued that FSIS is responding
to competitive, not consumer, concerns and to lobbying by the meat
industry. The Agency is responding to ``perceived inequity'' rather
than to food safety concerns.
Response: FSIS took seriously the determination by the Court that
the basis for its regulation of retained water in poultry was
inadequate. As a result of the decision, the Agency believed it was
necessary to re-examine the basis for regulation and determine the most
appropriate, science-based approach for regulating retained water in
poultry. The Agency's response on this issue was grounded in its
obligation to ensure that consumers are protected from adulterated and
misbranded product.
Comment: According to some poultry industry commenters, the rule is
arbitrary and capricious in that it makes unjustified sweeping changes
to the Agency's long-established policy of not requiring that meat or
poultry be labeled to show retained-water content. The rule could be
invalidated under the ``arbitrary and capricious'' standard applied by
the Supreme Court (in Automobile Manufacturers Assn. v. State Farm) to
the Department of Transportation's rescission of a rule requiring the
installation of passive restraints in new cars. Simply requiring that
meat and poultry establishments justify retained water in their
products would fully satisfy the mandate of the U.S. District Court in
Kenney v. Glickman.
Response: FSIS disagrees that, in requiring labeling of raw,
single-ingredient meat and poultry products to state the retained-water
content of the products, it is making ``arbitrary and capricious''
sweeping policy changes. Rather, FSIS is attempting to carry out its
statutory obligation to prevent the distribution of products that are
adulterated or misbranded under circumstances in which a regulation
intended to prevent adulteration or misbranding of poultry products has
been invalidated.
With respect to the labeling issue, FSIS thinks that the State Farm
case is inapposite. FSIS is willing to concede that it had a policy not
to require labeling of poultry products for retained water. However,
the Kenney decision represents a change in circumstances that requires
that the Agency rethink its policies and change them if it is unable to
justify them within the legal context established by the Court's
decision. The case has left the Agency without a published, regulatory
limit on retained water to prevent adulteration. Because there is no
longer such a limit, the case has also left the public without access
to information about the characteristics of poultry products. In the
absence of a specific level of retained water that is unavoidable in
the production of a safe product, FSIS finds that the level of retained
water is a fact that is material in that the product is being
represented as meat or poultry. Failure to disclose this fact would
misbrand the product.
Therefore, FSIS is requiring that meat and poultry products be
labeled to show the maximum amount of water they may retain. In the
absence of data, the Agency is taking the most logical and reasonable
course of action available to it.
Regarding the U.S. District Court decision in the Kenney case, the
Court agreed with the Department's contention that the PPIA (21 U.S.C.
457(b)(2)) gives the Secretary the authority to determine that the
composition of a poultry product includes a limited amount of water
retained from processing. The Court also stated that, given the
deference that must be shown the Secretary on this matter, ``the
Secretary did not abuse his discretion or act contrary to law by
failing to conclude that a label that does not disclose the retained
water in a poultry product was false or misleading.'' The Court further
held that, notwithstanding the quantity-of-contents labeling provisions
of the PPIA, the Secretary was within his discretion in not finding
poultry with retained water to be misbranded.
However, the Court found that the Secretary acted arbitrarily and
capriciously in not adequately explaining the reasons for the water
retention limits for poultry products and in not explaining why water
retention could not be further reduced. In other words, the Secretary
did not provide a basis for determining whether and what amount of
water retention should be permitted or could be considered non-
adulterative, or what amount of water retention is unavoidable in a
poultry product. Put another way, the Secretary did not provide a basis
for distinguishing a poultry product with permissible retained water
from such a product adulterated by excessive retained water. The Court
also found the Secretary to have acted arbitrarily and capriciously in
not according the same regulatory treatment to meat and to poultry. The
Court therefore set aside the regulation that provided the water
retention limits for poultry products (9 CFR 381.66(d)(2)).
Thus, this situation is distinguishable from that in State Farm.
FSIS is not simply abandoning a long-held, well-justified position.
When asked to justify its position on retained water in poultry, the
Agency could find no basis for it in the record compiled when the
position was adopted. Thus, the Court in Kenney found that FSIS water
retention levels for poultry were not sustainable. When FSIS sought a
reliable basis for arriving at a new level, it could find no evidence
that would justify any water retention in poultry. In view of this, and
the Agency's obligation, in the absence of evidence that justifies a
contrary approach, to treat meat and poultry products the same way in
its regulations, FSIS is left with little choice but to insist that
meat and poultry products contain no retained water unless there is a
substantial justification for permitting some water retention.
FSIS is not stating in this final rule what the justification for
retained water should be beyond stating that it must be an unavoidable
consequence of processing to meet food safety requirements. This is the
only justification FSIS can find for the presence of retained water in
a livestock or poultry carcass.
As stated previously in this document, the Agency has consistently
required that establishments minimize retained water in meat and
poultry
[[Page 1761]]
products, but the Agency no longer has a quantitative limit or measure
other than zero-percent retained water by which to determine that
retained water has been minimized. For this reason, and because the
Court found that the Agency did not have a basis for determining
unavoidable retained water in a product, the Agency must insist that,
in addition to justifying the presence of retained water,
establishments also substantiate the amount of retained water that is
unavoidable.
In order to determine whether or not a poultry product is
economically adulterated by retained water, the Agency must have
available to it data that show what the amount of unavoidable retained
water is and the amount that the product retains. Hence, the
requirement that establishments collect such data according to written
protocols.
Effect on Pathogens
Comment: Increasing water retention in achieving non-required
Salmonella levels (i.e., reducing Salmonella levels below the pathogen
reduction performance standards) would defeat the purpose and goal of
the rule.
Response: FSIS encourages establishment efforts to improve the
safety of meat and poultry products by reducing the incidence of
Salmonella below the prescribed performance standards. We recognize
that achieving such results may cause the product to have increased
retained water that would be required to be labeled on the package.
However, we feel that the requirement to label a product to indicate
the maximum amount of water that may be retained in the product is
necessary to reflect the material fact that water has been retained.
Comment: The proposal (at 63 FR 48977) suggested the possibility
that pathogens on product could increase with decreased retained water,
and that efforts to reduce the retained-water level would harm
consumers.
Response: The commenter misinterpreted the proposal. The commenter
took out of context a step in the Agency's reasoning on the potential
costs of a rejected option: that of establishing retained water limits
based solely on the capabilities of existing equipment. In fact, this
rule is based on the chosen option of limiting water retention to the
amount that is unavoidable in meeting food safety requirements.
Comment: A consumer group commented that FSIS has paid insufficient
attention to Lillard (1990), who reports a significant increase in the
incidence of Salmonella on post-chill poultry carcasses.
Response: The Lillard (1990) paper cited by the commenter did
indeed show that Salmonella incidence increased on post-chill as
compared with pre-chill poultry. The study identified immersion
chilling as the most significant point of cross contamination in modern
commercial poultry processing. However, the study also confirmed that
the immersion chilling process has a washing effect, and that even
though Salmonella incidence may have increased on the birds, the
microbiological quality of the poultry carcasses, as determined by
enumeration of aerobic bacteria and Enterobacteriaceae, improved. In
other words, though bacteria might be spread from bird to bird during
the process, the overall level of bacteria on the birds decreased.
Comment: A consumer group said that FSIS should determine the
pathogen levels in poultry package liquid and the relationship between
these levels and the risk of cross-contamination in the kitchen. FSIS
should compare the benefits in lower social and medical costs from
contaminated poultry, compared with increased costs to the poultry
industry and consumers from eliminating all retained water.
Response: As explained in the FRIA, FSIS has assumed as an indirect
benefit of the final rule the possible health effects from reducing
retained water. However, to determine the relationship between pathogen
levels in poultry and the risk of cross contamination in the consumer's
home, and to compare the increased costs to the poultry industry of
this rule with the possible health benefits to society from reducing
retained water, would require a lengthy study. If such a study were a
prerequisite for this final rule, the rule and its beneficial effects
would be delayed.
Apparent Inconsistency in Proposed Rule
Comment: There is, apparently, an inconsistency between the
preamble use of the term ``raw, single-ingredient, meat, meat products,
and poultry products'' and the term ``carcasses and parts'' in the
proposed regulation concerning products to be covered by the labeling
requirement.
Response: ``Raw, single-ingredient meat, meat products and poultry
products'' are broadly comprised of ``carcasses and parts,'' whether of
livestock or of poultry. The term ``carcass'' in the FSIS regulations
denotes ``all parts, including viscera, of any slaughtered livestock''
(9 CFR 301.2(p)) and in the poultry products regulations ``all parts,
including viscera, of any slaughtered poultry'' (9 CFR 381.1(b)(9). By
the term ``carcasses and parts,'' FSIS means a class of product
included in the terms ``meat and meat food product'' and ``poultry
product,'' namely, raw, single-ingredient products that have been
subject to no more than minimal processing, such as cutting or
grinding, before being sold in commerce. The current regulatory
definitions for ``meat food product'' and for ``poultry product''
include product made partly or wholly from carcasses and parts of
livestock or poultry for use as human food. Thus, FSIS finds no
inconsistency between the use of terms in the preamble of the proposed
rule and the proposed regulatory text.
Time and Flexibility for Final Rule Implementation
Comment: If FSIS proceeds to a final rule, the Agency should give
industry time and flexibility to minimize cost impacts. The industry
should have flexibility similar to that provided in the sausage casings
notice (FSIS Docket No. 96-020N: 61 FR 39853; July 31, 1996).
Response: FSIS believes that the commenter is referring to the
labeling options that would be available to establishments subject to
the proposed rule on sausage casings, ``Labeling of Natural or
Regenerated Collagen Sausage Casings'' (FSIS Docket No. 96-020N: 62 FR
38220; July 17, 1997). Under that proposal, the labels of sausages in
natural casings made from livestock or poultry viscera or regenerated
collagen casings would have to identify the type of livestock or
poultry from which the casings are derived, if different from the
livestock or poultry meat component of the sausage. The casing
identification could be on the principal display panel or in the
ingredient statement. Establishments producing, manufacturing, or using
natural or regenerated collagen casings would have to keep records on
the livestock or poultry source of the casings.
FSIS is trying to minimize the cost impacts of the labeling
requirements of this final rule by providing ample time for
implementation and allowing the industry to use existing stocks of
labels until they are exhausted. FSIS also is providing a degree of
flexibility by permitting establishments to place the required retained
water statement either contiguous to the product name or elsewhere on
the principal display panel of the label.
[[Page 1762]]
Recommendations for Various Technical Changes
Comment: The qualifier ``mature'' should be restored to the term
``reproductive organs'' in Sec. 381.1(b)(44).
Response: As discussed in the proposal, FSIS is revising the
definition of ``ready-to-cook poultry'' to account for the elimination
of the requirement to remove kidneys from mature birds. The qualifier
``mature'' was inadvertently dropped from the term ``mature
reproductive organs'' in the proposed regulatory text and is restored
in this final rule. The verb phrase expressing the action taken with
respect to mature reproductive organs and kidneys is changed from
``have been removed'' to ``may have been removed'' (in
Sec. 381.1(b)(44)) to reflect the fact that the decision to remove
these organs is HACCP-based. Some establishments, in operating their
HACCP systems, have shown that they can determine when poultry kidneys
constitute a hazard (e.g., when they contain cadmium) and when they do
not.
Comment: The phrase ``feet, crop and oil glands'' appears twice in
proposed Sec. 381.1(b)(44).
Response: FSIS is correcting this typographical error.
Comment: Remove Sec. 381.65(a) and (b). These are covered by HACCP
or Sanitation SOP.
Response: FSIS agrees that sanitary handling and processing of
poultry and the protection of poultry products from adulterants ought
to be covered by establishment Sanitation SOP's and HACCP plans. FSIS
is removing paragraph (b) of 9 CFR 381.65 for that reason, as proposed,
but retaining paragraph (a). The paragraph requires establishments to
conduct operations and procedures in a manner that will ensure sanitary
processing, proper inspection, and products that are not adulterated.
These are basic performance objectives for any official establishment.
The requirement to ensure proper inspection is especially pertinent to
poultry processing and is not duplicated by the SSOP and HACCP
regulations. Paragraph (c) is being re-designated as paragraph (b).
FSIS will review the requirements in these and other paragraphs for
further streamlining.
Comment: Remove Sec. 381.65(d) because it is redundant with
proposed Sec. 441.10.
Response: Proposed Sec. 381.65(d) is a re-designation of
Sec. 381.65(k), which requires ready-to-cook poultry to be adequately
drained after chilling to remove ice and free water before packaging or
packing. FSIS agrees that it is redundant with the new 9 CFR 441.10 and
is removing it.
Comment: Paragraph (d)(8) in Sec. 381.66 requiring the plant to
notify the inspector of changes in washing, chilling, and draining
procedures should be removed.
Response: FSIS is removing 9 CFR 381.66(d)(8) as proposed.
Comment: Proposed Sec. 381.66(c)(2)(i), restricting how plants
operate chillers, should be revised to eliminate prescriptive
requirements for the continuous overflow of water between chiller
sections and references to the design of multi-section chillers. The
paragraph should only require that the chiller be operated in a manner
consistent with meeting pathogen reduction performance standards.
Response: FSIS agrees in principle with the suggested change and is
revising the paragraph. The Agency is removing the prescriptive design
requirements for chillers and replacing them with a performance
standard requirement that is consistent with the PR/HACCP regulations.
Comment: Proposed Sec. 381.66(c)(2)(ii) should be revised to refer
to split carcasses as defined in Sec. 381.170(b)(22). FSIS should
revise the second sentence, the chilling method to be applied to
individual poultry parts, because it is not consistent with HACCP.
Response: FSIS agrees that the wording of proposed
Sec. 381.66(c)(2)(ii) should be modified as suggested by the commenter.
FSIS is removing the second sentence of the paragraph, which
prohibits the chilling in water and ice of individual parts from
salvage operations. While the purpose of this prohibition, to prevent
the marketing of parts that retain too much water, coincides with some
of the objectives of this final rule, it is a command-and-control
requirement that is inconsistent both with HACCP and with the basic
thrust of this final rule. FSIS published the retained-water proposal
in the same issue of the Federal Register as the final rule permitting
the continuous chilling of transversely split carcasses (63 FR 48957;
September 11, 1998). The split-carcass-chilling final rule left
unchanged the prohibition against the chilling in water and ice of
individual parts.
This final rule, however, applies to transversely split carcasses
and other portions and parts of poultry. It applies to all raw, single-
ingredient, poultry products. This final rule makes redundant the
requirements concerning the specific chilling method applied to these
parts or portions of poultry. Therefore, the Agency is removing these
requirements.
Comment: Delete the proposed Sec. 381.66(d)(1) and (2) as redundant
with Sec. 441.10.
Response: While 9 CFR 381.66(d)(1), which requires that poultry
washing, chilling, and draining practices minimize water absorption and
retention, may appear to some to be redundant with 9 CFR 441.10, it
articulates a general principle with which the Agency agrees
irrespective of the present rulemaking: Retained water should be
minimized. 9 CFR 381.66(d)(1) does not, however, present a measurable
criterion for judging minimization, as 9 CFR 441.10 does. Therefore,
FSIS finds it appropriate to adopt both provisions.
FSIS finds that the proposed 9 CFR 381.66(d)(2), requiring the
establishment to supply measuring devices or scales for use in
measuring retained water, should be retained to ensure that both the
establishment and the Agency can conduct in-plant checks for compliance
with this final rule.
Comment: Delete 9 CFR 381.66(f)(3), a prior-approval requirement
for FSIS approval for off-premises freezing of ready-to-cook poultry.
This prescriptive requirement is inconsistent with HACCP.
Response: The commenter's suggestion is beyond the scope of the
present rulemaking. FSIS regards the procedures for freezing poultry as
encompassing a separate set of issues that are peripheral to the
concerns of this rulemaking, which are focused on the chilling of
poultry.
Effect on International Trade
Comment: The proposal could distort international trade because the
only establishments that will be considered eligible to export to the
United States will be those that are able to demonstrate that
``residual water content is due to the final decontamination of the
products and not to the chilling process.''
Response: The final rule does not identify any specific post-
evisceration process that an establishment must use for any purpose.
Further, the rule is not expected to have significant impacts on
international trade. Any imports containing retained water will have to
be appropriately labeled, and poultry products are likely to be more
affected than meats. Only six countries, however, Canada, France, Great
Britain, Hong Kong, Israel, and Mexico, are listed as eligible to ship
poultry products to the United States. Currently, about 5 million
pounds of poultry imports enter the United States
[[Page 1763]]
annually. This is a relatively small amount of trade.
Provisions of the Final Rule
Under Sec. 441.10(a), raw livestock and poultry carcasses and parts
may not retain any amount of water resulting from post-evisceration
processing, absent a demonstration, with data, by the establishment
preparing them that such water is the unavoidable consequence of a
process used to meet applicable food safety requirements. The data must
have been collected according to a written protocol.
Under Sec. 441.10(c)(1), the establishment must keep this protocol
on file and available to FSIS personnel. The protocol must explain how
the data will be collected and used in making the required
demonstration for the product the protocol covers. Under
Sec. 441.10(c)(2), the establishment must notify FSIS as soon as its
data-collection protocol--whether new or revised--is available to the
Agency. Within 30 days after receipt of this notification, FSIS may
object to or require the establishment to make specified changes in the
protocol. FSIS will take this action if it determines that the protocol
is not valid, or that the data collected under it will not be
sufficient to demonstrate that the amount of water retained in the
product is an unavoidable consequence of the process used to meet
applicable food safety requirements.
FSIS is including in Sec. 441.10(d) the expected elements of a
protocol for gathering water retention data. These protocol elements
were published for comment as Appendix A of the September 11, 1998,
proposal.
Under Sec. 441.10(b), meat or poultry products will have to bear a
label statement of the maximum percentage of water absorbed and
retained as a result of post-evisceration processes. A qualifying
statement accompanying the product name could read, ``may contain up to
____ percent absorbed water.'' The percentage must reflect the maximum
percentage of water that may be retained in the product. Alternatively,
the label may simply bear an accurate statement of the percentage of
retained water in the product. Establishments having data or
information to demonstrate that their products do not contain retained
water will not have to label the products and could include a no
retained water claim on the product label. The labels will be
generically approved pursuant to 9 CFR 317.5(b)(2) or 381.133(b)(2).
This requirement, which is responsive, in part, to the AMI petition
discussed above, would ensure that accurate information concerning the
product is conveyed to the consumer in accordance with the misbranding
provisions of the FMIA and the PPIA (especially 21 U.S.C. 601(n)(1),
(6); 453(h)(1), (6)). It will ensure that the product labeling is not
misleading with respect to water retained by the product.
FSIS had proposed that the retained-water statement be contiguous
to the product name on the product label. In response to comments, the
Agency is providing some flexibility in this matter by also permitting
the statement to appear either contiguous to the product name or
elsewhere on the principal display panel of the label. The placement of
the required information on the label will ensure that the information
will be likely to be read and understood by the ordinary individual
under customary conditions of purchase and use.
With the required labeling information, consumers will be in a
better position to compare packaged raw meat or poultry products
containing retained water with alternatives in the meat case. The
market will provide incentives to plants to adopt new, cost-effective
technologies for reducing retained water. The rule will not affect raw
products that now bear complete labeling or nutrition labeling, such as
pre-basted frozen turkeys, or further processed products, such as deli
meats. This final rule also will not cover cooked and cured pork
products, such as those subject to protein-fat-free requirements (9 CFR
318.19(a)(5), 319.104-.105, 327.23).
As stated elsewhere in this document, the Agency's concern in this
rule is to ensure that products in commerce will not be adulterated or
misbranded. To alleviate some confusion on this point that was
expressed in a number of the comments received, the labeling provision
in new Sec. 441.10(b) has been more precisely phrased than in the
proposal.
Changes in Poultry Chilling Regulations
FSIS is amending the chilling requirements for poultry by removing
various prescriptive requirements and specifications, such as the
minimum amount of fresh water intake by continuous chillers for each
poultry carcass. The removal of those requirements should encourage
processors to use the most efficient and effective methods of
controlling microorganisms. Establishments will have the flexibility to
take advantage of the latest technologies and procedures.
This final rule amends 9 CFR 381.65, which concerns general
operating procedures, by removing provisions that are redundant,
excessively detailed, or inconsistent with the PR/HACCP final rule. The
final rule eliminates current paragraph (b), the prohibition on
handling and storing materials that could cause adulteration of poultry
products in any room where poultry products are processed, handled, or
stored. This provision is unnecessary because HACCP plans have been
implemented in every affected establishment and because each HACCP plan
must specify the measures to be taken to protect poultry products from
physical, chemical, or biological contamination. The requirements in
paragraphs (a) and (c) of 9 CFR 381.65 will be retained as paragraph
(a) and (b) because they set out general principles of sanitation and
commercial practice to which all establishments must adhere.
The requirements in paragraphs (h) and (j) of 9 CFR 381.65,
relating to poultry thawing and dressing techniques, are being replaced
with two performance standards. The first requires simply that
establishments use thawing procedures that will prevent adulteration
of, or net weight gain by, the product. The second requires that water
used in washing ready-to-cook poultry be permitted to drain freely from
the carcass. A new paragraph (c), which replaces paragraph (h),
requires that frozen poultry be thawed for further processing in a
manner that will prevent product adulteration but would not require
that any specific thawing method be used.
The thawing regulation that is being replaced does not prevent
practices that may constitute hazards to food safety. For example, it
does not prevent re-exposure of thawed, or partially thawed, product to
a thawing medium that may have become contaminated by previous use and
that may be too warm to prevent microbial growth. Paragraph (h)(1)(i)
specifies a maximum permitted thawing medium temperature of 70 deg.F,
which is too high to prevent microbial growth in product that is re-
exposed to or held in the medium. The regulation conflicts with HACCP
because establishments should assess thawing processes when conducting
their hazard analyses. Establishments must be given the responsibility
and flexibility to choose thawing measures that are effective and that
do not create food safety hazards.
A new paragraph (d) replaces paragraph (j), which specifies the
manner in which carcass wash water is to be drained, with a performance
standard requiring simply that the wash water be permitted to drain
freely from the carcass.
Paragraph (d), which contains a requirement to remove kidneys from
[[Page 1764]]
mature chickens and turkeys, is being eliminated. The kidneys of mature
chickens and turkeys are a source of cadmium, which can accumulate in
the human liver and kidneys and cause acute or chronic health problems.
Kidneys with excess cadmium are a ``food safety hazard reasonably
likely to occur'' that establishments will identify in their hazard
analyses and control through their HACCP systems. Thus, paragraph (d)
is redundant with the HACCP regulations. The requirement to remove
kidneys is referenced in the definition of ``ready-to-cook poultry'' at
9 CFR 381.1(b)(44). Therefore, the Agency is amending that definition.
Paragraph (i), which specifies how poultry carcasses are to be cut
open for evisceration, is being removed. The regulation is outdated and
prescriptive and may be an obstacle to improved product safety. The
regulation is intended to ensure that opening cuts are made without
cutting the intestinal tract and without contaminating the carcass.
Unnecessary cuts are prohibited because they may result in carcass
contamination during evisceration or excessive water absorption during
chilling. The regulation is also intended to maximize the viewing of
the interior and viscera of the carcass during the postmortem
inspection.
In recent years, the poultry industry has developed new methods of
poultry evisceration that do not result in adulteration. For example,
ultrasound techniques are available for use as a diagnostic aid to
detect malformities or other defects before carcasses are opened. Also,
equipment is available that can remove the viscera intact, using vacuum
suction, without breakage or spillage of intestinal contents, and other
available evisceration systems require that the carcass be opened by a
longitudinal cut. The regulation generally limits the opening cut to
the area around the vent (cloaca) to prevent birds from carrying excess
water under the skin that could cause water-control test failures.
Because of this limitation, the new technologies, which can improve
efficiency and product wholesomeness, are not likely to be implemented.
Establishments, however, should have the flexibility to innovate and to
implement promising new technologies, consistent with their HACCP
plans.
Paragraph (k), a requirement to adequately drain ready-to-cook
poultry after chilling to remove ice and water before packaging, is
redundant because of new part 441, and FSIS is removing it.
Paragraphs (l) through (p) are also being removed. These paragraphs
include requirements concerning the chilling of poultry parts, the
removal from establishments of offal resulting from evisceration, the
cleanliness of containers, the sturdiness of packaging materials, and
the use of protective coverings. These are all matters that are to be
addressed by establishments in their Sanitation SOP's and HACCP plan.
Finally, paragraph (q), concerning the harvesting of detached ova
for human food, is being re-designated as paragraph (e) and revised to
reduce duplication with requirements in Sec. 590.440 for handling ova
and to eliminate a command-and-control requirement to identify the ova
past the point of inspection. Also, the reference to a section of the
egg products inspection regulations has been amended to account for the
recent redesignation (63 FR 72353) of those regulations to Title 9,
CFR.
In 9 CFR 381.66, paragraph (a) is being revised. This paragraph
requires poultry to be chilled or frozen in a manner that promptly
removes animal heat from the carcasses and does not adulterate the
product. The second sentence of the paragraph, a command-and-control
requirement to file a description of the chilling or freezing
procedures with the inspector in charge, is being removed.
The general chilling requirements for poultry, paragraph (b),
remain the same. FSIS has long regarded the chilling of poultry to a
safe internal temperature within a minimum number of hours as a useful
food safety precaution. However, as mentioned above, the Agency intends
to undertake rulemaking on this matter. The table of maximum times and
temperatures in paragraph (b) is based on the duration of the lag phase
of bacterial growth on the surfaces of dressed, ready-to-cook poultry
carcasses under plant conditions. Although interested persons are
encouraged to submit data that would justify a change in this
provision, amending the paragraph is outside the scope of the present
rulemaking.
The numerous detailed, prescriptive, command-and-control
requirements in paragraph (c) are being removed. For example, the
amended paragraph (c)(2)(i) does not specify chilling media
temperatures or the use of recording thermometers. New paragraph (c)(1)
requires that potable water be used, and new paragraph (c)(2)(i)
requires that sufficient water be used to maintain the sanitation of
chilling media. However, specific requirements (paragraphs (c)(2)(ii)-
(iii) and (c)(2)(v)) concerning the operation of continuous chilling
systems, including the minimum amount of fresh water intake per bird,
are being removed.
Paragraph (c)(2)(iv) is being re-designated as (c)(2)(ii) and
revised as discussed above in the response to comments. This paragraph,
which concerns the chilling of major portions of poultry carcasses, was
the subject of a September 18, 1999, final rule (63 FR 48958; proposed
at 62 FR 31017; June 6, 1997).
Paragraph (c)(2)(vi), the highly detailed and prescriptive
requirements concerning water-reconditioning systems for poultry
chillers, including the requirement for prior approval of such systems
by FSIS, is being removed. Establishments subject to the poultry
product inspection regulations are not using these systems because none
have proven feasible in commercial operations.
The requirements in paragraphs (c)(4)(i) and (c)(4)(ii), concerning
the holding of poultry in chilling tanks, are being removed, and in
paragraph (c)(5), the highly specific requirements concerning the use
of continuous chillers to chill giblets are also being removed.
Establishments will address the food safety hazards associated with
these procedures in their HACCP plans. However, the requirement to
chill giblets to less than 40 deg.F in under 2 hours will remain at
this time.
Paragraph (d) of Sec. 381.66 is being completely revised. The
general requirement to minimize water absorption by raw poultry, and
the requirement to furnish equipment necessary for water tests, will
remain. The tables setting water absorption and retention limits for
the various kinds and weight classes of poultry are being eliminated,
as are the requirements for daily water testing by FSIS inspectors. The
requirement to notify FSIS of any adjustments in washing, chilling, and
draining methods is also being removed.
FSIS is removing paragraph (d)(10), which specifies how poultry may
be ice-packed in barrels and requires FSIS approval for the use of
alternative types of containers. Establishments will ordinarily have
procedures for determining appropriate containers for a product. If, in
their hazard analyses, they determine that there are food safety
hazards reasonably likely to occur that are associated with containers,
they will address these hazards in their HACCP plans.
The Agency is likewise removing paragraph (d)(11), which requires
establishments to prevent free water from being included in giblet
packages. Among other things, paragraph (d)(11) requires use of a
specific type of giblet wrapping material and incorporates by
[[Page 1765]]
reference the testing standards that must be met in evaluating the
material. This kind of detailed specification is no longer necessary
under the Agency's new regulatory approach. Also, establishments must
comply with the regulations on net quantity of contents and net weight
(9 CFR 317.18-.19, 381.121-121b). This provision will give
establishments flexibility in choosing giblet packaging materials, but
also the responsibility to ensure that their choice is suitable, as
well as safe, for this use. By complying with the retained-water
limitation requirements (discussed below) and by appropriately labeling
product, establishments will be ensuring that water absorption is
controlled as well as ensuring that consumers are appropriately
informed.
Finally, paragraph (e), on air chilling, and paragraph (f),
governing the freezing of poultry, are being retained substantially in
their present form. Paragraph (f)(6), concerning immersion or spray
freezing compounds and equipment, will be removed because it is a
prior-approval requirement inconsistent with the HACCP regulations and
is duplicative of other inspection regulations.
Implementation of the Final Rule
FSIS foresees little difficulty in implementing the revised poultry
chilling regulations, which relieve poultry establishments of certain
burdens without raising misbranding or adulteration issues. FSIS will
ensure compliance with the revised regulations through normal
inspection.
To implement the retained-water provisions of this final rule, on
the other hand, both the Agency and the regulated industry will have to
adopt new procedures. FSIS personnel will verify an establishment's
control of water retention by checking establishment records or by
conducting in-plant or in-distribution tests of sampled products. FSIS
intends to sample product in distribution channels and in official
establishments, using the oven-drying method described in Appendix A to
determine the amount of moisture in product samples. At poultry
processing establishments, the traditional method of weighing birds
before and after chilling to determine moisture pick-up will continue
to be available to both the Agency and the establishments as a process
control check.
FSIS also will conduct independent tests of the establishment's
retained-water control as part of investigations of suspected problems
or in the course of special studies. The overall focus of the Agency's
activities will be to ensure that raw products that enter commerce do
not contain water in excess of the amount that is unavoidable in
achieving food safety objectives.
FSIS is providing a full year from the publication date for
implementation of this final rule to mitigate the effects of the rule
on establishments that may have to consider changing or updating their
chilling processes and equipment. The extended implementation period
should be especially helpful to establishments that meet the small-
business-entity size criteria defined by the Small Business
Administration.
During the period before the effective date, FSIS will provide its
field inspection personnel with the instructions they will need to
carry out their review of protocols and verify that establishment data
demonstrate the amount of water retention that is unavoidable and
support product labeling statements. The Agency will prepare sampling,
testing, and document review procedures for Agency use; train Agency
personnel in the new procedures; and develop a new national reference
database on the natural moisture content of raw products in the various
meat and poultry product classes with which this rule is concerned.
To develop this national database on natural moisture content, FSIS
will test product samples drawn at official establishments. The Agency
will use a common, analogous point of reference in livestock carcass
and poultry product preparation at which to determine the naturally
occurring percentage of moisture in meat products and poultry products,
namely, the point at which the calculated yield weight is determined.
(Calculated yield weight of a carcass is its predicted ``green
weight''--the weight of the carcass after dressing and before any
additional in-plant processing.) In poultry plants, this point is at
the re-hanging operation (after de-feathering and hock removal). The
analogous point in livestock slaughtering establishments is before the
pre-evisceration carcass wash. FSIS has chosen these common reference
points to reduce the possibility of measurement errors caused by
various carcass-washing procedures.
To determine the moisture content of a product sample, the Agency
plans to rely on the oven-drying method described in its Chemistry
Laboratory Guidebook and in Appendix A of this document. This method
involves weighing, before and after drying, a dish containing a
homogenized meat or poultry product sample. The method can be applied
to products at any point in processing or distribution. Similar oven-
drying methods for determining the amount of moisture in meat, meat
products, and poultry products are described in the Official Analytical
Methods of the Association of Official Analytical Chemists and in ISO
1442, published by the International Organization for Standardization.
After developing sufficient information on the natural water
content of raw meat or poultry products, FSIS will be in a better
position to verify that the establishment is complying with the
requirement to minimize retained-water amounts when the final rule
becomes effective. To determine whether an establishment is complying
with the regulations, the Agency will verify the establishment's
protocol documentation and the data collected under the protocol,
including data on retained-water minimization and pathogen reduction.
FSIS also will verify compliance with the requirement that product
labels display retained-water amounts, and that the actual retained
water in the products corresponds to the labeled amount.
Usually, the verification will consist only of a document check.
However, the Agency will occasionally test products for moisture
content to verify the establishment's findings.
FSIS will randomly sample raw meat and poultry products both in-
plant and in-distribution and will test the products for retained water
content. FSIS will collect and run tests on product samples and
statistically analyze the results of the tests.
The Agency will directly measure the moisture content of the raw
products sampled in-plant at pre-shipment using its oven-drying method.
The Agency will compare the results of these tests with the naturally
occurring amounts of water in the national reference database and with
the retained-water statements on the product labels to determine
whether the products are in compliance with the requirement to minimize
retained water, and whether they are correctly labeled with a retained-
water statement.
To measure the amount of retained water and determine compliance
with the final rule in in-plant situations when using the weighing
method, FSIS will compare product weights taken after chilling, but
before the product leaves the establishment, to the pre-final-wash
weight or (in poultry plants) the calculated yield weight. In livestock
slaughtering plants, the Agency expects to be comparing pre-final wash
or ``hot'' carcass weights with the ``cold weights'' taken after spray
chilling in establishments using the spray-chill process.
[[Page 1766]]
The Agency does not expect to use calculated yield weight data as a
basis for comparing hot and cold livestock carcass weights because such
data are not available for most livestock establishments. The great
majority of such establishments do not weigh carcasses after de-hiding
or de-hairing and before the pre-evisceration wash. FSIS is aware that
there may be a slight, measurable gain in carcass weight immediately
after the pre-evisceration wash. However, this gain is usually more
than offset by moisture loss on the kill floor. Thus, the ``hot''
carcass weight does not include a moisture gain resulting from the pre-
evisceration wash.
FSIS is not prescribing any particular method that official
establishments must use to measure the amount of retained water in
their products. Establishments are free to use any scientifically valid
method for this purpose. Establishments may want to use the food
chemistry method described in Appendix A and used by FSIS to determine
the moisture content of their products. Because of the destructive
nature of the method and the delay in getting results, establishments
may find it more convenient on a day-to-day basis to compare the
weights of carcasses and parts before and after they are exposed to
washes, sprays, or immersion chilling. The data from such checks would
have to be available to FSIS to verify. As mentioned, poultry
establishments will continue to be able to use the traditional method
involving the weighing of birds before and after chilling as a check on
water retention controls.
FSIS also will conduct surveys of products in plants and in
distribution channels to obtain an overview of national compliance with
the regulations and to update the national reference database on the
moisture content of meat and poultry products. The Agency will compare
the results of these surveys with the information in its database to
determine whether any adjustments in its enforcement of the regulations
are necessary. Comments are requested on sampling and survey methods
that the Agency should consider using both for initially building the
national reference database and for the on-going compliance overview.
FSIS will continue to verify that products are in compliance with
the net-weight requirements for meat and poultry products. As stated
elsewhere in this document, neither the net-weight requirements nor the
obligation of an establishment to comply with them is affected by this
final rule.
FSIS expects there to be requests for adding water solutions to
meat and poultry manufacturing trimmings in an effort to reduce the
pathogen levels on product. Such applications may or may not result in
retained water, as well as chemical residues. FSIS expects such
applications to adhere to the same criteria as other applications
resulting in retained water. FSIS will allow establishments to
implement the provisions of this final rule in advance of the effective
date provided the establishment informs the appropriate District Office
in order that inspection program personnel are provided with the
necessary instructional materials. FSIS expects to provide instructions
regarding early implementation of the final rule.
Executive Order 12866 and Regulatory Flexibility Act
Current Practices in the Poultry Industry
The regulations controlling retained water in poultry carcasses
have consisted of three major components: (1) A performance standard
requiring washing, chilling, and draining practices that will minimize
water absorption and retention at time of packaging; (2) limits for
maximum retained water in birds that will be packaged as whole
carcasses; and (3) limits for maximum retained water in birds that will
be ice-packed or cut up prior to packaging. The performance standard is
to minimize the water that is absorbed and subsequently retained, i.e.,
it is not interpreted as requiring minimization of both water
absorption and water retention. In implementing the standard, FSIS
concludes that the performance standard is met when retained water is
under the maximum limits.
Until the Kenney case, argued in U.S. District Court and referred
to earlier in this document, various limits on maximum retained water
applied to the various weight classes of whole chickens and turkeys.
For example, the maximum retained water for most whole chickens
weighing 4.25 pounds or less was 8 percent. The maximum retained water
for chicken that is ice-packed or subsequently cut up into parts has
been 12 percent. In its July 1997 decision, the U.S. District Court
found that the regulation specifying water absorption and retention
limits for ready-to-cook poultry that is to be frozen, cooked, or
consumer-packaged as whole poultry was arbitrary and capricious because
the Secretary of Agriculture did not explain in the rulemaking record
how he determined the particular water retention levels, why water
retention cannot be reduced below those levels, or why meat and poultry
should be treated differently with respect to water retention. The
Court therefore set aside the water retention limits for poultry to be
consumer packaged, frozen, or cooked as whole poultry. In the wake of
the decision, there have been no regulatory criteria by which to
determine whether retained water has been minimized in chilled or
frozen whole birds.
As discussed previously, FSIS is mandated by the FMIA and PPIA to
prevent the distribution in commerce of meat or poultry products that
are adulterated or misbranded. Without limits on retained water, FSIS
cannot adequately protect consumers from adulteration and misbranding
due to excessive retained water in whole birds. Hence, the Agency is
establishing a new regulatory basis for minimizing retained water.
FSIS is replacing the regulations under which poultry establishment
was considered to be ``minimizing'' retained water when it was
operating within the regulatory limits. FSIS is aware that not all
establishments have really been minimizing retained water. Data
analyzed for this FRIA show that some poultry establishments have been
controlling their processes to retain the maximum allowed amount of
water. While this is considered acceptable in the sense that product is
not adulterated, it is not consistent with a regulatory intent to
minimize. However, it may be consistent with food safety objectives to
reduce pathogens.
The existence of the 12-percent limit for cut-up chicken is in
itself inconsistent with the concept of minimization. Many
establishments pack both whole-and cut-up chicken. In meeting the 8-
percent limit for whole birds, they demonstrate that their minimum is
below 8 percent. The 12 percent limit serves as an opportunity to
maintain water levels in cut-up poultry. The 12-percent limit is also
available as default when the 8-percent limit is not achieved. An
establishment can divert birds to cut-up operations when they fail the
whole bird limit.
With this final rule, FSIS also is addressing the issue of
inconsistent treatment of meat and poultry in its regulations because,
under the final rule, both meat and poultry products will be subject to
the same requirements.
Need for the Rule
The FMIA and PPIA, which the Agency administers, make clear the
[[Page 1767]]
obligation of producers of raw meat or poultry products not to mislead
consumers. FSIS thinks that if they market as meat or poultry a product
that contains something other than meat or poultry, that fact should be
disclosed. It has been the consistent policy of FSIS to ensure that
information that accurately discloses the contents of meat or poultry
products is made available to consumers of those products.
As noted earlier in this document, a 1997 U.S. District Court
decision set aside the regulatory limits on retained water in poultry
products. The District Court found that the Agency had not presented
the basis for its retained water levels, why water retention could not
be reduced below those levels, or why meat and poultry should be
regulated differently with respect to water retention.
The District Court ruling left FSIS without regulatory criteria for
determining whether retained water had been minimized or what levels
constituted adulteration. The Agency also no longer had available
published retained water limits that it could enforce in an effort to
protect consumers from misbranded product.
Analysis of Alternatives
This rule resulted from an analysis of six alternative regulatory
approaches for addressing retained water in raw meat and poultry
products. The six alternatives are as follows:
1. No limit on retained water but mandatory labeling that
identifies the percentage of retained water in the product. FSIS did
not recommend this alternative for adoption because it would not
reduce retained water so that economic adulteration would continue
to persist. It would, however, be advantageous to consumers because
it would enable them to compare alternative packages of poultry with
varying quantities of retained water and prices and select the
package to suit their budgets.
2. A requirement that all establishments meet a water limit
based on best available technology, with mandatory labeling to
indicate any retained water. FSIS did not propose this option
because the adoption of the best available technology would be a
step backward into a regime of command and control. It would also
impose considerable costs on plants that are currently not employing
such a technology without a corresponding improvement in food
safety. For example, if the best available technology is determined
to be the continuous chillers, there are several small and medium
size plants that do not employ this technology. The economic impact
of such an option would be significant on these plants. In the
current environment of regulatory reform, FSIS is moving away from
command and control to incentive-based performance standards. Such
standards permit plants to reduce their retained water levels
irrespective of the technology they employ. A moisture limit based
on the best performance achievable with existing equipment, with
mandatory labeling to show any retained water. FSIS did not adopt
this option because, beyond stating that water retention should be
minimized consistent with maximizing the safety of the product, it
would be difficult, if not impossible, for FSIS to define the best
performance achievable. This option would also encourage
establishments to continue to use existing equipment, perhaps beyond
the economic life of the equipment.
3. A standard of zero retained moisture. FSIS did not recommend
this option because the costs of this option might exceed the
benefits. Finally, some minimum amount of retained water might be
necessary for reducing pathogens.
4. A requirement that no retained water could be included in net
weight. FSIS did not recommend this option for adoption because it
would require establishments to adjust their scales to account for
retained water. The costs of adjusting these scales could be
excessive. Moreover, enforcement of net weight requirements is an
area where Federal, State and local authorities share responsibility
and must cooperate. The enforcement procedure, as adopted by the
National Conference on Weights and Measures, are published in NIST
Handbook 133, Third Edition, Supplement, ``Checking the Net Contents
of Packaged Goods''. The National Institute of Standards and
Technology (NIST) has a statutory responsibility for ``cooperation
with the states in securing uniformity of weights and measures laws
and methods of inspection.
5. A requirement of zero retained water unless the water
retention is unavoidable in processes necessary to meet food safety
requirements, e.g., to reduce pathogens, with product labeling to
indicate the presence of retained moisture, where applicable. FSIS
recommended this option because it prioritizes food safety above
retained water. It also includes the provision of labeling the
retained water to help consumers decide amongst alternative packages
with different levels of retained water and prices.
FSIS chose the last alternative. The selected option does not allow
retained water in an affected product unless it is an unavoidable
consequence of the process or processes used to meet applicable food
safety requirements. By ``unavoidable consequence'' the Agency means an
unavoidable and irreducible side effect. Under this option, inspected
establishments, associations, or other groups, using acceptable
protocols must establish levels of unavoidable retained water. Also,
the maximum amount of retained water that can be present must be stated
on the product label. FSIS has found that this option is likely to
provide greater benefits than other options because it is more flexible
and likely to prove less costly than some of the proposed alternatives.
A food safety requirement can be a regulatory prescription, such as the
temperature to which a product must be chilled and held. It can also be
a preventive measure taken at a CCP or a critical limit in the
establishment's HACCP plan. For example, the proposed rule might
increase human handling for transferring products from the chillers to
the freezer, thereby increasing cross contamination. A critical control
point at such handling could reduce, if not eliminate, cross
contamination. Given a food safety requirement, an establishment must
choose a method for satisfying the requirement.
The method selected for meeting food safety requirements may have
unintended consequences that cannot be eliminated. A consequence of an
antimicrobial treatment of carcasses or a carcass chilling method may
be an increase in the water content of carcasses and parts. FSIS is
requiring that the amount of water that might be retained in carcasses
and parts as a result of using such an anti-microbial or chilling
method be an unavoidable and irreducible effect of using that method.
To be applicable to the raw products of an inspected establishment,
a non-zero retained-water limit would have to be based on supporting
data collected in accordance with a written protocol that has been
subject to review by FSIS. This final rule will allow an individual
establishment or industry trade association or other group using the
same or similar processing techniques to develop a protocol and carry
out data-generating studies according to the protocol. Depending on the
design of the protocol, the data gathered could justify water-retention
limits for a single establishment, a group of establishments with
similar equipment processing similar classes of raw product, or all
such establishments in an industry. To establish a non-zero retained
water limit, an inspected establishment, industry trade association, or
other group would have to generate the necessary supporting data. The
labels of products would have to state the presence of retained water
in the products.
Cost Estimates
The analysis estimates a range of costs the poultry industry will
incur to meet this new regulatory requirement. If establishments are
able to demonstrate that current levels of retained water are
unavoidable in achieving applicable food safety standards,
establishments will not incur additional costs for reducing retained
water. These establishments would only incur costs for establishing
limits and costs for labeling the product. The costs of
[[Page 1768]]
establishing limits for the poultry industry are estimated to be $1.5
million (in 1998 dollars). This estimate is based on each establishment
conducting its own tests. The cost should be lower if associations or
other groups establish limits for different types of chiller systems.
Labeling costs are estimated to be $18.4 million (in 1998 dollars) if
all raw, single-ingredient poultry continues to retain water.
To the extent that establishments cannot demonstrate that current
retained water levels are unavoidable in achieving applicable food
safety standards, significant costs could be incurred as establishments
modify processes to minimize retained water levels. FSIS estimates that
the average retained water for chicken, as a percentage of net weight
is currently in the 5.0 to 6.5 percent range. The corresponding level
for turkey is 4.0 to 4.5 percent. Reducing retained water could entail
a wide range of process modifications, depending on the type of
chilling equipment currently used and amount of retained water that
would have to be removed. FSIS estimates that, if extensive
modifications to chilling systems were needed throughout the industry,
the fixed costs associated with removing a substantial portion of the
existing retained water could run to well over $100 million. The
substantial portion was defined in the PRIA, viz., that it would take
12 hours to drain substantial portion of the retained water in
chickens. The 12-hour drain would reduce the existing level range from
5-6.5 percent, by 4 to 5 percentage points, i.e., to 1-1.5 percentage
range, or by about 80 percent. The fixed costs estimates of these
extensive modifications were taken from USDA/ERS study, discussed in
the PRIA, and are summarized below.
The drip-dry process for chicken requires production workers to
remove chickens from a production line, place the chickens in vats,
place the vats in a cool room for 12 hours, and return the chickens to
the poultry line. Besides labor, this process requires cooling space,
stainless steel vats that hold up to 500 chickens, and a forklift to
transfer chickens from a production line to a storage room and then
back to the line after the drip-dry process is complete.
To extend draining or dripping time, many establishments would have
to add refrigerated facilities, purchase vats for storing birds being
drained, hire additional personnel, and purchase additional stock
handling equipment. There would be inventory costs due to holding birds
off the market for a longer time before shipment. Holding birds at
inspected establishments would also reduce the corresponding retail
shelf life.
The ERS staff developed some cost estimates for holding poultry
based on the following industry input:
1. One common method of draining uses stainless steel vats at a
cost of $1,000 each.
2. Vats hold approximately 500 chickens or 100 turkeys.
3. Cooler space costs $125 per square foot.
4. Vats can be stacked two high.
5. Stacked vats with aisles require 12 square feet of space per
vat.
6. Forklifts to move vats cost $24,000 each.
The Daily Moisture Records sometimes include a record of the
additional drain time required. The time varies with the initial water
level, the drain configuration and the location of the excess water,
i.e., under skin versus between muscle tissues or within muscle
tissues. Based on the violations data, it was determined that a 12-hour
drain would be the minimum time required to remove most of the retained
water from chickens.
Most of the drain time for turkeys ranged from \1/2\ to 1 hour on
an ``hour per percentage reduction'' basis. All of the turkey
violations noted were less than 1 percent above the existing limit
whereas some of the chickens started at water levels 4 to 5 percentage
points above the existing limits.
To drain chickens for 12 hours is equivalent to saying the industry
would need to add extra capacity to drain half a day's production,
since most chicken is processed in establishments running two shifts.
Since average chicken production is 29.5 million birds per day
(assuming a 260-day work year), half a day's production is 14.75
million birds. Using the above factors, this would require 29,510 vats
at $29.5 million; 354.12 square feet of cooler space at $44.3 million'
and $4.8 million of forklifts assuming the largest 200 chicken
establishments would each require an additional forklift. In this 12-
hour case, the total fixed costs would be $78.6 million ($29.5 + 44.3 +
4.8).
In addition, half a day's turkey production at 557,000 birds
requiring 5,570 vats would cost $5.57 million and cooler space would
cost $8.36 million. Assuming that the largest 70 turkey establishments
would require an additional forklift at a cost of $1.68 million, the
total fixed costs for draining all turkeys for 12 hours would be $15.61
million ($5.57 + 8.36 + 1.68).
In short, the total fixed costs for a 12-hour draining of chickens
and turkeys would be $94.2 million ($$78.6 + $15.61). Since these costs
were estimated in 1997, updating them with to the year 2000 would
amount to about $100 million.
Variable costs of holding poultry to drain would include increased
labor costs, higher utility costs, increased overheads, and the cost of
carrying additional inventory. Holding half a day's production is
equivalent to continually storing a wholesale value of $37 million
poultry ($19.2 billion divided by 520 shifts/year). At a 5 percent
interest rate, the annual cost of draining poultry for 12 hours would
be $1.85 million.
It would be conservative to assume a minimum average of one
additional employee per establishment. Since there are 300
establishments, the cost at $21,500 per employee per year would result
in an annual labor cost of $6.4 million ($21,500 x 300). The total
variable costs of $8.25 million ($1.85 + $6.4) would increase to about
$10 million in the year 2000 when updated by an increase in Employment
Cost Index.
To sum up, the first year costs of draining poultry would amount to
$110 million ($100 m + $10 m). These are the costs of reducing retained
water in the range of 1-1\1/2 \percent. Since the retained water is not
reduced to zero, these are merely the lower bounds. The upper bound
costs would be the costs of reducing retained water to zero percent.
However, if extensive modifications were not needed, the industry
would only incur the costs of establishing retained water limits and
meeting the labeling requirements of the final rule.
Benefits of Final Rule
Because of longstanding industry petitions and the decision in the
Kenney case, FSIS has had to develop new regulatory requirements to
carry out its responsibilities for protecting the public from economic
adulteration. Prevention of economic adulteration is a consumer
benefit. Consumers also will benefit from the additional information on
retained water that will be provided as a result of the labeling
requirement. The information on retained water should contribute to a
sounder basis for purchasing decisions. Consumers are currently not
being informed about the amount of retained water. Consumers will
benefit from having improved knowledge of product quantity in terms of
meat or poultry meat content.
The final rule will provide the meat industry with additional
flexibility for meeting the pathogen reduction performance standards.
Meat processors will be able to use pathogen reduction techniques
without having to be
[[Page 1769]]
concerned about meeting the existing zero retained water requirement.
Of course, if their single-ingredient raw products retain water, the
products will have to be labeled to indicate how much water may be
retained.
This final rule also will provide affected establishments with
increased flexibility to choose the most appropriate means for
implementing HACCP plans for protecting the safety or raw product while
minimizing the potential for economic adulteration. By removing certain
command-and-control requirements and providing increased flexibility
for HACCP implementation, this final rule may reduce the costs of HACCP
implementation.
As discussed in the preamble, this final rule eliminates many
requirements, including the following:
1. The requirement that poultry establishments provide FSIS with a
description of all chilling and freezing procedures.
2. The requirement that poultry establishments notify FSIS before
any changes in chilling procedures are implemented and provide FSIS
with test results demonstrating the effectiveness of the changes.
3. The requirements that meat carcasses cannot show any weight gain
resulting from the use of carcass spray systems.
4. Elimination of minimum water intake requirements for immersion
chillers.
Finally, the rule will also provide all affected establishments
with the flexibility and market incentives to implement new procedures
for meeting pathogen reduction performance standards. In addition, by
replacing command-and-control requirements with HACCP-consistent
performance standards, the final rule will eliminate some recordkeeping
and reporting burdens, provide for increased flexibility, and reduce
the costs of HACCP implementation.
Impact on Small Entities
The final rule should not have a significant impact on a large
number of small businesses. Almost half of all federally inspected
poultry slaughter establishments are large business entities, based on
the Small Business Administration size criterion of more than 500
employees.
These establishments, and indeed most poultry establishments, use
immersion chilling to meet the existing chilling requirements for
poultry, e.g., 9 CFR 381.66(b)(2) requires that poultry carcasses under
4 pounds must be chilled to 40 deg.F within 4 hours following
evisceration. It follows that, for most poultry establishments, the
unavoidable retained water amount is the minimum level that can be
reached with existing immersion chiller equipment while still meeting
the chilling requirement. FSIS recognizes that this minimum must be
established within practical limits for operating parameters such as
drip time and chiller water temperature. The industry already has
information concerning the chiller variable settings that minimize
water retention. Therefore, the poultry industry can establish water
retention limits for various chiller systems with minimal costs. FSIS
also recognizes the possibility that some poultry establishments may
have to use anti-microbial interventions that result in higher levels
of retained water to meet the Salmonella standards than they do to meet
the existing chilling requirements.
Fifty to 60 poultry slaughter establishments process under a
million birds annually. Many of these smaller operations do not use
continuous immersion chillers. They use ice or slush to meet the
existing chilling requirements. Few, if any, would have to reduce the
current level of retained water. The establishments most affected by
this final rule are the firms operating immersion chillers in a manner
that targets the maximum allowable retained water.
This final rule should not have a significant impact on the meat
industry because that industry is already achieving zero-percent
retained water. This final rule, however, provides an alternative for
establishments that are having or will have trouble meeting the
Salmonella performance standards. These establishments could use a full
range of anti-microbial rinses or hot-water rinses without having to
worry about meeting a zero-percent retained-water limit. If they can
demonstrate that they need a non-zero limit to meet the Salmonella
standards, they can use the flexibility provided by the final rule and
establish a new water limit as long as they state the maximum
percentage of water absorbed and retained on product labels. Of the
meat products affected by this final rule, edible organs prepared in
slaughtering plants are most likely to retain water. Of the 1,200
establishments that prepare these products, about 85 percent are small.
Most of these establishments will have to label their products to
indicate the maximum retained-water percentage in the products.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. States and local jurisdictions are preempted by
the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) from imposing any marking or packaging
requirements on federally inspected meat and meat products or poultry
products that are in addition to, or different than, those imposed
under the FMIA and PPIA. States and local jurisdictions may, however,
exercise concurrent jurisdiction over meat and poultry products that
are outside official establishments for the purpose of preventing the
distribution of meat or poultry products that are misbranded or
adulterated under the FMIA or PPIA. States and local jurisdictions also
may exercise concurrent jurisdiction, for the same purpose, over
imported meat and poultry products that are not at an official
establishment after the entry of such imported articles into the United
States.
This final rule is not intended to have retroactive effect.
There are no applicable administrative procedures that must be
exhausted prior to any judicial challenge to the provisions of this
final rule. However, the administrative procedures specified in 9 CFR
306.5 and 381.35 must be exhausted prior to any judicial challenge of
the application of the provisions of this final rule, if the challenge
involves any decision of an FSIS employee relating to inspection
services provided under the FMIA or PPIA.
Executive Order 12898
Pursuant to Executive Order 12898 (59 FR 7629; February 16, 1994),
``Federal Actions to Address Environmental Justice in Minority and Low-
Income Populations,'' FSIS has considered potential impacts of this
final rule on environmental and health conditions in low-income and
minority communities.
This final rule will provide new, uniform regulations limiting the
amount of water retained by raw, single-ingredient, meat and poultry
products as a result of post-evisceration processing, such as carcass
chilling, considered necessary to minimize pathogen growth on the
products. As explained in the economic impact analysis, the regulations
should generally benefit consumers of meat, meat products, and poultry
products. The regulations will not require or compel meat or poultry
establishments to relocate or alter their operations in ways that could
adversely affect the public health or environment in low-income and
minority communities. Further, this final rule will not exclude
[[Page 1770]]
any persons or populations from participation in FSIS programs, deny
any persons or populations the benefits of FSIS programs, or subject
any persons or populations to discrimination because of their race,
color, or national origin.
FSIS estimates that as many as 4 percent of meat and poultry
establishments under Federal and State inspection are owned by women or
members of non-white minority groups. Therefore, of the establishments
affected by this rule, as many as 4 percent of the establishments may
be under female or minority ownership. FSIS has no reason for
supposing, however, that the effects of this rule, whether adverse or
beneficial, on such establishments would be disproportionate.
Additional Public Notification
Public awareness of all stages of rulemaking and policy development
is important. Consequently, in an effort to better ensure that
minorities, women, and persons with disabilities are aware of this
final rule, FSIS will announce it and provide copies of this Federal
Register publication of this final rule in the weekly FSIS Constituent
Update. The FSIS Constituent Update is communicated via fax to over 300
organizations and individuals. In addition, the update is available on
line through the FSIS web page located at ``http://www.fsis.usda.gov''.
The update is used to provide information regarding FSIS policies,
procedures, regulations, Federal Register notices, FSIS public
meetings, recalls, and any other types of information that could affect
or would be of interest to the Agency's constituents/stakeholders. The
constituent fax list consists of industry, trade, and farm groups,
consumer interest groups, allied health professionals, scientific
professionals, and other individuals who have requested to be included.
Through these various channels, FSIS is able to provide information to
a much broader, more diverse audience. For more information and to be
added to the constituent fax list, readers of this document may fax
their requests to the Congressional and Public Affairs Office, at (202)
720-5704.
Paperwork Requirements
Title: Retained Water in Raw Meat and Poultry Products; Poultry
Chilling.
Type of Collection: Labels and labeling records; data or
information supporting labeling statements.
Abstract: Slaughtering establishments would have to have data to
support percent-absorbed-water statements on product labels and to
demonstrate that the amount of absorbed water in the product is
unavoidable under the establishments' HACCP plans. The data would have
to have been collected under written protocols.
This final rule will require an estimated 210,000 hours to develop
the data to support retained water levels above zero. All 300 federally
inspected poultry establishments will need to conduct studies to
establish minimum retained water levels. The FRIA assumed that the
average establishment would conduct studies for two product categories.
The FRIA assumed that a reasonable study would examine 10 alternative
chiller settings with four 50-bird water tests conducted for each
setting. Each test would require 2.5 hours. Thus, it would take an
estimated 200 hours for each of 300 poultry establishments, or more
than 30,000 hours.
The FRIA assumed that at most 500 meat establishments need to
develop non-zero water levels to meet the existing pathogen-reduction
performance standards. With larger carcasses, the recording time is
doubled to 200 hours per establishment. These 500 meat establishments
would also require 100 hours to collect microbial samples. Thus, the
information collection would be 300 hours for each of 500
establishments, or 150,000 hours.
All 800 establishments with non-zero levels would also have to
develop new, generically approved labels.
Estimate of Burden: Protocols for determining minimum feasible
water retention in product classes (3,000 hours); data supporting
absorbed-water label statements or the lack thereof (210,000 hours).
Changes to product labels would be generically approved and, therefore,
establishments would not incur a burden from label submission.
Respondents: Meat and poultry product establishments or trade
associations.
Estimated Number of Respondents: 800.
Estimated Number of Responses per Respondent: 1.
Estimated Total Annual Burden on Respondents: 213,000 hours.
Copies of this information collection assessment can be obtained
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection
Service, USDA, 112 Annex, 300 12th SW., Washington DC 20250.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; (b) the accuracy of the Agency's estimate of the burden of the
proposed collection of information including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
Specifically, FSIS is interested in comments regarding the label
requirements. Some commenters expressed concern about the usefulness,
or ``practical utility,'' of the information on the maximum percentage
of retained water that must be disclosed on the label. FSIS welcomes
any information and data to support this requirement or that presents
alternatives. FSIS will fully address any comments in its information
collection request that it will submit to the Office of Management
Budget 60 days after publication of this rule.
Comments may be sent to Lee Puricelli, see address above, and the
Desk Officer for Agriculture, Office of Information and Regulatory
Affairs, Office of Management and Budget, Washington DC 20253.
Comments are requested by March 12, 2001. To be most effective,
comments should be sent to OMB within 30 days of the publication date.
List of Subjects
9 CFR Part 381
Food labeling, Poultry and poultry products.
9 CFR Part 441
Consumer protection standards, Meat and meat products, Poultry
products.
For the reasons discussed in the preamble, FSIS is amending 9 CFR
Chapter III, as follows:
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
1. The authority citation for part 381 continues to read as
follows:
Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR
2.18, 2.53.
2. Paragraph (b) of Sec. 381.1 is amended by revising the
definition of Ready-to-cook poultry to read as follows:
Sec. 381.1 Definitions.
* * * * *
(b) * * *
(44) Ready-to-cook poultry. ``Ready-to-cook poultry'' means any
slaughtered
[[Page 1771]]
poultry free from protruding pinfeathers and vestigial feathers (hair
or down), from which the head, feet, crop, oil gland, trachea,
esophagus, entrails, and lungs have been removed, and from which the
mature reproductive organs and kidneys may have been removed, and with
or without the giblets, and which is suitable for cooking without need
of further processing. Ready-to-cook poultry also means any cut-up or
disjointed portion of poultry or other parts of poultry, such as
reproductive organs, head, or feet that are suitable for cooking
without need of further processing.
* * * * *
3. Section 381.65 is revised to read as follows:
Sec. 381.65 Operations and procedures, generally.
(a) Operations and procedures involving the processing, other
handling, or storing of any poultry product must be strictly in accord
with clean and sanitary practices and must be conducted in a manner
that will result in sanitary processing, proper inspection, and the
production of poultry and poultry products that are not adulterated.
(b) Poultry must be slaughtered in accordance with good commercial
practices in a manner that will result in thorough bleeding of the
carcasses and ensure that breathing has stopped prior to scalding.
Blood from the killing operation must be confined to a relatively small
area.
(c) When thawing frozen ready-to-cook poultry in water, the
establishment must use methods that prevent adulteration of, or net
weight gain by, the poultry.
(d) The water used in washing the poultry must be permitted to
drain freely from the body cavity.
(e) Detached ova may be collected for human food and handled only
in accordance with 9 CFR 590.440 and may leave the establishment only
to be moved to an official egg product processing plant for processing.
Ova from condemned carcasses must be condemned and treated as required
in Sec. 381.95.
4. Section 381.66 is amended by revising paragraphs (a), (c), and
(d) and removing paragraph (f)(6), to read as follows:
Sec. 381.66 Temperatures and chilling and freezing procedures.
(a) General. Temperatures and procedures that are necessary for
chilling and freezing ready-to-cook poultry, including all edible
portions thereof, must be in accordance with operating procedures that
ensure the prompt removal of the animal heat, preserve the condition
and wholesomeness of the poultry, and assure that the products are not
adulterated.
* * * * *
(c) Ice and water chilling. (1) Only ice produced from potable
water may be used for ice and water chilling. The ice must be handled
and stored in a sanitary manner.
(2)(i) Poultry chilling equipment must be operated in a manner
consistent with meeting the applicable pathogen reduction performance
standards for raw poultry products as set forth in Sec. 381.94 and the
provisions of the establishment's HACCP plan.
(ii) Major portions of poultry carcasses, as defined in
Sec. 381.170(b)(22), may be chilled in water and ice.
(3) Previously chilled poultry carcasses and major portions must be
maintained constantly at 40 deg.F or below until removed from the vats
or tanks for immediate packaging. Such products may be removed from the
vats or tanks prior to being cooled to 40 deg.F or below, for freezing
or cooling in the official establishment. Such products must not be
packed until after they have been chilled to 40 deg.F or below, except
when the packaging will be followed immediately by freezing at the
official establishment.
(4) Giblets must be chilled to 40 deg.F or below within 2 hours
from the time they are removed from the inedible viscera, except that
when they are cooled with the carcass, the requirements of paragraph
(b)(2) of this section must apply. Any of the acceptable methods of
chilling the poultry carcass may be followed in cooling giblets.
(d) Water absorption and retention. (1) Poultry washing, chilling,
and draining practices and procedures must be such as will minimize
water absorption and retention at time of packaging.
(2) The establishment must provide scales, weights, identification
devices, and other supplies necessary to conduct water tests.
* * * * *
(f) * * *
(6) [Removed]
5. A new Part 441 is added to subchapter E to read as follows:
PART 441--CONSUMER PROTECTION STANDARDS: RAW PRODUCTS
Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906;
7 CFR 2.18, 2.53.
Sec. 441.10 Retained water.
(a) Raw livestock and poultry carcasses and parts will not be
permitted to retain water resulting from post-evisceration processing
unless the establishment preparing those carcasses and parts
demonstrates to FSIS, with data collected in accordance with a written
protocol, that any water retained in the carcasses or parts is an
unavoidable consequence of the process used to meet applicable food
safety requirements.
(b) Raw livestock and poultry carcasses and parts that retain water
from post-evisceration processing and that are sold, transported,
offered for sale or transportation, or received for transportation, in
commerce, must bear a statement on the label in prominent letters and
contiguous to the product name or elsewhere on the principal display
panel of the label stating the maximum percentage of water that may be
retained (e.g., ``up to X% retained water,'' ``less than X% retained
water,'' ``up to X% water added from processing''). The percent water
statement need not accompany the product name on other parts of the
label. Raw livestock and poultry carcasses and parts that retain no
water may bear a statement that no water is retained.
(c)(1) An establishment subject to paragraph (a) of this section
must maintain on file and available to FSIS its written data-collection
protocol. The protocol must explain how data will be collected and used
to demonstrate the amount of retained water in the product covered by
the protocol that is an unavoidable consequence of the process used to
meet specified food safety requirements.
(2) The establishment must notify FSIS as soon as it has a new or
revised protocol available for review by the Agency. Within 30 days
after receipt of this notification, FSIS may object to or require the
establishment to make changes in the protocol.
(d) Expected elements of a protocol for gathering water retention
data:
(1) Purpose statement. The primary purpose of the protocol should
be to determine the amount or percentage of water absorption and
retention that is unavoidable using a particular chilling system while
achieving the regulatory pathogen reduction performance standard for
Salmonella as set forth in the PR/HACCP regulations (9 CFR 310.25(b),
381.94(b)) and the time/temperature requirements set forth in 9 CFR
381.66. Additional purposes that could be included are determining
chilling system efficiency and evaluating product quality.
[[Page 1772]]
(2) Type of washing and chilling system used by the establishment.
Any post-evisceration washing or chilling processes that affect water
retention levels in and microbial loads on raw products should be
described. For poultry establishments, the main chiller types,
identified by the mechanism used to transport the birds through the
chiller or to agitate the water in the chiller, are the drag-through,
the screw type, and the rocker-arm type.
(3) Configuration and any modifications of the chiller system
components. A description of chiller-system configurations and
modifications should be provided. The description should include the
number and type of chillers in a series and arrangements of chilling
system components, and the number of evisceration lines feeding into a
chiller system. If there is a pre-chilling step in the process, its
purpose and the type of equipment used should be accurately described.
Any mechanical or design changes made to the chilling equipment should
be described.
(4) Special features in the chilling process. Any special features
in the chilling process, such as antimicrobial treatments, should be
described. Also, the length and velocity of the dripping line should be
described, as well as the total time allowed for dripping. Any special
apparatus, such as a mechanism for squeezing excessive water from
chilled birds, should be explained.
(5) Description of variable factors in the chilling system. The
protocol should describe variable factors that affect water absorption
and retention. In poultry processing, such factors are typically
considered to be the time in chiller water, the water temperature, and
agitation. The protocol should consider air agitation, where
applicable. Additional factors that may affect water absorption and
retention are scalding temperature and the pressure or amount of
buffeting applied to birds by feather removal machinery, and the
resultant loosening of the skin. Another factor that should be
considered is the method used to open the bird for evisceration.
(6) Standards to be met by the chilling system. For example, the
chilling system may be designed simply to achieve a reduction in
temperature of ready-to-cook poultry to less than 40 deg.F within the
time limit specified by the regulations, or in less time. As to the
standard for pathogen minimization, the Salmonella pathogen reduction
standards, as set forth in the PR/HACCP final rule, have been
suggested. Although there is not yet an applicable Salmonella standard
for turkeys, establishments are free to adopt practicable criteria for
use in gathering data on turkeys under the protocols here suggested.
Additional microbiological targets, such as E. coli or Campylobacter
levels, or reductions in numbers of other microorganisms, may also be
used.
(7) Testing methods to be employed. The protocol should detail the
testing methods to be used both for measuring water absorption and
retention and for sampling and testing product for pathogen reductions.
The protocol should call for water retention and pathogen reduction
tests at various chilling equipment settings and chilling time-and-
temperature combinations. The method to be used in calculating water
absorption and retention should be reproducible and statistically
verifiable. With respect to the pathogen-reduction aspect of the
testing, FSIS recommends the methods used for E. coli and Salmonella
testing under the PR/HACCP regulations. The number of samples, the type
of samples, the sampling time period, and the type of testing or
measurement should be included in the protocol.
(8) Reporting of data and evaluation of results. The protocol
should explain how data obtained are to be reported and summarized. The
criteria for evaluating the results and the basis for conclusions to be
drawn should be explained.
(9) Conclusions. The protocol should provide for a statement of
what the data obtained demonstrate and what conclusions were reached.
Done at Washington, DC: January 3, 2001.
Thomas J. Billy,
Administrator.
Note: Appendix A will not be codified in Title 9 of the Code of
Federal Regulations.
Appendix A--Method for Determining Moisture in Meat and Meat Products
and Poultry Products
A. Introduction
Theory: In this determination, a weighed sample is heated,
cooled, and then re-weighed. The loss in weight is calculated as
moisture content.
B. Equipment
Apparatus:
a. Covered aluminum dish. At least 50 mm. diameter and not
greater than 40 mm. deep, containing a paddle.
b. Mechanical convection oven, preferably one equipped with a
booster heater.
c. Food chopper with plate openings \1/8\" (3 mm.),
or Robot Coupe or equivalent food processor.
C. [Reserved.]
D. [Reserved.]
E. Sample Preparation Procedure for Fresh Meat or Poultry
For accurate and reliable measurement, the raw meat or poultry
sample should be finely ground to a homogeneous consistency.
F. Analytical Procedure
a. Accurately weigh sample (representing approximately 2 g. of
dry material) into an aluminum dish.
i. Weigh the sample as rapidly as possible to minimize loss of
moisture.
ii. The weight of the pan should include the paddle, which is
used in spreading the sample across the bottom of the pan, thereby
presenting a greater sample surface area, which is beneficial to
moisture removal.
iii. If the sample is relatively dry when received, a small
quantity of distilled water may be added to the pan only after the
sample weight is obtained. This quantity of water will be helpful in
spreading the sample across the bottom of the pan, and will
introduce no error since it will be evaporated when the sample is
oven-dried.
b. Dry, with cover removed, for 16-18 hours at 100-102 deg.C,
or for 4 hours at 125 deg.C in mechanical convection oven.
Do not overload the drying oven or sample may be insufficiently
dried and give low results. Drying time will start when the original
temperature has been reached. Use the oven's booster heater, if the
oven is so equipped, to minimize this recovery time.
G. Calculations
1. Procedure
[GRAPHIC] [TIFF OMITTED] TR09JA01.000
A = sample weight
B = weight of dish + sample before drying
C = weight of dish + sample after drying
Note: If laboratory is not air-conditioned, and humidity is
high, dishes should be desiccated before the initial and final
weighings.
Reference: Official Methods of Analysis of the Association of
Official Analytical Chemists, 16th Edition, 950.46.
[FR Doc. 01-460 Filed 1-4-01; 10:35 am]
BILLING CODE 3410-DM-P