[Federal Register Volume 67, Number 7 (Thursday, January 10, 2002)]
[Rules and Regulations]
[Pages 1277-1281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-738]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 381 and 441

[Docket No. 01-046N]
RIN 0583-AC87


Retained Water in Raw Meat and Poultry Products: Suspension of 
Regulation

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final Rule; Suspension of regulation.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is suspending 
until January 9, 2003, regulations that limit water retained by raw 
meat and poultry products from post-evisceration processing to the 
amount that is unavoidable in meeting applicable food safety 
requirements and that require labeling for the amount of water 
retained. The original effective date of these final regulations was 
January 9, 2002. FSIS is taking this action in response to a petition 
from four trade associations representing the meat and poultry 
industries. The petitioners requested the effective date be extended 
until August, 2004. However, FSIS has decided that a one-year 
suspension of the regulation will allow the meat and poultry industry 
sufficient time to complete necessary experimentation, including 
microbial testing and chilling system trials under FSIS-accepted data 
collection protocols; to fine-tune and stabilize newly adjusted 
processes; and to conduct regular measurements of retained water at 
packaging. Suspension of the regulation also will provide members of 
the meat and poultry industry sufficient time to order new supplies of 
labels with statements reflecting the amount of retained water in their 
raw products.
    The final rule promulgating the retained water regulations also 
made numerous technical amendments in the sections of the poultry 
products inspection regulations that concern poultry chilling 
practices. The effective date of these amendments will remain January 
9, 2002.

DATES: The effective date of the amendments of 9 CFR 381.65 and 381.66 
published January 9, 2001 (66 FR 1750), as corrected by the Federal 
Register notice published April 17, 2001, at 66 FR 19713-19714, is and 
remains January 9, 2002. 9 CFR part 441 is suspended from January 9, 
2002, until January 9, 2003.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel L. Engeljohn, Director, 
Regulations and Directives Development Staff, OPPDE, FSIS, U.S. 
Department of Agriculture, Washington, DC 20250-3700; (202) 720-3219.

SUPPLEMENTARY INFORMATION:

Background

    On January 9, 2001, FSIS published a final rule in the Federal 
Register (66 FR 1750) that, among other things, promulgated regulations 
limiting the amount of water that could be retained by raw, single-
ingredient, meat and poultry products as a result of post-evisceration 
processing, such as carcass washing and chilling. Under these 
regulations (codified at 9 CFR 441.10), 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 
under a written protocol, that any water retained in the carcasses and 
parts is an inevitable consequence of the

[[Page 1278]]

process used to meet applicable food safety requirements. The labels of 
products covered by the rule must bear statements indicating the 
maximum percentage of retained water in the products. On June 29, 2001, 
FSIS issued instructions to its personnel (FSIS Notice 22-01) on 
procedures, including those for review of data collection protocols, 
that are to be followed during the period before the new water 
retention regulations become effective.
    In the Federal Register of October 17, 2001 (66 FR 52715), FSIS 
published a notice on a petition by the National Chicken Council, the 
National Turkey Federation, the National Food Processors Association, 
and the American Meat Institute requesting that FSIS postpone until 
August 1, 2004, the effective date of the water retention regulations.
    The petitioners assert that postponement of the effective date is 
necessary because affected companies will not be able to comply with 
the regulations until they have completed several steps for which the 
Agency did not allow sufficient time. The petitioners maintain that 
some companies will not be able to begin data collection under FSIS-
accepted data collection protocols until late 2001; that testing to 
determine the relationship between Salmonella and water retention 
levels and seasonal variation in the moisture content of poultry will 
not be completed until early 2003; and that, after such testing, 
changes in labels and the labeling of many products affected by the 
final rule cannot be completed until mid-2004.

Comments on the Industry Petition

    In the October 17, 2001, Federal Register notice, FSIS posed five 
questions:
    1. Did the Agency allow the regulated industry sufficient time--one 
year from publication of the final rule--to prepare for implementation? 
Explain why the time for implementation was adequate or inadequate.
    2. Is available laboratory capacity sufficient or insufficient to 
enable the industry to comply with the new regulations by the effective 
date?
    3. Is there additional information on the time necessary to produce 
new labels for retained-water products that the Agency should consider?
    4. Would postponement of the effective date be fair or unfair to 
anyone and, if so, how?
    5. Would postponement of the effective date of the new retained 
water regulations (9 CFR 441.10) affect consumers and, if so, how?
    In posing these questions, FSIS was seeking additional information 
not already available to help the Agency decide the matter addressed by 
the petition.
    Most of the commenters responded to some or all of the five 
questions that FSIS posed in the notice. The Agency received 41 
comments in response to the Federal Register notice on the petition. 
Thirty-seven comments were from poultry processing establishment 
managers or other poultry company officials. All favored postponing the 
effective date of the retained water regulations. A meat and poultry 
industry association also filed a comment supporting postponement. Two 
cattle producer associations and an FSIS employee opposed postponement.

Comments Supporting the Petition

    Commenters that supported postponement of the effective date of the 
final rule stated that the time allowed the industry to prepare for 
implementation--one year--was insufficient. They noted that adequate 
guidelines for developing a moisture data collection protocol were not 
available from FSIS until summer 2001 and waiting for the FSIS to 
review protocols voluntarily submitted to the Agency consumed 
additional time. After completion of experimentation under the 
protocol, the commenters claimed, additional time would be necessary to 
develop a process control program and make the necessary adjustments to 
ensure its effectiveness.
    Comments asserted that companies would have to have 2-to-12 months 
to exhaust their supplies of labeled packaging materials already in 
stock. Also, once reliable data on the amount of retained water in raw 
products had been developed, 2 to 3 months would be necessary for label 
suppliers to prepare new plates and labels for the products. Commenters 
noted that the development of new pre-labeled packaging for poultry 
products is a two-stage process involving, first, the development of 
new plates and second, the printing of new labels. They stated that 
there is insufficient label-making capacity in the industry to meet the 
demands for new labels of all companies trying to comply with the new 
regulations by the existing effective date.
    Several managers of one firm argued that the short, one-year 
implementation time provided by the final rule would effectively force 
companies to label parts with ``up to X% retained moisture'' with X = 
the whole-bird retention amount. The reason for this is that the amount 
of retained moisture in whole birds is easier to determine than that 
for parts. But that amount is also likely to be significantly higher 
than the retention amount for parts.
    The commenters that favored postponement of the effective date of 
the final rule argued that laboratory capacity available to 
establishments was insufficient for them to be able to meet the 
effective date. Most commenting on this issue said that their 
establishments do not have on-premises capability to do Salmonella 
testing and that they had no drying oven to use in the oven-drying test 
for total moisture. They also stated that they needed to collect 
additional samples to determine whether they would be meeting generic 
E. coli process control criteria under the new rule.
    Those supporting the petition tended to argue that postponement 
would be fair to both consumers and the industry. Not postponing could 
result in a virtual shutdown of the industry because product would 
suddenly be misbranded and could not be sold legally. As a result, with 
the amount of animal protein product available to consumers decreasing, 
such product would only be available to them at higher prices. Also, a 
shutdown in the industry would affect farmers, feed suppliers, 
truckers, warehouses, and many others. Unemployment would increase. 
Reduced tax revenues would adversely affect the Government.
    Those supporting the petition argued that postponement of the 
effective date would be fair to consumers. Consumers would continue to 
have protein product choices in the marketplace. The effect of the 
postponement on their budgets would be minimal. They would still be 
able to make informed purchasing decisions based on past industry 
performance. And they would experience no change in the acceptability 
and safety of the products.
    Some poultry company officials argued that postponement would allow 
time for industry and Government to develop ``best practices,'' with 
the goal of providing more accurate information to consumers.
    Some poultry company officials argued that non-poultry entity 
arguments, especially regarding the alleged unfairness to red meat of 
allowing retained water in poultry products, are political and not 
supportable without testing.
    The association representing both meat and poultry companies 
suggested that precautions taken since the recent anthrax attacks 
through the mail may have resulted in delayed delivery of some draft 
protocols to FSIS, and thus their review.

[[Page 1279]]

Commenters Opposing Postponement

    Those opposing postponement of the effective date of the final rule 
argued that the issue of allowing retained water in poultry products 
has been before FSIS for more than seven years. To delay implementation 
of the new regulations would be to perpetuate an inequity.
    Moreover, these comments pointed out, the industry has known since 
at least September 1998 that changes in the regulations were imminent. 
These comments stated that some companies have prepared for the January 
9, 2001, changes and will be ready, while other companies have 
deliberately avoided preparing in hopes that the effective date would 
be postponed and current practices continued.
    These commenters said that the time frame for implementing the 
final rule was adequate and that the poultry products industry is only 
dragging its feet. The trade association representing cattle producers 
agreed with these commenters and added that since the poultry industry 
and FSIS had in July 2001 finally reached agreement on a protocol 
framework for determining retained water in products, the effective 
date for the entire poultry industry should be no later than July 2002.
    Another opponent of the petition stated that available testing 
facilities are adequate. Many establishments are capable of performing 
necessary tests.
    One opponent of the petition stated that simple labeling changes 
are often made at the establishment and can be effected in a few 
minutes. Elaborate labeling changes can be accomplished in just a few 
days.
    Several opponents of the petition said that postponement of the 
effective date of the final rule would be unfair both to consumers and 
to the red meat industry. The poultry industry would benefit by 
continuing to be able to sell water to consumers at poultry prices.
    One opponent of the petition stated that postponement of the 
effective date would certainly affect consumers. Since July 1997, there 
has been no regulatory limit on water retention in most raw poultry 
products; therefore, the consumer does not know how much water the 
product may retain from processing because the amount is not on the 
label. This commenter calculated that a postponement of 660 days would 
allow an average large poultry establishment to gain $30.2 million by 
in effect selling excess water without being held accountable for doing 
so.
    One of the cattle producer associations stated that FSIS should 
acknowledge that the poultry industry has made dramatic progress in 
reducing Salmonella prevalence in the wake of the PR/HACCP rulemaking. 
Therefore FSIS should not force the poultry industry to perform a 
complicated analysis of the relationship between water retention levels 
and Salmonella prevalence at this time. Rather, the Agency should focus 
on requiring the poultry industry to minimize the amount of retained 
water in meeting the time/temperature chilling requirements for poultry 
and HACCP requirements.
    This association said that, given the fact that the poultry 
industry and FSIS did not agree on a data-collection protocol framework 
until July 2001, labeling should be in place by January 2002 for those 
companies that are capable of meeting that deadline and by July 2002 
for the whole industry.

FSIS' Response to the Petition and Comments

    Having considered the petition and the comments received, the 
Agency differs somewhat with the industry on several matters addressed 
in the petition. Among these are: the effect of FSIS review of data 
collection protocols on poultry industry chilling system tests and data 
collection; the burden that testing associated with implementation of 
the new regulations will impose on industry laboratory capacity; the 
need for additional data collection to account for seasonal variation 
in naturally occurring moisture in poultry; and, moisture levels having 
been determined, the need for up to 14 additional months for labels to 
be prepared for all affected products.

Review of Protocols

    Although FSIS has established a procedure for Agency review of 
protocols submitted by industry, the new retained water regulations 
merely require an establishment subject to the regulations to notify 
the Agency and make the protocol available for review and gives the 
Agency 30 days to object to or require the establishment to make 
changes in the protocol. The regulations do not literally preclude the 
establishment from undertaking data collection under a sound protocol 
as soon as the protocol is developed. An establishment's decision to 
wait until it receives a ``no objection'' letter from the Agency is not 
mandated.
    On the point that the industry has had only since July 2001 to 
begin data collection under acceptable protocols, it is the case that 
questions about a ``model'' protocol were resolved by that time. 
However, the Agency's expectations respecting the necessary elements of 
such a protocol were known well before then. The Agency has encouraged 
the industry to undertake data collection since at least December 9, 
1997, when FSIS published a Federal Register notice (62 FR 64767) 
detailing the elements of a data collection protocol for water 
retention in raw meat and poultry products.
    In its petition, the industry asserts that because of the time 
needed for FSIS review of protocols, not all establishments will be 
able to begin data collection on retained water until December 2001. At 
present, FSIS has reviewed well over 200 protocols (238 by December 6, 
2001) that were submitted for the most part by poultry slaughtering 
establishments. As the review of submitted protocols has proceeded, the 
review time per protocol has decreased and the review procedures have 
been perfected to the point that the Agency's Office of Policy, Program 
Development, and Evaluation will soon be able to turn over protocol 
review responsibilities to the Office of Field Operations.
    FSIS understands that most establishments whose protocols have been 
reviewed are now well into the process of collecting retained water 
data and will soon have reliable information to support new product 
labels. This fact indicates to us that a typical poultry establishment 
may not need more than a few weeks to carry out trials of its chilling 
system using different sets of variables and obtain data that is 
sufficient to support retained water labeling.

Laboratory Capacity

    Since the protocol review process is resulting in a phased 
beginning of data collection in the industry, the laboratories employed 
by the establishments can be expected to adjust to the gradually rising 
load on their analytical resources. Nor do the retained water 
regulations entail laboratory testing on a grandiose scale. 
Consequently, the scenario of an over burdened industry laboratory 
capacity as envisioned by the industry petition should not develop.
    In their comments on the petition, many establishments expressed an 
interest in the oven drying method discussed in the final rule. These 
establishments noted that few of their laboratories were equipped with 
the apparatus necessary to apply the method. The need to send samples 
to an outside laboratory to obtain definitive total and retained water 
measurements would result in delaying results. Further, with many 
establishments requiring the same tests, the laboratory capacity 
available to the industry for

[[Page 1280]]

these tests would quickly become overburdened.
    FSIS observes that, although the Agency does not discourage them 
from doing so, FSIS is not requiring establishments to perform 
microbiological testing on the scale contemplated by the industry in 
its petition. Nor does FSIS specifically require the use of the oven-
drying method to determine the moisture content of raw products. FSIS 
merely has presented the method as the one that the Agency plans to use 
in its in-distribution sampling of products subject to the new 
regulations. Establishments may use other procedures to which they may 
be more accustomed to determine retained water in their products. For 
example, they may weigh product before and after chilling or other 
processing to determine whether the product weight has increased, and 
use this difference as a basis for calculating water retention. But 
they are not restricted to using any one method.
    Seasonal variation: Regarding the effect of seasonal variation in 
the naturally occurring moisture in poultry on the total amount of 
water in raw products, FSIS disagrees with the industry's contention. 
The industry states in its petition, and supplies a chart to 
illustrate, that in some months naturally occurring moisture levels in 
poultry are higher than the annual mean, while in other months the 
levels are below the mean. Therefore, according to the petition, it 
will be necessary for any given establishment to have a full year's 
worth of data to be able to know precisely, on an on-going basis, what 
the total amount of water, and hence the retained water level in its 
product, will be.
    In FSIS Notice 22-01 discussed above, FSIS states that the Agency 
will enforce the labeling provisions of the regulations in a manner 
similar to its enforcement of the nutrition labeling regulations. That 
is, FSIS plans to allow the labeled amount of retained water to vary by 
as much as 20 percent of the actual amount of retained water in the 
product. Such a variation is typically allowed to account for such 
factors as seasonal fluctuations in the occurrence of specific 
nutrients in raw food ingredients. The industry has indicated in its 
petition that the seasonal variation in poultry carcass yield, which is 
partly affected by changes in the amount of naturally occurring 
moisture in poultry, is typically just a small percent of yield weight. 
Since retained water is computed as a percent of the product weight, a 
small percentage point change in the natural product weight should not 
lead to discrepancies between actual and labeled retained water amounts 
that would ordinarily exceed the 20 percent allowable variation. Thus, 
it is unlikely that the variability in raw product moisture content 
would be so great as to cause FSIS to take an enforcement action 
against the establishment. That being the case, while more precise data 
are desirable, the need to collect additional data on seasonal 
variation in naturally occurring water should not influence a decision 
on the effective date of the retained water regulations.

Label Changes

    The industry says in its petition that not until early 2003 will 
all establishments know the amount of retained moisture in their 
products. Also, according to the petition, the label printing capacity 
available to the industry is limited by the fact that only a few 
hundred label changes a month can be made, while about 6,500 poultry 
labels will have to be changed. Therefore, argues the industry, not 
until summer 2004 can new labels be printed for all establishments.
    FSIS believes that most establishments will know the minimized 
levels of retained water in their products well before 2003, and 
indeed, some establishments already are in a position to change their 
labels. FSIS does not think the industry will have to study seasonal 
variation in naturally occurring moisture in poultry for a full year 
before it will be in a position to include retained water statements on 
product labels. Further, as one commenter on the petition noted, 
labeling changes are often made at the establishment. Simple labeling 
changes can be made in a few minutes; elaborate labeling changes can be 
accomplished in a few days. Of course, where printing plates for labels 
must be retooled, the change may take longer. Extending the effective 
date for one year should allow all establishments ample time to have 
the necessary changes made in their labels.
    FSIS therefore thinks that most necessary product label changes can 
be made in the course of a year. Thus, FSIS does not think it necessary 
to postpone the effective date of the regulation for an extended period 
to allow for the completion, first, of seasonal variation studies and 
then of label changes.

FSIS' Response to Comments Opposing the Petition

    FSIS agrees that postponement of the petition until August 2004 is 
not warranted. However, as discussed in the following section of this 
notice, FSIS believes that a one-year postponement is necessary and 
appropriate. In response to the comments concerning inequity between 
the meat and poultry industry and benefits to consumers resulting from 
the water retention regulations, FSIS does not believe that these 
comments are relevant to the date of enforcement of the regulations. 
With regard to the comments on labeling changes, FSIS agrees that an 
extension until August 2004 is not necessary. However, as discussed 
above, FSIS recognizes that if printing plates for labels must be 
retooled, the change may take longer than the opposing comments 
suggested. Finally, in response to the comment that FSIS should not 
force the poultry industry to perform a complicated analysis of the 
relationship between water retention levels and Salmonella prevalence 
at this time and that the Agency should focus instead on requiring the 
poultry industry to minimize the amount of retained water in meeting 
the time/temperature chilling requirements for poultry and HACCP 
requirements, FSIS believes the type of hazard most likely to be 
identified as susceptible of being controlled by the post-evisceration 
processes envisioned by the retained water regulations is a biological 
hazard. Similar arguments for postponement of the effective date of the 
regulations could be made on the basis of the need for microbial tests 
to verify HACCP controls as for microbial tests to verify that 
Salmonella performance targets are being met. Also, it should be noted 
that the Agency is developing a proposed rule to eliminate the time/
temperature chilling requirements for poultry.

FSIS's Reasons for Granting a One-Year Suspension

    FSIS is granting a one-year suspension of the water retention 
regulations in 9 CFR 441 because the Agency recognizes that some 
establishments in the poultry industry are not yet in a position to 
operate in compliance with the new regulations. Also, some small meat 
slaughtering and processing operations have yet to determine whether or 
not they are subject to the regulations and need some guidance 
respecting the kind of information they need to have to demonstrate 
that their raw products do not retain water. With additional time, if 
these establishments find that they are subject to the regulations, 
they will be able to take steps to ensure that they are in compliance 
with it.
    A one-year suspension will allow the industry sufficient time to 
complete necessary experimentation, including microbial testing and 
chilling system trials, under FSIS-accepted data

[[Page 1281]]

collection protocols; to fine-tune and stabilize newly adjusted 
processes; and to conduct regular measurements of retained water at 
packaging. Members of this industry would have sufficient time to order 
new supplies of labels with statements reflecting the amount of 
retained water in raw products.
    FSIS did not agree that an extension of the effective date until 
August 1, 2004, would be necessary for the reasons explained above in 
FSIS' response to the petition and comments. First, FSIS does not 
believe that industry laboratory capacity would become overburdened as 
a result of this rule. Second, FSIS does not believe that 
establishments would need to have a full year's worth of data on 
seasonal variation in naturally occurring water to be able to comply 
with the labeling requirements in the rule. Finally, FSIS believes that 
most necessary product label changes can be made in the course of a 
year.
    In summary, FSIS believes that a one-year suspension of the water 
retention provisions in 9 CFR part 441 is appropriate and necessary. 
However, FSIS does not believe a further suspension would be warranted 
and does not intend to suspend the regulation beyond January 9, 2003.

Technical Amendments

    The final rule promulgating the retained water regulations made 
numerous technical amendments in the sections of the poultry products 
inspection regulations that concern poultry chilling practices to 
improve consistency with the Pathogen Reduction/Hazard Analysis and 
Critical Control Points regulations, eliminate ``command- and control'' 
features, and reflect current technological capabilities and good 
manufacturing practices. FSIS also revised the definition of ``ready-
to-cook'' poultry to account for the elimination of the requirement to 
remove kidneys from mature birds and removed several redundant 
provisions from the poultry products inspection regulations. These 
technical amendments were not controversial, and the effective date of 
these amendments will remain January 9, 2002.

Additional Public Notification

    Public awareness of all segments 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 
notice, FSIS will announce the meeting and provide copies of this 
Federal Register publication in the FSIS Constituent Update. FSIS 
provides a weekly FSIS Constituent Update, which 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, our constituents/stakeholders. The 
constituent fax list consists of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals that 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, fax your 
request to the Congressional and Public Affairs Office, at (202) 720-
5704.
    For the reasons set out in the preamble, 9 CFR Part 441, added at 
66 FR 1771, January 9, 2001, is suspended from January 9, 2002, until 
January 9, 2003.

    Done at Washington, DC, on January 8, 2002.
Margaret O'K. Glavin,
Acting Administrator.
[FR Doc. 02-738 Filed 1-8-02; 3:58 pm]
BILLING CODE 3410-DM-P