[Federal Register: January 10, 2002 (Volume 67, Number 7)]
[Rules and Regulations]
[Page 1277-1281]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ja02-2]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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