[Federal Register Volume 66, Number 201 (Wednesday, October 17, 2001)]
[Proposed Rules]
[Pages 52715-52721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26168]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 66, No. 201 / Wednesday, October 17, 2001 / 
Proposed Rules  

[[Page 52715]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 381 and 441

[Docket No. 01-030N]
RIN 0583-AC87


Announcement of and Request for Comment on Industry Petition to 
Postpone the Effective Date of Regulations Limiting and Requiring 
Labeling for Retained Water in Raw Meat and Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Opportunity to comment.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is requesting 
comment on a petition that asks FSIS to postpone until August 1, 2004, 
the effective date of new 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, such as the pathogen reduction requirements for 
Salmonella, and require labeling for the amount of water retained. The 
regulations were published in the final rule ``Retained Water in Raw 
Meat and Poultry Products; Poultry Chilling Requirements,'' in the 
Federal Register on January 9, 2001.
    The petitioners, four trade associations representing the meat and 
poultry industries, assert that the postponement 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: Because of the 
time necessary to obtain Agency review of industry data collection 
protocols for determining minimum retained water in products, some 
companies will not be able to begin data collection under the protocols 
until late in 2001; because of insufficient laboratory capacity in the 
industry and because of the need to determine seasonal variation in 
moisture content of poultry and the relation between water retention 
controls and Salmonella levels on raw product, data collection on water 
absorbed during chilling processes, and then on water retention in 
individual raw products at packaging, cannot be completed until early 
2003; and once retained water levels have been determined, changes to 
plates for printing labels and the labeling of the many products 
affected by the final rule cannot be completed until mid-2004. The 
petitioners elaborate on these points in their petition and supporting 
documentation. Finally, they argue that if no extension were granted, 
the economic consequences would be severe. Much of the industry would 
have to shut down because of the inability to ship product that is not 
misbranded.

DATES: Comments must be received on or before November 16, 2001.

ADDRESSES: Submit one original and one copy of written comments to 
Docket Clerk, U.S. Department of Agriculture, Food Safety and 
Inspection Service, 300 12th Street, SW., Room 102 Cotton Annex, 
Washington, DC 20250. Please refer to docket number 01-030N in your 
comments. All comments submitted in response to this proposal, as well 
as research and background information used by FSIS in developing this 
document, will be available for public inspection in the FSIS Docket 
Room between 8:30 a.m. and 1 p.m., and 2 p.m. and 4:30 p.m., Monday 
through Friday.

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

    For many years, meat and poultry slaughtering establishments have 
conducted carcass-chilling operations differently. In livestock 
slaughtering establishments, carcasses undergo a final wash after 
slaughter and dressing to remove remaining consumer protection defects 
before being air-chilled in large coolers. In the coolers, a water mist 
is typically applied to the carcasses to minimize shrinkage and promote 
rapid heat loss. Water mist systems must be operated in a manner that 
does not result in meat carcasses weighing more than their pre-chilled 
weight.
    Most poultry processors chill poultry using the water immersion 
chilling method, which is faster and more cost efficient than air 
chilling, but results in absorption and retention of water both in the 
skin and in the tissue under the skin. Because immersion chilling is 
considered an efficient way to lower the internal temperature of 
poultry, FSIS has permitted the retention of some water in poultry. But 
because a product containing excessive water may be considered 
adulterated, FSIS has consistently required that the retention of water 
in meat and poultry be minimized and has enforced regulations limiting 
the retained water percentage in the carcasses.
    In 1994, a group of poultry consumers and red meat producers sued 
the USDA in U.S. District Court (Kenney, et al. v. Glickman), alleging 
that poultry products containing absorbed water were both economically 
adulterated and misbranded within the meaning of the Poultry Products 
Inspection Act (PPIA). They also disputed the differences in 
regulations concerning water retention by meat and poultry.
    In July 1997, the Court found that the presence of absorbed water 
in poultry did not mean that the product was necessarily economically 
adulterated or misbranded under the PPIA. However, the Court set aside 
the regulations specifying water absorption and retention limits for 
whole poultry. The court noted that the record of the rulemaking in 
which those levels were established did not explain how the particular 
water retention levels were determined, why water retention in poultry 
cannot be reduced below current levels, or why meat and poultry levels 
should be treated differently.
    In September 1998, responding to the Court's ruling and rulemaking 
petitions filed with the Agency by several livestock industry 
associations, FSIS issued a proposed rule that would restrict the 
amount of water that could be retained by raw meat and poultry 
carcasses and parts. Specifically, the Agency proposed revising the 
moisture absorption and retention regulations by limiting the amount of 
water retained by

[[Page 52716]]

raw meat and poultry carcasses and parts as a result of post-
evisceration processing to the amount unavoidable in achieving a food 
safety objective.
    FSIS also proposed revisions to the poultry chilling regulations to 
improve consistency with the Agency's 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. Some of the regulatory 
provisions that were to be eliminated or replaced with performance 
standards were those specifying the manner in which opening cuts are to 
be made in poultry before evisceration, chilling equipment features, 
fresh water replenishment rates for continuous chillers, the type of 
giblet wrap to be used, and the method for thawing frozen poultry to be 
used in further processed products.
    On January 9, 2001, FSIS published a final rule in the Federal 
Register (66 FR 1750) promulgating regulations that limit 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 the regulations (codified at 9 CFR 
441.10), which become effective January 9, 2002, 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 process used to 
meet applicable food safety requirements. The protocol and data 
collected under it must be available for review by FSIS. The labels of 
products covered by the rule must bear statements on their labels 
indicating the maximum percentage of retained water in the products. 
The final rule also revises the poultry chilling regulations (in 9 CFR 
381.65, 381.66) as proposed, with technical adjustments made in 
response to comments. 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.
    Since publication of the final rule, FSIS has met on several 
occasions with representatives of the regulated industry, has responded 
to requests for clarifications and further information, and has 
exchanged correspondence with the industry on various matters relating 
to the final rule. During this time, some industry representatives have 
consistently expressed doubts about the ability of companies to comply 
with the provisions for retained water minimization by the effective 
date.
    In a July 16, 2001, letter to the Secretary of Agriculture, the 
National Cattlemen's Beef Association (NCBA) stated that NCBA had been 
informed by representatives of the poultry industry that they were 
considering seeking an extension of the implementation deadline. Citing 
the chronicle of litigation, industry petitions, and regulatory 
proposals on retained water from 1994 till the present, NCBA 
characterized the process leading to the final rule as ``painfully 
slow.'' NCBA maintained that the beef industry had worked hard to bring 
fairness to the issue and was ready for the meat and poultry industry 
to comply with the new regulations, and that the association could not 
support an extension.

Petition

    FSIS received a petition dated August 17, 2001, signed by the 
following organizations: The American Meat Institute, National Chicken 
Council, National Food Processors Association, and the National Turkey 
Federation. The petition requests that FSIS postpone until August 1, 
2004, the effective date of the new regulations that limit and require 
labeling for the amount of water retained by raw meat and poultry 
products from post-evisceration processing (9 CFR 441.10).
    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 complete several steps for which the Agency 
allowed insufficient time. First, the petitioners state that the time 
necessary to obtain Agency review of industry data collection protocols 
for determining minimum retained water in products will mean that some 
companies will not be able to begin data collection under the protocols 
until late in 2001. Second, they state that, because of insufficient 
laboratory capacity in the industry, data collection on water absorbed 
during chilling processes and then on water retention in individual 
products at the time of packaging, cannot be completed until early in 
2003. In this connection, they note that a one-year data collection 
period will be necessary to determine seasonal variation in the 
moisture content of poultry and the relation between water retention 
controls and Salmonella prevalence on raw products. Finally, they state 
that changes to plates for printing labels and the labeling of the many 
products affected by the final rule cannot be completed until mid-2004.
    The petitioners elaborate on these points in their petition and 
supporting documentation. They present an ``optimistic timeline'' that 
begins with the submission of industry protocols for FSIS review by 
September 15, 2001, and ends with the printing of all new retained-
water labels by August 1, 2004, cautioning that the timeline assumes no 
significant problems at any stage that would introduce delays. ``Given 
the realities associated with this optimistic timeline,'' they say, 
``it is critical that the agency adjust the effective date to allow for 
a realistic implementation of the new labeling requirement.'' They say 
it is possible that some establishments or labels will not be in 
compliance with an August 1, 2004, implementation date, and that the 
Agency should invoke the regulatory provisions for temporary label 
approvals (9 CFR 381.132(f)) in that eventuality.
    The petitioners conclude their petition by forecasting an extremely 
severe economic impact if an extension is not granted because of the 
inability of the poultry industry to avoid shipping product that is 
misbranded under the PPIA. Misbranded product cannot bear the mark of 
inspection and thus cannot be shipped (21 U.S.C. 457(d), 458(a)(2)). An 
establishment that cannot ship product is closed, for practical 
purposes. ``In fact,'' the petitioners emphasize, ``if no extension is 
granted, industry would simply have to cease production, throwing 
thousands of people out of work and resulting in the bankruptcy of 
virtually all companies.''
    The petitioners do not address the technical revisions of the 
poultry chilling regulations. FSIS therefore assumes that they do not 
object to the January 9, 2002, effective date for those revised 
regulations.

Questions

    FSIS is seeking public comment on the industry petition. To help in 
deciding this matter, FSIS would appreciate any additional information 
not already made available to the Agency. In particular, responses to 
the following questions relating to the petition would be appreciated:
    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

[[Page 52717]]

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?

Text of the Petition

    Citizen's Petition to Extend the Effective Date of 9 CFR 441.10.
    The undersigned associations, on behalf of their members, 
respectfully submit this Citizen's Petition to extend the effective 
date of the Food Safety and Inspection Service's (FSIS or the agency) 
final regulation entitled ``Retained Water in Raw Meat and Poultry 
Products: Poultry Chilling Requirements,'' 66 FR 1479 (January 9, 2001) 
(to be codified at 9 CFR 441.10).
    This regulation is scheduled to become effective on January 9, 
2002. Simply put, it is impossible for our members to comply with the 
regulation by that date. This petition sets before the agency the 
obstacles preventing January 2002 compliance, obstacles which are out 
of our members' control. Even with the smoothest of implementations, 
the earliest date for compliance is August 1, 2004.

A. Action Requested

    We respectfully request that the effective date of the moisture 
regulation be extended until August 1, 2004.

B. Statement of Grounds

    To achieve compliance with the regulation, establishments need to 
complete four separate tasks--tasks that must be done consecutively, 
not concurrently:
    1. The establishment has to determine the amount of absorbed 
moisture that is an unavoidable consequence of meeting a food safety 
requirement. To determine this level, the regulation requires that the 
establishment develop a protocol. Until FSIS accepts a protocol, an 
establishment cannot begin to collect the data.
    2. After receiving a ``No Objection'' letter from the agency, an 
establishment would initiate the procedure to determine the unavoidable 
amount of absorbed moisture.
    3. Once the establishment has validated the amount of moisture that 
is unavoidable, there remains the matter of ascertaining the amount of 
moisture retained by product at time of packaging.
    4. Finally, the establishment must work with its suppliers to 
obtain new packages bearing the required declaration.
    Only after these four steps have been completed can there be 
compliance. Unfortunately, each step poses a variety of difficulties 
that simply cannot be overcome to meet the effective date set by FSIS, 
even if companies act in the most expeditious manner.
1. Protocol Approval
    Upon publication of the final rule, we immediately began a complete 
review of the new requirements and planned for the ambitious 
undertaking of converting labels to be in compliance with the new 
required label declaration. Following extensive industry technical 
meetings, it became apparent that there were significant questions not 
addressed by the final rule for which clarification is necessary before 
implementation can commence. We have, and will continue to work closely 
with the agency to ensure compliance with the final rule.
    The first task is to develop the protocol to ascertain the amount 
of moisture unavoidably absorbed by the product as a consequence of a 
process used to meet food safety standards. As promulgated, the 
regulation imposes the ``command and control'' requirement that such 
protocols must be submitted to FSIS. Only protocols receiving a ``No 
Objection'' letter could be used to ascertain the moisture absorption.
    In light of this requirement, we contacted FSIS as soon as the 
regulation was published to obtain guidance on what would be required 
in such protocols. A meeting, prompted by significant questions raised 
by industry as to practical compliance with the new rule, was held at 
the FSIS Technical Service Center in February. There were a host of 
issues surrounding the protocols, as well as general regulatory 
compliance with the rule. Many of these issues have been resolved, such 
as what food safety standard would be appropriate to use in determining 
unavoidability. However, several key issues remain unresolved, such as 
the use of thighs to determine compliance. We hope that, with further 
dialogue, industry and the agency will work to a cooperative and timely 
resolution of these issues, thereby paving the way for complete 
implementation.
    Having discussed the agency's expectations regarding the protocol 
in February, we agreed to submit generic protocols for agency review 
and comment in order to obtain guidance on what the agency wanted in 
the protocol. On May 21, 2001, four generic protocols were submitted to 
FSIS. (Attachment 1). Notwithstanding the good faith efforts to submit 
protocols in compliance with the regulatory requirements, FSIS 
responded on July 5, stating: ``None of the protocols fully addressed 
the data collection and information required by the regulations.'' 
Letter from Phillip S. Derfler, Deputy Administrator, FSIS. (Attachment 
2). In lieu of comments on the draft protocols, FSIS developed its own 
model protocol. Unfortunately, we have unresolved questions with the 
model. Believing it is more expedient to resolve any uncertainties 
before having our members submit protocols, we submitted a request for 
clarification on August 3, 2001. (Attachment 3). That request is still 
pending.
    Assuming the agency responds promptly to our request for 
clarification (e.g. September 1, 2001), our members can begin to draft 
the protocols. We estimate that such drafting will be relatively simple 
once the outstanding questions are resolved. Assuming two weeks for 
drafting and submission, FSIS will begin receiving protocols from the 
majority of the industry on or about September 15th.\1\
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    \1\ We understand that some companies have already submitted 
protocols that have been reviewed by the agency. However, the 
majority of broiler establishments and almost all turkey 
establishments have not yet done so.
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    Under the regulation, FSIS has 30 days to review and comment on a 
protocol. However, we respectfully submit that the agency lacks 
adequate resources to review the estimated number of protocols in a 
timely manner. The National Chicken Council estimates that its members 
will submit at least 265-300 protocols and the National Turkey 
Federation estimates approximately 80 protocols. This number does not 
include protocols from poultry slaughter establishments that may not be 
a member of either association. Likewise, it does not include any 
protocols submitted by red meat companies. We do not know how much 
staff time FSIS has allocated to the review, but we anticipate that 
completion of the review of approximately 400 protocols will take over 
thirty days.\2\
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    \2\ We note that it took FSIS six weeks to review four generic 
protocols and develop one of its own.
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    Although the regulation provides for passive ``approval'' of the 
protocols (i.e., if no objection is raised within the 30 days, the 
agency cannot subsequently raise an objection), we respectfully 
disagree that this will be how the matter will be implemented in the 
field. In this regard, we direct your attention to FSIS Notice 22-01; 
specifically, the Retained

[[Page 52718]]

Moisture Checklist for IICs.\3\ Item 2 on this checklist requires the 
IIC to identify the date of the FSIS No Objection Letter. If 30 days 
have passed and no letter has been received, we believe many, if not 
most, IICs will not permit the establishment to proceed in light of the 
instructions contained in the Notice. Moreover, we remain concerned 
that the agency may indeed suggest changes to a protocol after the 
thirty-day period has passed. Hence, some legal counsel have advised 
members not to initiate any protocol until a No Objection letter has 
actually been received.
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    \3\ This Notice, issued June 29. 2001, also codified the 
agency's position on many issues discussed at the February meeting 
in Omaha. (Attachment 4.).
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    We can only speculate as to the time it will take for FSIS to 
complete the review. Assuming that FSIS anticipated 300 protocols 
(because it estimated there are approximately 300 establishments 
covered by the rule, 66 Fed. Reg at 1,768, colt 3) and established a 30 
day review period, it seems that 400 protocols would take 40 days. 
Adding five days for mail delivery, the earliest time for all 
establishments to have received the No Objection letter is November 1, 
2001.
2. Collection and Analysis of Data
a. Laboratory Capacity
    Once the establishment receives its No Objection letter, the second 
task is to conduct the protocol. Although the establishment should be 
ready to commence the study within 30 days (e.g. December 1, 2001), the 
sheer volume of the sampling will cause bottleneck delays at the 
laboratories--delays beyond an establishment's control.
    Assuming all establishments follow the Model Protocol\4\ contained 
in the FSIS July 5 letter, the establishment is to select five groups 
of 10 carcasses to determine moisture absorption during the chilling 
process. In addition, under section 7.2 of the Model, the establishment 
is to randomly select five groups of 10 carcasses from the flocks 
selected for moisture absorption testing. This latter sample set is to 
be analyzed for Salmonella. The Salmonella sampling and analysis is to 
be done for each of the four variations in chiller factors; in other 
words, 200 samples are to be analyzed for Salmonella that week. 
Moreover, under the Model Protocol, there must be three replicates of 
the testing for different processing days. Thus, the draft proposal 
calls for 600 Salmonella samples to be analyzed per protocol. If 400 
protocols are ultimately submitted, this means 240,000 Salmonella tests 
are to be conducted by the industry. To put this number in context, in 
the first two years of HACCP implementation, FSIS only conducted 44,272 
Salmonella analyses \5\ or approximately 18% of the total FSIS expects 
the industry to conduct before the January 9, 2002, effective date.
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    \4\ The FSIS Model Protocol was an enclosure to the July 5th 
Derfler letter (our Attachment 2).
    \5\ http://www.fsis.usda.gov/ophs/haccp/salmcomp.htm.
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    Put bluntly, there is insufficient laboratory capacity to handle 
such a sampling and testing overload. We have spoken with several of 
the major private laboratories that can perform Salmonella analyses. 
According to Dr. Paul Gerhardt of the National Food Laboratories, his 
laboratory can handle 700 samples per week at the current time (or 
36,400 per year, about 15% of the total required). To be sure, existing 
laboratory capacity could be increased, but this would take six months 
lead-time and ``contractual assurance of testing.'' (Attachment 5.) Dr. 
Gerhardt's conclusion is supported by other private laboratories with 
which we have spoken.
    Dr. William Brown of ABC Research, one of the major laboratories 
analyzing meat and poultry products, estimated that his laboratory 
could handle approximately 150 additional samples per day or 39,000 in 
12 months. Dr. Brown also cautioned that such a massive testing program 
could result in a shortage of laboratory supplies, thereby increasing 
cost of these materials and the analyses themselves. (Attachment 6.)
    Mr. Kurt Westmoreland of Silliker Laboratories Group, one of the 
largest laboratories, commented that, even though Silliker has eleven 
laboratories, the volume of tests required ``would be very difficult to 
complete within the time frame.'' Moreover, this additional Salmonella 
testing would displace ``other much needed food safety based testing.'' 
Although Mr. Westmoreland did not anticipate higher costs for the 
supplies given his laboratory's buying power, he too was concerned as 
to the availability of testing supplies. (Attachment 7.)
    Beyond private laboratories, several of our members with their own 
laboratories have estimated the time it would take to analyze the 
additional Salmonella samples generated by the Model Protocol. 
According to Dr. Neal Apple, Vice President of Tyson Corporate 
Laboratory and Research Services, it would take his laboratory 
approximately 10.5 months to conduct the 42,000 Salmonella analyses his 
company anticipates would be required under the Model Protocol, 
``[b]arring any sample submission or testing problems.'' Even this 
would ``generate a considerable amount of overtime for our laboratory 
group and contribute to decreasing the technical flexibility that the 
laboratory currently has.'' Statement of Dr. Neal Apple. (Attachment 
8.) \6\
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    \6\ Interestingly, this company would be required to analyze 
approximately the same number of samples as FSIS analyzed in all of 
1998 and 1999.
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    Dr. Lee G. Johnson, Chief Microbiologist, ConAgra Refrigerated and 
Prepared Foods, anticipates it will take six months at the very least, 
with eight months being more realistic, to complete the analysis for 
its establishments. Statement of Dr. Lee G. Johnson. (Attachment 9.) 
Dr. Johnson also raises the issue of whether there will be enough 
testing reagents and supplies available to conduct the analyses. A 
shortage of these materials caused by excess demand would delay the 
analyses even further.
    Mr. Jason Tisch, Assistant Manager, Deibel Laboratories (Cargill) 
frankly admitted his laboratory would be forced to contract out the 
additional volume generated by the protocols and it would still likely 
take 10.5 months to complete the necessary analysis. In addition, the 
added tests ``will limit the amount of research and development 
currently being conducted'' by the laboratory. Statement of Jason 
Tisch. (Attachment 10.)
    Obviously, the above does not even address the significant testing 
costs.\7\
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    \7\ At approximately $30 per sample for Salmonella, the costs 
are $7.2 million, assuming the costs of the reagents/supplies do not 
increase, a potential problem noted by Dr. Brown (Attachment 6).
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    As the statements of the laboratory managers demonstrate, available 
laboratory resources, private or corporate, cannot handle in an 
expeditious fashion the workload generated by the Salmonella testing 
requirement. It is a matter of capacity. Moreover, available capacity 
cannot easily be expanded: Not all laboratories are structured to 
conduct pathogen testing; the laboratories may be in the plant (with 
exposure to other raw product and cross contamination); or, the 
employees may not be trained in handling such biological hazards. As 
Dr. Gerhardt pointed out (Attachment 5), not only will it take time to 
significantly expand capacity, but laboratories would expect 
``contractual assurances of future testing,'' assurances that may not 
be forthcoming given that the testing here would be a one time 
occurrence. Nor, as Mr. Westmoreland cautioned, is it advisable to 
shift existing resources from current pathogen testing currently

[[Page 52719]]

used to maintain and enhance food safety. Hence, the new requirement 
can only be fulfilled through excess capacity which will result in 
longer turnaround times.
    In short, barring any problems whatsoever we estimate it will take 
the majority of establishments approximately 12 months from the time a 
``No Objection'' letter is issued, to complete the required data 
collection to determine the amount of absorbed moisture unavoidably 
occurring as a consequence of the process used to meet a food safety 
requirement. This brings us to December 1, 2002, as the best case 
scenario.\8\
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    \8\ Please note, this does not factor in any additional time for 
data analysis. Nor does it account for the possibility that 
additional tests may need to be conducted.
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b. Seasonality
    Even though the above demonstrates the impossibility of conducting 
all the necessary analyses in less than one year, there is another 
factor which supports conducting the analysis over a year's time--
seasonal variation.
    i. Naturally occurring, variability in moisture. On the issue of 
moisture variation, as FSIS has recognized, there may be ``more than 
one level of naturally occurring water'' based on seasonal differences. 
Notice 22-01, section X (Attachment 4). Although an establishment may 
choose to have different declarations based on seasonal variation, it 
is essential that, in determining the appropriate moisture level to 
declare on the labels, the establishment know what the maximum amount 
will be, regardless of what time of year it occurs.
    To confirm the FSIS conclusion as to seasonal moisture variability, 
we have received some data from our members concerning moisture levels. 
Because we do not have data on moisture levels per se, our members have 
provided us with data comparing the live weight of the birds to the 
finished yield. As the attached data (Attachment 11) show, the yield 
was low during the summer months, even though bird weight remained 
constant. In the winter months the bird weight varied, but yield 
remained constant. A likely cause of this variability in yield during 
the summer (without a corresponding variation in weight) is that 
moisture content of the birds is low in the summer. When the 
temperature cools, the moisture content is no longer a variable and the 
establishment can control yield better, notwithstanding fluctuations in 
live weight.
    An extension of the effective date to permit a one year collection 
period would enable establishments to ensure that the moisture level 
declarations placed on labels will be valid no matter what seasonal 
variations there are in moisture.
    ii. Salmonella incidence variability. To better ensure compliance 
with the agency's performance standards, several of our members conduct 
their own Salmonella testing. Based on the data provided to us by 
establishments, it is clear that even at establishments with an overall 
low Salmonella incident rate, the incidence rate is not consistent 
throughout the year. For some establishments there is a higher incident 
rate in the summer months. Indeed, the data forms a rough bell curve 
when plotted by months. (Attachment 10). However, we have received data 
from other establishments that show Salmonella incidence rises in the 
fall/winter. (Attachment 13).
    The amount of unavoidable moisture is tied to achieving a food 
safety requirement; specifically, the Salmonella performance standard. 
If Salmonella incidence varies during the year, it is important to 
ensure that controls on the moisture levels do not restrict the 
establishment's ability to achieve compliance with this food safety 
standard.
    In sum, a data collection period of one year will assist us in 
better ascertaining the amount of moisture absorption that is an 
unavoidable consequence of the process used to meet a food safety 
standard. However, we wish to re-emphasize that a one-year data 
collection period is unavoidable in any event due to the restrictions 
imposed by laboratory capacity.
3. Determining Amount of Moisture Retained in Products
    Once the establishment has determined the amount of moisture 
absorption that is unavoidable, it will proceed to the third task--to 
determine how much moisture is retained at time of packaging. For all 
items, the amount retained will be less than the amount absorbed and, 
in many cases, significantly less.
    This calculation will be done by taking representative samples of 
whole birds and parts to determine the average naturally occurring 
moisture, such as with the oven drying method. The establishment must 
then conduct similar sampling and analysis on the product as it will be 
packaged. An establishment would not conduct this sampling until it has 
determined which chiller method results in the lowest absorption; 
otherwise, it would be required to conduct this sampling/analysis for 
each of the four variations, increasing costs and straining laboratory 
capacity.
    We conservatively estimated the number of moisture retention tests 
that must be conducted. In that regard, we multiplied the number of 
estimated protocols submitted (400) by the number of major raw 
products.\9\ We then multiplied the resulting number (3,600) by the 
number of samples in a set (we estimate that 10 samples would be the 
minimum amount to provide statistically significant results). This 
total of 36,000 was doubled (because an establishment must ascertain 
the naturally occurring moisture and the moisture content before 
packaging) and then multiplied by three repetitions (which we took from 
the FSIS model protocol for absorption). This results in a total of 
216,000 moisture samples. Although many of our members will conduct the 
analysis in house, we expect it will take at least two, if not three, 
months to conduct the sampling and analyze the data. This process 
brings us to February, 2003, at the very earliest.
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    \9\ Whole birds; halves; quarters; breast (with and without 
skin); wings; legs: drumsticks; and ground.
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4. Labeling Implementation
    According to the above time line, it will be February of 2003 
before all establishments will know the amount of retained moisture, as 
contemplated by the regulation. Only then can establishments begin 
their fourth and final task, to make label changes. There are two steps 
in implementing any label change: New plates have to be created and the 
actual labeled packages have to be printed/shipped.\10\ The majority of 
the labels are printed on the film package and not affixed by 
sticker.\11\ This is because the processing and storage of the 
products, such as frozen turkeys, makes it impossible for an adhesive 
to remain on the film. Based upon an informal survey of our members, we 
estimate more than 6,500 labels (5,600 broiler labels and 950 turkey 
labels) will need to be revised to declare moisture. See Statements of 
Stephen Pretanik (attachment 14--broiler labels) and J. Roy Escoubas 
(attachment 15--turkey labels). To estimate the necessary time to 
perform such modifications, Mr. Escoubas contacted the principal 
packaging

[[Page 52720]]

suppliers to the industry. The suppliers estimated that they have a 
capacity to design and tool a maximum of 450 new product labels per 
month. See Escoubas Statement. (Attachment 15). Taking the total number 
of labels and dividing by the excess capacity of 40, we estimate it 
will take 14.4 months before the plates have even been tooled. This 
means actual printing could not begin on all labels until April 1, 
2004.
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    \10\ During the data collection period, our members could work 
on redesigning labels to expedite the process. However, until the 
retained moisture level is ascertained, the plates cannot be tooled.
    \11\ The discussion herein will focus on obtaining retail 
labeled packages. Labels of products intended for institutions and/
or further processing are normally printed on the shipping container 
or affixed by a sticker. These labels will not pose the difficulties 
generated by retail product.
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    Finally, at this point, labels bearing the required declaration 
will be printed. Recognizing that there can be a ``rolling'' plate 
change/printing schedule, where labels are printed as soon as plates 
are ready, there would clearly need to be some period for printing 
after the last plate has been finalized. We estimate four months. 
Accordingly, as a matter of printing capacity, labels bearing the 
moisture declaration will not appear on all products until August 1, 
2004.

Summary

    As established by the above discussion and supporting 
documentation, it is simply impossible for companies to be in 
compliance with the moisture regulation until August 1, 2004. The time 
line once again:
     Protocols submitted by September 15, 2001
     Protocols receive No Objection letters by November 1, 2001
     Data collection on absorption started by December 1, 2001
     Data collection on absorption completed by December 1, 
2002
     Data collection on moisture retention, by item, completed 
by February 1, 2003
     All plates changed by April 1, 2004
     All labels printed by August 1, 2004
    Given the realities associated with this optimistic timeline, it is 
critical that the agency adjust the effective date to allow for a 
realistic implementation of the new labeling requirement.

Margin of Error

    We cannot overemphasize that the above timeline presumes no 
significant problems. For example, if FSIS objects to many of the 
protocols, there will be delay as the agency and the establishments 
work to resolve any differences. There may also be delay in gathering 
the data at some establishments given the FSIS policy decision not to 
permit experimentation if the establishment has failed its most recent 
Salmonella performance standard series. Notice 22-01, section XII 
(Attachment 4). There may also be delay in obtaining new labels if FSIS 
mandates any new labeling requirement, such as mandatory nutritional 
labeling for single ingredient products, so as to require additional 
revisions of the labels after companies have begun printing the labels 
in compliance with the moisture regulation. It may be advisable to 
provide some margin for error in the revised effective date.
    Obviously, we hope that the vast majority of labels would be in 
compliance by August 1, 2004. However, for the reasons discussed above, 
and for other unforeseen difficulties, there is a strong possibility 
that some establishments and/or product labels will not be in 
compliance by the revised date.\12\ Accordingly, we respectfully 
request that FSIS acknowledge this potential and indicate that the 
provisions of 9 C.F.R. Sec. 381.132(f) dealing with temporary label 
approvals would apply in such circumstances.
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    \12\ This may be especially true for turkey products, many of 
which are sold during the holidays in November and December, only 
three months after the earliest possible compliance date.
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C. Environmental Impact

    Petitioners are unaware of any adverse environmental impact that 
would result from an extension of an effective date for a mandatory 
label requirement. We do note that a viable effective date would 
minimize the amount of film labels that will have to be discarded.\13\
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    \13\ Our members have informed us that approximately $8 million 
of label inventory would have to be destroyed if the effective date 
is unchanged.
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D. Economic Impact

    Up until this point, we have not focused on the economic impact on 
the industry to comply with the regulation by the current effective 
date. Obviously, an impossibly short effective date could have an 
extremely adverse economic impact. In fact, if no extension is granted, 
industry would simply have to cease production, throwing thousands of 
people out of work and resulting in the bankruptcy of virtually all 
companies.
    The closure of a company constitutes irreparable injury.\14\
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    \14\ From a legal perspective, a product is misbranded if its 
label does not bear all mandatory information. Section 4(h)(12) of 
the Poultry Products Inspection Act. Upon the effective date of the 
moisture regulation, a moisture declaration is mandatory. 
Accordingly, any product whose label does not bear this information 
is misbranded. Misbranded product cannot bear the mark of 
inspection, and cannot be shipped. Sections 8(d) & 9(a)(2). If an 
establishment cannot ship product, it is, for all intents and 
purposes, closed.
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E. Certification

    The undersigned certifies that, to the best knowledge and belief, 
this petition includes all information and views on which the petition 
relies, and that it includes representative data and other information 
known to the petitioners which are unfavorable to the petitioners.

 Respectfully submitted

The American Meat Institute
The National Chicken Council
The National Food Processors Association
The National Turkey Federation

Submitted August 17, 2001

Description of Attachments

    As mentioned, the petition is accompanied by 14 attachments, which 
are available for viewing in the FSIS Docket Clerk's Office at the 
location indicated in ADDRESSES. The attachments are as follows:
Attachment 1--May 21, 2001, letter to Mr. Philip S. Derfler, Deputy 
Administrator, OPPDE/FSIS, from National Turkey Federation and National 
Chicken Council, enclosing 2 proposed protocols for evaluating moisture 
retention in poultry products
Attachment 2--July 5, 2001, letter from Mr. Philip S. Derfler, Deputy 
Administrator, OPPDE/FSIS, to Mr. Stephen Pretanik, National Chicken 
Council, enclosing FSIS-amended generic protocol for evaluating 
retained water in single-ingredient poultry products
Attachment 3--August 3, 2001, letter to Mr. Philip S. Derfler, Deputy 
Administrator, OPPDE/FSIS, from Mr. Stuart E. Proctor, Jr., National 
Turkey Federation, and Mr. Steve Pretanik, National Chicken Council.
Attachment 4--FSIS Notice 22-01, 6/29/01, ``Procedures for FSIS 
Personnel during Pre-implementation Period for `Retained Water in Raw 
Meat and Poultry Products; Poultry Chilling Requirements' ''
Attachment 5--August 14, 2001, letter from Paul N. M. Gerhardt, Ph.D. 
National Food Laboratory, Inc., ``to whom it may concern,'' on 
laboratory capacity limitations affecting microbiological testing of 
poultry product samples
Attachment 6--August 14, 2001, electronic mail message from William L. 
Brown, Ph.D., President, ABC Research Corporation, ``to whom it may 
concern,'' on laboratory capacity for microbiological testing of meat 
samples
Attachment 7--August 15, 2001, electronic message from Kurt 
Westmoreland, Silliker Laboratories Group, Inc., to Mr. Steve Pretanik, 
National Chicken Council, on laboratory capacity for

[[Page 52721]]

microbiological testing of poultry product samples
Attachment 8--July 27, 2001, letter from Dr. Neal Apple, Vice President 
of Tyson Corporate Laboratory and Research, Tyson Foods, Inc., ``to 
whom it may concern,'' on laboratory capacity for microbiological 
testing of poultry product samples
Attachment 9--August 2, 2001, letter from Lee G. Johnson, Chief 
Microbiologist, Con Agra Refrigerated and Prepared Foods, ``to whom it 
may concern,'' on laboratory capacity for microbiological testing of 
product samples
Attachment 10--August 16, 2001, letter from Jason Tisch, Assistant 
Manager, Deibel Laboratories, on laboratory capacity for 
microbiological testing of poultry product product samples
Attachment 11--Line graphs showing monthly percentage variation of 
turkey pre-baste yield and monthly variation of poultry live weight 
yield in pounds
Attachment 12--Chart showing monthly variability in Salmonella 
incidence on poultry carcasses at some establishments
Attachment 13--Chart showing monthly variability in Salmonella 
incidence on poultry carcasses at some establishments, other than those 
represented the chart in Attachment 12
Attachment 14--Letter from Mr. Stephen Pretanik, Director of Science 
and Technology, National Chicken Council, ``to whom it may concern,'' 
reporting results of membership survey on labels affected by the 
retained water rule
Attachment 15--Letter from J. Roy Escoubas, Ph.D., Technical 
Enhancements, Inc., to Mr. Stuart Proctor, President, National Turkey 
Federation, reporting on number of new printing plates and labels 
needed to bring turkey processors in compliance with retained water 
regulations

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 it 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.

    Done, at Washington, D.C.: October 12, 2001.
Thomas J. Billy,
Administrator.
[FR Doc. 01-26168 Filed 10-16-01; 8:45 am]
BILLING CODE 3410-DM-P