September
10, 2001
FSIS
Docket #97-013P
USDA,
Food Safety and Inspection Service
Room
102, Cotton Annex
300
12th Street, S.W.
Washington,
DC 20250
Re: Docket #97-013P, Performance Standards for
the Production of Processed Meat and Poultry Products, Proposed Rule, Federal Register Tuesday, February 27,
2001
National Meat
Association [NMA] respectfully submits the following comments on Docket #97-013P, Performance Standards for
the Production of Processed Meat and Poultry Products, Proposed Rule. NMA
represents over 300 firms who have a USDA grant of inspection. These firms manufacture a significant
portion of the ready-to-eat [RTE] meat and poultry products produced in the
United States. Specifically, they specialize in manufacturing high quality
gourmet and traditional RTE products.
These firms are
keenly sensitive and supportive of USDA’s effort to ensure the safest meat and
poultry products for American consumers.
NMA is pleased to work cooperatively with regulatory and legislative
bodies to this end. It is in the public
interest that we maintain the highest standards for production of meat and
poultry products that can be reasonably attained and supported by science.
To this end, NMA
member firms have voluntarily implemented, at great expense, programs and
procedures to reduce the incidence of foodborne illness that may result from
the consumption of RTE products. These programs and procedures include the
development and implementation of Good Manufacturing Practices (GMPs), Standard
Operating Procedures (SOPs); and Environmental Sampling and Testing Programs
beyond those currently required federal regulations. In 1999, NMA developed, in cooperation with several industry and
academic organizations, GMP, SOP and environmental sampling guidelines as a
resource for RTE processors, and these have been widely used throughout the
industry. These guidelines are
available free of charge and may be downloaded from the NMA web site at
www.nmaonline.org.
Actions taken to
reduce pathogens and prevent foodborne illness need to be based on sound
science with evidence that they will produce outcomes that have effects on food
safety and improve consumer protection.
This is particularly important when these actions are codified in
government regulations as they will affect the economic condition of the
industry.
NMA is of the
opinion that FSIS has failed to demonstrate, in either this proposed regulation
or in related public meetings, that this regulation will improve food safety or
protect consumers. In fact, NMA asserts
that this regulation is a detriment to food safety because it is unsupported by
science.
NMA
agrees that any detectable level of viable Salmonella
microorganisms adulterates a RTE meat or poultry product. NMA also agrees that
it is reasonable for consumers to expect RTE products to meet this
standard. In addition, a recent private
industry survey revealed that the majority of inspected establishments
currently employ a CCP that meets this proposed requirement for lethality. However, we question the agency’s basis for
codifying that plants validate their RTE processes to either a 6.5-log
reduction in Salmonella for RTE meat
products or a 7.0-log reduction in Salmonella
for RTE poultry products.
In
the preamble, FSIS states that it derived “worst case” microorganism levels using data from the USDA/FSIS 1994 Nationwide Microbiological
Baseline Data Collection Program Surveys.
This data is seven years old and based on samples taken prior to the
implementation of HACCP. FSIS claims that pathogen levels on meat and poultry
products are declining since the implementation of HACCP. Agriculture Secretary Veneman announce
earlier this year the release of an FSIS report that showed the decrease in Salmonella prevalence levels in
1998-2000 than in the baseline studies.
Therefore, a regulatory requirement based on outdated data may cause a
huge impact on the industry and no consumer protection benefit. This is an unjustified government mandated
burden that is unacceptable.
Large
establishments have the technical and economic resources (private industry surveys report the cost of validating a CCP for
lethality ranges from $10,000 to over $300,000, depending on the complexity and
variety of products) to establish their own “worst case” levels and
validate alternative lethality methods, thus allowing them greater flexibility
in their processes. Small establishments, particularly those who produce a
variety of products, will most likely employ the “FSIS Schedule-A Lethality Guidelines” or any subsequent FSIS
guidelines to meet the 6.5-log/7.0-log Salmonella
reduction standards. By setting the 6.5-log/7.0-log pathogen reduction as a
regulatory standard, FSIS is locking
these smaller establishments into what could become more costly production
methods then those employed at large processors, thus putting them at an
economic disadvantage. NMA therefore
suggests that the agency review this hypothetical “worst case” level and
re-propose based on more current data.
Similarly,
NMA agrees with the agency that the proper monitoring of stabilization of meat
and poultry products is necessary to ensure food safety and consumer
protection. However, FSIS has used the
same outdated USDA/FSIS 1994 Nationwide
Microbiological Baseline Data Collection Program Surveys to establish the
“worst case” microbiological levels for
the stabilization standard. If
finalized as written, this section of the regulation would require that the
processing of RTE products prevent the multiplication of microorganisms such as
Clostridium botulinum and allow no
more than 1-log multiplication of Clostridium
perfringens within the product.
FSIS is aware that the infective dose
for C. perfringens is a cell
population of 105 CFUs or more. FSIS has set the standard for C. perfringens multiplication at 1-log or less based on obsolete
surveys. NMA encourages FSIS to
re-propose a stabilization standard that is based on current data and that
allows for the measuring of actual level of C.
perfringens to establish the wholesomeness of RTE products.
This
proposed regulation would require that firms producing fermented meat or
poultry products containing beef validate their process to achieve a
performance standard probability of no surviving E. coli O157:H7 given an incoming raw material “worst case”
level. Plants may also employ processes validated to achieve a
5-log reduction of E. coli O157:H7 throughout a finished RTE
product containing beef. NMA
understands the potential of serious illness associated with this organism, yet
advises the agency to provide firms that produce fermented products with the
with sufficient regulatory flexibility by which to meet these standards. The NCBA, Blue Ribbon Task Force, Dry Fermented Sausage and E. coli
O157:H7 Research Report may provide some assistance to the agency in this
task.
Many
of these products currently employ traditional processing methods and
consistantly produce wholesome products.
However, they may lack scientific validation, due to their relatively
limited share in the market. By
providing flexibility for these product in meeting this performance standard,
the agency avoids the risk of driving these traditional, fermented beef
products from the market place.
NMA is concerned that FSIS is
proposing to require that, “Establishments would be required to maintain
these levels of pathogen reduction and pathogen growth in their products, under
normal handling conditions, and until their products reach the consumer (page
12592).”
NMA feels that this italicized statement contained in the proposed
regulation is sufficiently vague as to invite contention and needs clarification.
NMA
has supported environmental testing of product contact surfaces for Listeria species as a tool for plants to
evaluate the effectiveness of their sanitation programs and recommends to its
members that they consider implementing such a program as appropriate for their
operation. NMA’s Environmental Sampling
and Testing Recommendations (ESTRs) for RTE product production is a guideline
for developing such programs. A recent
industry survey conducted by several trade associations indicates that many
firms conduct extensive environmental testing on a voluntary basis.
NMA
cannot, however, support a regulation that would require plants to either test
product contact surfaces for Listeria (species) at prescribed frequencies based on
plant size or identify Listeria
monocytogenes as a hazard reasonably likely to occur and control it in
their HACCP plan. These actions are not
supported by science and most likely will become a detriment to human health
and food safety. The basis for this
statement is in the following paragraphs.
Food
processing experts agree that the most effective means to prevent post
lethality contamination of RTE products is to focus on sanitation. Control of L. monocytogenes belongs in a plant’s sanitation
program, not in its HACCP program. Plants that attempt to control L. monocytogenes in their HACCP plan may
divert establishment resources and personnel from focusing on sanitation
activities, which may actually increase the risk of L. monocytogenes contaminating a RTE product.
The
agency has failed to provide any scientific evidence that would show how the
proposed, prescriptive environmental testing frequencies based on plant size as
set forth in this proposed regulation will reduce the incidence of L. monocytogenes in RTE products. In
fact, FSIS states in the preamble to the rule, “FSIS has not been able to
correlate risk of product contamination with production volume or establishment
size.” In addition, NMA contends that
any mandatory testing program that ultimately punishes plants that find Listeria (species) on product contact
surfaces will discourage plants from aggressively testing and locating
potential Listeria reservoirs. Current voluntary testing programs are
aggressive and designed with the intent of locating potential Listeria reservoirs. If finalized as written, this regulation may
discourage plants from implementing aggressive programs as they will lead to
punitive regulatory actions and mislead new processors into implementing an
ineffective program.
Environmental testing is costly. NMA estimates that for a small processor environmental testing could cost around $10,000 a year. A small firm would more effectively control Listeria by focusing financial resources on sanitation activities and plant improvement projects.
In addition, FSIS has ignored differences in certain RTE foods in regards to the Listeria testing and to stabilization. Specifically, the inclusion of dried meat snacks in the environmental testing and stabilization proposed requirements is not supported by any of the available scientific or epidemiological data. Shelf Stable Dried Products such as meat snack sticks and jerky have a water activity of 0.85 or less and will not support the post processing growth of pathogens such as L. monocytogenes or C. perfringens. FSIS writes in the discussion on hazards presented by the dried products category that “based on the epidemiological data and research studies on jerky, it does not appear that E. coli O157:H7 or Listeria represent serious hazards in commercially produced jerky.” The 1999 FDA Food Code defines a food that is “potentially hazardous.” Shelf stable dried and fermented products produced under a validated HACCP plan that include control of water activity and other barriers when the water activity is less than 0.85 would be specifically exempted from this categorization. Based on this evidence, NMA recommends that the categories of shelf stable dried and fermented products be eliminated from the proposed requirements for environmental testing and stabilization.
Thermally
Processed Commercial Products
The
National Meat Association strongly disagrees with the Agency's proposed changes
to the current regulations pertaining to Canning and Canned Products contained
in 9CFR 318.300 - 318.311 and 381.300 - 381.311 for the following reasons. FSIS
has again failed to demonstrate how these proposed regulations will improve
food safety and consumer protection.
The current regulations are "HACCP" based and have demonstrated
over many years to have effectively ensured the safety of shelf stable canned
meat and poultry products. In fact,
these regulations have virtually eliminated the potential severe public health
hazard (i.e., C. botulinum) associated with improperly
canned product. This fact alone warrants leaving the current regulations in
place. In addition, current regulations
are consistent with those of the Food and Drug Administration (FDA). Removing
large portions of the current requirements would create a great deal of
confusion in plants that produce both FDA and USDA product and weaken controls
currently in place at plants producing only canned meat and poultry products.
Actions taken to
reduce pathogens and prevent foodborne illness need to be based on sound
science with evidence that these actions will affect food safety and improve
consumer health. FSIS has failed to demonstrate, in either this regulation or
subsequent public meetings, that this regulation will improve food safety or consumer
health. NMA asserts that this regulation is a detriment to food safety as it is
unsupported by sound science.
NMA
agrees that any detectable level of viable Salmonella
microorganisms adulterates a RTE meat or poultry product but questions the
agency’s basis for the lethality standard on data that is seven years old. Similarly, NMA agrees with the agency that
the proper monitoring of stabilization of meat and poultry products is
necessary to ensure food safety and protect human health but disagrees with
setting the standard for C. perfringens multiplication
at 1-log or less and not allowing for the actual measurement of C. perfringens to determine the
wholesomeness of product.
NMA
understands the potential of serious illness associated with this E. coli O157:H7, yet advises the agency to provide firms that
produce fermented products with the with sufficient regulatory flexibility by
which to meet this standards. By
providing flexibility for these product in meeting this performance standard,
the agency avoids the risk of driving these traditional, fermented beef
products from the market place.
NMA
is concerned that FSIS is proposing to require that, “Establishments would be
required to maintain these levels of pathogen reduction and pathogen growth in
their products, under normal handling conditions, and until their products
reach the consumer (page 12592).” NMA feels that this italicized statement
contained in the proposed regulation is sufficiently vague as to invite
contention and needs clarification.
NMA
will not support a regulation that would require plants to either test product
contact surfaces for Listeria (species)
at prescribed frequencies based on plant size or identify L. monocytogenes as a hazard reasonably likely to occur and control
it in their HACCP plan because these actions are not supported by science and
most likely will become a detriment to human health and food safety. NMA also contends that FSIS has ignored
differences in certain RTE foods in regards to the Listeria testing and to stabilization. Specifically, the inclusion of dried meat snacks in the
environmental testing and stabilization proposed requirements.
NMA
appreciates the opportunity to comment
on this proposed rule.
Sincerely,
Teresa Frey
Director of Technical
Services