[Federal Register Volume 64, Number 36 (Wednesday, February 24, 1999)]
[Proposed Rules]
[Pages 9089-9105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4401]
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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. 64, No. 36 / Wednesday, February 24, 1999 /
Proposed Rules
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317, 318, and 381
[Docket No. 97-076P]
RIN 0583-AC50
Irradiation of Meat and Meat Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the meat inspection regulations to permit the use of ionizing
radiation for treating refrigerated or frozen uncooked meat, meat
byproducts, and certain other meat food products to reduce levels of
food borne pathogens and to extend shelf-life. FSIS is proposing this
action in light of the Food and Drug Administration's recent final rule
which amended its food additive regulations to provide for the safe use
of ionizing irradiation sources to treat these same meat food products.
FSIS also is proposing to revise the regulations governing the
irradiation of poultry so that they will be as consistent as possible
with the proposed regulations for the irradiation of meat food
products.
DATES: Comments must be received on or before April 26, 1999.
ADDRESSES: Submit one original and two copies of written comments to
FSIS Docket #97-076P, U.S. Department of Agriculture, Food Safety and
Inspection Service, Room 102, Cotton Annex, 300 12 St., SW, Washington,
DC 20250-3700. All comments submitted in response to this proposed rule
will be available for public inspection in the Docket Clerk's Office
between 8:30 a.m. and 4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director,
Regulation Development and Analysis Division, Office of Policy, Program
Development, and Evaluation, Food Safety and Inspection Service, U.S.
Department of Agriculture (202) 720-5627.
SUPPLEMENTARY INFORMATION:
Background
Food irradiation is the process of exposing food to high levels of
radiant energy. Forms of radiant energy include: microwave and infrared
radiation that heat food during cooking; visible light or ultraviolet
light used to dry food or kill surface microorganisms; and ionizing
radiation, resulting from cobalt-60, cesium-137, x-ray machines, or
electron accelerators, that penetrates deeply into food, killing insect
pests and microorganisms without raising the temperature of the food
significantly. Food is most often irradiated commercially to extend
shelf-life, eliminate insect pests, or reduce numbers of pathogenic
microorganisms. Food irradiation for these purposes is practiced in
many countries, including the United States.
Section 201(s) of the Federal Food, Drug and Cosmetic Act (FFDCA)
defines sources of radiation used to treat food as ``food additives.''
The Food and Drug Administration (FDA) of the Department of Health and
Human Services has the primary responsibility for determining whether
or not food additives are safe for particular uses. FDA lists uses of
food additives it has concluded are safe in 21 CFR parts 172 through
180.
On August 25, 1994 (59 FR 43848), FDA announced that it had
received a petition from Isomedix, Inc., requesting that FDA amend the
food additive regulations in 21 CFR part 179 (Irradiation in the
Production, Processing and Handling of Food). The petition requested
that FDA authorize the safe use of sources of ionizing radiation to:
control microbial pathogens in raw, fresh-chilled, and frozen intact
and comminuted edible tissue of the skeletal muscle and organ meat
of domesticated mammalian food sources; with concomitant control of
infectious parasites, and, extension of acceptable edible/marketable
life of chilled/refrigerated and defrosted meat through the
reduction in levels of spoilage microorganisms.
The petition further specified that the proposed foods were to be
``primarily from bovine, ovine, porcine, and equine sources.'' Also,
Isomedix requested that a maximum dose of 4.5 kiloGray (kGy) be
established for the irradiation of fresh (chilled, not frozen) meat,
and that a maximum dose of 7.0 kGy be established for the irradiation
of frozen meat.
On December 3, 1997, FDA published a final rule (FDA Docket No.
94F-0289; 62 FR 64107) granting this petition. In that publication, FDA
expanded the list of products (21 CFR 179.26(b)) for which ionizing
irradiation may be safely used to control food borne pathogens and
extend shelf life to include: refrigerated and frozen uncooked meat;
meat byproducts (e.g., edible organs, such as the liver and the
kidneys); and certain meat food products (e.g., ground beef and
hamburger). Specifically, the foods that may be irradiated are: meat,
as defined by FSIS in 9 CFR 301.2(rr); meat byproducts, as defined by
FSIS in 9 CFR 301.2(tt); and other meat food products within the
meaning of 9 CFR 301.2(uu), with or without nonfluid seasoning, that
are otherwise composed solely of intact or ground meat or meat
byproducts, or of both.
FDA's Evaluation of the Safety of Irradiation
Under Sec. 409(c)(3)(A) of the FFDCA, a food additive cannot be
listed for a particular use unless a fair evaluation of the evidence
establishes that the additive is safe for that use. In response to the
Isomedix petition, FDA identified the various effects that could result
from the irradiation of meat food products and then assessed whether
any of these effects could pose a human health risk. FDA did not
consider whether irradiation of meat would bring about health or other
benefits for consumers.
FDA examined the data and studies submitted by Isomedix, as well as
other information in its files relevant to the safety and nutritional
adequacy of meat treated with irradiation. Specifically, FDA evaluated:
Studies of the radiation chemistry of food components
and whole foods, including flesh foods (``radiation chemistry''
refers to the chemical reactions that occur as a result of absorbing
radiation);
Toxicity studies of irradiated beef, pork, chicken, and
fish;
Studies of the nutritional adequacy of irradiated
products derived from livestock and poultry, in light of the dietary
consumption patterns for these products; and
[[Page 9090]]
Studies of the effects of irradiation on both
pathogenic and nonpathogenic microorganisms.\1\
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\1\ Because Clostridium botulinum spores are very resistant to
the effects of irradiation and would be more likely to suvive
irradiation than other pathogens and most spoilage bacteria, and
because the illness associated with botulinal toxin is so severe,
FDA, in its evaluation, focused particularly on the effects of
irradiation on the probability of significantly increased growth of,
and subsequent toxin production by, C. botulinum. FDA detrmined that
irradiation of meat food products under the conditions set forth in
its regulation will not result in any additional health hazard from
C. botulinum or from other common pathogens.
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Based on its evaluation of available data, FDA concluded that
irradiation of meat, meat byproducts, and certain other meat food
products under the conditions requested in the petition would not
present toxicological or microbiological hazards and would not
adversely affect the nutritional adequacy of these products. FDA
therefore granted the petition and added meat, meat byproducts, and
certain other meat food products to the list in 21 CFR 179.26(b) of
foods that may be treated with ionizing radiation to reduce levels of
food borne pathogens and to extend shelf-life.
Under Sec. 318.7 of the meat inspection regulations, FSIS may
approve a substance for use in the preparation of meat food products if
the substance has been previously approved by FDA and if FSIS has
determined that:
Its use is in compliance with applicable FDA
requirements;
The use of the substance will not render the product in
which it is used adulterated or misbranded or otherwise not in
compliance with the requirements of the Federal Meat Inspection Act;
and
Its use is functional and suitable for the product and
it is permitted for use at the lowest level necessary to accomplish
the stated technical effect as determined in specific cases. FSIS
has made these determinations and therefore, in this document is
proposing to amend its meat inspection regulations to provide for
the safe use of ionizing radiation for the treatment of meat, meat
byproducts, and certain other meat food products. FSIS also is
proposing labeling requirements for these same products.
Irradiation as a Food Additive in Meat and Poultry
Pathogenic microorganisms are the most significant cause of food
borne illness. Ionizing radiation will reduce, and in some
circumstances eliminate, pathogenic microorganisms in or on meat and
poultry. FSIS therefore recognizes irradiation as a important
technology for helping to ensure the safety of meat and poultry. FSIS
already has listed ionizing radiation as an approved additive in pork
carcasses or fresh or previously frozen cuts of pork carcasses that
have not been cured or heat-processed for the control of Trichinella
spiralis (9 CFR 318.7); and as an approved additive in fresh or frozen,
uncooked, packaged poultry products and mechanically separated poultry
for the purpose of reducing pathogenic microorganisms (9 CFR 381.147).
In fact, FSIS originally petitioned FDA to allow the irradiation of
poultry.
Available scientific data indicate that ionizing radiation can
significantly reduce the levels of many of the pathogenic
microorganisms of concern in meat food products, including various
species of Salmonella; E. coli O157:H7; Clostridium perfringens;
Staphylococcus aureus; Listeria monocytogenes; Campylobacter jejuni;
and the protozoan parasite Toxoplasma gondii. The available reports and
published articles establish that the radiation dose necessary to
reduce the initial population of many of the bacterial pathogens by 90
percent (the ``D value,'' which is equivalent to 1-log10)
ranges from 0.1 kGy to just under 1 kGy. The following chart lists the
approximate D values for some of the pathogens of concern in meat food
products.\2\
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\2\ These approximate D-values are from: ``Irradiation of red
meat: A compilation of technical data for its authorization and
control,'' International Consultative Group on Food Irradiation,
August 1996.
Pathogen Irradiation D values
C. jejuni................................. 0.18 kGy (in refrigerated
product) to 0.24 kGy (in
frozen product).
C. perfringens............................ 0.586 kGy (in refrigerated
product).
E. coli O157:H7........................... 0.25 kGy (in refrigerated
product) to 0.45 kGy (in
frozen product).
L. monocy- togenes........................ 0.4 kGy to 0.64 kGy.
Salmonella spp............................ 0.48 kGy to 0.7 kGy.
S. aureus................................. 0.45 kGy.
T. gondii................................. 0.4 kGy to 0.7 kGy.
T. spiralis............................... 0.3 kGy to 0.6 kGy.
These approximate ranges of D values are all well beneath the
maximum dosages of irradiation authorized by FDA and proposed by FSIS
for refrigerated and frozen meat food products (4.5 kGy and 7 kGy,
respectively). Treating product with a maximum dose of irradiation,
therefore, could result in a significant reduction or even the
elimination of certain pathogens. For example, given the highest
approximate D value for E. coli O157:H7 from the table above,
irradiation of a frozen meat food product at 7 kGy could achieve an
approximate 15 log10 per gram reduction of E. coli O157:H7.
That is, approximately 99.9999999999999 percent of the pathogen could
be eliminated from the product. Considering that E. coli O157:H7 is
usually found at levels of 3 log10 per gram or lower in
ground meat products \3\, there is a high probability that irradiation
of frozen ground meat products with a 7 kGy dose could eliminate E.
coli O157:H7 from the product.
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\3\ National Advisory Committee on Microbiological Criteria for
Foods, Meat and Poultry Subcommittee Report, November 20, 1997.
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It is important to remember, however, that the D value for any
individual pathogen varies depending on such factors as the type of
food to be irradiated, the physical state (frozen versus nonfrozen) of
the food, product temperature, and ambient oxygen level. For example,
higher radiation doses are needed to achieve the same antimicrobial
effect in a frozen food versus a nonfrozen food of the same type (hence
the two different maximum doses for refrigerated and frozen product
approved by FDA and proposed in this document by FSIS). Further, the
load of pathogens on incoming product can vary widely, due to animal
husbandry and sanitation practices, as well as other factors.
Regardless, it is apparent that irradiation would be a highly effective
antimicrobial treatment for meat food products.
Finally, as mentioned in footnote 1, the pathogen C. botulinum is
very resistant to irradiation. Spores have D values of approximately
3.45 to 3.6 kGy in refrigerated product and 3.73 to 3.85 kGy in frozen
product.\4\ However, in its microbiological assessment of irradiation,
FDA determined that the probability for significant growth of, and
toxin production by, C. botulinum in irradiated meat stored under
adequate temperature control (properly refrigerated or frozen) is
extremely remote for several reasons. First, C. botulinum spores occur
with extremely low frequency and in extremely low numbers in meat, and
these numbers will be further reduced by irradiation at the permitted
doses. Second, most strains of C. botulinum that have been found in
meat do not grow and produce toxin under refrigeration conditions
appropriate for transport and storage of
[[Page 9091]]
flesh foods. Third, various species of other microorganisms commonly
found on meat, particularly spoilage bacteria (e.g., Lactobacillus spp.
and others), survive irradiation in sufficient numbers to grow and
inhibit growth of, and toxin production by, C. botulinum in both
refrigerated and temperature-abused irradiated meats. FDA concluded,
therefore, that irradiation of meat food products under the conditions
set forth in its regulation will not result in any health hazard from
C. botulinum additional to that which may be found in non-irradiated
product.
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\4\ ``Irradiation of red meat: A compilation of technical data
for its authorization and control,'' International Consultative
Group on Food Irradiation August 1996.
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Irradiation and HACCP
On July 25, 1996, FSIS published a final rule that requires every
meat and poultry establishment to develop and implement Hazard Analysis
and Critical Control Point (HACCP), a science-based process control
system designed to improve the safety of meat and poultry products
(FSIS Docket No. 93-016F, ``Pathogen Reduction; Hazard Analysis and
Critical Control Point (HACCP) Systems''; 61 FR 38806). Under this
final rule, meat and poultry establishments are responsible for
developing and implementing HACCP plans incorporating the controls
determined by the establishment to be necessary and appropriate to
produce safe products. HACCP is a flexible system that enables
establishments to tailor their control systems to the needs of their
particular plants and processes. In the paragraphs that follow, FSIS
outlines how irradiation could be used within a HACCP system by poultry
establishments and, if FSIS finalizes this rule, by meat
establishments.
To meet the HACCP requirements, establishments must first conduct a
hazard analysis to identify and list the food safety hazards reasonably
likely to occur in a production process, as well as the preventive
measures necessary to control the hazards. A food safety hazard is any
biological, chemical, or physical property that may cause a food to be
unsafe for human consumption. Establishments that identify microbial
pathogens as hazards within their processes could choose irradiation as
a method to reduce or even eliminate such pathogens.
Next, establishments must establish critical control points
(CCP's). A CCP is a point, step, or procedure at which control can be
applied so that a food safety hazard can be prevented, eliminated, or
reduced to an acceptable level. Meat and poultry establishments
choosing to irradiate product would integrate irradiation into their
HACCP systems as a CCP.
Establishments then must establish critical limits for their CCP's.
Critical limits are most often based on process parameters such as
temperature, time, physical dimensions, humidity, moisture level, water
activity, pH, and survival of target pathogens. Establishments that
irradiate product probably would have as some of their critical limits
radiation dosage, product temperature, and ambient oxygen level. By
ensuring that specific limits for each of these parameters were met,
establishments could be reasonably sure that a predetermined reduction
in pathogens had been achieved within the irradiated product.
Establishments would be free to establish any critical limits
appropriate for their HACCP systems, as long as they remain in
compliance with the FSIS and FDA regulations governing irradiation,
such as the regulatory limits on maximum dosage.
The remaining HACCP requirements include monitoring of CCP's, plans
for corrective action in the event of processing deviations, record
keeping, and HACCP plan verification. It is likely that establishments
that irradiate product would meet these requirements no differently
than other official establishments. Establishments that irradiate meat
or poultry product should keep in mind, however, that their HACCP plans
must address all processing, from receiving to shipment. Therefore, an
establishment that ships product to a separate facility for irradiation
would need to address the conditions of shipment (handling, packaging,
refrigeration, etc.) within its HACCP plan. Similarly, the irradiation
facility would need to address shipment and receiving of the product,
as well as the irradiation treatment itself, in its HACCP plan.
Controlling the conditions of product from initial processing through
irradiation and packaging will be necessary to ensure and preserve the
intended antimicrobial effects of irradiation.
There are numerous possible scenarios involving the use of
irradiation within a HACCP system and FSIS could not enumerate them all
in this document. There is available from FSIS, however, a generic
HACCP model for irradiation developed by the International Meat and
Poultry HACCP Alliance. The model, entitled ``Generic HACCP Model for
Irradiation,'' is available from the FSIS Docket Room (see ADDRESSES
above) and from the Texas A&M University World Wide Web site at http://
ifse.tamu.edu/alliance/haccpmodels.html.
To account for the numerous possible processing situations and to
allow for maximum flexibility and innovation in developing HACCP
systems incorporating irradiation, FSIS is proposing only those
requirements necessary to ensure product safety. For example, FSIS is
proposing no minimum dose for the irradiation of meat products. FDA did
not establish a minimum irradiation dose for meat food products in its
final rule, although they stated that FSIS could establish a minimum
dose without petitioning FDA. FDA concluded that different doses could
be appropriate, in different circumstances, for achieving a desired
technical effect and that its regulation should allow for flexibility
in this regard. FSIS agrees. FSIS also is proposing to eliminate the
minimum dose that it currently requires for poultry. The minimum dosage
for poultry was intended to ensure a certain reduction of pathogens.
Under the HACCP requirements, FSIS wants to allow poultry
establishments, like meat establishments, to determine what level of
irradiation (subject to a maximum level) and consequent reduction of
pathogens is appropriate within their HACCP systems.
Furthermore, FSIS is proposing no specific handling or packaging
requirements for the irradiation of meat food products. Under this
proposal, establishments will be responsible for determining, within
their HACCP systems, what sort of handling and packaging is appropriate
for ensuring that irradiated product is not adulterated. FSIS also is
proposing to revise the packaging requirements for irradiated poultry
to maximize processing flexibility and innovation. The proposed
revisions are explained in detail below under ``Revision of the
Requirements for Irradiated Poultry.''
Finally, FSIS is proposing no restrictions on the specific function
of irradiation as a CCP within a HACCP system. If this proposal is
finalized, some establishments may choose to irradiate packaged ground
product at high dosages to achieve maximal pathogen reduction
throughout the product. Other establishments may choose to irradiate
only a few millimeters into whole muscle products to control pathogenic
bacterial contamination on the surface. These types of pathogen
reduction treatments and others will be allowed under the proposed
regulations.
FDA did approve irradiation of meat food products as a means to
extend product shelf-life, as well as a means to reduce pathogens. FSIS
is proposing to allow irradiation for this purpose too. Were an
establishment to irradiate meat food products solely for the purpose of
[[Page 9092]]
extending shelf-life, it is conceivable, although highly unlikely, that
the establishment could disregard any amount of pathogen reduction
achieved by the irradiation and therefore not list irradiation as a CCP
in it HACCP plan. However, such an establishment still would have to
meet the other requirements for irradiation facilities promulgated by
FSIS and other Federal and State agencies, such as requirements for
dosimetry and documentation. FSIS does not anticipate that any
establishment will irradiate product solely to extend shelf life and
not account for the antimicrobial effects of irradiation in its HACCP
plan.
Products Affected by the Proposed Rule
FSIS worked with FDA during its review of the Isomedix petition,
primarily to identify the various types of meat food products suitable
for irradiation, in light of the petitioner's request and FDA
restrictions concerning the irradiation of ingredients (e.g. water,
brine, spices) contained in certain meat products. FSIS also consulted
with FDA regarding which forms of comminuted meats (e.g. low-
temperature rendered meat, advanced meat recovery system meat, finely
textured meat) would be suitable for irradiation. As a result of those
consultations, FDA approved ionizing irradiation as an additive for the
following types of uncooked, refrigerated or frozen meat food products:
Meat, as defined in 9 CFR 301.2(rr):
(1) The part of the muscle of any cattle, sheep, swine, or
goats, which is skeletal or which is found in the tongue, or in the
diaphragm, or in the heart, or in the esophagus, with or without the
accompanying and overlying fat, and the portions of bone, skin,
sinew, nerve, and blood vessels which normally accompany the muscle
tissue and which are not separated from it in the process of
dressing. It does not include the muscle found in the lips, snout,
or ears. This term, as applied to products of equines, shall have a
meaning comparable to that provided in this paragraph with respect
to cattle, sheep, swine, and goats.
(2) The product derived from the mechanical separation of the
skeletal muscle tissue from the bones of livestock using the
advances in mechanical meat/bone separation machinery and meat
recovery systems that do not crush, grind, or pulverize bones, and
from which the bones emerge comparable to those resulting from hand-
deboning (i.e., essentially intact and in natural physical
conformation such that they are recognizable, such as loin and rib
bones, when they emerge from the machinery) which meets the criteria
of no more than 0.15 percent or 150 mg/100 gm of product for calcium
(as a measure of bone solids content) within a tolerance of 0.03
percent or 30 mg.
Meat byproducts, as defined in 9 CFR 301.2(tt):
Any part capable of use as human food, other than meat, which
has been derived from one or more cattle, sheep, swine, or goats.
This term, as applied to products of equines, shall have a meaning
comparable to that provided in this paragraph with respect to
cattle, sheep, swine, and goats. (This category of byproducts would
include blood and blood plasma.)
Meat food products within the meaning of 9 CFR
301.2(uu), with or without nonfluid seasoning, that are otherwise
composed solely of intact or ground meat and/or meat byproducts
(e.g., ground beef as in 9 CFR 319.15(a); hamburger as in 9 CFR
319.15(b); certain defatted beef or pork products as in 9 CFR
319.15(e) and 9 CFR 319.29(a), respectively; mechanically separated
(species) as in 9 CFR 319.5).
FSIS's proposed irradiation requirements would be applicable to these
same meat food products.
It has come to the attention of the Agency that several
establishments may wish to irradiate ``hot-boned'' meat. Hot-boned meat
is meat carcasses or parts that are deboned immediately following
slaughter and then chilled. It is likely that an establishment wishing
to irradiate hot-boned meat would irradiate between the deboning and
the chilling of the carcasses or parts. The meat, therefore, would not
have been refrigerated prior to irradiation and FDA has listed ionizing
irradiation as an additive only for refrigerated or frozen, uncooked
meat products.
FSIS believes that the irradiation of hot-boned meat poses no
unique risks and further, that the assessment conducted by FDA
regarding the safety of irradiating refrigerated meat is completely
applicable to hot-boned meat. In the proposed regulatory text, FSIS has
specified only refrigerated and frozen meat food products as products
that may be irradiated in Sec. 318.7(c)(4). However, FSIS currently is
consulting with FDA to determine what action is necessary and
appropriate in regard to the possible irradiation of hot-boned meat.
FSIS requests public comment on this issue as well. Depending upon
these consultations with FDA and other information submitted by the
public, FSIS may specifically provide for the irradiation of hot-boned
meat in the final rule that succeeds this document.
Addition of Irradiation to the Table of Substances Approved for Use in
the Preparation of Meat Food Products
FSIS is proposing to amend the table in Sec. 318.7(c)(4) of its
meat inspection regulations by adding ionizing radiation as a substance
suitable for controlling food borne pathogens in the meat, meat
byproducts, and other meat food products described above. In accordance
with the FDA final rule, FSIS is proposing a maximum absorbed dosage of
4.5 kGy for refrigerated products and 7 kGy for frozen products. As
explained above, FSIS is proposing no minimum dosage.
This addition to the table would supercede the current entry
allowing the use of ionizing radiation from gamma rays for the control
of Trichinella spiralis in pork. Current FSIS regulations permit the
use of ionizing irradiation from cobalt-60 and cesium-137 for control
of Trichinella spiralis in specified pork products. Additionally, the
regulation specifies minimum and maximum dosages. Under this proposal,
establishments could continue to irradiate pork for the control of
trichinae, but could employ higher doses, as well as ionizing radiation
from machine sources. In its recent final rule, FDA did not remove the
entry allowing the use of ionizing radiation for the control of
Trichinella spiralis in pork from the table in 21 CFR 179.26(b).
However, FDA's addition of sources of radiation as a treatment for meat
food products seems to supercede the entry for Trichinella spiralis.
FSIS will consult with FDA to clarify the intent of its new rule on
this issue.
Processing Requirements for the Irradiation of Meat Food Products
FSIS is proposing to amend Sec. 318.11 (currently reserved) by
establishing processing requirements specific to the irradiation of
specified meat food products. Of primary importance is that the
irradiation of meat food products be conducted only in accordance with
written procedures. Absorbed radiation dosage cannot be measured in
treated product. Only through adherence to written procedures can
establishments ensure that product receives doses of radiation within
the regulatory limits.
To this end, FSIS is proposing to require that establishments
conduct irradiation of meat and meat products only in accordance with
either a HACCP plan, as defined in Part 417 of the FSIS meat and
poultry inspection regulations, or a process schedule validated for
efficacy by a processing authority (proposed Sec. 318.11(a)). Written
irradiation procedures must describe the specific, sequential
operations employed by the establishment in the irradiation and
associated processing of meat food products, including the control,
validation, monitoring, and corrective action activities.
Because the smallest meat and poultry establishments will not be
required to implement HACCP until January 25, 2000, it is possible that
there will be establishments ready to irradiate meat food products
before they have
[[Page 9093]]
implemented HACCP. FSIS would prefer that establishments develop and
implement HACCP plans sooner than required. The Agency is proposing
however, that establishments desiring to irradiate meat food products
before they have implemented HACCP, have on file a written process
schedule describing the specific operations employed by the
establishment to accomplish the objectives of irradiation. FSIS is
proposing to require that this process schedule contain the control,
validation, monitoring, and corrective action activities associated
with the establishment's irradiation procedures (proposed
Sec. 318.11(a)(2)). These activities are the safety, sanitation, and
basic good manufacturing practices generally regarded as essential
prerequisites for the production of safe food. Further, these
activities are likely to be similar, if not identical, to the control,
monitoring, validation, and corrective action activities developed by
the establishment as part of its HACCP plan.
Under this proposal, the process schedule will have to be evaluated
and approved for safety and efficacy by a process authority. A
``process authority'' is defined in Sec. 301.2 of the regulations as
``A person or organization with expert knowledge in meat production
process control and relevant regulations.'' The process authority will
evaluate the establishment's prospective irradiation and related
processing procedures using appropriate validation methods such as
laboratory challenge studies or comparison to peer-reviewed and -
accepted procedures. The process authority must approve in writing the
safety and efficacy of the irradiation procedures. The process
authority must have access to the establishment in order to evaluate
the safety of that establishment's planned production processes.
FSIS is proposing to sunset these proposed process schedule
requirements after all establishments have been required to develop and
implement HACCP plans. These requirements will be duplicative of what
is required by HACCP and an establishment would not need both an
approved process schedule and a validated HACCP plan for the same
process. FSIS anticipates that if an establishment develops a process
schedule for irradiating meat food products prior to implementing
HACCP, it would incorporate elements of that process schedule into its
HACCP plan.
Dosimetry
FSIS also is proposing to require in Sec. 318.11(b) that any
establishment irradiating meat food products have in place a dosimetry
system. Dosimetry is the process of measuring an absorbed dose of
radiation. FSIS is proposing to require establishments to implement a
dosimetry system to ensure that each lot of treated product has
received the dose defined in the process schedule or HACCP plan.
FSIS is proposing dosimetry requirements for the irradiation of
meat food products that are almost identical to the dosimetry
requirements currently in place for the irradiation of poultry food
products. Under current and proposed requirements, establishments that
irradiate poultry or meat food products must have in place: procedures
for determining the absorbed radiation dose value from the
dosimeter(s); procedures for calibrating dosimeters and other means of
measurement (e.g., time clocks and weight scales); procedures for
ensuring specific absorbed dosages of irradiation by product unit and
product lot; and procedures for verifying the integrity of the
radiation source and the processing procedure. The current and proposed
dosimetry requirements are based upon standards promulgated by the
American Society for Testing and Materials (ASTM).
It is likely that establishments will incorporate many dosimetry
procedures into their HACCP plans. For example, procedures for
verifying routine dosimetry (i.e., ensuring each product lot receives
the total absorbed dose) could be incorporated into an HACCP plan as
critical limits for the irradiation process. Also, calibration of
dosimeters and other instruments could be incorporated as ongoing
verification activities.
Documentation Requirements
Finally, FSIS is proposing to require that any establishment
irradiating meat food products have on file, along with its validated
process schedule or HACCP plan, the following documents that relate to
its compliance with other Federal requirements concerning irradiation.
These are almost identical to the documentation requirements currently
in place for the irradiation of poultry products.
Documentation that the irradiation facility is licensed
and possesses gamma radiation sources registered with the Nuclear
Regulatory Commission (NRC) or the appropriate State government
acting under authority granted by the NRC (proposed
Sec. 318.11(c)(2)).
Documentation that the machine radiation source
irradiation facility is registered with the Occupational Safety and
Health Administration (OSHA) or the appropriate State government
acting under authority granted by OSHA, and that a worker safety
program addressing OSHA regulations is in place (proposed
Sec. 318.11(c)(3)).
Citations or other documents that relate to the
instances in which the establishment was found not to comply with
Federal or State agency requirements for irradiation facilities
(proposed Sec. 318.11(c)(4)).
Certification by the operator that the irradiation
facility personnel are operating under supervision of a person who
has successfully completed a course of instruction for operators of
food irradiation facilities (proposed Sec. 318.11(c)(5)).
Certification by the operator that the key irradiation
personnel have been trained in food technology, irradiation
processing, and radiation health and safety (proposed
Sec. 318.11(c)(6)).
Guarantees from the suppliers of all food-contact
packaging materials that may be subject to irradiation, that those
materials comply with the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) and with regulations in 21 CFR 179.45 for food
irradiation processing (proposed Sec. 318.11(c)(7)).
Labeling Requirements for Irradiated Meat Food Products
FSIS is proposing to amend Sec. 317.14 by establishing requirements
for the labels and labeling of irradiated meat and meat products. For
meat and meat products irradiated in their entirety (as opposed to a
multi-ingredient product that merely contains an irradiated
ingredient), FSIS is proposing to require that package labels contain
the radura symbol and a statement indicating that the product was
treated with irradiation. The symbol must be placed prominently and
conspicuously in conjunction with the required statement. The statement
must appear as a qualifier contiguous to the product name. Further,
FSIS is proposing to require that for unpackaged meat food products
irradiated in their entirety, the required logo and a statement must be
prominently and conspicuously displayed to purchasers either through
labeling on a bulk container or some other appropriate device. These
proposed requirements are consistent with those promulgated by FSIS for
poultry and by FDA for meat and poultry.
Under this proposal, establishments could use irradiated meat food
products as ingredients in multi-ingredient meat food products. FSIS is
proposing to require that the ingredient statement on such products
reflect the inclusion of irradiated meat food product ingredients. For
example, an ingredient statement for a sausage product containing
irradiated pork would be required to include an entry such as,
``irradiated pork'' or ``pork, treated by
[[Page 9094]]
irradiation.'' Consumers and consumer advocacy groups have requested
that such information be disclosed in the labeling of multi-ingredient
food products.
Further, disclosure of processing is consistent with current FSIS
labeling policy. For example, Sec. 317.2(e) of the meat inspection
regulations requires that ``Product which has been prepared by salting,
smoking, drying, cooking, chopping, or otherwise shall be so described
on the label unless the name of the product implies, or the manner of
packaging shows that the product was subjected to such preparation.''
Unlike the effects of these other forms of processing, the effects of
irradiation processing upon meat usually would not be detectable by the
consumer. However, some of the effects brought about by irradiation,
such as antimicrobial effects and certain changes to product quality,
are similar to the effects of other forms of processing, especially
cooking. Furthermore, the use of treatments has been considered part of
the common or usual name for various ingredients in meat food products,
such as ``dehydrated onions'' and ``reconstituted potatoes.''
Because FDA has not promulgated a similar requirement, and because
FSIS anticipates opposition from certain sectors of the meat industry,
FSIS specifically requests comment on this proposed labeling
requirement. Notably, in a recently published Advance Notice of Public
Rulemaking, FDA has requested public comment on this same issue and
other issues related to the labeling of irradiated food products. FDA's
labeling requirements and this recent notice are further discussed
below under ``Other Labeling Issues.''
Incentive Labeling for Irradiated Meat Food Products
FSIS would consider for approval labeling statements for meat food
products indicating the elimination or reduction of certain pathogens.
Under 9 CFR 381.135(c), FSIS already allows qualifiers on labels of
irradiated poultry, e.g., ``Treated by irradiation to reduce Salmonella
and other pathogens.'' The prerequisite for such labeling statements on
meat and poultry products would be a HACCP plan or process schedule
validated as achieving, through irradiation, the specific elimination
or reduction in pathogens indicated by the labeling. FSIS is proposing
to require that labeling statements indicating a specific reduction in
microbial pathogens be substantiated by processing documentation.
Further, FSIS is proposing to require that such labeling meet all other
applicable labeling requirements contained in Sec. 317.
Several representatives of the meat and poultry industries have
stated to FSIS that they would like to label product as being free of
certain pathogens as a result of irradiation, e.g., ``Free of E. coli
O157:H7.'' It may be possible for an establishment to determine the
pathogen load on incoming product, irradiate the product to completely
eliminate those pathogens with an appropriate margin of safety, and
ensure that the product remains free of that pathogen until it reaches
the consumer. FSIS requests comment on whether to allow this type of
incentive labeling. Specifically, FSIS is interested in whether it
should establish performance standards for labeling statements that
reflect a specific reduction of pathogens. For example, FSIS could
require that to use such labeling, establishments must achieve, through
a validated HACCP system incorporating irradiation, a specific
reduction of a pathogen of concern (e.g., an x-log10
reduction of E. coli O157:H7). FSIS requests comment on this regulatory
option, as well as any others, concerning the truthful labeling of
irradiated meat and poultry products.
Currently, FSIS does not have the scientific data necessary to
propose regulations that specifically address the necessary
preconditions for an ``E. coli O157:H7 free'' label or similar labels
indicating the elimination of other pathogens. Based upon comments and
other data FSIS receives, FSIS would consider a modified version of the
proposed labeling requirements in Sec. 317.2(c) that would allow the
labeling of meat products as being free of E. coli O157:H7 or other
pathogens. Following an evaluation of submitted comments and data, FSIS
will determine whether to provide for such labeling.
Other Labeling Issues
On November 21, 1997, President Clinton signed into law the FDA
Modernization Act (FDAMA) of 1997 (Pub. L. 105-115). Section 306
(Disclosure of Irradiation) of FDAMA amends the Federal Food, Drug, and
Cosmetic Act (FFDCA) by adding a new section 403C, as follows:
(a) No provision of section 201(n), 403(a), or 409 shall be
construed to require on the label or labeling of a food a separate
radiation disclosure statement that is more prominent than the
declaration of ingredients required by section 403(i)(2).
(b) In this section, the term ``radiation disclosure statement''
means a written statement that discloses that a food has been
intentionally subject to irradiation.
FDA's regulations currently do not specify how prominent a radiation
disclosure statement must be. However, FDA believed that there was
merit to amending 21 CFR 179.26 to include the prominence specification
of the new statutory provision. Accordingly, FDA has amended its
labeling provisions for irradiated foods in 21 CFR 179.26 to reflect
that a radiation disclosure statement is not required to be any more
prominent than the declaration of ingredients required under the
applicable regulation promulgated under section 403(i)(2) of the FFDCA.
The labeling requirements proposed in this document for irradiated meat
and poultry products are consistent with these FDA provisions.
Also, the Joint Explanatory Statement of the Committee of
Conference that accompanied the FDAMA directed FDA to publish for
public comment proposed changes to current regulations relating to the
labeling of foods treated with ionizing radiation. In response, on
February 17, 1997, FDA published an Advance Notice of Proposed
Rulemaking concerning possible revisions to the labeling requirements
for irradiated food (64 FR 7834). In keeping with the FDAMA joint
statement, FDA is specifically requesting comments on two issues: (1)
Whether the wording of the current radiation disclosure statement
should be revised and (2) whether such labeling requirements should
expire at a specified date in the future. FDA also is requesting
comments on other possible revisions to other labeling requirements for
irradiated food, including the possibility of requiring disclosure of
irradiated ingredients in multi-ingredient food products. FSIS will
continue to consult with FDA on their labeling requirements and will
also review the comments submitted in response to their notice. As is
necessary and appropriate, FSIS will make any final labeling
requirements for irradiated meat and poultry products that are
consistent with the labeling requirements promulgated by FDA.
Finally, in the course of developing this proposal, FSIS received a
petition from the National Food Processors Association (NFPA) regarding
labeling requirements for irradiated food. Specifically, NFPA requested
that FSIS address whether labeling requirements concerning the
disclosure of irradiation are warranted for meat and poultry, and how
such labeling affects consumer acceptance of irradiation. FSIS is
reviewing this petition and will respond following its review of
comments on this proposed rule.
[[Page 9095]]
Other Requirements
Establishments that irradiate meat food products are ``official
establishments,'' as defined by Sec. 301.2(zz) of the regulations.
Consequently, irradiation facilities will have to comply with all of
the applicable regulatory requirements governing the processing of meat
food products, including requirements concerning grants of inspection,
sanitation, and the development and implementation of Sanitation
Standard Operating Procedures and HACCP plans.
Revision of the Requirements for Irradiated Poultry
FSIS's regulations governing the irradiation of meat and poultry
products must be based upon FDA's requirements for the use of ionizing
radiation as an additive in those products. FDA's requirements for the
use of ionizing radiation as an additive in poultry are far more
restrictive than their recently issued requirements for the use of
ionizing radiation as an additive in meat food products. Therefore,
until FDA changes certain requirements concerning ionizing radiation as
an additive in poultry, FSIS will be unable to make its requirements
for irradiated poultry entirely consistent with those for irradiated
meat. For example, FSIS cannot propose to change the restrictions on
the maximum irradiation dose for poultry, the types of poultry products
allowed to be irradiated, and certain packaging requirements. However,
FSIS is proposing other permissible changes to the poultry regulations
to make them as consistent as possible with the meat regulations and
with HACCP.
First, FSIS is proposing to eliminate the requirements in
Secs. 381.19 and 381.149 that establishments irradiate poultry only in
accordance with Partial Quality Control programs (PQC's). Instead, FSIS
is proposing to require that, like meat establishments, poultry
establishments irradiating product develop and implement process
schedules or HACCP plans that account for the irradiation treatment.
PQC's contain all or most of the elements required in a process
schedule or HACCP plan, and all poultry establishments eventually will
be required to implement HACCP. Consequently, FSIS anticipates that
this conversion, if this proposal is finalized, will be relatively
simple and pose no significant burden.
FSIS also is proposing to eliminate the requirement that only
packaged poultry may be treated with irradiation. FSIS adopted this
requirement to ensure that the antimicrobial effects of irradiation
would be maintained throughout the processing and distribution of the
poultry:
To best ensure a reduction of the microbial load on poultry product,
FSIS believes that all irradiated poultry would be packaged, in
compliance with 21 CFR 179.25 and 179.26, prior to irradiation and
remain in the same package through the distribution in commerce to
the point of purchase.
(57 FR 19463; May 6, 1992)
Because FSIS is requiring all poultry establishments to develop and
implement HACCP plans, this prescriptive packaging requirement is no
longer necessary. Under the HACCP requirements, poultry establishments
have both the responsibility and the flexibility to determine the best
means for reducing hazards within a specific processing environment. A
poultry establishment with irradiation as a CCP within its HACCP plan
may choose whatever means is appropriate to preserve the antimicrobial
effects of irradiation throughout processing and distribution. One
result of this proposed revision will be that, as with irradiated meat
food products, irradiated poultry products can be used as ingredients
in further processed products.
FSIS cannot, however, propose to rescind the FDA requirement in 21
CFR 179.26(b)(6) which mandates that if packaged poultry product is
irradiated, that packaging be air permeable: ``* * * any packaging used
shall not exclude oxygen.'' FSIS originally requested that FDA
establish this requirement for control of the pathogen C. botulinum.
FDA agreed, noting that ``use of air-permeable packaging materials
provides an extra margin of safety from C. botulinum toxin production
and spoilage in chicken incubated both aerobically (with oxygen) and
anaerobically (without oxygen)'' (57 FR 19463; May 6, 1992). In light
of the new HACCP requirements, FSIS believes that this prescriptive
requirement is no longer necessary. Under HACCP, poultry establishments
have both the responsibility and the flexibility to determine the best
means for controlling any hazards resulting from the irradiation of
product in anaerobic packaging. FSIS plans to petition FDA to eliminate
this packaging requirement.
FSIS is proposing to eliminate the minimum dose requirement for
irradiated poultry contained in Sec. 381.147(f)(4). FSIS adopted this
requirement to ensure that the irradiation of poultry, which may occur
only after the product is packaged for retail sale, does in fact
achieve a specific reduction in pathogens. However, as stated above,
FDA and FSIS have concluded that different doses of ionizing radiation
can be appropriate, in different circumstances, for achieving different
technical effects and, therefore, that to continue to require a minimum
dose of irradiation for poultry would limit the flexibility needed for
the successful implementation of HACCP. FSIS considers irradiation to
be just one of many treatments that could be used within a HACCP system
to achieve a compounded reduction in pathogens.
The optional labeling statements currently allowed for irradiated
poultry in Sec. 381.135(c) are premised upon an establishment employing
the minimum dose. As with meat food products, FSIS is proposing instead
to approve qualifiers based upon whether a poultry establishment has in
place a HACCP plan or process schedule validated as achieving, through
irradiation, the elimination or reduction of pathogens indicated on the
label (proposed Sec. 381.135(c)).
FSIS cannot propose to revise the FDA limits on the maximum
absorbed radiation dose for poultry. However, it is possible that
poultry may be safely treated with higher doses of radiation than that
which are currently allowed. Higher doses could achieve greater
reductions in pathogens. FSIS intends to petition FDA to reconsider and
raise the limit on the maximum absorbed dose of radiation in poultry.
FSIS is proposing to eliminate two of the labeling requirements in
Sec. 381.135(a): the requirement that the radura logo on irradiated
poultry labels must be colored green and the requirement that ``letters
used for the qualifying statement shall be no less than one-third the
size of the largest letter in the product name.'' The elimination of
these requirements will make FSIS requirements consistent with FDA
requirements and provide more flexibility for labeling irradiated meat
and poultry products, without affecting the information content of such
labels.
Because FSIS is proposing to allow irradiated poultry products to
be used as ingredients in further processed products, FSIS also is
proposing to require that the ingredient statement on such products
reflect the inclusion of irradiated poultry products (Sec. 381.135(b)).
For example, an ingredient statement for a sausage product containing
irradiated poultry would be required to include an entry such as,
``irradiated poultry'' or ``poultry, treated by irradiation.''
Consumers and consumer advocacy groups have requested that such
information be disclosed in the labeling
[[Page 9096]]
of multi-ingredient food products. This proposed disclosure requirement
is identical to the requirement proposed in this document for
irradiated meat used as an ingredient. Because FDA has not promulgated
a similar requirement for irradiated meat or poultry, and because FSIS
anticipates strong opposition from certain sectors of the meat and
poultry industries, FSIS specifically requests comment on this proposed
labeling requirement.
Further, because FSIS is proposing to allow unpackaged poultry
product to be irradiated, it is proposing labeling requirements for
unpackaged, irradiated poultry product sold at the retail level
(proposed Sec. 318.135(b)). The proposed labeling requirements are
consistent with those proposed for unpackaged, irradiated meat food
products and with FDA labeling requirements for irradiated products
sold in bulk (21 CFR 179.26(c)(2)).
Finally, to further streamline and clarify the regulations
governing the irradiation of poultry, FSIS is proposing to remove the
``Definitions'' section from those regulations (current
Sec. 381.149(a)). These definitions serve as general references for the
PQC requirements that FSIS is proposing to remove from the regulations.
Further, these definitions are already acknowledged and understood by
irradiation facilities, as they are a paraphrase of those provided by
ASTM.
Combination Meat and Poultry Products
Under the proposed requirements, FSIS will allow products composed
of both meat and poultry to be irradiated. Such products would have to
meet the requirements in proposed Sec. 318.7(c)(4) and in existing
Sec. 381.147(f)(4) concerning the types of meat and poultry products
that may be irradiated. Furthermore, establishments that irradiate
combination product in its entirety will be required to meet the more
restrictive requirements of the FSIS poultry irradiation regulations,
namely the maximum radiation dose requirement in 9 CFR 381.147(f)(4)
and the air-permeable packaging requirement in 9 CFR 381.149(c)(7).
FSIS anticipates that establishments producing low-fat products, such
as pepperoni or salami composed of both meat and poultry, will be
especially interested in irradiation as an antimicrobial treatment.
Risk Analysis
Section 304 of the Federal Crop Insurance Reform and Department of
Agriculture Reorganization Act of 1994 (P.L. 103-354) requires any
regulation published by USDA concerning human health, safety, or the
environment, and having an annual economic impact of at least $100
million in 1994 dollars, contain a risk assessment and cost-benefit
analysis. The risk assessment and cost-benefit analysis must be
``performed consistently and use reasonably obtainable and sound
scientific, technical, economic, and other data.'' The USDA Office of
Risk Assessment and Cost-Benefit Analysis (ORACBA), also established by
the 1994 Act, must ensure that major rules include such analyses.
ORACBA and FSIS have agreed that FDA has already conducted a
definitive risk analysis concerning the safety of meat food products
treated with ionizing radiation in developing their final rule,
``Irradiation in the Production, Processing and Handling of Food'' (62
FR 64107; December 3, 1997). Therefore, FSIS and ORACBA are adopting
the FDA finding as their risk assessment. Further, FSIS and ORACBA also
have agreed that the cost-benefit and economic impact analyses that
FSIS has performed for this proposed rule, as required by E.O. 12866
and the Regulatory Flexibility Act, satisfy the cost-benefit analysis
requirements of the Reorganization Act. Consequently, FSIS, with
assistance from ORACBA, has produced only an analytical literature
review addressing existing research and risk assessments on the safety
of food irradiation for consumers and the related risks posed by
irradiation, including worker safety and environmental concerns. This
literature review is available from the FSIS Docket Clerk's Office (see
ADDRESSES above).
In this document, FSIS is proposing revisions to the current
regulations governing the irradiation of poultry to make them more
consistent with the proposed regulations for meat and with HACCP. These
proposed revisions to the poultry regulations would pose no new risks
to human health, the environment, or worker safety. Therefore, FSIS has
not addressed these changes in a separate risk assessment or in the
above mentioned literature review.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. States and local jurisdictions are preempted by
the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) from imposing any marking, labeling, packaging,
or ingredient requirements on federally inspected meat and poultry
products that are in addition to, or different than, those imposed
under the FMIA and PPIA. States and local jurisdictions may, however,
exercise concurrent jurisdiction over meat products that are outside
official establishments for the purpose of preventing the distribution
of meat and poultry products that are misbranded or adulterated under
the FMIA and PPIA, or, in the case of imported articles, that are not
at such an establishment, after their entry into the United States.
This proposed rule is not intended to have retroactive effect.
If this proposed rule is adopted, administrative proceedings will
not be required before parties may file suit in court challenging this
rule. However, the administrative procedures specified in 9 CFR 306.5
and 381.35 must be exhausted prior to any judicial challenge of the
application of the provisions of this proposed rule, if the challenge
involves any decision of an FSIS employee relating to inspection
services provided under the FMIA or PPIA.
Compliance With Executive Order 12866--Preliminary Analysis
This action has been reviewed for compliance with Executive Order
12866. As this action is determined to be economically significant for
purposes of Executive Order 12866, the Office of Management and Budget
has reviewed it.
On December 3, 1997, FDA granted a petition from Isomedix, Inc.
requesting that FDA permit the use of ionizing radiation to treat the
fresh or frozen raw edible tissue of domesticated mammalian human food
sources for purposes of reduction of parasites and microbial pathogens
and extension of product shelf-life. Accordingly, in this document,
FSIS is proposing to amend its meat inspection regulations to allow for
the safe use of ionizing radiation for the treatment of meat, meat
byproducts, and certain other meat food products. FSIS also is
proposing to revise the existing regulations governing the irradiation
of poultry so as to render them more consistent with the proposed
regulations for meat.
FSIS has endeavored to propose regulations for the irradiation of
meat food products that set forth performance objectives, rather than
prescribe specific processing methods. For the irradiation of meat food
products, and where possible for the irradiation of poultry products,
FSIS has proposed requirements that allow for significant flexibility
in integrating irradiation into the processing environment. It is
possible that FSIS will be able to provide for even greater flexibility
based upon the comments received in response to this proposal.
[[Page 9097]]
If this proposal is made final, the use of ionizing irradiation as
a treatment for meat food products will be voluntary. Although FSIS
recognizes the capability of irradiation treatment to reduce pathogens
below current performance standards for pathogen reduction, the
proposed rule does not change the performance standards. With standards
unchanged, the primary benefit of the proposed rule to establishments
is the increased flexibility they are allowed with this rule.
Alternatives
Executive Order 12866 requires that FSIS identify and assess
alternative forms of regulation. FSIS considered two alternatives to
this proposed regulation: (1) not proposing to allow for the
irradiation of meat food products and (2) proposing to allow the
irradiation of meat food products only under very limited conditions,
similar to those currently prescribed for the irradiation of poultry
products. FSIS rejected these two alternatives for reasons explained
below.
No Action
Central to the FSIS food safety strategy are efforts to reduce the
level of microbiological pathogens in raw meat and poultry products.
Irradiation has been shown to be a highly effective method for reducing
the levels of microbiological pathogens in raw meat food products.
Further, FDA has concluded that irradiation of meat food products,
under the conditions requested by Isomedix, Inc. and granted by FDA,
would not present toxicological or microbiological hazards and would
not adversely affect the nutritional adequacy of these products. FSIS,
therefore, sees compelling reasons to propose regulations providing for
the irradiation of meat food products and has rejected the option of
disallowing irradiation.
Notably, the irradiation of meat food products would be voluntary.
Although it is an effective antimicrobial treatment, irradiation may
not be appropriate, feasible, or affordable in certain processing
environments. Also, in certain situations, other antimicrobial
treatments may be more effective. FSIS, therefore, is not requiring
that raw meat food products be irradiated.
Irradiation of Meat Food Products Under Limited Conditions
The existing requirement for the irradiation of poultry are fairly
prescriptive in that they mandate a minimum dosage and require that
only packaged product be irradiated. FSIS could have proposed similar
requirements for the irradiation of meat food products. However, as
explained above, FSIS believes that the minimum dosage and packaging
requirements for irradiated product, intended to ensure that the
effects of irradiation are maintained, are no longer necessary in light
of the new HACCP requirements. Therefore, FSIS is proposing no minimum
irradiation dose and no specific packaging requirements for meat food
products and is proposing to rescind the minimum dose requirements for
irradiated poultry and to revise the packaging requirements, where
possible.
Furthermore, such an action would not meet FSIS' goal to propose
regulations for the irradiation of meat food products that set forth
performance objectives, rather than prescribe specific processing
methods. For the irradiation of meat food products, and where possible
for the irradiation of poultry products, FSIS has proposed requirements
that allow for significant flexibility in integrating irradiation into
the processing environment. It is possible that FSIS will be able to
provide for even greater flexibility based upon the comments received
in response to this proposal.
Benefits
An establishment's decision to irradiate will be based on whether
the net return on an investment in irradiation is positive. If an
official establishment chooses to irradiate its meat food products, it
can be assumed from the establishment's decision to incur the expense
of irradiation that it expects the economic benefits of the investment
in irradiation to exceed the costs of that investment. In that sense,
the rule could have favorable economic consequences for firms that
choose to irradiate.
The meat industry may accrue numerous qualitative benefits from the
use of irradiation. For example, slaughter establishments will gain
added flexibility in treating products so as to meet pathogen reduction
performance standards. Similarly, processors may use irradiated meat in
further processed products. Product shelf life could be increased, the
market for meat products could expand, and exports of irradiated
products could increase. These benefits and others are discussed more
fully under the section ``Net Benefits.''
In its final rule requiring that official meat and poultry
establishments to develop and implement HACCP, the Agency estimated a
range of public health benefits that could result from the consequent
reduction of food borne microbial pathogens (61 FR 38858). Society may
realize further benefits from this proposal if the use of irradiation
results in a reduction of illnesses beyond what could be achieved by
the implementation of HACCP alone. Several types of microbial pathogens
can be present in meat food products, including E. coli O157:H7,
Salmonella, Clostridium perfringens, and the protozoan parasite
Toxoplasma gondii. Irradiation at the dose levels proposed in this
action can reduce the levels of these pathogens substantially. The
economic benefits associated with these reductions would be decreases
in the diseases associated with these pathogens, as well as
productivity losses associated with them that would not have occurred
with the implementation of HACCP. The reductions in the disease rates
would translate into a reduction in the number of visits to physicians
and hospitals.
This analysis focuses on the irradiation of ground beef. FSIS
believes that ground beef is likely to be the first meat product
irradiated in great quantity. Furthermore, ground beef constitutes a
significant proportion of beef consumption. For example, according to
an industry source, of the per capita consumption of beef at 68 pounds
(in 1998), ground beef comprised of 40 percent and another 5 to 10
percent was consumed as hamburger or other ground products. FSIS is
aware, however, of industry plans to irradiate other types of raw meat
and poultry products, including vacuum-packed primal cuts of meat,
steaks, prime ribs, and bulk poultry. If, during the comment period,
FSIS receives data concerning the types and volumes of meat and poultry
products to be irradiated under the proposed regulations, FSIS will be
able to develop an expanded cost-benefit analysis for inclusion in a
final rule.
Following a 1993 outbreak of food borne illness associated with E.
coli O157:H7 in hamburger, FSIS implemented a policy under which it
considers raw ground beef containing E. coli O157:H7 to be adulterated.
Currently, establishments can distribute ground beef containing E. coli
O157:H7 only after they have thoroughly cooked it, so as to eliminate
the pathogen. If irradiation is permitted, establishments will have a
means to effectively eliminate E. coli O157:H7 from raw ground beef
without cooking it. Establishments, therefore, would likely benefit
from the availability of irradiation as an additional treatment for
rendering adulterated raw ground beef product safe.
To give some sense of the potential benefit from the reduction of
illnesses
[[Page 9098]]
that may occur as a result of the irradiation of ground beef, an USDA
Economic Research Service (ERS) study on the use of irradiation to
reduce E. coli O157:H7 and Salmonella in ground beef, conducted before
the implementation of HACCP, is instructive. Morrison, et al. (1997),
of ERS estimated the annual pre-HACCP economic value of the health
costs and productivity losses attributable to E. coli O157:H7 to be
between $196 million and $441 million.\5\ These figures are also
reported in Table 1 (row 1). ERS calculated the annual, pre-HACCP
medical costs and productivity losses associated with salmonellosis to
range from $30 million to $111 million (Table 1, row 2).
---------------------------------------------------------------------------
\5\ Morrison, R.M., et al., ``Irradiating Ground Beef to Enhance
Food Safety,'' Food Review, January-April 1997, pp. 33-37.
---------------------------------------------------------------------------
Irradiation of ground beef is unlikely to completely eliminate the
diseases associated with consumption of ground beef because not all
ground beef is likely to be irradiated; initially acceptance of
irradiated ground beef may be slow. After consumers are informed about
the safety of irradiated ground beef, however, acceptance is likely to
increase. Morrison, et al., 1997 assumed that market acceptance, the
associated reductions in pathogens, and the decrease in the incidence
of associated diseases would be 25% over the next 20 years. It was also
assumed that the reduction in the incidence of the number of illnesses
would be directly proportional to the acceptance of irradiated ground
beef, i.e., 25%. Based on these assumptions, Table 1 (row 3 and 4)
reports the extent of pre-HACCP health and economic benefits associated
with reductions of E. coli O157:H7 and salmonellosis. (The higher
number of cases of salmonellosis, but lower economic benefits of their
reduction relative to that of E. coli O157:H7, is due to the fact that
the former is less severe compared to the latter.) The last row of
Table 1 shows that the total pre-HACCP economic benefits of reduction
in these two diseases would range from $56.5 million to $138 million.
Table 1.--Health and Economic Benefits of Irradiating Ground Beef Pre-HACCP
----------------------------------------------------------------------------------------------------------------
Low High
estimate of estimate of
Low High health health
estimate of estimate of costs in costs in
annual annual col. (1) in col. (2) in
illnesses illnesses 1995$ 1995$
million million
----------------------------------------------------------------------------------------------------------------
Total Annual Incidence of E. coli O157:H7 due to consumption 4,900 9,800 $196.0 $441.00
of ground beef.............................................
Total Annual Salmonellosis cases due to consumption of 24,000 120,000 30.0 111.00
ground beef................................................
Estimated benefits of 25% reduction in E. coli O157:H7 cases 1,225 2,450 49.0 110.25
due to irradiation.........................................
Estimated benefits of 25% reduction in Salmonellosis cases 6,000 30,000 7.5 27.75
due to irradiation.........................................
Total benefits from reductions in E-coli and Salmonellosis.. 7,225 32,450 56.5 138.00
----------------------------------------------------------------------------------------------------------------
Because these estimates were developed prior to the implementation
of the HACCP requirements, and due to the lack of data on benefits
resulting from HACCP implementation so far, these estimated benefits
are most likely higher than the benefits that would actually occur in
the current HACCP environment.
FSIS, like Morrison, et al., (1997), is assuming that 25% of
consumers will accept irradiated ground beef products. This assumption
is conservative in light of a 1993 survey, conducted by the American
Meat Institute Foundation, which reported that 54 percent of
respondents said that they would buy irradiated beef rather than non-
irradiated beef after being told that irradiation can kill pathogens in
raw meat.\6\ This survey also reported that 60 percent of respondents
said that they were willing to pay ten cents more per pound for
hamburger sold at $2/lb. if bacteria levels were ``greatly reduced by
irradiating the meat.''
---------------------------------------------------------------------------
\6\ American Meat Institute Foundation, ``Consumer Awareness,
Knowledge, and Acceptance of Food Irradiation,'' November, 1993.
---------------------------------------------------------------------------
The experience with poultry irradiation also indicates that the
benefits from poultry irradiation have been slow in being realized
because only about 1% of poultry production has been irradiated since
the final rule was published. One reason that only a small percentage
of poultry has been irradiated is that poultry primarily is sold
through product differentiation, that is, brand names of major
producers (Perdue, Holly Farms, etc.), and most of these major
producers have not irradiated their products. In the case of beef in
general and ground beef in particular, there are hardly any brand
names, so that lack of brand loyalty is likely to accelerate acceptance
of irradiated beef.
Furthermore, it is likely that the current restrictions governing
the irradiation of poultry (packaging and minimum dosage requirements)
have limited the cost-effectiveness of irradiation. FSIS is proposing
to repeal these restrictive requirements, where possible, in this
document. FSIS anticipates that numerous establishments, if granted the
processing flexibility proposed in this rule, will choose to employ
irradiation as an antimicrobial treatment for their raw poultry
products.
Incremental Costs
As explained above, if an official establishment chooses to
irradiate its meat food products, it can be assumed from the
establishment's decision to incur the expense of irradiation that it
expects the economic benefits of the investment in irradiation to
exceed the costs of that investment. Irradiation of meat food products
will be voluntary. The meat industry will not be required to have their
products irradiated, nor will consumers be forced to purchase
irradiated meat and products.
This analysis assumes that meat and poultry plants would contract
out their irradiation requirements to centralized plants. Therefore,
the costs would include fees or prices charged by these facilities.
Since irradiation of meat food products is not currently permitted,
information on prices of irradiating meat food products is not
available. If prices of irradiation were available, one would add other
incidental costs to meat establishments such as the costs of marketing,
labeling, and transportation to and from irradiation facilities to
estimate comprehensive costs of irradiation. In the absence of prices
for irradiation, one has to estimate annualized costs (in cents per
pound of meat or poultry) of irradiation to the irradiating facility.
The annualized cost of irradiation depends on fixed costs, such as
the cost
[[Page 9099]]
of Cobalt-60 irradiators and variable costs of electricity to power the
electron accelerators. The latter costs vary by throughput rate
(quantity of meat to be irradiated), the dose (kilograys or kGy), the
amount of the beam power actually absorbed by the product or the net
utilization efficiency, and the number of workers employed in a plant.
The number of workers employed in these plants is small because the
processes are highly automated.
Assuming a dosage of 2.5 kGy, Morrison (1989) estimated the
annualized per pound cost of irradiating poultry and ground beef (the
annual average of fixed and operating costs) to range from 1.2 cents/
lb. for a plant having the capacity to irradiate 52 million pounds
annually to 0.51 cents/lb. for a plant that irradiates 416 million
pounds annually.\7\ Morrison, et al. (1997), updated these annualized
cost estimates and concluded that the annualized costs for a plant that
irradiates 52 million pounds would be 1.6 cents/lb. in 1995 dollars.
This estimate assumes an annualized, constant charge after initial
costs are incurred.\8\ The 1.6 cents/lb. estimate does not include
costs of marketing the irradiated products such as labels or the costs
of transporting the product from the slaughter houses/processing
establishments to an irradiating facility.
---------------------------------------------------------------------------
\7\ Morrison, R.M., ``An Economic Analysis of electron
accelerators and Cobalt-60 for Irradiating Food,'' ERS Publication
No. 1762, June 1989.
\8\ Morrison, et al., (1989) p. 28.
---------------------------------------------------------------------------
To estimate the cost of labels, FSIS assumes that about 50 beef
plants would participate in the irradiation program with about 10
labels each. The cost of making the initial labeling plate would be
$800 per label, if the label were without any color, and printing costs
in the out years. Therefore, the initial cost of these labels would
amount to $400,000 (50 x 10 x $800 = $400,000). If FSIS were to
continue to require that the labels be green, the cost of making the
initial labeling plate would be $1,500, and the estimated total cost
would be $750,000 (50 x 10 x $1500 = $750,000). These costs would
be distributed over 1.7 billion pounds of ground beef (7 billion pounds
of ground beef were sold in 1995; twenty-five per cent would be 1.7
billion pounds). FSIS assumed that the labeling costs would add about
0.2 cents/lb. to the irradiation costs. Such an addition would increase
the irradiation cost from 1.6 to 1.8 cents/lb. (in 1995 dollars).
FSIS is proposing to require that single ingredient meat or poultry
products irradiated in their entirety be labeled with a radura and a
statement indicating that the product was irradiated. FSIS also is
proposing to require disclosure, in the ingredients statements, that
multi-ingredient products contain irradiated meat or poultry
ingredients. FSIS also is considering the possibility of allowing
irradiated meat or poultry products to be labeled as being free of
certain pathogens, under certain circumstances. FSIS requests comments
on these estimated labeling costs, as well as comments on the economic
effects of changes to the proposed labeling requirements and the
possible use of incentive labeling for irradiated meat and poultry
products.
FSIS conservatively assumes the costs of transporting ground beef
from slaughter houses/processing plants to and from irradiating
facilities at 0.2 cents/lb. Therefore, the incremental cost of
irradiation would amount to 2.0 cents/lb. (1.6 + 0.2 + 0.2). These
costs are shown in Table 2. The last column of Table 2 reveals that the
cost of irradiating 1.7 billion pounds of ground beef at 2 cents/lb.
would amount to $35 million. It must be noted that these costs refer to
a dose of 2.5 kGy and hence are underestimated compared to the costs of
irradiating at 4.5 or 7 kGy as permitted under the proposed rule.
Information on extrapolating costs for irradiation at these levels is
not available. FSIS requests comments on the costs of transporting meat
to and from irradiation facilities.
A second estimate of the cost of irradiating meat was available
from an engineering consulting firm. This estimate was developed as a
conceptual design by this firm for one of their meat processing
clients. The assumptions included an average dose of 3 kGy, a
production rate of 2.4 million lbs./week, a product configuration of
boxed frozen ground beef patties, employment of 20 workers and 4
supervisors, capital cost of $14.2 million, and operating cost of $1.9
million/year. The resulting cost estimate, determined by estimating
discounted present value of future costs, amounted to 2.2 cents/lb. An
addition of 0.2 cents/lb. for labeling and another 0.2 cents/lb. for
transportation would increase this cost to 2.6 cents/lb. It must be
noted that the plant size assumption of 2.4 million lbs./week
translates to a plant size of 124.8 million lbs./year. This plant is
more than double the size assumed by Morrison et al., (1997) at 52
million lbs./year. The cost estimates in Table 2, therefore, relate to
different plant sizes with different levels of utilization of capacity.
It also must be noted that these costs refer to a dose of 3kGy and
hence are lower than the costs of irradiating at 4.5 or 7 kGy, as
permitted under the rule. Information on extrapolating costs for
irradiation at these levels is not available.
A third estimate of cost can be developed from the current
approximate cost of irradiating poultry, obtained from an industry
source. For this estimate, it is assumed that the cost of irradiating
meat food products would be the same as the cost of irradiating
poultry, since the irradiation method is the same. The current cost of
irradiating poultry, for an establishment operating at only 5% of
capacity, is approximately 6 cents/lb. Any increase in utilization of
capacity would spread the costs over a larger volume of production and
hence tend to reduce irradiation costs. This high cost scenario,
reported in Table 2, suggests that the incremental cost of irradiating
1.7 billion pounds of ground beef would amount to $105 million (in 1995
dollars).
The preceding cost estimate is higher than the costs FSIS
originally estimated for irradiating poultry--about a penny a pound. In
estimating the cost of irradiating poultry, ERS had assumed that 10% of
all poultry products would be irradiated. The current costs are higher
because only around one percent of poultry is being irradiated. The
lower volume of irradiation results in higher costs. Since FSIS is
proposing to remove many of the restrictions governing the irradiation
of poultry and is not proposing any similar restrictions on the
irradiation of meat, and because the demand for irradiated meat and
poultry may increase, it is very unlikely that such high costs will
continue to be incurred by the industry. FSIS anticipates that the
lower cost estimates are more likely to reflect the true future costs.
[[Page 9100]]
Table 2.--Estimated Costs of Irradiating Ground Beef
------------------------------------------------------------------------
Quantity
of ground
beef
Irradiation irradiated Irradiation
Cost scenario cost cents/ (25% of costs $
lb total million
sales) (1995$)
billion
pounds
------------------------------------------------------------------------
Low cost.......................... 2.0 1.75 $35
Midrange cost..................... 2.6 1.75 $46
High cost......................... 6.0 1.75 $105
------------------------------------------------------------------------
Net Benefits
Executive Order 12866 requires the proposed action maximize net
benefits to society, including potential economic, environmental,
public health and safety benefits, distributional impacts and equity.
FSIS believes that the net benefits of the proposed action are
positive. However, the current lack of quantification of both benefits
and costs would make comparison meaningless at this time. As discussed
above, the benefit estimates are incomplete. First, several indirect
benefits have been excluded. As mentioned above, the meat industry may
accrue qualitative benefits from the use of irradiation. Slaughter
establishments will gain added flexibility in treating products so as
to meet pathogen reduction performance standards. Similarly, processors
may use irradiated meat in further processed products. Non-quantified
industry benefits would also include a decrease in the number of
potential court cases for product liability from avoidance of illnesses
associated with pathogens in their products. Also, the market for meat
products could expand; consumers desiring meat products with reduced
numbers of pathogens could increase the demand for irradiated products.
Market expansion could also take place via increased exports,
especially to numerous European and Asian countries, where irradiation
of poultry products already is permitted and practiced. The potential
increase in exports cannot be estimated for a lack of data. Only one of
the meat products, ground beef accounting for about one-half of the
beef industry, is analyzed. Inclusion of other meat products would tend
to increase the estimated benefits. The analysis also does not account
for the indirect benefits to consumers that include the avoidance of
costs of pain and suffering associated with the diseases. These costs
are generally greater than the direct costs of treatment of illnesses
and productivity losses. Second, FSIS has not calculated the benefits
from the reduction in illness that might occur with the use of ionizing
irradiation in meat products within the context of HACCP
implementation. Though the ground beef example discussed above is
informative, FSIS expects that substantial reductions in these
pathogens will be made with HACCP without the use of irradiation.
Therefore, any analysis of benefits from this action must account for
those reductions in illnesses and the associated costs that would have
occurred without this action.
Finally, another important economic benefit to industry, as well as
to consumers, is the extended shelf life of irradiated products.
Andrews, et al. (1998), reviewed five studies encompassing shelf lives
of different types of red meat products.\9\ Their results suggest that
shelf life of products treated with irradiation increase considerably
(d log extension) compared to untreated products These results are
reported in Table 4.
---------------------------------------------------------------------------
\9\ Andrews, L.S., et al. ``Food Preservaton Using Ionizing
Radiation,'' Review of Environmental Contaminant Toxicology, Vol.
154, 1998, pp. 1-53.
Table 4.--Shelf Life Extension of Irradiated Red Meat
------------------------------------------------------------------------
Untreated Irradiated
Meat product Dose (kGy) shelf Shelf life
life (d) (d)
------------------------------------------------------------------------
Beef................................. 2.5 2-3 9
Beef top round....................... 2.0 8-11 28
Beef burgers......................... 1.54 8-10 26-28
Beef cuts............................ 2.0 1X 2X
Beef cuts irradiated under vacuum.... 2.0 NA 70
Corned beef.......................... 4.0 14-21 35
Lamb, whole and minced............... 2.5 7 28-35
------------------------------------------------------------------------
Source: Andrews et al., (1998), p. 26.
As with the estimates of benefits, the cost estimates also are
incomplete. The costs estimated in this analysis of the potential
irradiation of ground beef are likely to be overestimated for three
reasons. First, the cost estimates are based on the assumption that
irradiation of ground beef would take place in the smallest, and hence
the least efficient, plant having the capacity to irradiate only 52
million pounds per year. An increase in capacity to, for instance, 416
million pounds per year would reduce annualized operating costs to less
than half the estimated costs (from 1.2 cents for 52 million pounds
size to 0.51 cents for 416 million pounds). Second, the cost estimation
assumes that all beef
[[Page 9101]]
slaughtering/processing plants would ship their products to an
independent irradiating facility. To save the shipping costs, it is
possible that large slaughter/processing plants might set up their own
on-line irradiating facilities, using electron accelerators instead of
Cobalt 60. These on-line irradiation facilities are likely to have
lower operating costs. For example Morrison (1989) notes that electron
accelerators or machine irradiators have significantly declining unit
costs at annual throughput between 50 and 100 million pounds, and even
between 100 and 200 million pounds. Third, this analysis assumes that
only 25 percent of ground beef would be irradiated. Any increase in the
irradiation quantity would tend to reduce costs considerably.
Furthermore, because this proposal will allow for the irradiation
of numerous meat food products other than ground beef and numerous
poultry products which previously could not be irradiated, it is
possible that the social and economic benefits of the proposed
regulations have been underestimated in this analysis. As stated above,
FSIS is aware of industry plans to irradiate several other types of raw
meat and poultry products. Again, FSIS requests comments specific to
this analysis, as well as any additional relevant data. Using such
data, FSIS will develop an expanded cost-benefit analysis for inclusion
in a final rule.
Compliance With Regulatory Flexibility Act of 1996
The Administrator has determined that, for the purposes of the
Regulatory Flexibility Act (5 U.S.C. 601-612), this proposed rule would
not have a significant economic impact on a substantial number of small
entities.
Data from the U.S. Bureau of Census, Survey of Industries, 1994,
indicate that the beef industry is predominated by small firms and
establishments. For example, based on the U.S. Small Business
Administration definition of small business by the number of employees
(fewer than 500), 96% of 1,226 firms comprising this industry are
small. Similarly, 90% of individual meat establishments or plants in
this industry are small. In 1994, these small businesses accounted for
19% of total employment in the industry. Their share of payroll was 18%
of the total payroll of $2.8 billion and their revenues were 16% of the
total revenues of $55.8 billion. FSIS believes that these small
businesses would not be affected adversely by the proposed irradiation
requirements since the use of irradiation would be voluntary; no meat
establishments, large or small, would be required to irradiate their
product under this rule.
In the long term, however, these small establishments may start
irradiating their products to keep their market shares. In so doing,
they may be affected relative to large size establishments because of
economies of scale in irradiation. For example, bulk discounts provided
by irradiating facilities would be realized mainly by the large size
establishments. FSIS requests comment and data regarding the impact of
the proposed regulations on small businesses.
Purchase of irradiated ground beef also is voluntary for consumers.
Moreover, the estimated impact of the incremental cost of 2 to 6 cents
per pound of irradiated ground beef is an insignificant proportion of
the approximate price of ground beef, $2 per pound. Above all, the
industry would be able to pass through the cost of irradiation to
consumers without losing its market share significantly because demand
for beef products is very inelastic. Huang (1993) analyzed a group of
meats and other animal proteins consisting of products including beef
and veal, pork, other meats, chicken, turkey, fresh and frozen fish,
canned and cured fish, eggs and cheese. He concluded that price
elasticity of demand for this group of products was (-0.3611), i.e., a
one percent increase in price for one of these products would reduce
demand by only 0.3611 percent.\10\
---------------------------------------------------------------------------
\10\ Huang, Kao S., A Complete System of U.S. Demand for Food,
ERS Technical Bulletin No. 1821, 1993, p. 24.
---------------------------------------------------------------------------
Review of about a dozen recent studies annotated by William Hahn of
the Economic Research Service reveals that estimates of price
elasticity of demand for most beef products (ground beef, steak, chuck
roast, etc.) is less than one.\11\ This implies that demand for beef
products is price-insensitive because an increase in price of any one
of these products by one percent would result in a decrease in its
demand by less than one percent. In short, consumers are unlikely to
reduce their demand for beef significantly when beef price is increased
by a few pennies a pound. In fact, some consumers may demand irradiated
product, even at higher prices per pound. Therefore, the small
businesses in this industry are unlikely to be impacted adversely by an
increase in price associated with irradiation.
---------------------------------------------------------------------------
\11\ Hahn, William F., An Annotated Bibliography of Recent
Elasticity and Flexibility Estimates for Meat and Livestock, Staff
Paper, Commercial Agriculture Division, Economic Research Service,
July 1996, pp. 1-19.
---------------------------------------------------------------------------
The supply of beef products also is likely to be very price
elastic. The high elasticity of supply is attributable to the presence
of over 1,200 firms in this industry, 96 percent of whom are small
businesses. Any single producer cannot raise prices of its products
without losing its market share significantly.
The proposed action would have a negligible economic impact on
other small organizations or entities that are not engaged in the
business of processing meat and meat products. To the extent that these
entities purchase irradiated meat products, they could be impacted
somewhat by an increase in price.
Finally, FSIS is proposing to revise the regulatory requirements
concerning the irradiation of poultry for consistency with HACCP and
with the requirements proposed for meat food products. Significantly,
FSIS is proposing to eliminate the minimum dosage requirements, certain
packaging requirements, and the requirement that poultry establishments
develop and implement PQC's addressing irradiation. All poultry
establishments are required to develop and implement HACCP; the costs
of HACCP will probably offset any benefits from the elimination of the
PQC requirements. However, FSIS assumes that large and small poultry
establishments will realize benefits from the reduction in the cost of
compliance with some of the packaging requirements and the minimum
dosage for irradiated poultry. In addition, the industry will also
benefit from the expansion in its market for other poultry products
that could be irradiated under this proposal. Consumers also could
benefit from the availability of a wider variety of irradiated poultry
products.
Executive Order 12898
Pursuant to Executive Order 12898, ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations,'' FSIS has considered potential impacts of this proposed
rule on environmental and health conditions in low-income and minority
communities.
This proposed rule would allow the use of ionizing radiation for
treating fresh or frozen uncooked meat, meat byproducts, and certain
meat food products to reduce levels of pathogens. As explained in the
economic impact analysis above, the proposed regulations should
generally benefit FSIS, the regulated industry, and consumers. The
proposed regulations would not require or compel meat or poultry
establishments to relocate or alter their
[[Page 9102]]
operations in ways that could adversely affect the public health or
environment in low-income and minority communities. Further, this
proposed rule would not exclude any persons or populations from
participation in FSIS programs, deny any persons or populations the
benefits of FSIS programs, or subject any persons or populations to
discrimination because of their race, color, or national origin.
Establishments choosing to irradiate meat or meat products would be
required to comply not only with FSIS and FDA requirements regarding
the safety of irradiated product, but also with NRC, EPA, OSHA, DOT,
and State and local government requirements governing the operation of
irradiation facilities. Compliance with these requirements would ensure
the maintenance of appropriate environmental, worker safety, and public
health protections, thus further reducing the probability that this
rule would have any disparate impact on low-income or minority
communities. FSIS currently is investigating the possibility of
developing stronger partnerships with these Federal, State, and local
agencies so as to better ensure the maintenance of environmental,
worker safety, and public health protections.
Paperwork Requirements
Title: Irradiation of Meat and Poultry Products
Type of Collection: New
Abstract: FSIS has reviewed the paperwork and record keeping
requirements in this proposed rule in accordance with the Paperwork
Reduction Act. Under this proposed rule, FSIS is requiring several
information collection and record keeping activities. FSIS is proposing
to require that establishments conduct irradiation of meat and meat
products only in accordance with either an HACCP plan, as defined in
Part 417 of the FSIS meat and poultry inspection regulations, or a
process schedule validated for efficacy by a processing authority
(proposed Sec. 318.11(a)). Written irradiation procedures must describe
the specific, sequential operations employed by the establishment in
the irradiation and associated processing of meat food products,
including the control, validation, monitoring, and corrective action
activities. FSIS also is proposing to require that establishments
implement a dosimetry system to measure the dosage of radiation
absorbed by product. FSIS also is requiring that any establishment
irradiating meat food products have on file a number of documents as
identified in the section ``Documentation Requirements.'' Finally,
products irradiated by establishments would need to be properly
labeled.
FSIS inspection personnel would initially, and periodically as
required, review the records from the process schedule or HACCP plan,
the required documentation, and the product labels. FSIS personnel
would not evaluate the procedures for efficacy.
Estimate of Burden: FSIS estimates that the development of a HACCP
plan or process schedule would take an average of 2 days (16 hours) and
5 minutes to file. FSIS estimates that an establishment will spend
about 5 minutes a day developing an average of 8 monitoring records,
per HACCP plan or process schedule, and 2 minutes a day filing each
record. These monitoring records are highly likely to include records
of dosimetry measurements, since establishments that irradiate product
will probably select dosimetry as the monitoring step for an
irradiation CCP. FSIS estimates that it would take an establishment 30
minutes for the preparation of each of the necessary documents
discussed in the ``Required Documentation'' section of this preamble
and about 5 minutes to file each document. FSIS estimates that an
establishment would develop about 10 new product labels and each label
would be developed in about 2 hours. Because of the elimination of the
partial quality control requirements for poultry irradiation, FSIS
would request OMB to delete the 60 hours of burden approved for poultry
irradiation under the OMB approval number 0583-0090.
Respondents: Meat and poultry product establishments and
irradiation facilities.
Estimated Number of Respondents: 10 (this number represents the
current number of facilities with the capability to irradiate meat and
poultry products).
Estimated Number of Responses per Respondent: 4009.
Estimated Total Annual Burden on Respondents: 2,730 hours.
Copies of this information collection assessment can be obtained
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection
Service, USDA, 112 Annex, 300 12th St., SW, Washington DC 20250.
Comments are invited on: (a) whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; (b) the accuracy of the Agency's estimate of the burden of the
proposed collection of information including the validity of the
methodology and assumptions used: (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
Comments may be sent to Lee Puricelli, see address above, and the
Desk Officer for Agriculture, Office of Information and Regulatory
Affairs, Office of Management and Budget, Washington, DC 20253.
Comments are requested by April 26, 1999. To be most effective,
comments should be sent to OMB within 30 days of the publication date.
List of Subjects
9 CFR Part 317
Food labeling, Food packaging, Meat inspection, Reporting and
recordkeeping requirements.
9 CFR Part 318
Food additives, Food packaging, Meat inspection, Reporting and
recordkeeping requirements, Signs and symbols.
9 CFR Part 381
Food labeling, Poultry and poultry products, Reporting and
recordkeeping requirements, Signs and symbols.
Accordingly, title 9, chapter III, of the Code of Federal
Regulations is proposed to be amended as follows:
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
1. The authority citation for part 317 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
2. Section 317.14 would be added to read as follows:
Sec. 317.14 Irradiated meat food products.
(a) The labels on packages of meat food products irradiated in
their entirety, in conformance with Sec. 318.7(c)(4) of this chapter,
must bear the following logo along with a statement such as ``Treated
with radiation'' or ``Treated by irradiation.'' The logo must be placed
prominently and conspicuously in conjunction with the required
statement. The statement must appear as a qualifier contiguous to the
product name. Any label bearing the logo and any wording of explanation
with respect to this logo must be approved as required by Sec. 317.4.
This
[[Page 9103]]
requirement applies only to meat food products irradiated in their
entirety, not to multi-ingredient products that merely contain an
irradiated ingredient. The logo is as follows:
[GRAPHIC] [TIFF OMITTED] TP24FE99.000
(b) For meat food products irradiated in their entirety, but not in
package form, the required logo and a statement such as ``Treated with
radiation'' or ``Treated by irradiation'' shall be displayed to the
purchaser with either the labeling of the bulk container plainly in
view or a counter sign, card, or other appropriate device bearing the
information that the product has been treated with radiation. In either
case, the information must be prominently and conspicuously displayed
to purchasers. This requirement applies only to meat food products
irradiated in their entirety, not to multi-ingredient products that
merely contain an irradiated ingredient.
(c) The inclusion of an irradiated meat food product ingredient in
any multi-ingredient meat food product must be indicated in the
ingredient statement on the finished product labeling.
(d) Optional labeling statements about the purpose for radiation
processing may be included on the product label in addition to the
stated requirements elsewhere in this section. Such statements must not
be false or misleading. Statements indicating a specific reduction in
microbial pathogens must be substantiated by processing documentation.
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCT
3. The authority citation for part 318 would continue to read as
follows:
Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7
CFR 2.18, 2.53.
4. Section 318.7(c)(4) would be amended by removing the entry for
``Sources of radiation'' in the chart of substances and adding an entry
for ``Radiation sources'' in alphabetical order, to read as follows:
Sec. 318.7 Approval of substances for use in the preparation of
products.
* * * * *
(c) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Class of
substance Substance Purpose Products Amount
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Radiation Ionizing radiation For control of food Refrigerated or frozen, No more than 4.5
sources. sources approved in 21 borne pathogens and the uncooked meat, as kiloGrays (450
CFR 179.26(a). extension of shelf- defined in 9 CFR kilorads) for
life.. 301.2(rr); meat refrigerated
byproducts, as defined products and no
in 9 CFR 301.2(tt); and more than 7
other meat food kiloGrays (700
products within the kilorads) for
meaning of 9 CFR frozen product.
301.2(uu), with or
without nonfluid
seasoning, that are
otherwise composed
solely of intact or
gound meat and/or meat
byproducts.
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
* * * * *
5. Section 318.11 would be added to read as follows:
Sec. 318.11 Irradiation of meat food products.
(a) General requirements. (1) Meat food products may be treated to
reduce food borne pathogens by the use of ionizing radiation as
identified in Sec. 318.7(c)(4). Official establishments may irradiate
meat food products for food uses only in accordance with
Sec. 318.7(c)(4) and the Hazard Analysis and Critical Control Point
(HACCP) system requirements in part 417 of this chapter or, if not yet
operating under HACCP, in accordance with a process schedule, as
defined in Sec. 301.2 of this chapter.
(2) Each process schedule must be approved in writing by a process
authority for safety and efficacy. A process authority must have access
to the establishment in order to evaluate and approve the safety and
efficacy of each process schedule. Under the auspices of a processing
authority, an establishment must validate new or altered process
schedules by scientifically supportable means, such as information
gleaned from the literature or by challenge studies conducted outside
the plant.
(b) Dosimetry. Official establishments that irradiate meat food
products must have the following procedures in place:
(1) Laboratory operation procedures for determining the absorbed
dose value from the dosimeter.
(2) Calibration criteria for verifying the accuracy and consistency
of any means of measurement (e.g., time clocks and weight scales).
(3) Calibration and accountability criteria for verifying the
traceability and accuracy of dosimeters for the intended purpose, and
the verification of calibration at least every 12 months. To confirm
traceablility, establishments must relate, through documentation, the
end point measurement of a dosimeter to recognized standards.
(4) Procedures for ensuring that the product unit is dose mapped to
identify the regions of minimum and maximum absorbed dose and such
regions are consistent from one product unit to another of like
product.
(5) Procedures for accounting for the total absorbed dose received
by the product unit (e.g., partial applications of the absorbed dose
within one production lot).
(6) Procedures for verifying routine dosimetry (i.e., assuring each
production lot receives the total absorbed dose). Each production lot
must have at least one dosimeter positioned at the regions of minimum
and maximum absorbed dose (or at one region verified to represent such)
on at least the first, middle, and last product unit.
(7) Procedures for verifying the relationship of absorbed dose as
measured by the dosimeter to time exposure of the product unit to the
radiation source.
(8) Procedures for verifying the integrity of the radiation source
and processing procedure. Aside from expected and verified radiation
source activity decay for radionuclide sources, the radiation source or
processing procedure must not be altered, modified, replenished, or
adjusted without repeating dose mapping of
[[Page 9104]]
product units to redefine the regions of minimum and maximum absorbed
dose.
(c) Documentation. Official establishments that irradiate meat
products must have the following documentation on premises, available
to FSIS:
(1) The validated process schedule, if the establishment is not
operating under HACCP.
(2) Documentation that the irradiation facility is licensed or
possesses gamma radiation sources registered with the Nuclear
Regulatory Commission (NRC) or the appropriate State government acting
under authority granted by the NRC.
(3) Documentation that the machine radiation source irradiation
facility is registered with the Occupational Safety and Health
Administration (OSHA) or the appropriate State government acting under
authority granted by OSHA, and that a worker safety program addressing
OSHA regulations (29 CFR chapter XVII) is in place.
(4) Citations or other documents that relate to incidences in which
the establishment was found not to comply with Federal or State agency
requirements for irradiation facilities.
(5) A certification by the operator that the irradiation facility
personnel would operate under supervision of a person who has
successfully completed a course of instruction for operators of food
irradiation facilities.
(6) A certification by the operator that the key irradiation
personnel have been trained in food technology, irradiation processing,
and radiation health and safety.
(7) Guarantees from the suppliers of all food-contact packaging
materials that may be subject to irradiation that those materials
comply with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.) and with regulations in 21 CFR 179.45 for food irradiation
processing.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
6. The authority citation for part 381 would continue to read as
follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18,
2.53.
Sec. 381.19 [Removed and Reserved]
7. Section 381.19 would be removed and reserved.
8. Section 381.135 would be revised to read as follows:
Sec. 381.135 Irradiated poultry product.
(a) The labels on packages of poultry food products irradiated in
their entirety, in conformance with Sec. 381.147(f)(4), must bear the
following logo along with a statement such as ``Treated with
radiation'' or ``Treated by irradiation.'' The logo must be placed
prominently and conspicuously in conjunction with the required
statement. The statement must appear as a qualifier contiguous to the
product name. Any label bearing the logo and any wording of explanation
with respect to this logo must be approved as required by subparts M
and N of this part. This requirement applies only to meat food products
irradiated in their entirety, not to multi-ingredient products that
merely contain an irradiated ingredient. The logo is as follows:
[GRAPHIC] [TIFF OMITTED] TP24FE99.001
(b) For poultry food products irradiated in their entirety, but not
in package form, the required logo and a statement such as ``Treated
with radiation'' or ``Treated by irradiation'' shall be displayed to
the purchaser with either the labeling of the bulk container plainly in
view or a counter sign, card, or other appropriate device bearing the
information that the product has been treated with radiation. In either
case, the information must be prominently and conspicuously displayed
to purchasers. This requirement applies only to poultry food products
irradiated in their entirety, not to multi-ingredient products that
merely contain an irradiated ingredient.
(c) The inclusion of an irradiated poultry food product ingredient
in any multi-ingredient poultry food product must be indicated in the
ingredient statement on the finished product labeling.
(d) Optional labeling statements about the purpose for radiation
processing may be included on the product label in addition to the
stated requirements elsewhere in this section. Such statements must not
be false or misleading. Statements indicating a specific reduction in
microbial pathogens must be substantiated by processing documentation.
Sec. 381.147 [Amended]
9. In Sec. 381.147(f)(4), the entry for ``Radiation Sources'' in
Table 1 would be amended by removing the phrase ``, packaged'' from the
sentence under the ``Products'' column; and, by revising the sentence
under the ``Amount'' column to read ``A maximum absorbed dose of 3.0
kiloGray (300 kilorads).''.
10. Section 381.149 would be revised to read as follows:
Sec. 381.149 Irradiation of poultry products.
(a) General requirements. (1) Poultry products may be treated to
reduce food borne pathogens by the use of ionizing radiation as
identified in Sec. 381.147(f)(4). Official establishments may irradiate
poultry product for food uses only in accordance with
Sec. 381.147(f)(4) and the Hazard Analysis and Critical Control Point
(HACCP) system requirements in part 417 of this chapter, or if not yet
operating under HACCP, in accordance with a process schedule, as
defined in Sec. 381.1(b).
(2) Each process schedule must be approved in writing by a process
authority for safety and efficacy. A process authority must have access
to the establishment in order to evaluate and approve the safety and
efficacy of each process schedule. Under the auspices of a processing
authority, an establishment must validate new or altered process
schedules by scientifically supportable means, such as information
gleaned from the literature or by challenge studies conducted outside
the plant.
(b) Dosimetry. Official establishments that irradiate poultry
products must have the following procedures in place:
(1) Laboratory operation procedures for determining the absorbed
dose value from the dosimeter.
(2) Calibration criteria for verifying the accuracy and consistency
of any means of measurement (e.g., time clocks and weight scales).
(3) Calibration and accountability criteria for verifying the
traceability and accuracy of dosimeters for the intended purpose, and
the verification of calibration at least every 12 months. To confirm
traceability, establishments must relate, through documentation, the
end point measurement of a dosimeter to recognized standards.
(4) Procedures for ensuring that the product unit is dose mapped to
identify the regions of minimum and maximum absorbed dose and such
regions are consistent from one product unit to another of like
product.
(5) Procedures for accounting for the total absorbed dose received
by the product unit (e.g., partial applications of the absorbed dose
within one production lot).
(6) Procedures for verifying routine dosimetry (i.e., assuring each
production lot receives the total
[[Page 9105]]
absorbed dose). Each production lot must have at least one dosimeter
positioned at the regions of minimum and maximum absorbed dose (or at
one region verified to represent such) on at least the first, middle,
and last product unit.
(7) Procedures for verifying the relationship of absorbed dose as
measured by the dosimeter to time exposure of the product unit to the
radiation source.
(8) Procedures for verifying the integrity of the radiation source
and processing procedure. Aside from expected and verified radiation
source activity decay for radionuclide sources, the radiation source or
processing procedure must not be altered, modified, replenished, or
adjusted without repeating dose mapping of product units to redefine
the regions of minimum and maximum absorbed dose.
(c) Documentation. Official establishments that irradiate poultry
products must have the following documentation on premises, available
to FSIS:
(1) The validated process schedule, if the establishment is not
operating under HACCP.
(2) Documentation showing that the irradiation facility is licensed
and/or possesses gamma radiation sources registered with the Nuclear
Regulatory Commission (NRC) or the appropriate State government acting
under authority granted by the NRC.
(3) Documentation showing that the machine radiation source
irradiation facility is registered with the Occupational Safety and
Health Administration (OSHA) or the appropriate State government acting
under authority granted by OSHA, and that a worker safety program
addressing OSHA regulations (29 CFR chapter XVII) is in place.
(4) Citations or other documents that relate to incidences in which
the establishment was found not to comply with Federal or State agency
requirements for irradiation facilities.
(5) A certification by the operator that the irradiation facility
personnel would operate under supervision of a person who has
successfully completed a course of instruction for operators of food
irradiation facilities.
(6) A certification by the operator that the key irradiation
personnel have been trained in food technology, irradiation processing,
and radiation health and safety.
(7) Guarantees from the suppliers of all food-contact packaging
materials that may be subject to irradiation that those materials
comply with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.) and with regulations in 21 CFR 179.45 for food irradiation
processing and that the food-contact packaging material is air-
permeable, but does exclude moisture and microorganisms from
penetrating the package barrier.
Done in Washington, DC on: February 18, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 99-4401 Filed 2-18-99; 3:37 pm]
BILLING CODE 3410-DM-P
