[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]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 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  

[[Page 9089]]


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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