[Federal Register: February 24, 1999 (Volume 64, Number 36)]

[Proposed Rules]               

[Page 9089-9105]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr24fe99-9]



========================================================================

Proposed Rules

                                                Federal Register

________________________________________________________________________



This section of the FEDERAL REGISTER contains notices to the public of 

the proposed issuance of rules and regulations. The purpose of these 

notices is to give interested persons an opportunity to participate in 

the rule making prior to the adoption of the final rules.



========================================================================







[[Page 9089]]





-----------------------------------------------------------------------



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.



-----------------------------------------------------------------------



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:



    <bullet> 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);

    <bullet> Toxicity studies of irradiated beef, pork, chicken, and 

fish;

    <bullet> 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]]



    <bullet> Studies of the effects of irradiation on both 

pathogenic and nonpathogenic microorganisms.\1\

---------------------------------------------------------------------------



    \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.

---------------------------------------------------------------------------



    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:



    <bullet> Its use is in compliance with applicable FDA 

requirements;

    <bullet> 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

    <bullet> 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-log<INF>10</INF>) 

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\

---------------------------------------------------------------------------



    \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 log<INF>10</INF> 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 log<INF>10</INF> 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.

---------------------------------------------------------------------------



    \3\ National Advisory Committee on Microbiological Criteria for 

Foods, Meat and Poultry Subcommittee Report, November 20, 1997.

---------------------------------------------------------------------------



    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.

---------------------------------------------------------------------------



    \4\ ``Irradiation of red meat: A compilation of technical data 

for its authorization and control,'' International Consultative 

Group on Food Irradiation August 1996.

---------------------------------------------------------------------------



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:



    <bullet> 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.

    <bullet> 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.)

    <bullet> 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.



    <bullet> 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)).

    <bullet> 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)).

    <bullet> 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)).

    <bullet> 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)).

    <bullet> 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)).

    <bullet> 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-log<INF>10</INF> 

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