[Federal Register: December 23, 1999 (Volume 64, Number 246)]

[Rules and Regulations]               

[Page 72149-72166]

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

[DOCID:fr23de99-15]                         





[[Page 72149]]



_______________________________________________________________________



Part II











Department of Agriculture











_______________________________________________________________________







Food Safety and Inspection Service







_______________________________________________________________________







9 CFR Parts 381 and 424







Irradiation of Meat Food Products; Final Rule





[[Page 72150]]







DEPARTMENT OF AGRICULTURE



Food Safety and Inspection Service



9 CFR Parts 381 and 424



[Docket No. 97-076F]



 

Irradiation of Meat Food Products



AGENCY: Food Safety and Inspection Service



ACTION: Final rule.



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



SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its 

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 foodborne pathogens and to 

extend shelf-life. FSIS also is revising the regulations governing the 

irradiation of poultry products so that they will be as consistent as 

possible with the regulations for the irradiation of meat food 

products.



EFFECTIVE DATES: February 22, 2000.



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



    On February 24, 1999, the Food Safety and Inspection Service (FSIS) 

published a proposal (64 FR 9089) to permit the use of ionizing 

radiation for treating refrigerated or frozen uncooked meat, meat 

byproducts, and certain other meat food products (hereafter referred to 

as ``meat food products'' when discussed as a group) to reduce levels 

of foodborne pathogens and to extend shelf-life. FSIS also proposed to 

revise the regulations governing the irradiation of poultry products so 

that they will be as consistent as possible with the regulations for 

the irradiation of meat food products. FSIS initially provided 60 days 

for public comment, ending the comment period on April 26, 1999. 

Because of the great interest in this proposal, FSIS reopened the 

comment period for 15 days on June 2, 1999 (64 FR 29602). FSIS 

announced that it would consider all comments received between April 

27, 1999 and June 17, 1999. In this document, FSIS makes final the 

proposed regulations, with some revision in response to comments.



Food Irradiation



    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 term ``food additive'' means any substance the intended use 

of which results or may reasonably be expected to result, directly 

or indirectly, in its becoming a component or otherwise affecting 

the characteristics of any food (including any substance intended 

for use in producing, manufacturing, packing, processing, preparing, 

treating, packaging, transporting, or holding food; and including 

any source of radiation intended for any such use), if such 

substance is not generally recognized * * * to be safe under the 

conditions of its intended use * * *.



    The Food and Drug Administration (FDA) of the Department of Health 

and Human Services has the primary responsibility for determining 

whether food additives are safe for particular uses. FDA lists uses of 

food additives it has concluded are safe in 21 CFR parts 172 through 

179.

    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 refrigerated meat, and that a 

maximum dose of 7.0 kGy be established for the irradiation of frozen 

meat.

    After an evaluation of available data, FDA concluded that there was 

a reasonable certainty of no harm from the irradiation of meat food 

products under the conditions requested in the petition and that 

irradiation would not adversely affect the nutritional adequacy of 

these products. On December 3, 1997, FDA published a final rule (FDA 

Docket No. 94F-0289; 62 FR 64107) granting the Isomedix petition. In 

that publication, FDA expanded the list of products (21 CFR 179.26(b)) 

for which ionizing irradiation may be safely used to include: 

refrigerated and frozen uncooked meat, as defined by FSIS in 9 CFR 

301.2(rr); meat byproducts (e.g., edible organs, such as the liver and 

the kidneys), as defined by FSIS in 9 CFR 301.2(tt); and certain meat 

food products (e.g., ground beef and hamburger) 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.



The FSIS Proposal



    As stated above, on February 24, 1999, FSIS proposed regulations 

governing the irradiation of refrigerated and frozen, uncooked meat 

food products and also proposed to revise the poultry irradiation 

regulations for consistency. Specifically, FSIS proposed the following:



Dosage



    FSIS proposed that the defined meat food products could be treated 

with ionizing irradiation at dosages of up to 4.5 kiloGrays (kGy), if 

refrigerated, and 7 kGy, if frozen. FSIS proposed no minimum dosage.



Process Control



    FSIS proposed to require that official establishments irradiate 

meat food products for food uses only in accordance with a Hazard 

Analysis and Critical Control Point (HACCP) system or, if not yet 

operating under HACCP requirements, in accordance with a process 

schedule validated by a process authority.



Dosimetry



    FSIS proposed to require that official establishments that 

irradiate meat food products have in place a dosimetry system to 

measure the absorbed dose of radiation. The dosimetry system would



[[Page 72151]]



ensure that each lot of treated product has received the dose defined 

in the process schedule or HACCP plan. The proposed requirements 

mandated that each dosimetry system included:

    <bullet> Procedures for determining the absorbed radiation dose 

value from the dosimeter;

    <bullet> Procedures for calibrating dosimeters and other means of 

measurement (e.g., time clocks and weight scales);

    <bullet> Procedures for ensuring specific absorbed dosages of 

irradiation by product unit and product lot; and

    <bullet> Procedures for verifying the integrity of the radiation 

source and the processing procedure.



Documentation



    FSIS proposed to require official establishments that irradiate 

meat food products to have on file the following documents that relate 

to the establishment's compliance with other Federal requirements 

concerning irradiation:

    <bullet> Documentation that an irradiation facility that possesses 

gamma radiation sources is licensed with the Nuclear Regulatory 

Commission (NRC) or the appropriate State government acting under 

authority granted by the NRC, and that a worker safety program 

addressing OSHA regulations is in place;

    <bullet> Documentation that an irradiation facility that uses 

machine radiation sources is registered with the appropriate State 

government, if applicable;

    <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;

    <bullet> Certification by the operator that the irradiation 

facility's personnel are operating under the supervision of a person 

who has successfully completed a course of instruction for operators of 

food irradiation facilities;

    <bullet> Certification by the operator that the key irradiation 

personnel have been trained in food technology, irradiation processing, 

and radiation health and safety; and

    <bullet> Guarantees from the suppliers of all food-contact 

packaging materials that may be subject to irradiation, that those 

materials comply with the FFDCA (21 U.S.C. 301 et seq.).



Labeling



    FSIS proposed that labeling for packaged meat food products 

irradiated in their entirety bear the radura logo along with a 

statement such as ``Treated with radiation'' or ``Treated by 

irradiation.'' FSIS proposed that the logo be placed prominently and 

conspicuously in conjunction with the required statement and that the 

statement appear as a qualifier contiguous to the product name. Also, 

FSIS proposed to require that inclusion of an irradiated meat food 

product ingredient in any multi-ingredient product be reflected in the 

ingredient statement on the finished product labeling. Finally, FSIS 

stated that it would allow optional labeling statements about the 

purpose for radiation processing to be included on the product label in 

addition to the above stated requirements. Statements indicating a 

specific reduction in microbial pathogens would have to be 

substantiated by processing documentation.

    FSIS proposed 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.



Poultry



    FSIS also proposed to revise the existing regulations governing the 

irradiation of poultry products to make them as consistent as possible 

with the regulations proposed for meat food products. FSIS proposed to 

eliminate the regulations requiring that establishments irradiate 

poultry products only in accordance with Partial Quality Control 

programs and to instead require that poultry establishments, like meat 

establishments, irradiate product in accordance with HACCP plans or 

process schedules. FSIS also proposed to eliminate the provision that 

stated that only packaged poultry products may be treated with 

irradiation. FSIS had adopted this requirement to ensure that the 

antimicrobial effects of irradiation would be maintained throughout the 

processing and distribution of the poultry products. However, because 

under the proposal all poultry establishments would be required to 

develop and implement HACCP plans, this prescriptive packaging 

requirement would no longer be necessary.

    FSIS could not, however, propose to rescind the FDA requirement in 

21 CFR 179.26(b)(6) 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. In light of the 

new HACCP requirements, 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 submitted a petition to FDA on August 19, 

1999, to eliminate this packaging requirement.

    FSIS proposed to eliminate the minimum dose requirement for 

irradiated poultry products contained in Sec. 381.147(f)(4). FSIS 

adopted this requirement to ensure that the irradiation of poultry 

product, which may occur only after the product is packaged for retail 

sale, does in fact achieve a specific reduction in pathogens. However, 

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 products 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 reduction in pathogens.

    FSIS could not propose to revise the FDA limits on the maximum 

absorbed radiation dose for poultry products. However, it is possible 

that poultry products could be safely treated with higher doses of 

radiation than those that are currently allowed. Higher doses could 

achieve greater reductions in pathogens. In the August 19, 1999, 

petition mentioned above, FSIS asked FDA to reconsider and raise the 

limit on the maximum absorbed dose of radiation in poultry products.

    FSIS proposed to eliminate two of the labeling requirements in 

Sec. 381.135(a): the requirement that the radura logo on irradiated 

poultry product labels 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 poultry products, without affecting the information 

content of such labels.

    Because FSIS proposed to allow unpackaged poultry product to be 

irradiated, it also proposed 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,



[[Page 72152]]



irradiated meat food products and with FDA labeling requirements for 

irradiated products sold in bulk (21 CFR 179.26(c)(2)).

    Also, because FSIS proposed to allow irradiated poultry products to 

be used as ingredients in further processed products, FSIS also 

proposed to require that the ingredient statement on such products 

reflect the inclusion of irradiated poultry products (Sec. 381.135(b)). 

For example, under the proposal, 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.''



Comments and Responses



    By the close of the comment period, FSIS received about 1,100 

comments from consumers, consumer advocacy organizations, academia, 

trade and professional associations, scientific organizations, the meat 

and poultry products industries, the irradiation equipment industry, 

industry consultants, and State governments. Generally, industry, 

academia, and professional organizations supported the proposal. These 

commenters expressed concerns about the proposed labeling requirements, 

which they believe are too prescriptive, about the length of time it 

took to publish the proposal, and made recommendations for broadening 

the scope of the proposal. Consumer advocacy groups, for the most part, 

expressed qualified support for the proposal. All expressed concern 

that establishments will use irradiation to treat product produced 

under insanitary conditions and all wanted FSIS to require explicit and 

conspicuous product labeling. Many of the individual consumers and a 

few organizations opposed the irradiation of meat food products 

altogether, but demanded explicit and conspicuous product labeling in 

the event FSIS allowed it. Summaries of issues raised by commenters and 

Agency responses follow.



Safety of Irradiation



    Comment: Numerous consumers questioned the research regarding the 

safety of irradiated food. Some demanded more research before 

irradiation is allowed; some opposed irradiation altogether. Several 

opposed irradiation because they believe it will significantly degrade 

the nutritional quality of treated food.

    A few commenters opposed irradiation because, they asserted, its 

use would increase the risk of accidents involving radioactive 

material. Some raised concerns about worker safety and environmental 

issues related to irradiation. One consumer advocacy group argued that 

the rule's potential impact on the environment must be reviewed under 

the National Environmental Policy Act (NEPA, 42 U.S.C. 4321 et seq.). 

Finally, a few consumers requested that parents be asked to give their 

permission before their children are served irradiated food in the 

school lunch program.

    Response: The safety and efficacy of food irradiation, as 

demonstrated by numerous experiments and studies, is widely accepted by 

Federal regulatory agencies and national and international food and 

public health organizations. Before listing the uses of sources of 

ionizing radiation permitted on meat food products, as well as on other 

foods, FDA examined numerous studies on the chemical effects of 

radiation, the impact of radiation on nutrient content of foods, 

potential toxicity concerns, and effects on microorganisms in or on 

irradiated products. FDA concluded that irradiation is safe in reducing 

disease-causing microbes in or on meat food products and that it does 

not compromise the nutritional quality of treated products. 

Furthermore, the World Health Organization, the Food and Agriculture 

Organization, the American Medical Association, and the American 

Dietetic Association endorse food irradiation.

    FSIS has examined the potential impacts of food irradiation in a 

review of risk analysis literature made available with the proposed 

rule. This literature review is available from the FSIS Docket Clerk's 

Office (see ADDRESSES above) and from the FSIS Internet world wide web 

page at http://www.fsis.usda.gov/OA/topics/irrad-risk.htm.

    From this review of recent studies, FSIS concluded that the 

proposed regulations permitting the irradiation of meat food products 

and the revision of the regulations governing the irradiation of 

poultry products would pose no significant risk to worker or 

transportation safety. FSIS concluded that oversight by other Federal 

and State agencies will ensure the safety of food irradiation 

facilities:



    In summary, proper design and operating procedures of commercial 

irradiators have been shown to operate without significant radiation 

risk to workers or the public. NRC [Nuclear Regulatory Commission] 

has set stringent environmental protection requirements for any 

facilities that use radionuclide sources (10 CFR Parts 20, 30, 51, 

and 71). There are special carrier requirements for transport of 

hazardous materials (such as the radionuclides used at the facility) 

set by the DOT [Department of Transportation]. Any extraneous 

radiation from radionuclides would be contained in plants by 

shielding required by the NRC and the Bureau of Radiological Health 

at FDA. The risk of radiation exposure to workers is very low with 

adherence to the required NRC, OSHA, and other safety requirements. 

And finally, FSIS ensures that the risks from food irradiation are 

insignificant by its requirement that all irradiation facilities 

adhere to the safety regulations of the NRC, DOT, and FDA.



    Furthermore, FSIS employees will receive training from FSIS in 

radiation health and safety and will be required to wear dosimetry 

devices. The Agricultural Research Service (ARS) will issue the devices 

as part of their radiological safety program for all USDA employees. 

Radiation exposure records for FSIS employees will be maintained and 

monitored by ARS, and kept indefinitely.

    Concerning NEPA, USDA has determined that FSIS programs and 

activities have been found to have no individual or cumulative effect 

on the human environment. Accordingly FSIS is categorically excluded 

from the preparation of an Environmental Assessment (EA) or 

Environmental Impact Statement unless the Administrator determines that 

an action may have a significant environmental effect (7 CFR 1b.4). The 

irradiation of various food products has been permitted and safely 

conducted for over 30 years. The irradiation of poultry products has 

been permitted and safely conducted since 1992. Therefore, the 

Administrator has not determined that circumstances dictate the need 

for preparation of an EA for the voluntary use of irradiation in meat 

food products.

    FSIS works closely with the other agencies within USDA responsible 

for the school lunch program. Should USDA or individual school 

districts choose to purchase irradiated products for the school lunch 

program, FSIS would support that decision. Irradiation can 

significantly reduce the levels of pathogenic microorganisms in treated 

meat food and poultry products. Therefore, irradiated food products 

would be ideal for the school lunch program, which serves children, a 

population particularly vulnerable to foodborne illness. FSIS sees no 

need for any special notification of the parents of children 

participating in a school lunch program that serves irradiated meat 

food or poultry products because FSIS agrees with FDA's finding that 

food irradiation poses no toxicological or microbiological risks for 

consumers and does not affect the nutritional adequacy of treated 

product.



[[Page 72153]]



Efficacy of Irradiation



    Comment: Several commenters from industry and academia requested 

that FSIS either maintain a minimum absorbed dose requirement or, if 

there is to be no required minimum dose, require establishments that 

irradiate product to achieve a minimum level of pathogen reduction (one 

irradiator suggested 1-log<SUP>10</SUP> reduction of the pathogen of 

concern in a product). One commenter argued that unscrupulous 

processors could irradiate product with a minimal dosage, achieving an 

insignificant antimicrobial effect, merely to accrue the benefit of the 

label and extended product shelf-life. This commenter also maintained 

that consumers would be misled by product labeled as irradiated, but 

treated with only a negligible dose. Another industry commenter 

maintained that although FSIS should not mandate irradiation, FSIS 

should mandate that all official establishments achieve the level of 

pathogen reduction resulting from irradiation, regardless of the 

antimicrobial intervention they use.

    Several consumer advocacy organizations recommended that FSIS 

maintain the minimum dose requirement for treated poultry and establish 

a minimum dose for meat food products so as to ensure specific 

reductions in pathogens.

    Response: FSIS will allow meat and poultry establishments to 

determine what level of irradiation (subject to a maximum level) and 

what consequent reduction of pathogens is appropriate within their 

HACCP systems. Depending on the processing environment, the type of 

meat food or poultry product, and the type of radiation source 

employed, varying dosages of radiation will be appropriate. A required 

minimum dosage would undercut the flexibility needed for the successful 

implementation of HACCP.

    Furthermore, FSIS finds that it is unnecessary to establish a 

minimum level of pathogen reduction to be achieved by irradiation or by 

any other specific antimicrobial intervention. Establishments must 

determine what level of pathogen reduction is necessary from a 

particular intervention based on the results of the hazard analysis 

they conduct when developing their HACCP plan. Establishments are 

required to meet specific pathogen reduction performance standards for 

numerous meat food and poultry products and FSIS plans to propose more 

standards to eventually cover every processing category. FSIS will 

ensure that safe meat food and poultry products are produced through 

compliance with these standards, but need not hinder processing 

innovation by mandating the use of specific antimicrobial 

interventions, or specific results from specific interventions.

    Comment: Several consumer advocacy organizations argued that FSIS 

should require establishments that irradiate product, and especially 

establishments not yet under HACCP, to conduct regular micro-testing 

prior to irradiation. One organization requested that FSIS require end-

product microbial testing of irradiated product. This testing would 

discourage establishments from using irradiation to treat ``dirty'' 

product or operate under insanitary conditions. Another suggested that 

FSIS clarify in the final rule that irradiation would in no way satisfy 

the ``zero-fecal'' policy. Finally, another organization argued that 

FSIS should allow meat food products to be irradiated only after final 

packaging, to prevent any recontamination of the treated product.

    Response: Irradiation is just one of the many antimicrobial 

interventions available to establishments. As with other interventions, 

its use in no way exempts establishments from meeting statutory 

sanitation requirements. Moreover, FSIS emphasizes that establishments 

that employ irradiation still must meet the zero-tolerance requirements 

for visible fecal matter on meat or poultry carcasses.

    FSIS will neither require special microbial testing nor conduct 

such testing in establishments that irradiate product (although FSIS 

may conduct microbial testing to verify pathogen reduction claims or 

for enforcement purposes). Compliance with the HACCP requirements, 

along with other FSIS requirements governing sanitation, will preclude 

the irradiation of product produced under insanitary conditions, as 

well as the adulteration of product after an irradiation treatment.

    Finally, in order to promote processing flexibility and innovation 

that will lead to improvements in food safety, FSIS did not propose to 

require that meat food products be irradiated only after final 

packaging. Using a HACCP system, an establishment must control the 

conditions under which product is held from initial processing through 

irradiation and packaging to ensure and preserve the intended 

antimicrobial effects of irradiation. By law, establishments must 

produce unadulterated meat food and poultry products regardless of 

whether or when they irradiate within their processing systems.

    Comment: Numerous commenters opposed irradiation of meat food and 

poultry products because they believe irradiation will allow 

establishments to clean up insanitary meat food and poultry products 

resulting from ``factory farming'' (concentrated animal production 

methods), which they believe is unethical and inhumane. They argue, 

therefore, that irradiation would indirectly promote the expansion of 

``factory farming.''

    Response: As stated above, the use of irradiation in no way exempts 

establishments from meeting statutory and regulatory sanitation 

requirements. Establishments are not permitted to produce meat food or 

poultry products under insanitary conditions, regardless of whether 

they irradiate. Furthermore, FSIS prohibits the inhumane handling and 

slaughter of livestock. Under the Humane Slaughter Act (7 U.S.C. 1901-

1906), FSIS personnel may suspend inspection of an official 

establishment if the Agency determines that the method by which 

livestock is slaughtered is inhumane, as defined by the Humane 

Slaughter Act.

    As part of its ``farm-to-table'' food safety strategy, FSIS is 

interested in effects of concentrated animal production methods on food 

safety, as well as humane handling and slaughter. Notably, no data was 

submitted that supported comments concerning concentrated animal 

production. FSIS would welcome and thoroughly review any such data.

    Comment: One consumer advocate organization requested that FSIS 

provide information on how it intends to redeploy inspection program 

employees to irradiation facilities.

    Response: As stated in the proposal, facilities that irradiate meat 

food and poultry products are considered by FSIS to be official 

establishments. As such, they are subject to inspection as provided for 

by the Federal Meat Inspection Act (FMIA) and Poultry Products 

Inspection Act (PPIA). FSIS will deploy inspection program employees to 

irradiation facilities based on a number of factors, such as inspection 

force workload and the type of activities conducted at the individual 

facilities (e.g., product irradiation only, irradiation and additional 

processing, slaughter and irradiation) Assignment of FSIS program 

personnel to irradiation facilities will not differ from assignment to 

other types of official establishments.



Irradiation and HACCP



    Comment: A few establishments and trade associations argued that 

FSIS should not mandate a critical control point (CCP) for irradiation, 

as they believed that the preamble implied that FSIS will mandate a CCP 

for irradiation.



[[Page 72154]]



    Response: FSIS did not mandate any specific CCP or critical limit 

in the proposed rule language, although the Agency did give some 

examples. Because most, if not all, establishments will irradiate 

product specifically to reduce microbial pathogens (identified 

hazards), they would include irradiation as a CCP in their HACCP plans. 

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. Dosage, ambient temperature, oxygen levels or 

other factors that affect the antimicrobial efficacy of irradiation 

will likely be monitored to determine if the critical limits for an 

irradiation CCP are being met.

    In accordance with the FDA regulation on the use of irradiation, 

establishments could irradiate product solely to extend shelf-life. In 

its proposal to provide for the use of irradiation on meat food 

products, FSIS stated that it therefore might be possible for an 

establishment to irradiate product solely to extend shelf-life and not 

account for effects of the treatment on pathogens in its HACCP plan:



Were an establishment to irradiate meat food products solely for the 

purpose of 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 its 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.



(64 FR 9091-9092)

    FSIS still maintains this position, but notes that there is a 

safety factor inherent in product shelf-life determination. Pathogenic 

and non-pathogenic microorganisms, including spoilage organisms, 

compete for nutrients in food products. Non-pathogenic and spoilage 

organisms generally are more plentiful than pathogenic organisms. 

Increasing the shelf-life of a product involves reducing the levels of 

the spoilage organisms. Although most antimicrobial treatments, 

including irradiation, reduce microbial levels fairly proportionately, 

an establishment must ensure that its treatment does not give a 

competitive advantage to pathogenic organisms, allowing for their 

disparate growth.

    More specifically, irradiation can affect the levels and projected 

growth of microbial pathogens, which would be identified by 

establishments as hazards. Establishments should take into account the 

levels and projected growth of microbial pathogens in meat food and 

poultry products when determining product shelf-life. Therefore, in its 

HACCP plan, an establishment would need to account for the reduction of 

pathogens (and possibly the reduction of competing microorganisms) 

resulting from irradiation conducted solely to extend product shelf-

life. Nonetheless, FSIS is not mandating the specific CCP or critical 

limit to be employed.

    Comment: Numerous industry groups and establishments argued that 

facilities that only irradiate packaged product should not be 

considered official establishments, since, in their view, such 

establishments would not be processing product (traditionally 

considered to be grinding, salting, etc.). A few of these commenters 

noted that FSIS does not currently consider certain warehouses that 

freeze packaged meat food and poultry products to destroy parasites to 

be official establishments. One commenter suggested that third party 

irradiators be required to implement HACCP anyway; several suggested 

that irradiation conducted at a remote facility be considered under the 

HACCP plan of the establishment that provides the meat food or poultry 

products for irradiation.

    Response: FSIS disagrees and will consider any facility that 

irradiates meat food or poultry products to be an official 

establishment. Sources of radiation used to treat food are defined as 

food additives under Sec. 201(s) of the FFDCA. FSIS believes that the 

act of using any food additive constitutes processing, and the 

processing of meat food and poultry products may only take place in 

official establishments subject to FSIS inspection and regulation.

    In regard to the freezing of meat food and poultry products to kill 

internal parasites, it is true that FSIS has allowed certain warehouses 

to freeze beef and pork for this purpose, without being designated as 

official establishments. FSIS is now reviewing this policy decision to 

determine whether this freezing constitutes processing and will 

designate these facilities as official establishments if it concludes 

that it does.

    Because facilities that irradiate product will be designated as 

official establishments, FSIS will not permit such establishments to 

operate under other establishments' HACCP plans. Each official 

establishment must develop and implement its own.

    Comment: Several commenters contended that the validation 

requirement for process schedules is inadequate, since irradiation is 

so complicated and relatively new to the meat food product industry. 

They suggested FSIS require that radiation specialists review process 

schedules and HACCP plans. One consumer advocacy organization suggested 

that FSIS should validate HACCP plans that include irradiation.

    Response: FSIS disagrees. Food irradiation has been practiced in 

the United States for over 30 years. Further, the irradiation of 

poultry products has been permitted and safely conducted since 1992. 

Industry possesses the expertise and the resources to safely and 

effectively irradiate meat food products.

    FSIS is requiring certain employees of official establishments 

conducting irradiation to be trained in various aspects of food 

irradiation and radiation safety (new Sec. 424.22(c)(3)(v) and (vi)); 

FSIS already requires this training for personnel at establishments 

that irradiate poultry.

    In regard to the proposed requirements for process schedule 

validation, because all official meat and poultry establishments will 

be operating under the HACCP requirements by the time the regulations 

are in effect, FSIS has not carried forward the proposed process 

schedule requirements (meant for establishments not yet operating under 

HACCP) into this final rule. FSIS does not validate establishment HACCP 

plans, regardless of the processing systems employed. In accordance 

with Sec. 417.4(a) of the regulations, it is the responsibility of an 

establishment to validate its HACCP plan's adequacy in controlling the 

identified food safety hazards. FSIS does review HACCP plans for 

conformance with the HACCP regulations. Further, FSIS and 

establishments are responsible for verifying that HACCP plans are 

adequate and working on a day-to-day basis. Establishments must monitor 

and verify the performance of the controls in their HACCP plans and 

maintain records of this monitoring and verification. FSIS evaluates 

the HACCP plan's adequacy and successful operation as part of the 

inspection process.



Scope of Meat Food and Poultry Products That May Be Irradiated



    Comment: Several commenters requested that FSIS specifically 

provide for irradiation as an acceptable treatment for raw, non-intact 

beef products contaminated with Escherichia coli O157:H7.

    Response: On January 19, 1999, FSIS published a notice in the 

Federal Register (54 FR 2803; ``Beef Products Contaminated With 

Escherichia Coli



[[Page 72155]]



O157:H7'') clarifying that non-intact beef products, as well as intact 

cuts of muscle that are to be further processed into non-intact product 

prior to distribution for consumption, that are contaminated with E. 

coli O157:H7 are adulterated under the Federal Meat Inspection Act 

unless the products are further processed to destroy this pathogen. 

Also in that notice, FSIS stated that it was considering irradiation as 

an option for effectively eliminating E. coli O157:H7 from contaminated 

beef products, since the only type of effective processing available at 

the time of the notice was cooking. Now, under the regulations in this 

final rule, establishments may use irradiation as a means of 

eliminating E. coli O157:H7 from contaminated beef products.

    An establishment that irradiates beef product known to be 

contaminated with E. coli O157:H7 and intended for distribution as a 

non-intact product must have controls in place to ensure that the 

pathogen is eliminated from the product prior to its distribution for 

consumption. The establishment also must document its actions to 

eliminate E. coli O157:H7 from the product in accordance with 

applicable regulations. Establishments should refer to the above 

mentioned notice, as well as guidance available from the FSIS Internet 

site (www.fsis.usda.gov), for further clarification on the Agency's 

policy in regard to the treatment of beef products containing E. coli 

O157:H7.

    Comment: Consumer and industry groups asked FSIS to broaden the 

scope of the final rule to provide for the irradiation of processed 

products, especially ready-to-eat products. Many commenters believed 

that the FDA finding in regard to the Isomedix petition allows FSIS to 

do this without petitioning FDA again. Also, several commenters 

criticized FSIS and FDA for failing to cooperate more closely in regard 

to approving the irradiation for various products. They suggested that:

    <bullet> FSIS should act quickly to petition FDA to make the 

regulations for irradiating poultry consistent with those for meat and 

to allow for the irradiation of hot-boned meat.

    <bullet> FSIS and FDA should expedite the approval of new packaging 

materials for product irradiated while packaged.

    <bullet> FSIS should make final and implement Docket No. 88-026P 

(``Substances Authorized for Use in the Preparation of Meat and Poultry 

Products''; 60 FR 67459) so as to end the need for duplicative 

rulemaking by FDA and FSIS when approving food additives, including the 

use of sources of ionizing radiation.

    Response: FDA's authority to regulate the uses of ionizing 

radiation on food is clear under Sec. 409 of the FFDCA. FDA has 

approved the use of sources of ionizing radiation only on the uncooked 

meat food products described above. Until FDA approves the use of 

ionizing radiation on other meat food products, including processed or 

cooked products, FSIS will not provide for the irradiation of such 

products.

    In August 23, 1999, a consortium of organizations, including the 

National Food Processor's Association (NFPA), petitioned FDA to allow 

for the use of approved sources of ionizing radiation on processed meat 

food and poultry products. Because the irradiation treatment is 

intended to significantly reduce the levels of pathogens in food, FDA 

is reviewing this petition in an expedited clearance process. FSIS will 

cooperate with FDA in reviewing this petition. Further, On August 19, 

1999, FSIS petitioned FDA to clarify that sources of ionizing radiation 

may be used on ``hot-boned'' (unrefrigerated) meat food products and to 

revise the dosage and packaging restrictions on the irradiation of 

poultry products for consistency. FDA also is reviewing these petitions 

in an expedited clearance process.

    FDA is also working to expedite the process for reviewing packaging 

materials to be used during food product irradiation and FSIS will 

cooperate with FDA in reviews of such packaging for poultry and meat 

food products. Under its new Premarket Notification Program, FDA will 

continue to review all food contact substances, including food 

packaging materials intended for use during irradiation, but will no 

longer necessarily list those permitted in the Code of Federal 

Regulations.

    In regard to the approval of food additives in meat food and 

poultry products, elsewhere in this issue of the Federal Register, FSIS 

has published a final rule (FSIS Docket No. 88-026F; ``Substances 

Authorized for Use in the Preparation of Meat and Poultry Products'') 

that ends duplicative approval by both FDA and FSIS. Requests to 

approve the use of food additives in or on meat food and poultry 

products not permitted now must be sent to FDA. Although FDA will 

receive and review such petitions, FDA also intends to amend its 

regulations to provide for FSIS review of petitions for uses of food 

additives in or on meat food or poultry products. These actions will 

eliminate the need for separate FSIS rulemakings. FSIS will limit 

substance-specific rulemakings to those necessary to establish 

prohibitions or limitations on the use of substances in meat food or 

poultry products that are necessary to protect public health or to 

achieve other consumer protection benefits, such as to prevent product 

misbranding.

    In this final rule, FSIS is consolidating its regulations governing 

irradiation into a single set of generic regulations under new 

Sec. 424.22(c), applicable to the irradiation of all types of meat food 

and poultry products (FSIS proposed separate, but identical sets of 

regulations for meat and poultry). Therefore, in the future, when FDA 

lists new uses of ionizing radiation on various types of meat food and 

poultry products, unless FSIS needs to establish a prohibition or 

restriction, establishments may immediately take advantage of the newly 

approved usage of irradiation without waiting for additional FSIS 

rulemaking.



Consumer Acceptance of Irradiation



    Comment: Numerous industry groups argued that FSIS should actively 

promote irradiation and implement a consumer education program 

regarding its benefits.

    Response: Recognizing the diversity of meat food and poultry 

products and processing environments, FSIS does not mandate or actively 

promote any single intervention or antimicrobial technology. The meat 

food and poultry product industries, as well as consumer and public 

health organizations, have the primary responsibility for promoting 

irradiation and educating the public about the benefits and limitations 

of irradiation. However, FSIS recognizes the potential of irradiation 

to safely and effectively reduce foodborne pathogens in meat food and 

poultry products and therefore is eager to provide for its use as one 

of the many antimicrobial treatments that may be used within a HACCP 

system.



Labeling



    Comment: Numerous commenters requested that FSIS make its labeling 

requirements for irradiated meat food and poultry products identical 

with FDA's requirements. Several commenters noted that the proposed 

labeling requirements regarding placement of the statement and radura, 

as well as the proposed disclosure requirements for irradiated meat 

food or poultry ingredients contained in multi-ingredient products, are 

inconsistent with FDA labeling requirements and with the Food and Drug 

Administration Modernization Act (FDAMA) of 1997 (Pub. L. 105-115). 

Many commenters argued that the proposed requirements are unworkable 

and expensive and



[[Page 72156]]



therefore will prevent the wide scale adoption of irradiation. A few 

trade associations maintained that establishments producing multi-

ingredient meat food and poultry products will have to maintain two 

sets of labeling, since they will not always be using irradiated meat 

food or poultry products as ingredients.

    Commenters suggested numerous and varied revisions to the proposed 

labeling requirements:

    <bullet> One trade association requested that FSIS require the 

radura but not the statement on product irradiated in its entirety;

    <bullet> An irradiator suggested that FSIS not require the 

irradiation statement to be contiguous to the product name and argued 

that the radura should be voluntary;

    <bullet> A few commenters requested that FSIS require 

``irradiated'' to be part of the product name. One commenter suggested 

that FSIS should then eliminate other labeling requirements, while 

another suggested this be an additional requirement;

    <bullet> Several commenters asked that FSIS require the radura with 

a qualified statement indicating the beneficial effects of irradiation;

    <bullet> One commenter requested that FSIS allow labeling that 

indicates the source of radiation, i.e., gamma or machine source;

    <bullet> One trade association suggested that multi-ingredient 

products containing irradiated meat food or poultry product ingredients 

be labeled with the radura and statement such as ``contains beef 

products treated with irradiation;''

    <bullet> One company maintained that the proposed labeling 

requirements for multi-ingredient products are inconsistent with FDA 

requirements in 21 CFR 101.100(a)(3)(i), which exempt from labeling 

disclosure ``Substances that have no technical or functional effect but 

are present in a food by reason of having been incorporated into the 

food as an ingredient in another food, in which the substance did have 

a functional or technical effect.''

    <bullet> An irradiator suggested that there be no required 

disclosure in multi-ingredient products unless the irradiated component 

makes up more than 50% of the total product;

    <bullet> One scientific organization argued that no irradiation 

labeling should appear on product irradiated before its final 

packaging. They contended that the treated product would not maintain 

the antimicrobial effects of irradiation and therefore, that any 

labeling implying otherwise would be misleading;

    <bullet> Numerous individual consumers and consumer advocacy 

organizations commented in favor of explicit and conspicuous labeling 

disclosing that product has been irradiated or contains an irradiated 

ingredient. Two organizations submitted poll results suggesting that a 

majority of consumers are in favor of explicit and conspicuous 

disclosure of irradiation. Many of these commenters generally supported 

the labeling requirements FSIS proposed and opposed efforts at 

consistency with FDA regulations and the requirements of the FDAMA.

    <bullet> Consumer advocacy groups and numerous consumers argued 

that, in the interest of the visually impaired, FSIS should not rescind 

the existing letter size requirements for the irradiation statement on 

treated poultry and should apply this same requirement to irradiated 

meat food products.

    <bullet> One consumer advocacy group argued that multi-ingredient 

products with an irradiated poultry or meat food product ingredient 

making up more than 50% of the total weight should be labeled with the 

irradiation statement, as well as disclosure in the ingredient 

statement.

    Response: FSIS proposed to require that the radura be contiguous to 

the irradiation statement and the statement to be contiguous to the 

name. In Sec. 317.2(c)(1) of the regulations, FSIS requires that 

product names be on the principal display panel. Therefore, under the 

proposed regulations the statement and the radura would be required to 

be on the principal display panel. FDA, however, in response to the 

FDAMA, recently amended its regulations to clarify that the statement 

does not have to be any more prominent than the ingredients statement; 

that is, the statement and the radura can appear somewhere other than 

the principal display panel.

    In response to comments and as part of an effort to make FSIS 

labeling requirements more consistent with those of FDA, FSIS will not 

require, as proposed, that the irradiation statement and the radura be 

any more prominent than the ingredients statement on the labeling of 

irradiated meat food and poultry products. Thus, the statement and the 

radura may appear somewhere other than on the principal display panel. 

The requirement in Sec. 317.2(b) that any statement must be placed and 

in such terms so as to ``render it likely to be read and understood by 

the ordinary individual under customary conditions of purchase and 

use'' will still apply to the irradiation statement, however. This 

requirement prohibits labeling of irradiated product in a manner that 

would intentionally mislead consumers.

    FSIS disagrees with the comment that it should have letter size 

requirements for irradiation disclosure statements in the interest of 

the visually impaired. FSIS is working with FDA and other agencies to 

make food labeling regulations consistent. Maintaining the existing or 

proposing new letter size requirements solely for irradiated meat food 

and poultry products would counter these efforts. However, FSIS will 

continue to examine methods for improving the communication of food 

safety and other relevant information to all consumers.

    Also in response to public comment, FSIS will allow the word 

``irradiated'' to be part of the name of irradiated meat food or 

poultry product. FSIS will not require the irradiation statement on the 

labeling of product that has the word ``irradiated'' as part of its 

name. Having ``irradiated'' in a product name will be as meaningful to 

consumers as labeling irradiated product with the statement.

    Although FDA does not exempt irradiated product from being labeled 

with the statement when ``irradiated'' is included in the product name, 

it is considering this issue as part of its ongoing reexamination of 

labeling requirements for irradiated foods. FDA recently solicited 

comment on possible revisions to the labeling requirements for 

irradiated food in an advance notice of proposed rulemaking 

(``Irradiation in the Production, Processing, and Handling of Food''; 

February 17, 1999; 64 FR 7834). During the comment period on for this 

notice, FSIS informed FDA of this revision to the labeling requirements 

for irradiated meat food and poultry products. If FDA ultimately does 

not adopt this labeling approach, FSIS will reassess its labeling 

requirements for irradiated products to determine how to best improve 

consistency between the requirements of the two agencies.

    FSIS will allow labeling statements and claims regarding the 

beneficial effects of irradiation, provided they are truthful and not 

misleading. FSIS already has approved such claims for the labeling of 

irradiated poultry and FDA allows for such claims on the labeling of 

other irradiated foods. As proposed, any claims must be substantiated 

by processing documentation. The specificity and complexity of the 

documentation required will vary and depend on the specificity of the 

claim. For example, a general labeling claim, such as a statement that 

product was irradiated ``to reduce pathogens such as Salmonella,'' 

could be easily



[[Page 72157]]



substantiated by the establishment's HACCP plan and monitoring records. 

Salmonella and other microbial pathogens would need to be identified as 

a hazard in the establishment's HACCP plan and plan validation and 

monitoring records would demonstrate the claimed reduction. If an 

establishment wished to claim that a particular pathogen had been 

eliminated from the product as a result of irradiation, more specific 

documentation substantiating this would be required. This type of claim 

is discussed further below in the response to comments concerning the 

claimed elimination of E. coli O157:H7 from an irradiated product.

    FSIS will allow labeling statements disclosing the specific source 

of radiation (gamma or machine source). FDA already allows such 

statements on irradiated food (e.g. ``Treated by electron beam 

irradiation'').

    FSIS is making final the proposed requirement that inclusion of an 

irradiated meat food product ingredient in any multi-ingredient product 

be reflected in the ingredient statement on the finished product 

labeling. The FMIA and PPIA, like the FFDCA, require that food labeling 

not be false or misleading. In determining whether labeling is false or 

misleading under these statutes, FSIS must consider not only 

representations made or suggested by elements of the label, but also 

the failure to reveal material facts in light of such representations.

    FSIS views the irradiation of meat and poultry products as a 

``material fact'' that must be disclosed in product labeling, even if 

the irradiated meat and poultry products are used as ingredients in 

multi-ingredient products. Under this final rule, establishments may 

irradiate meat food or poultry products only to control foodborne 

pathogens or to extend product shelf-life. In FSIS's view, effects on 

pathogen levels or product shelf-life, whether achieved in single-

ingredient or multi-ingredient meat or poultry products, are material 

facts that would not be evident to consumers in the absence of 

labeling. Moreover, some, and probably much, of the antimicrobial 

effect and extension of shelf-life achieved through irradiation is 

likely to persist in irradiated meat and poultry used as ingredients in 

multi-ingredient products, especially considering that FSIS anticipates 

that products in which irradiated meat or poultry are likely to be used 

as ingredients are also likely to contain a significant amount of these 

ingredients.

    Thus, FSIS concludes that irradiation of a meat or poultry 

ingredient in a multi-ingredient product must be disclosed. FSIS will, 

however, continue to monitor how irradiation is used. As new 

information based on experience in the marketplace becomes available, 

and should FDA approve other uses of irradiation for meat and poultry 

products, FSIS may revisit whether irradiation of ingredients for those 

uses is a material fact that requires disclosure.

    FSIS disagrees with the comment that disclosure of the irradiated 

ingredient will mislead consumers about the product's safety because, 

according to the commenter, multi-ingredient products with irradiated 

meat or poultry ingredients would be no different microbiologically 

than those without. FSIS acknowledges that the antimicrobial effects of 

irradiation will be maintained at varying levels in a multi-ingredient 

meat food or poultry product, depending on the type of product, how it 

is processed, whether it is combined with other non-irradiated 

ingredients, or if specific microorganisms are reintroduced. However, 

some antimicrobial effect from the irradiation would be maintained in 

the irradiated meat food or poultry product ingredient and that would 

not be apparent to consumers without labeling.

    FSIS disagrees with the comment that the this disclosure 

requirement is inconsistent with FDA regulations in 21 CFR 

101.100(a)(3)(i), which exempt from labeling disclosure ``Substances 

that have no technical or functional effect but are present in a food 

by reason of having been incorporated into the food as an ingredient in 

another food, in which the substance did have a functional or technical 

effect.'' FDA applies this requirement only to food ingredients. FDA 

consider sources of radiation to be additives, but not ingredients.

    In regard to the possibility of requiring this disclosure on the 

basis of the percentage of the irradiated meat food or poultry product 

ingredient in a multi-ingredient product, FSIS, in cooperation with 

FDA, will continue to examine the issue. Although numerous commenters 

suggested labeling disclosure options based on a percentage, no data 

was submitted. FSIS is aware that Canada requires labeling disclosure 

only if the irradiated ingredient comprises more than 15 percent of a 

multi-ingredient product. FSIS is reviewing this Canadian policy.

    FSIS could revise the labeling requirements in the future. In fact, 

as discussed in the next two comments and response, FSIS and FDA are 

considering the option of eventually revising some of the labeling 

requirements.

    Comment: Numerous industry groups requested that FSIS plan to 

sunset all labeling requirements related to irradiation within 5 years 

or sooner. They note that FDA discusses this possibility in the recent 

notice (64 FR 7834).

    Response: FSIS is consulting with FDA on this issue and will review 

the comments on the FDA notice. Central to the option of revising any 

of the labeling requirements will be consumer awareness and 

understanding of food irradiation. FSIS also will continue to assess 

the impact and effectiveness of its labeling requirements for 

irradiated meat food and poultry products. Interested persons may wish 

to submit information on this issue to FSIS.

    Comment: A few commenters argued that labeling of irradiated 

product should be voluntary. They argued that demand for irradiated 

products will give producers and retailers incentive to disclose that 

their products were irradiated. Further, numerous commenters claimed 

that consumers will regard the statement and radura as a warning and 

not purchase the product and argued that irradiation, therefore, will 

not be widely adopted by industry. A few commenters claimed that if 

irradiation is not widely employed by the food industry as result of 

labeling requirements and other perceived regulatory impediments, 

significant reductions in foodborne illness will not occur.

    Response: As explained above, to prevent misleading labeling, the 

FMIA, PPIA, and FFDCA require disclosure of facts material to food 

products. Irradiation can affect food in a manner that is not obvious 

to consumers in the absence of labeling. Antimicrobial effects, changes 

in product shelf-life, and in some cases, changes in characteristics of 

food (taste, smell, texture) can result from irradiation. FSIS views 

irradiation of meat and poultry, therefore, as a material fact that 

must be disclosed in product labeling. However, both FSIS and FDA are 

continuing to examine their labeling requirements and the options for 

revising these requirements so as to better convey information to 

consumers.

    Although FSIS acknowledges that labeling may initially have some 

effect on consumer acceptance of irradiated meat food and poultry 

products, FSIS expects that as consumer awareness increases, the demand 

for these products will expand and the labeling will serve to promote 

these products. FSIS will continue to examine ways to remove regulatory 

impediments to



[[Page 72158]]



advances in food safety technologies, including irradiation, but it is 

the responsibility of industry to promote irradiated meat food and 

poultry products. FSIS does not agree that its labeling requirements 

will decrease the level of possible reductions in foodborne illness 

that may result from the use of irradiation. Potential reduction in 

foodborne illness are examined in detail below in the discussion of the 

economic impact of these regulations.

    Comment: FSIS noted in the proposed rule that it had received a 

petition from NFPA regarding labeling requirements for irradiated food. 

In the petition, NFPA requested that FSIS address whether labeling 

requirements concerning the disclosure of irradiation are warranted for 

meat food and poultry products and how such labeling affects consumer 

acceptance of irradiation. In a subsequent comment on the irradiation 

proposal, NFPA demanded that FSIS publicly respond to each issue raised 

in its petition and ask for public comment on each issue, although they 

added that the FSIS's actions should not delay a final rule.

    In its petition and subsequent comment, NFPA requested that FSIS 

address several labeling issues discussed elsewhere in this document, 

including: whether labeling of irradiated product is 

``constitutionally, statutorily, and scientifically unwarranted;'' 

whether disclosure of radiation would contribute to unfounded 

apprehension among consumers and therefore preclude widespread use of 

irradiation; and whether FSIS and FDA labeling requirements for 

irradiated products should be identical. NFPA cited case law 

(International Dairy Food Association v. Amestoy, 92 F.3d 67, 73 (2d. 

Cir. 1996) and Central Hudson Gas & Elec. Corp. v. Public Service 

Commission, 447 U.S. 557 (1980)) in support of its argument that 

consumer desire to know how food was processed is not alone sufficient 

to justify mandatory disclosure of the processing. NFPA also requested 

that FSIS address whether irradiation is a material fact under section 

403(a)(1) of the FFDCA; that is, should irradiated meat food or poultry 

products be labeled as such since otherwise, consumers would be unaware 

of the material fact that the products had been processed with 

radiation?

    Response: All the labeling issues raised by NFPA in its petition 

and in its subsequent comment were also raised in other comments and 

FSIS has responded to them in this document. Furthermore, FDA has 

requested comment on these and other labeling issues in its recent 

notice and FSIS will review those comments. FSIS sees no need, 

therefore, to again solicit public comment on these labeling issues, 

and, NFPA did request that the response to their petition not delay any 

final regulations.

    In response to NFPA questions regarding the legal basis for 

requiring disclosure, FSIS has reviewed the Supreme Court standards for 

governmental regulation of commercial speech as announced in Central 

Hudson Gas & Elec. Corp. v. Public Service Commission and summarized in 

the dissenting opinion in International Dairy Food Association v. 

Amestoy:



    At the outset, commercial speech enjoys no First Amendment 

protection at all unless it is not misleading (and related to lawful 

activity). If the speech passes that test, it is nonetheless subject 

to regulation if the government has a substantial interest in 

regulating the speech, the regulation directly advances that 

interest, and it is no more intrusive than necessary to accomplish 

its goal. 447 U.S. at 566, 100 S.Ct. at 2351. The Supreme Court 

later clarified that government's power to regulate commercial 

speech includes the power to compel such speech. Zauderer v. Office 

of Disciplinary Counsel, 471 U.S. 626, 651, 105 S.Ct. 2265, 2281-82, 

85 L.Ed.2d 652 (1985).



International Dairy Food Association v. Amestoy, 92 F.3d 67, 77 (2d. 

Cir. 1996).



    FSIS does have a substantial interest in requiring the disclosure 

that meat or poultry products have been irradiated; such irradiation is 

a material fact that must be disclosed to consumers through labeling to 

avoid deception, since it can affect the meat or poultry products in a 

manner that is not obvious to consumers in the absence of labeling. 

Disclosure of irradiation through labeling is the most direct way to 

advance this interest. FSIS believes that the labeling requirements 

contained in this regulation are the least intrusive possible, but 

still accomplish the goal of disclosure. Therefore, FSIS is requiring 

labeling that indicates meat and poultry products have been treated 

with irradiation.

    Comment: Numerous industry and academic commenters requested that 

FSIS allow alternative, euphemistic statements on irradiated products 

that would be more appealing to consumers, such as ``cold,'' 

``electronic,'' and ``ionizing'' pasteurization. Several of these 

commenters cited or submitted consumer polling data to support the use 

of their claims. One food processor suggested that any euphemistic 

labeling statements containing the word ``pasteurization'' be 

contingent upon specific levels of pathogen reductions. Consumers and 

consumer advocacy organizations, for the most part, maintained that 

alternative and euphemistic statements would be misleading and 

erroneous and opposed them.

    Response: FSIS will review, on a case-by-case basis, labels with 

alternative or euphemistic statements regarding irradiation. FSIS is 

requiring, however, that labels of meat food or poultry products that 

have been irradiated in their entirety be labeled with statements such 

as ``Treated with irradiation'' or ``Treated by irradiation,'' or, that 

the word ``Irradiated'' be part of the product name. FSIS will allow 

the terms ``cold,'' ``electronic,'' and ``ionizing'' to be used in 

conjunction with term ``irradiation,'' if truthful.

    At this time, however, labeling statements or claims for irradiated 

product that include the term ``pasteurization'' probably would be 

misleading. ``Pasteurization'' implies the destruction of all 

vegetative microorganisms in the product as a result of irradiation. At 

the maximum dosages allowed by FDA and FSIS, it would be highly 

unlikely that all of the vegetative microorganisms in irradiated 

product would be destroyed.

    For example, an establishment irradiates refrigerated, raw beef 

round or chuck using a gamma radiation source. They determine that they 

will achieve a 2:1 overdose ratio \1\ using the maximum allowed dosage 

of 4.5 kGy. That is, the irradiation treatment will achieve at least a 

minimum absorbed dosage of 2.25 kGy throughout the product.

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



    \1\ Product shape, density, and its distance from the source of 

radiation, as well as other factors, influence the absorbed dosage 

in an irradiated product. Therefore, it is difficult to achieve a 

uniform absorbed dosage in irradiated products, especially if the 

product is densely packed in large quantities. To achieve specific 

absorbed dosages of radiation in treated products, irradiators 

calculate a maximum/minimum ``overdose ratio.'' Using this ratio 

they are able to irradiate product so as to accurately predict that 

while some of the treated product will have absorbed the maximum 

dosage, all will have absorbed at least the minimum dosage.

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



    According to the International Consultative Group on Food 

Irradiation \2\, the dosage necessary to eliminate 90 percent of 

Salmonella sp. in a gram of product (the ``D value,'' which is 

equivalent to 1-log<INF>10</INF>), ranges from 0.48 kGy to 0.7 kGy. 

Therefore, this establishment, by achieving a minimum absorbed dosage 

of 2.25 kGy throughout the product, also would effect a minimum 

reduction of Salmonella sp. ranging between 4.7-log<INF>10</INF> and 

3.2-log<INF>10</INF> per gram of product, throughout the product. These 

hypothetical reductions are significant



[[Page 72159]]



and would greatly reduce the risk of foodborne illness from treated 

product. However, these reductions are well below the levels necessary 

to achieve a ready-to-eat roast beef product. FSIS recently established 

that it is necessary to achieve at least a 6.5-log<INF>10</INF> 

reduction of Salmonella sp. throughout a roast beef product to consider 

that product ready-to-eat (64 FR 732; 9 CFR 318.17).

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



    \2\ International consultative Group on Food Irradiation, 

``Irradiation of red meat: A compilation of technical data for its 

authorization and control,'' August 1996.

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



    FSIS acknowledges that if an establishment were to greatly minimize 

the pathogen load on incoming whole muscle meat product, it could 

possibly use irradiation combined with stringent process controls to 

produce a ready-to-eat, though uncooked, meat product, such as steak 

tartar. In such a case, irradiation would effectively pasteurize the 

product. FSIS would allow ``pasteurized'' to be in the labeling 

statement on such a product. However, under the current regulations, 

FSIS would require that the product also be labeled with statements 

such as ``Treated with irradiation'' or ``Treated by irradiation,'' or, 

that the word ``Irradiated'' be part of the product name. FSIS will 

continue to examine these requirements in light of developments in 

irradiation technology and FDA policy.

    Comment: Commenters from industry overwhelmingly supported 

incentive labeling (labeling claims regarding the benefits of 

irradiation) and most suggested that FSIS clarify what types of 

substantiating documentation would be required for using it. Most 

consumer advocacy groups expressed concerns about incentive labeling 

and requested that FSIS require stringent levels of pathogen reduction 

as prerequisites for making any claims, as well as regular microbial 

testing. One group argued that FSIS should allow claims only on product 

irradiated in its final packaging.

    All of the consumer advocacy groups that commented, as well as a 

few industry commenters, opposed the use of labels claiming that a 

product is ``free'' of any pathogen as a result of irradiation 

treatment. Many cited concerns about post-processing contamination of 

treated and labeled product. Several commenters argued that consumers, 

misled by labeling claims, would mishandle treated product, believing 

that it is free of all pathogens.

    One consumer advocacy organization suggested that FSIS put in place 

special ``trace back'' mechanisms for irradiated product. The 

organization is concerned that consumers, misled by claims concerning 

the efficacy of irradiation, may mishandle irradiated product that 

still contains pathogens. Special ``trace back'' mechanisms would 

ensure that establishments label irradiated products so as not to 

mislead consumers regarding the safety of those products.

    Response: As proposed, FSIS will allow labeling statements on 

irradiated meat food and poultry products that indicate general or 

specific reductions in microbial pathogens, provided they can be 

substantiated by processing documentation. The amount and specificity 

of the required documentation will vary depending on the statement or 

claim.

    Also in the proposal, FSIS discussed the possibility of product 

being labeled as ``free'' of the pathogen E. coli O157:H7:



    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).



(64 FR 9094)

    Irradiation, as provided for in this rule, could eliminate E. coli 

O157:H7 from products with an appropriate margin of safety. Therefore, 

FSIS will allow labeling of sufficiently irradiated product to state 

that processing has been conducted to eliminate E. coli O157:H7. As 

with any labeling statement that claims a specific reduction of 

pathogens resulting from irradiation, FSIS is requiring establishments 

claiming that E. coli O157:H7 has been eliminated from their products 

to have processing documentation substantiating this.

    FSIS agrees with commenters that stringent processing controls 

(probably including monitoring of pathogen load on incoming product and 

the prevention of product recontamination and post processing 

temperature abuse) would be needed to substantiate a label claiming 

that a product was ``free'' of E. coli O157:H7. FSIS will expect 

establishments that treat product known to be adulterated with E. coli 

O157:H7 to implement such controls. FSIS emphasizes that it will 

closely assess any requests for labeling that a product is free of E. 

coli O157:H7 and, through inspection, will verify that processes to 

eliminate the pathogen are under control.

    FSIS does not now have the data necessary to establish in the 

regulations a minimum level of reduction of E. coli O157:H7 that 

establishments must achieve in order to label products as being free of 

E. coli O157:H7. The FSIS Office of Public Health and Science currently 

is conducting a risk assessment concerning E. coli O157:H7. Using the 

results of this risk assessment, as well as other data that may be 

developed, FSIS may, in the future, propose to require that any such 

labeling claims be used only if establishments achieve a specific, 

minimum level of reduction of E. coli O157:H7 within treated product.

    In the interim, establishments may want to note that for certain 

ready-to-eat products, establishments have been processing to achieve a 

5-log<INF>10</INF> reduction in E. coli O157:H7. For example, the 

cooking requirements for meat patties in Sec. 318.23 of the regulations 

achieve an approximate 5-log<INF>10</INF> reduction in E. coli O157:H7 

and that compliance with the regulations in this section results in the 

production of a ready-to-eat meat patty. Further, since 1995, FSIS has 

encouraged establishments manufacturing ready-to-eat fermented sausage 

products to implement processes validated to achieve at least a 5-

log<INF>10</INF> reduction of E. coli O157:H7. Several outbreaks of 

food borne illness attributable to E. coli O157:H7 in fermented, shelf-

stable sausage products led FSIS, in cooperation with the Agricultural 

Research Service, meat and poultry industry representatives, and 

members of the National Advisory Committee on Microbiological Criteria 

for Food (NACMCF) to develop a policy for ensuring the safety of ready-

to-eat fermented sausages. This group developed several processing 

options that would ensure a 5-log<INF>10</INF> reduction of E. coli 

O157:H7 in fermented sausages. In an August 21, 1995 correspondence, 

FSIS wrote to establishments producing fermented sausages and strongly 

encouraged that they implement one of the validated processing options 

contained in the document or that they validate their processes to 

ensure the processing used achieves at least a 5-log<INF>10</INF> 

reduction of E. coli O157:H7. This specific level of reduction may not 

be adequate for all products or processes and establishments should 

carefully evaluate the specific product and processes at issue when 

developing treatments to eliminate E. coli O157:H7 from meat products.

    In regard to consumer perceptions regarding pathogen reduction 

claims,



[[Page 72160]]



irradiated raw ground beef still must carry the safe handling 

instruction, regardless of the claimed pathogen reduction. FSIS 

recognizes that it may be asked to reconsider its requirements 

regarding safe handling instructions in the event establishments 

develop methods to pasteurize raw meat food and poultry products 

through irradiation or other means.

    Comment: One commenter requested that FSIS permit irradiated meat 

and poultry to be labeled as being ``organic.'' A comment from an 

organic food cooperative opposed any such designation.

    Response: The Organic Foods Production Act (OFPA) of 1990 requires 

USDA to develop national standards and regulations for organically 

produced agricultural products and to assure consumers that 

agricultural products marketed as ``organic'' are consistent with these 

standards. The OFPA also provides for USDA to establish an organic 

certification program based on recommendations received from a 14-

member National Organic Standards Board (NOSB). Although the OFPA did 

not specifically address the use of irradiation, the NOSB has 

recommended, consistent with most existing State and private 

certification agency organic standards, that the use of irradiation be 

prohibited in handling organic products. This issue is most 

appropriately resolved in the agency rulemaking process under OFPA.

    Comment: Several industry groups recommended that FSIS explicitly 

allow product irradiated at a separate establishment to be fully 

labeled before shipment to that facility. One trade organization asked 

that FSIS no longer require such product to be shipped under seal. 

Several industry commenters requested that FSIS specifically exempt 

irradiation facilities from using their marks of inspection over those 

of the originating plant and instead allow the irradiator to use a 

separate stamp, so as to facilitate trace-back.

    Response: Meat food or poultry products may be packaged and labeled 

as being irradiated before shipment to an irradiation facility, 

provided that the shipping establishment implements controls to prevent 

the labeled, but as yet not irradiated, product from being distributed 

to consumers. Most establishments could control the shipment of such 

product through the maintenance and verification of records, such as 

bills of lading. FSIS inspection personnel will verify that these 

controls are implemented.

    FSIS does not and will not require irradiators or other processors 

to place their marks of inspection over those of the establishments 

from which the product originated. In regard to which inspection legend 

and establishment number would be placed on an irradiated product, 

different scenarios are possible. For example, if bulk shippers of 

trimmings or cuts are received by an irradiator, irradiated, and then 

repackaged in smaller units such as retail trays, the irradiator will 

be required to declare its establishment number on the retail package. 

However, if an irradiator receives packaged and labeled products for 

irradiation, the legend and number of the originating establishment 

will be declared on the retail package label. FSIS would expect that 

the irradiator would place its legend on the shipper container in which 

it packs the product, even if the irradiator uses the same shipper in 

which the product was received. In all cases, every establishment that 

processes the product must maintain records, as part of its HACCP 

paperwork, showing where the product originated, where it was 

processed, and where it was distributed for consumption. Any necessary 

trace-back will be facilitated by review of these records.

    Comment: Numerous consumers requested that FSIS extend required 

disclosure to restaurants and institutions that serve irradiated meat 

food and poultry products.

    Response: Historically, FSIS has not extended its regulations 

regarding meat food and poultry product labeling or misbranding to 

restaurant and institutional menus. Requiring and enforcing disclosure 

that restaurant or institutional food has been irradiated would require 

a heavy expenditure of Agency resources for as yet indeterminate 

benefits. FSIS will continue to examine this issue. FSIS is aware that 

a restaurant in Florida has been disclosing on its menu that it serves 

irradiated poultry products. Possibly, other restaurants and 

institutions may want to disclose this information for marketing or 

other purposes.



Technical Concerns



    Comment: One commenter stated that the hypothetical reduction of E. 

coli O157:H7 given in the preamble is misleading, as it does not take 

minimum/maximum ratios into account.

    Response: The example of pathogen reduction given in the preamble 

was hypothetical and intended to emphasize the potential effectiveness 

of irradiation against pathogens. This level of reduction would be 

possible under the permitted dosages, though costly and probably 

unnecessary.

    Comment: Several commenters requested that FSIS clarify its 

proposed training requirements for irradiation facility managers and 

``key personnel.'' One commenter claimed that existing short courses 

available in North America are inadequate because they either concern 

only electron beam irradiation or are too simplistic and argued that 

``in-house'' training should satisfy the intent proposed requirement. 

Another requested clarification as to who ``key personnel'' are and 

suggested that the ``key personnel'' include the facility manager, QC 

manager, an external consultant, or corporate management.

    Response: FSIS proposed to require establishments that irradiate 

meat food products to have on file ``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,'' as well as ``certification 

by the operator that the key irradiation personnel have been trained in 

food technology, irradiation processing, and radiation health and 

safety.'' These requirements already are in effect for poultry 

establishments.

    The intent of the first training requirement is to ensure that 

supervisors of irradiation facilities gain an understanding about the 

process controls necessary when irradiating food, as well as the 

requirements set forth in FSIS regulations. FSIS is aware of numerous 

irradiation facilities that plan to irradiate meat food and poultry 

products, but that have previously irradiated only medical devices and 

other non-food products. Supervisors of such establishments certainly 

need and would benefit from food irradiation training.

    The second training requirement is intended to ensure that ``key'' 

personnel in an establishment also have instruction in the safe and 

proper operation of an irradiation facility. Key personnel would 

include managers, supervisors, or other personnel of the facility who 

monitor or control daily operations. Key personnel must be 

knowledgeable about the environmental safeguards and worker safety 

precautions necessary in any irradiation facility and required by other 

Federal and State agencies. FSIS is revising Sec. 424.22(c)(3)(vi) to 

clarify the term ``key irradiation personnel.''

    FSIS is aware of several available food irradiation training 

courses, but does not intend to review or endorse any specific training 

course. Further, FSIS



[[Page 72161]]



agrees that in-house training in food irradiation or radiation safety 

could be adequate to meet the requirements. FSIS will verify that 

establishments have records confirming that the required training was 

received by the establishment personnel.

    Comment: One irradiator objected to proposed Secs. ((318.11(b)(6) 

and 381.149(b)(6) which appear to prescriptively specify minimum 

dosimeter placements. They suggested FSIS instead allow for 

statistically based validation and dose mapping to determine the number 

and placement of dosimeters.

    Response: FSIS agrees and will revise the requirement in 

Sec. 424.22(c)(2)(vi) accordingly. FSIS recommends that establishments 

consult some of the various technical guides on dosimetry when 

developing their systems. The American Society for Testing and 

Materials and the International Consultative Group on Food Irradiation 

both have published guides on food irradiation dosimetry.

    Comment: Another irradiator asked that FSIS revise proposed 

Secs. 318.11(b)(7) and 381.149(b)(7) to account for dosimetry from 

machine sources of radiation.

    Response: The proposed provisions (a single provision in this final 

rule, Sec. 424.22(c)(2)(vii)) did account for machine sources of 

irradiation in that they required establishments to have in place 

``Procedures for verifying the relationship of absorbed dose as 

measured by the dosimeter to time exposure of the product unit to the 

radiation source.'' The radiation source could be a machine source of 

radiation, such as an electron beam accelerator. This requirement 

remains unchanged.

    Comment: One commenter suggested that establishments employing 

irradiation be exempted from pathogen reduction (Salmonella) and 

process control microbial testing (generic E. coli) requirements for 

raw meat food and poultry products. This commenter argued that 

irradiation will reduce pathogens to immeasurable levels and testing 

would therefore be unnecessary. The commenter also maintained that such 

an exemptions would bring about cost savings to industry in excess of 

$100 million.

    Response: FSIS disagrees. The microbial testing requirements are 

still necessary for measuring an establishment's performance in process 

control and pathogen reduction, even if an establishment irradiates its 

product. Establishments may irradiate product at any point in their 

processing system, including before the required testing for Salmonella 

or generic E. coli. Irradiation of raw product before testing could not 

only significantly improve a single establishment's performance, but 

also could lower the national baselines, compelling improvements in 

process control and pathogen reduction by all establishments. Although 

rescission of these testing requirements (or any regulatory 

requirements, for that matter) might result in cost savings to the 

regulated industry, FSIS has determined that these requirements are a 

necessary and cost-effective means for improving the safety of meat 

food and poultry products.



Costs and Benefits of Irradiation



    Comment: A few commenters recommended revisions to the Agency's 

cost/benefit and economic impact analyses in the proposal. One 

commenter questioned FSIS's estimate of the cost of shipping irradiated 

products, arguing that the Agency underestimated the costs by an order 

of magnitude. Several commenters maintained that the required labeling 

would be perceived by consumers as a warning and, as discussed, would 

prevent the wide-scale acceptance of irradiated product. Many of these 

commenters argued that labeling should be voluntary, since demand for 

irradiated products would create adequate incentives for labeling.

    Response: FSIS addresses the comments and reviews the submitted 

cost data below in the economic impact analyses.



Summary of the Final Rule



    FSIS is amending it regulations to provide for irradiation of 

uncooked meat food and poultry products under the following conditions:

    <bullet> Meat food products may be treated with ionizing 

irradiation, for purposes of reducing pathogens and extending shelf-

life, at dosages up to 4.5 kiloGrays (kGy), if refrigerated, and 7 kGy, 

if frozen.

    <bullet> Establishments may irradiate meat food and poultry 

products only in accordance with a HACCP system.

    <bullet> Establishments that irradiate meat food products must have 

in place a dosimetry system to measure the absorbed dose of radiation.

    <bullet> Establishments that irradiate meat food products must have 

on file documents that relate to other compliance with the requirements 

of Federal Agencies with jurisdiction over irradiation, such as NRC and 

OSHA.

    <bullet> Labeling of meat food and poultry products irradiated in 

their entirety must bear the international radura logo. Also, either 

the product name must include the word ``Irradiated'' or the labeling 

must bear a disclosure statement such as ``Treated with radiation'' or 

``Treated by irradiation.'' The logo must be placed in conjunction with 

the disclosure statement, if the disclosure statement is used. The 

radiation disclosure statement is not required to be more prominent 

than the declaration of ingredients.

    <bullet> The inclusion of irradiated meat food or poultry product 

in a multi-ingredient product must be reflected in the ingredient 

statement on the finished product labeling.

    <bullet> Optional labeling statements about the purpose for 

radiation processing may be included on the product label in addition 

to the above stated requirements. Statements that there has been a 

specific reduction in microbial pathogens must be substantiated by 

processing documentation.

    <bullet> The regulations governing the irradiation of poultry 

products are now entirely consistent with the regulations governing the 

irradiation of meat food products but for the maximum dosage allowed (3 

kGy) and the requirement that if packaged poultry product is 

irradiated, that packaging must be air permeable.



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 final rule, as required by E.O. 12866 and 

the Regulatory Flexibility Act, satisfy the cost-benefit analysis 

requirements of the



[[Page 72162]]



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) and from the 

FSIS Internet world wide web page at http://www.fsis.usda.gov/OA/

topics/irrad-risk.htm.

    In this document, FSIS is revising the current regulations 

governing the irradiation of poultry to make them more consistent with 

the proposed regulations for meat and with HACCP. These revisions to 

the poultry regulations would pose no new risks to human health or 

worker safety and do not concern the environment. Therefore, FSIS has 

not addressed these changes in a separate risk assessment or in the 

above mentioned literature review.



Executive Order 12988



    This final 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 the PPIA. States and local jurisdictions may, 

however, exercise concurrent jurisdiction over meat and poultry 

products that are within their jurisdiction and 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 rule is not intended to have retroactive effect.

    Under this rule, 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 rule, if the challenge involves a decision of an 

FSIS program employee relating to inspection provided under the FMIA 

and the PPIA.



Compliance With Executive Order 12866--Final 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.

    FSIS is amending 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 revising 

the existing regulations governing the irradiation of poultry so as to 

render them more consistent with the proposed regulations for meat. In 

the proposal preceding this final action, FSIS requested comment 

concerning the potential economic effects of the proposed regulations, 

as well as data concerning the costs of and benefits from irradiation 

of meat and poultry. FSIS received only a few comments that included 

economic data or questioned the economic analysis included in the 

proposal. These comments are addressed below.

    FSIS believes that the net benefits of this action will be 

positive. As discussed in the preamble, irradiation can reduce the 

levels of pathogens in meat food and poultry products significantly. 

Further, the use of irradiation is voluntary. If an 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. However, the current lack of 

quantification of both the benefits and costs of irradiation make 

comparison difficult.

    FSIS endeavors to develop regulations 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 proposed requirements that allow 

for significant flexibility in integrating irradiation into processing 

operations. In this final rule, FSIS has been able to provide for even 

greater flexibility through revisions based upon the comments received 

in response to proposal.

    Although FSIS recognizes the capability of irradiation treatment to 

reduce pathogens below current regulatory performance standards for 

pathogen reduction, these regulations do not change the existing 

performance standards. With standards unchanged, the primary benefit of 

the regulations to establishments is the increased processing 

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 

the proposed regulation: (1) Not allowing for the irradiation of meat 

food products and (2) allowing the irradiation of meat food products 

only under very limited conditions, similar to those previously 

prescribed for the irradiation of poultry products. FSIS rejected these 

two alternatives for reasons explained below.

    FSIS did not consider alternatives that would not be permissible 

under current FDA regulations, such as allowing irradiation at higher 

doses or allowing the irradiation of ready-to-eat meat and poultry 

products. FSIS believes that the regulations in this final rule are the 

most permissive possible under current FDA regulations. Also, as 

explained in the preamble above, FSIS has petitioned FDA to raise the 

allowable absorbed dosage for poultry, to remove certain requirements 

regarding the packaging for irradiated poultry, and to specifically 

allow the irradiation of unrefrigerated (``hot-boned'') meat food 

products. Further, an industry consortium has petitioned FDA to allow 

the irradiation of processed meat and poultry products.



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 provide for the irradiation of 

meat food products and has rejected the option of disallowing 

irradiation.

    Notably, the irradiation of meat food products is 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.



[[Page 72163]]



Irradiation of Meat Food Products Under Limited Conditions



    The previous requirements governing the irradiation of poultry were 

fairly prescriptive in that they mandated a minimum dosage and required 

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 previous 

requirements mandating minimum dosages and packaging for irradiated 

poultry products, originally intended to ensure that the effects of 

irradiation were maintained, are no longer necessary in light of the 

new HACCP requirements. Therefore, FSIS is making final no minimum 

irradiation dose and no specific packaging requirements for meat food 

products, rescinding the minimum dose requirements for irradiated 

poultry, and revising the packaging requirements for poultry, where 

possible.



Benefits



    FSIS has concluded that the meat industry may accrue numerous 

benefits from the use of irradiation. As with other antimicrobial 

treatments, FSIS is allowing irradiation to be used at any point within 

a HACCP system and is requiring no minimum dosage. Establishments 

employing irradiation may accrue benefits from this flexibility. 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.

    Further, through the use of irradiation, product shelf-life can be 

increased. Andrews, et al. (1998), reviewed five studies encompassing 

shelf lives of different types of red meat products.\3\ Their results 

suggest that shelf life of products treated with irradiation increase 

considerably compared to untreated products.

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



    \3\ Andrews, L.S., et al. ``Food Preservation Using Ionizing 

Radiation,'' Review of Environmental Contaminant Toxicology, Vol. 

154, 1998, pp. 1-53.

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



    Society also may realize benefits from these final regulations if 

the use of irradiation results in a reduction of illnesses beyond what 

is achieved by current technologies. Several types of harmful 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 allowed by 

this action can reduce the levels of these pathogens substantially. 

Economic benefits associated with these reductions would be decreases 

in the diseases associated with these pathogens. The reductions in the 

disease rates would translate into a reduction in the number of visits 

to physicians and hospitals.

    FSIS believes that ground beef is likely to be the first meat 

product irradiated in great quantity. It is likely that ground beef 

will be irradiated in relatively large quantities initially because 

irradiation is a means for establishments to effectively eliminate E. 

coli O157:H7 from raw ground beef without cooking it. 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. Until now, 

establishments could distribute ground beef containing E. coli O157:H7 

only after they had thoroughly cooked it, so as to eliminate the 

pathogen. Establishments, therefore, are likely to benefit from the 

availability of irradiation as an additional treatment for rendering 

adulterated raw ground beef product safe. Of course, other types of raw 

meat and poultry products also may be irradiated to reduce or eliminate 

pathogens.

    To give some sense of the potential benefit from the reduction of 

illnesses that may occur as a result of the irradiation of ground beef, 

a USDA Economic Research Service 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. In that study, Morrison, 

et al. (1997), estimated the annual pre-HACCP economic value of the 

health costs and productivity losses attributable to E. coli O157:H7 

and salmonellosis to be between $226 and $552 million.\4\ If 25 percent 

of all ground beef were irradiated, the benefits could range between 

$56.5 and $138 million.

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



    \4\ Morrison, R.M., et al., ``Irradiating Ground Beef to Enhance 

Food Safety,'' Food Review, January-April 1997, pp. 33-37.

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



    An assumption that only 25% of ground beef will be irradiated may 

be 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.\5\ 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.''

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



    \5\ American Meat Institute Foundation, ``Consumer Awareness, 

Knowledge, and Acceptance of Food Irradiation,'' November, 1993.

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



    One consumer advocacy organization requested clarification 

regarding FSIS use of the estimates of benefits from Morrison (1997). 

The group questioned whether Morrison assumed that ground beef would be 

irradiated only after final packaging, as was required for poultry 

irradiated at the time of the study. The group suggested that if 

Morrison made such an assumption, the estimated reductions in foodborne 

illness would be inflated if applied to the proposed regulations, which 

allow ground beef to be irradiated before final packaging. The group 

claimed that because the ground beef could be re-contaminated after 

irradiation and before final packaging, reductions in pathogens and 

consequently, foodborne illness, would not be so high.

    FSIS disagrees. Morrison did not specify whether their estimates of 

benefits applied only to ground beef irradiated in its final packaging. 

However, FSIS is allowing meat and poultry product to be irradiated 

only in accordance with a HACCP system of process controls, regardless 

of when it is packaged. HACCP controls will considerably lessen, and 

likely prevent, the possibility that meat and poultry product will be 

re-contaminated after irradiation and before packaging. Therefore, 

these estimates of reductions in foodborne illness are applicable to 

these final regulations.

    Another commenter suggested that the proposed labeling requirements 

could prevent the wide-scale acceptance of irradiated products by 

consumers, who will view the required labeling as a warning, and 

therefore diminish the potential benefits from reductions in foodborne 

illnesses. This commenter suggested the use of voluntary instead of 

mandatory labeling and argued that demand for irradiated product will 

give producers and retailers incentive to disclose that their products 

were irradiated.

    As discussed above, disclosure of facts material to food products 

is required by the FMIA, PPIA, and the FFDCA. Irradiation can affect 

food in a manner that is not obvious to consumers in the absence of 

labeling and therefore is a material fact that must be disclosed to 

consumers to prevent misleading labeling. FSIS is requiring that 

irradiation of meat or poultry products be disclosed in product 

labeling. FSIS will consider, however, revising some or all of its 

labeling requirements as consumer awareness grows.

    FSIS has made some revisions to the proposed labeling requirements 

that



[[Page 72164]]



will increase flexibility for processors and could represent some 

minimal cost savings. First, FSIS is requiring that single ingredient 

meat or poultry products irradiated in their entirety be labeled with a 

radura and either a statement indicating that the product was 

irradiated or the inclusion of the word ``irradiated'' in the product 

name. Allowing establishments to use the word ``irradiated'' as part of 

the product name instead of including a labeling statement was 

suggested in industry comments as a means of providing more labeling 

flexibility.

    Also, in response to comments and as part of an effort to make FSIS 

labeling requirements more consistent with those of FDA, FSIS will not 

require, as proposed, that the irradiation statement and the radura be 

any more prominent than the ingredients statement on the labeling of 

irradiated meat food and poultry products. Thus, the statement and the 

radura may appear somewhere other than on the principal display panel.

    Finally, the same commenter estimated the annual net social welfare 

gains from irradiation, without HACCP, to be $900 million, i.e., almost 

ten times the benefits presented above. This higher estimate of 

benefits was based on an assumption that demand for irradiated ground 

beef would be similar to the potential demand for irradiated poultry as 

estimated by Fox and Olson (1998) from market surveys conducted between 

1995 and 1996.\6\ FSIS views this comment as further evidence that 

there could be benefits in excess of the health costs savings estimated 

by Morrison (1997).

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



    \6\ Fox, John A. and Dennis G. Olson, ``Market Trials of 

Irradiated Chicken,'' Radiation Physical Chemistry, 52 (1-6), 1998, 

pp. 63-66.

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



Incremental Costs



    In the proposed rule, using estimates from Morrison (1997) and 

other sources, FSIS estimated the incremental costs of irradiation to 

range from 2 to 6 cents/lb. of ground beef in 1995 dollars. These 

estimates included the cost of labels and of transportation of the 

ground beef products from establishments to third-party irradiators. 

Assuming that 25 percent of the total annual sales of ground beef (1.75 

billion lbs.) would be irradiated, FSIS estimated the annual cost of 

irradiation to range from $35 to $105 million in 1995 dollars.

    These costs are likely to be overestimated for two reasons. First, 

the cost estimates are based on the assumption that irradiation of 

ground beef would take place in the smallest plants, which have the 

capacity to irradiate only 52 million pounds per year. Second, FSIS 

assumed that only 25 percent of ground beef would be irradiated. Any 

increase in the irradiated quantity would tend to reduce costs 

considerably.

    Buzby and Morrison \7\ (1999) recently published updated cost 

estimates for ground beef for irradiation. They employed two estimates 

of costs, 1.6 cents/lb. and 5.0 cents/lb. in 1996 dollars. Again 

assuming that 25 percent of ground beef would be irradiated, they 

estimated that the costs of irradiation would range from $28.6 million 

to $89.3 million. Their new estimates fall within the range of costs 

estimated by FSIS in the proposed rule.

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



    \7\ Buzby, Jean C. and Rosanna M. Morrison, ``Food Irradiation--

An Update'' Food Review, May-August 1999, p. 21-22.

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



    In the analysis included with the proposal, FSIS assumed the costs 

of transporting ground beef from slaughter houses or processing plants 

to and from irradiating facilities to be 0.2 cents/lb. A commenter 

suggested that this estimate was ``too low by more than one order of 

magnitude.'' In response to this comment, FSIS recalculated the 

transportation costs to be twice the amount originally estimated, that 

is 0.4 cents/lb. instead of 0.2 cents/lb. This assumption would 

increase the irradiation costs to range from 2.2 to 6.2 cents/lb. FSIS 

believes that these possible cost increases are too small to 

significantly decrease the net benefits of meat irradiation.

    In conclusion, although FSIS has incomplete data regarding the 

costs and benefits of the rule, FSIS believes that the net benefits of 

this action will be positive. As discussed above, irradiation can 

reduce the levels of pathogens in meat food and poultry products 

significantly. Further, the meat industry may accrue numerous benefits 

from the use of irradiation.



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 final rule will 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 will not be affected adversely by the irradiation 

requirements because the use of irradiation is voluntary.

    The industry may 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 of these products would reduce demand by 

only 0.3611 percent.\8\

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



    \8\ 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.\9\ An increase in price of any one 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.

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



    \9\ 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.

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



    In the long term, small establishments may have to irradiate 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. 

However, FSIS believes that eventually technological innovations may 

reduce the cost of in-plant accelerators and that the increased 

availability of such devices could help small firms compete with the 

larger firms.

    This final rule may 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



[[Page 72165]]



that these entities purchase irradiated meat products, they could be 

affected somewhat by an increase in price.

    Finally, FSIS is revising the regulatory requirements concerning 

the irradiation of poultry for consistency with HACCP and with the 

requirements proposed for meat food products. Significantly, FSIS is 

eliminating 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.



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 rule on 

environmental and health conditions in low-income and minority 

communities.

    This rule allows 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 regulations should generally benefit 

consumers and the regulated industry. The regulations would not require 

or compel meat or poultry establishments to relocate or alter their 

operations in ways that could adversely affect the public health or 

environment in low-income and minority communities. Further, this rule 

does 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 are 

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 ensures 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.



Public Notification and Request for Data



    FSIS requests information regarding the impact of this final rule 

on minorities, women, and persons with disabilities, including 

information on the number of minority-owned meat and poultry 

establishments, the makeup of establishment workforces, and the 

communities served by official establishments.

    Public involvement in all segments of rulemaking and policy 

development are important. FSIS provides a weekly FSIS Constituent 

Update, which is communicated via fax to over 300 organizations and 

individuals. In addition, the update is available on line through the 

FSIS web page located at http://www.fsis.usda.gov. The update is used 

to provide information regarding FSIS policies, procedures, 

regulations, Federal Register notices, FSIS public meetings, recalls, 

and any other types of information that could affect or would be of 

interest to our constituents/stakeholders. The constituent fax list 

consists of industry, trade, and farm groups, consumer interest groups, 

allied health professionals, scientific professionals, and other 

individuals that have requested to be included. Through these various 

channels, FSIS is able to provide information to a much broader, more 

diverse audience. For more information and to be added to the 

constituent fax list, fax your request to the Congressional and Public 

Affairs Office, at (202) 720-5704.



Paperwork Requirements



    In response to comments and as part of an effort to make FSIS 

labeling requirements more consistent with those of FDA, FSIS will not 

require, as proposed, that the irradiation statement and the radura be 

any more prominent than the ingredients statement on the labeling of 

irradiated meat food and poultry products. Thus, the statement and the 

radura may appear somewhere other than on the principal display panel. 

Because of this change the 2-hour label development that FSIS included 

in the original paperwork analysis has been decreased to 1 hour. This 

change will decrease the overall burden estimate by 100 hours. 

Therefore, FSIS resubmitted an information collection request to OMB 

requesting approval for 2,601 burden hours, not 2,701.

    The Office of Management and Budget (OMB) has approved the 

reporting and recordkeeping requirements associated with this final 

rule under OMB control number 0582-0115.



List of Subjects



9 CFR Part 381



    Food labeling, Poultry and poultry products, Reporting and 

recordkeeping requirements, Signs and symbols.



9 CFR Part 424



    Food additives, Food packaging, Meat inspection, Poultry and 

poultry products.

    Accordingly, title 9, chapter III, of the Code of Federal 

Regulations is amended as follows:



PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS



    1. 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]



    2. Section 381.19 is removed.





Sec. 381.135  [Removed]



    3. Section 381.135 is removed.

    4. In Sec. 424.22, paragraph (c) is added to read as follows:





Sec. 424.22  Certain other permitted uses.



* * * * *

    (c) Irradiation of meat food and poultry products.

    (1) General requirements. Meat food and poultry products may be 

treated to reduce foodborne pathogens and to extend product shelf-life 

by the use of sources of ionizing radiation as identified in 21 CFR 

179.26(a). Official establishments must irradiate meat food and poultry 

products in accordance with 21 CFR 179.26(b), the Hazard Analysis and 

Critical Control Point (HACCP) system requirements in part 417 of this 

chapter, and the provisions of this section.

    (2) Dosimetry. Official establishments that irradiate meat food and 

poultry products must have the following procedures in place:

    (i) Laboratory operation procedures for determining the absorbed 

dose value from the dosimeter.

    (ii) Calibration criteria for verifying the accuracy and 

consistency of any means of measurement (e.g., time clocks and weight 

scales).

    (iii) Calibration and accountability criteria for verifying the 

traceability and accuracy of dosimeters for the intended



[[Page 72166]]



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.

    (iv) 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.

    (v) 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).

    (vi) Procedures for verifying routine dosimetry, i.e., assuring 

each production lot receives the total absorbed dose. Establishments 

may either position one dosimeter 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 in each production lot or use 

statistically based validation and dose mapping to determine the number 

and placement of dosimeters in each production lot.

    (vii) Procedures for verifying the relationship of absorbed dose as 

measured by the dosimeter to time exposure of the product unit to the 

radiation source.

    (viii) 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.

    (3) Documentation. Official establishments that irradiate meat food 

or poultry products must have the following documentation on premises, 

available to FSIS:

    (i) 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.

    (ii) Documentation that the machine radiation source irradiation 

facility is registered with the appropriate State government, if 

applicable.

    (iii) Documentation that a worker safety program addressing OSHA 

regulations (29 CFR chapter XVII) is in place.

    (iv) 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.

    (v) A certification by the operator that the irradiation facility 

personnel will only operate under supervision of a person who has 

successfully completed a course of instruction for operators of food 

irradiation facilities.

    (vi) A certification by the operator that the key irradiation 

personnel, who monitor or control daily operations, have been trained 

in food technology, irradiation processing, and radiation health and 

safety.

    (vii) 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.).

    (4) Labeling.

    (i) The labels on packages of meat food and poultry products 

irradiated in their entirety, in conformance with this section and with 

21 CFR 179.26(a) and (b), must bear the logo shown at the end of this 

paragraph (c)(4)(i). Unless the word ``Irradiated'' is part of the 

product name, labels also must bear a statement such as ``Treated with 

radiation'' or ``Treated by irradiation.'' The logo must be placed in 

conjunction with the required statement, if the statement is used. The 

statement is not required to be more prominent than the declaration of 

ingredients required under Sec. 317.2(c)(2). Any label bearing the logo 

or any wording of explanation with respect to this logo must be 

approved as required by Section 317.4. of this chapter or subparts M 

and N of part 381.

[GRAPHIC] [TIFF OMITTED] TR23DE99.000



    (ii) For meat food or poultry products that have been irradiated in 

their entirety, but that are not sold in packages, the required logo 

must 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. Unless the word ``Irradiated'' 

is part of the product name, the labeling counter sign, card, or other 

device also must bear a statement such as ``Treated with radiation'' or 

``Treated by irradiation.'' The logo must be placed in conjunction with 

the required statement, if the statement is used.

    (iii) The inclusion of an irradiated meat food or poultry product 

ingredient in any multi-ingredient meat food or poultry product must be 

reflected in the ingredient statement on the finished product labeling.

    (iv) 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, provided that such 

statements are not false or misleading. Statements that there has been 

a specific reduction in microbial pathogens must be substantiated by 

processing documentation.



    Done in Washington, DC, on December 13, 1999.

Thomas J. Billy,

Administrator.

[FR Doc. 99-32660 Filed 12-22-99; 8:45 am]

BILLING CODE 3410-DM-P