[Federal Register Volume 64, Number 246 (Thursday, December 23, 1999)]
[Rules and Regulations]
[Pages 72150-72166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32660]



[[Page 72149]]

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Part II





Department of Agriculture





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Food Safety and Inspection Service



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9 CFR Parts 381 and 424



Irradiation of Meat Food Products; Final Rule

  Federal Register / Vol. 64, No. 246 / Thursday, December 23, 1999 / 
Rules and Regulations  

[[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:
     Procedures for determining the absorbed radiation dose 
value from the dosimeter;
     Procedures for calibrating dosimeters and other means of 
measurement (e.g., time clocks and weight scales);
     Procedures for ensuring specific absorbed dosages of 
irradiation by product unit and product lot; and
     Procedures for verifying the integrity of the radiation 
source and the processing procedure.

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:
     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;
     Documentation that an irradiation facility that uses 
machine radiation sources is registered with the appropriate State 
government, if applicable;
     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;
     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;
     Certification by the operator that the key irradiation 
personnel have been trained in food technology, irradiation processing, 
and radiation health and safety; and
     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.

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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-log10 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:
     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.
     FSIS and FDA should expedite the approval of new packaging 
materials for product irradiated while packaged.
     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:
     One trade association requested that FSIS require the 
radura but not the statement on product irradiated in its entirety;
     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;
     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;
     Several commenters asked that FSIS require the radura with 
a qualified statement indicating the beneficial effects of irradiation;
     One commenter requested that FSIS allow labeling that 
indicates the source of radiation, i.e., gamma or machine source;
     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;''
     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.''
     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;
     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;
     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.
     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.
     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-log10), 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-log10 and 
3.2-log10 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-log10 
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-log10 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-log10 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-log10 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-
log10 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-log10 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-log10 
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:
     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.
     Establishments may irradiate meat food and poultry 
products only in accordance with a HACCP system.
     Establishments that irradiate meat food products must have 
in place a dosimetry system to measure the absorbed dose of radiation.
     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.
     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.
     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.
     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.
     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