Irradiation of Meat Food Products

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

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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,

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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.

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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\

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\8\ Huang, Kao S., A Complete System of U.S. Demand for Food,

ERS Technical Bulletin No. 1821, 1993, p. 24.

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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.

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\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.

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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