[Federal Register Volume 64, Number 246 (Thursday, December 23, 1999)]
[Rules and Regulations]
[Pages 72150-72166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32660]
[[Page 72149]]
_______________________________________________________________________
Part II
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
_______________________________________________________________________
9 CFR Parts 381 and 424
Irradiation of Meat Food Products; Final Rule
Federal Register / Vol. 64, No. 246 / Thursday, December 23, 1999 /
Rules and Regulations
[[Page 72150]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 381 and 424
[Docket No. 97-076F]
Irradiation of Meat Food Products
AGENCY: Food Safety and Inspection Service
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its
regulations to permit the use of ionizing radiation for treating
refrigerated or frozen, uncooked meat, meat byproducts, and certain
other meat food products to reduce levels of foodborne pathogens and to
extend shelf-life. FSIS also is revising the regulations governing the
irradiation of poultry products so that they will be as consistent as
possible with the regulations for the irradiation of meat food
products.
EFFECTIVE DATES: February 22, 2000.
FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director,
Regulation Development and Analysis Division, Office of Policy, Program
Development, and Evaluation, Food Safety and Inspection Service, U.S.
Department of Agriculture (202) 720-5627.
SUPPLEMENTARY INFORMATION:
Background
On February 24, 1999, the Food Safety and Inspection Service (FSIS)
published a proposal (64 FR 9089) to permit the use of ionizing
radiation for treating refrigerated or frozen uncooked meat, meat
byproducts, and certain other meat food products (hereafter referred to
as ``meat food products'' when discussed as a group) to reduce levels
of foodborne pathogens and to extend shelf-life. FSIS also proposed to
revise the regulations governing the irradiation of poultry products so
that they will be as consistent as possible with the regulations for
the irradiation of meat food products. FSIS initially provided 60 days
for public comment, ending the comment period on April 26, 1999.
Because of the great interest in this proposal, FSIS reopened the
comment period for 15 days on June 2, 1999 (64 FR 29602). FSIS
announced that it would consider all comments received between April
27, 1999 and June 17, 1999. In this document, FSIS makes final the
proposed regulations, with some revision in response to comments.
Food Irradiation
Food irradiation is the process of exposing food to high levels of
radiant energy. Forms of radiant energy include: microwave and infrared
radiation that heat food during cooking; visible light or ultraviolet
light used to dry food or kill surface microorganisms; and ionizing
radiation, resulting from cobalt-60, cesium-137, x-ray machines, or
electron accelerators, that penetrates deeply into food, killing insect
pests and microorganisms without raising the temperature of the food
significantly. Food is most often irradiated commercially to extend
shelf-life, eliminate insect pests, or reduce numbers of pathogenic
microorganisms. Food irradiation for these purposes is practiced in
many countries, including the United States.
Section 201(s) of the Federal Food, Drug and Cosmetic Act (FFDCA)
defines sources of radiation used to treat food as food additives:
The term ``food additive'' means any substance the intended use
of which results or may reasonably be expected to result, directly
or indirectly, in its becoming a component or otherwise affecting
the characteristics of any food (including any substance intended
for use in producing, manufacturing, packing, processing, preparing,
treating, packaging, transporting, or holding food; and including
any source of radiation intended for any such use), if such
substance is not generally recognized * * * to be safe under the
conditions of its intended use * * *.
The Food and Drug Administration (FDA) of the Department of Health
and Human Services has the primary responsibility for determining
whether food additives are safe for particular uses. FDA lists uses of
food additives it has concluded are safe in 21 CFR parts 172 through
179.
On August 25, 1994 (59 FR 43848), FDA announced that it had
received a petition from Isomedix, Inc., requesting that FDA amend the
food additive regulations in 21 CFR part 179 (Irradiation in the
Production, Processing and Handling of Food). The petition requested
that FDA authorize the safe use of sources of ionizing radiation to:
control microbial pathogens in raw, fresh-chilled, and frozen intact
and comminuted edible tissue of the skeletal muscle and organ meat
of domesticated mammalian food sources; with concomitant control of
infectious parasites, and, extension of acceptable edible/marketable
life of chilled/refrigerated and defrosted meat through the
reduction in levels of spoilage microorganisms.
The petition further specified that the proposed foods were to be
``primarily from bovine, ovine, porcine, and equine sources.'' Also,
Isomedix requested that a maximum dose of 4.5 kiloGray (kGy) be
established for the irradiation of refrigerated meat, and that a
maximum dose of 7.0 kGy be established for the irradiation of frozen
meat.
After an evaluation of available data, FDA concluded that there was
a reasonable certainty of no harm from the irradiation of meat food
products under the conditions requested in the petition and that
irradiation would not adversely affect the nutritional adequacy of
these products. On December 3, 1997, FDA published a final rule (FDA
Docket No. 94F-0289; 62 FR 64107) granting the Isomedix petition. In
that publication, FDA expanded the list of products (21 CFR 179.26(b))
for which ionizing irradiation may be safely used to include:
refrigerated and frozen uncooked meat, as defined by FSIS in 9 CFR
301.2(rr); meat byproducts (e.g., edible organs, such as the liver and
the kidneys), as defined by FSIS in 9 CFR 301.2(tt); and certain meat
food products (e.g., ground beef and hamburger) within the meaning of 9
CFR 301.2(uu), with or without nonfluid seasoning, that are otherwise
composed solely of intact or ground meat or meat byproducts, or of
both.
The FSIS Proposal
As stated above, on February 24, 1999, FSIS proposed regulations
governing the irradiation of refrigerated and frozen, uncooked meat
food products and also proposed to revise the poultry irradiation
regulations for consistency. Specifically, FSIS proposed the following:
Dosage
FSIS proposed that the defined meat food products could be treated
with ionizing irradiation at dosages of up to 4.5 kiloGrays (kGy), if
refrigerated, and 7 kGy, if frozen. FSIS proposed no minimum dosage.
Process Control
FSIS proposed to require that official establishments irradiate
meat food products for food uses only in accordance with a Hazard
Analysis and Critical Control Point (HACCP) system or, if not yet
operating under HACCP requirements, in accordance with a process
schedule validated by a process authority.
Dosimetry
FSIS proposed to require that official establishments that
irradiate meat food products have in place a dosimetry system to
measure the absorbed dose of radiation. The dosimetry system would
[[Page 72151]]
ensure that each lot of treated product has received the dose defined
in the process schedule or HACCP plan. The proposed requirements
mandated that each dosimetry system included:
Procedures for determining the absorbed radiation dose
value from the dosimeter;
Procedures for calibrating dosimeters and other means of
measurement (e.g., time clocks and weight scales);
Procedures for ensuring specific absorbed dosages of
irradiation by product unit and product lot; and
Procedures for verifying the integrity of the radiation
source and the processing procedure.
Documentation
FSIS proposed to require official establishments that irradiate
meat food products to have on file the following documents that relate
to the establishment's compliance with other Federal requirements
concerning irradiation:
Documentation that an irradiation facility that possesses
gamma radiation sources is licensed with the Nuclear Regulatory
Commission (NRC) or the appropriate State government acting under
authority granted by the NRC, and that a worker safety program
addressing OSHA regulations is in place;
Documentation that an irradiation facility that uses
machine radiation sources is registered with the appropriate State
government, if applicable;
Citations or other documents that relate to the instances
in which the establishment was found not to comply with Federal or
State agency requirements for irradiation facilities;
Certification by the operator that the irradiation
facility's personnel are operating under the supervision of a person
who has successfully completed a course of instruction for operators of
food irradiation facilities;
Certification by the operator that the key irradiation
personnel have been trained in food technology, irradiation processing,
and radiation health and safety; and
Guarantees from the suppliers of all food-contact
packaging materials that may be subject to irradiation, that those
materials comply with the FFDCA (21 U.S.C. 301 et seq.).
Labeling
FSIS proposed that labeling for packaged meat food products
irradiated in their entirety bear the radura logo along with a
statement such as ``Treated with radiation'' or ``Treated by
irradiation.'' FSIS proposed that the logo be placed prominently and
conspicuously in conjunction with the required statement and that the
statement appear as a qualifier contiguous to the product name. Also,
FSIS proposed to require that inclusion of an irradiated meat food
product ingredient in any multi-ingredient product be reflected in the
ingredient statement on the finished product labeling. Finally, FSIS
stated that it would allow optional labeling statements about the
purpose for radiation processing to be included on the product label in
addition to the above stated requirements. Statements indicating a
specific reduction in microbial pathogens would have to be
substantiated by processing documentation.
FSIS proposed to require that for unpackaged meat food products
irradiated in their entirety, the required logo and a statement must be
prominently and conspicuously displayed to purchasers either through
labeling on a bulk container or some other appropriate device.
Poultry
FSIS also proposed to revise the existing regulations governing the
irradiation of poultry products to make them as consistent as possible
with the regulations proposed for meat food products. FSIS proposed to
eliminate the regulations requiring that establishments irradiate
poultry products only in accordance with Partial Quality Control
programs and to instead require that poultry establishments, like meat
establishments, irradiate product in accordance with HACCP plans or
process schedules. FSIS also proposed to eliminate the provision that
stated that only packaged poultry products may be treated with
irradiation. FSIS had adopted this requirement to ensure that the
antimicrobial effects of irradiation would be maintained throughout the
processing and distribution of the poultry products. However, because
under the proposal all poultry establishments would be required to
develop and implement HACCP plans, this prescriptive packaging
requirement would no longer be necessary.
FSIS could not, however, propose to rescind the FDA requirement in
21 CFR 179.26(b)(6) that if packaged poultry product is irradiated,
that packaging be air permeable: ``* * * any packaging used shall not
exclude oxygen.'' FSIS originally requested that FDA establish this
requirement for control of the pathogen C. botulinum. In light of the
new HACCP requirements, this prescriptive requirement is no longer
necessary. Under HACCP, poultry establishments have both the
responsibility and the flexibility to determine the best means for
controlling any hazards resulting from the irradiation of product in
anaerobic packaging. FSIS submitted a petition to FDA on August 19,
1999, to eliminate this packaging requirement.
FSIS proposed to eliminate the minimum dose requirement for
irradiated poultry products contained in Sec. 381.147(f)(4). FSIS
adopted this requirement to ensure that the irradiation of poultry
product, which may occur only after the product is packaged for retail
sale, does in fact achieve a specific reduction in pathogens. However,
FDA and FSIS have concluded that different doses of ionizing radiation
can be appropriate, in different circumstances, for achieving different
technical effects and, therefore, that to continue to require a minimum
dose of irradiation for poultry products would limit the flexibility
needed for the successful implementation of HACCP. FSIS considers
irradiation to be just one of many treatments that could be used within
a HACCP system to achieve a reduction in pathogens.
FSIS could not propose to revise the FDA limits on the maximum
absorbed radiation dose for poultry products. However, it is possible
that poultry products could be safely treated with higher doses of
radiation than those that are currently allowed. Higher doses could
achieve greater reductions in pathogens. In the August 19, 1999,
petition mentioned above, FSIS asked FDA to reconsider and raise the
limit on the maximum absorbed dose of radiation in poultry products.
FSIS proposed to eliminate two of the labeling requirements in
Sec. 381.135(a): the requirement that the radura logo on irradiated
poultry product labels be colored green and the requirement that
``letters used for the qualifying statement shall be no less than one-
third the size of the largest letter in the product name.'' The
elimination of these requirements will make FSIS requirements
consistent with FDA requirements and provide more flexibility for
labeling irradiated poultry products, without affecting the information
content of such labels.
Because FSIS proposed to allow unpackaged poultry product to be
irradiated, it also proposed labeling requirements for unpackaged,
irradiated poultry product sold at the retail level (proposed
Sec. 318.135(b)). The proposed labeling requirements are consistent
with those proposed for unpackaged,
[[Page 72152]]
irradiated meat food products and with FDA labeling requirements for
irradiated products sold in bulk (21 CFR 179.26(c)(2)).
Also, because FSIS proposed to allow irradiated poultry products to
be used as ingredients in further processed products, FSIS also
proposed to require that the ingredient statement on such products
reflect the inclusion of irradiated poultry products (Sec. 381.135(b)).
For example, under the proposal, an ingredient statement for a sausage
product containing irradiated poultry would be required to include an
entry such as, ``irradiated poultry'' or ``poultry, treated by
irradiation.''
Comments and Responses
By the close of the comment period, FSIS received about 1,100
comments from consumers, consumer advocacy organizations, academia,
trade and professional associations, scientific organizations, the meat
and poultry products industries, the irradiation equipment industry,
industry consultants, and State governments. Generally, industry,
academia, and professional organizations supported the proposal. These
commenters expressed concerns about the proposed labeling requirements,
which they believe are too prescriptive, about the length of time it
took to publish the proposal, and made recommendations for broadening
the scope of the proposal. Consumer advocacy groups, for the most part,
expressed qualified support for the proposal. All expressed concern
that establishments will use irradiation to treat product produced
under insanitary conditions and all wanted FSIS to require explicit and
conspicuous product labeling. Many of the individual consumers and a
few organizations opposed the irradiation of meat food products
altogether, but demanded explicit and conspicuous product labeling in
the event FSIS allowed it. Summaries of issues raised by commenters and
Agency responses follow.
Safety of Irradiation
Comment: Numerous consumers questioned the research regarding the
safety of irradiated food. Some demanded more research before
irradiation is allowed; some opposed irradiation altogether. Several
opposed irradiation because they believe it will significantly degrade
the nutritional quality of treated food.
A few commenters opposed irradiation because, they asserted, its
use would increase the risk of accidents involving radioactive
material. Some raised concerns about worker safety and environmental
issues related to irradiation. One consumer advocacy group argued that
the rule's potential impact on the environment must be reviewed under
the National Environmental Policy Act (NEPA, 42 U.S.C. 4321 et seq.).
Finally, a few consumers requested that parents be asked to give their
permission before their children are served irradiated food in the
school lunch program.
Response: The safety and efficacy of food irradiation, as
demonstrated by numerous experiments and studies, is widely accepted by
Federal regulatory agencies and national and international food and
public health organizations. Before listing the uses of sources of
ionizing radiation permitted on meat food products, as well as on other
foods, FDA examined numerous studies on the chemical effects of
radiation, the impact of radiation on nutrient content of foods,
potential toxicity concerns, and effects on microorganisms in or on
irradiated products. FDA concluded that irradiation is safe in reducing
disease-causing microbes in or on meat food products and that it does
not compromise the nutritional quality of treated products.
Furthermore, the World Health Organization, the Food and Agriculture
Organization, the American Medical Association, and the American
Dietetic Association endorse food irradiation.
FSIS has examined the potential impacts of food irradiation in a
review of risk analysis literature made available with the proposed
rule. This literature review is available from the FSIS Docket Clerk's
Office (see ADDRESSES above) and from the FSIS Internet world wide web
page at http://www.fsis.usda.gov/OA/topics/irrad-risk.htm.
From this review of recent studies, FSIS concluded that the
proposed regulations permitting the irradiation of meat food products
and the revision of the regulations governing the irradiation of
poultry products would pose no significant risk to worker or
transportation safety. FSIS concluded that oversight by other Federal
and State agencies will ensure the safety of food irradiation
facilities:
In summary, proper design and operating procedures of commercial
irradiators have been shown to operate without significant radiation
risk to workers or the public. NRC [Nuclear Regulatory Commission]
has set stringent environmental protection requirements for any
facilities that use radionuclide sources (10 CFR Parts 20, 30, 51,
and 71). There are special carrier requirements for transport of
hazardous materials (such as the radionuclides used at the facility)
set by the DOT [Department of Transportation]. Any extraneous
radiation from radionuclides would be contained in plants by
shielding required by the NRC and the Bureau of Radiological Health
at FDA. The risk of radiation exposure to workers is very low with
adherence to the required NRC, OSHA, and other safety requirements.
And finally, FSIS ensures that the risks from food irradiation are
insignificant by its requirement that all irradiation facilities
adhere to the safety regulations of the NRC, DOT, and FDA.
Furthermore, FSIS employees will receive training from FSIS in
radiation health and safety and will be required to wear dosimetry
devices. The Agricultural Research Service (ARS) will issue the devices
as part of their radiological safety program for all USDA employees.
Radiation exposure records for FSIS employees will be maintained and
monitored by ARS, and kept indefinitely.
Concerning NEPA, USDA has determined that FSIS programs and
activities have been found to have no individual or cumulative effect
on the human environment. Accordingly FSIS is categorically excluded
from the preparation of an Environmental Assessment (EA) or
Environmental Impact Statement unless the Administrator determines that
an action may have a significant environmental effect (7 CFR 1b.4). The
irradiation of various food products has been permitted and safely
conducted for over 30 years. The irradiation of poultry products has
been permitted and safely conducted since 1992. Therefore, the
Administrator has not determined that circumstances dictate the need
for preparation of an EA for the voluntary use of irradiation in meat
food products.
FSIS works closely with the other agencies within USDA responsible
for the school lunch program. Should USDA or individual school
districts choose to purchase irradiated products for the school lunch
program, FSIS would support that decision. Irradiation can
significantly reduce the levels of pathogenic microorganisms in treated
meat food and poultry products. Therefore, irradiated food products
would be ideal for the school lunch program, which serves children, a
population particularly vulnerable to foodborne illness. FSIS sees no
need for any special notification of the parents of children
participating in a school lunch program that serves irradiated meat
food or poultry products because FSIS agrees with FDA's finding that
food irradiation poses no toxicological or microbiological risks for
consumers and does not affect the nutritional adequacy of treated
product.
[[Page 72153]]
Efficacy of Irradiation
Comment: Several commenters from industry and academia requested
that FSIS either maintain a minimum absorbed dose requirement or, if
there is to be no required minimum dose, require establishments that
irradiate product to achieve a minimum level of pathogen reduction (one
irradiator suggested 1-log10 reduction of the pathogen of
concern in a product). One commenter argued that unscrupulous
processors could irradiate product with a minimal dosage, achieving an
insignificant antimicrobial effect, merely to accrue the benefit of the
label and extended product shelf-life. This commenter also maintained
that consumers would be misled by product labeled as irradiated, but
treated with only a negligible dose. Another industry commenter
maintained that although FSIS should not mandate irradiation, FSIS
should mandate that all official establishments achieve the level of
pathogen reduction resulting from irradiation, regardless of the
antimicrobial intervention they use.
Several consumer advocacy organizations recommended that FSIS
maintain the minimum dose requirement for treated poultry and establish
a minimum dose for meat food products so as to ensure specific
reductions in pathogens.
Response: FSIS will allow meat and poultry establishments to
determine what level of irradiation (subject to a maximum level) and
what consequent reduction of pathogens is appropriate within their
HACCP systems. Depending on the processing environment, the type of
meat food or poultry product, and the type of radiation source
employed, varying dosages of radiation will be appropriate. A required
minimum dosage would undercut the flexibility needed for the successful
implementation of HACCP.
Furthermore, FSIS finds that it is unnecessary to establish a
minimum level of pathogen reduction to be achieved by irradiation or by
any other specific antimicrobial intervention. Establishments must
determine what level of pathogen reduction is necessary from a
particular intervention based on the results of the hazard analysis
they conduct when developing their HACCP plan. Establishments are
required to meet specific pathogen reduction performance standards for
numerous meat food and poultry products and FSIS plans to propose more
standards to eventually cover every processing category. FSIS will
ensure that safe meat food and poultry products are produced through
compliance with these standards, but need not hinder processing
innovation by mandating the use of specific antimicrobial
interventions, or specific results from specific interventions.
Comment: Several consumer advocacy organizations argued that FSIS
should require establishments that irradiate product, and especially
establishments not yet under HACCP, to conduct regular micro-testing
prior to irradiation. One organization requested that FSIS require end-
product microbial testing of irradiated product. This testing would
discourage establishments from using irradiation to treat ``dirty''
product or operate under insanitary conditions. Another suggested that
FSIS clarify in the final rule that irradiation would in no way satisfy
the ``zero-fecal'' policy. Finally, another organization argued that
FSIS should allow meat food products to be irradiated only after final
packaging, to prevent any recontamination of the treated product.
Response: Irradiation is just one of the many antimicrobial
interventions available to establishments. As with other interventions,
its use in no way exempts establishments from meeting statutory
sanitation requirements. Moreover, FSIS emphasizes that establishments
that employ irradiation still must meet the zero-tolerance requirements
for visible fecal matter on meat or poultry carcasses.
FSIS will neither require special microbial testing nor conduct
such testing in establishments that irradiate product (although FSIS
may conduct microbial testing to verify pathogen reduction claims or
for enforcement purposes). Compliance with the HACCP requirements,
along with other FSIS requirements governing sanitation, will preclude
the irradiation of product produced under insanitary conditions, as
well as the adulteration of product after an irradiation treatment.
Finally, in order to promote processing flexibility and innovation
that will lead to improvements in food safety, FSIS did not propose to
require that meat food products be irradiated only after final
packaging. Using a HACCP system, an establishment must control the
conditions under which product is held from initial processing through
irradiation and packaging to ensure and preserve the intended
antimicrobial effects of irradiation. By law, establishments must
produce unadulterated meat food and poultry products regardless of
whether or when they irradiate within their processing systems.
Comment: Numerous commenters opposed irradiation of meat food and
poultry products because they believe irradiation will allow
establishments to clean up insanitary meat food and poultry products
resulting from ``factory farming'' (concentrated animal production
methods), which they believe is unethical and inhumane. They argue,
therefore, that irradiation would indirectly promote the expansion of
``factory farming.''
Response: As stated above, the use of irradiation in no way exempts
establishments from meeting statutory and regulatory sanitation
requirements. Establishments are not permitted to produce meat food or
poultry products under insanitary conditions, regardless of whether
they irradiate. Furthermore, FSIS prohibits the inhumane handling and
slaughter of livestock. Under the Humane Slaughter Act (7 U.S.C. 1901-
1906), FSIS personnel may suspend inspection of an official
establishment if the Agency determines that the method by which
livestock is slaughtered is inhumane, as defined by the Humane
Slaughter Act.
As part of its ``farm-to-table'' food safety strategy, FSIS is
interested in effects of concentrated animal production methods on food
safety, as well as humane handling and slaughter. Notably, no data was
submitted that supported comments concerning concentrated animal
production. FSIS would welcome and thoroughly review any such data.
Comment: One consumer advocate organization requested that FSIS
provide information on how it intends to redeploy inspection program
employees to irradiation facilities.
Response: As stated in the proposal, facilities that irradiate meat
food and poultry products are considered by FSIS to be official
establishments. As such, they are subject to inspection as provided for
by the Federal Meat Inspection Act (FMIA) and Poultry Products
Inspection Act (PPIA). FSIS will deploy inspection program employees to
irradiation facilities based on a number of factors, such as inspection
force workload and the type of activities conducted at the individual
facilities (e.g., product irradiation only, irradiation and additional
processing, slaughter and irradiation) Assignment of FSIS program
personnel to irradiation facilities will not differ from assignment to
other types of official establishments.
Irradiation and HACCP
Comment: A few establishments and trade associations argued that
FSIS should not mandate a critical control point (CCP) for irradiation,
as they believed that the preamble implied that FSIS will mandate a CCP
for irradiation.
[[Page 72154]]
Response: FSIS did not mandate any specific CCP or critical limit
in the proposed rule language, although the Agency did give some
examples. Because most, if not all, establishments will irradiate
product specifically to reduce microbial pathogens (identified
hazards), they would include irradiation as a CCP in their HACCP plans.
A CCP is a point, step, or procedure at which control can be applied so
that a food safety hazard can be prevented, eliminated, or reduced to
an acceptable level. Dosage, ambient temperature, oxygen levels or
other factors that affect the antimicrobial efficacy of irradiation
will likely be monitored to determine if the critical limits for an
irradiation CCP are being met.
In accordance with the FDA regulation on the use of irradiation,
establishments could irradiate product solely to extend shelf-life. In
its proposal to provide for the use of irradiation on meat food
products, FSIS stated that it therefore might be possible for an
establishment to irradiate product solely to extend shelf-life and not
account for effects of the treatment on pathogens in its HACCP plan:
Were an establishment to irradiate meat food products solely for the
purpose of extending shelf-life, it is conceivable, although highly
unlikely, that the establishment could disregard any amount of
pathogen reduction achieved by the irradiation and therefore not
list irradiation as a CCP in its HACCP plan. However, such an
establishment still would have to meet the other requirements for
irradiation facilities promulgated by FSIS and other Federal and
State agencies, such as requirements for dosimetry and
documentation. FSIS does not anticipate that any establishment will
irradiate product solely to extend shelf-life and not account for
the antimicrobial effects of irradiation in its HACCP plan.
(64 FR 9091-9092)
FSIS still maintains this position, but notes that there is a
safety factor inherent in product shelf-life determination. Pathogenic
and non-pathogenic microorganisms, including spoilage organisms,
compete for nutrients in food products. Non-pathogenic and spoilage
organisms generally are more plentiful than pathogenic organisms.
Increasing the shelf-life of a product involves reducing the levels of
the spoilage organisms. Although most antimicrobial treatments,
including irradiation, reduce microbial levels fairly proportionately,
an establishment must ensure that its treatment does not give a
competitive advantage to pathogenic organisms, allowing for their
disparate growth.
More specifically, irradiation can affect the levels and projected
growth of microbial pathogens, which would be identified by
establishments as hazards. Establishments should take into account the
levels and projected growth of microbial pathogens in meat food and
poultry products when determining product shelf-life. Therefore, in its
HACCP plan, an establishment would need to account for the reduction of
pathogens (and possibly the reduction of competing microorganisms)
resulting from irradiation conducted solely to extend product shelf-
life. Nonetheless, FSIS is not mandating the specific CCP or critical
limit to be employed.
Comment: Numerous industry groups and establishments argued that
facilities that only irradiate packaged product should not be
considered official establishments, since, in their view, such
establishments would not be processing product (traditionally
considered to be grinding, salting, etc.). A few of these commenters
noted that FSIS does not currently consider certain warehouses that
freeze packaged meat food and poultry products to destroy parasites to
be official establishments. One commenter suggested that third party
irradiators be required to implement HACCP anyway; several suggested
that irradiation conducted at a remote facility be considered under the
HACCP plan of the establishment that provides the meat food or poultry
products for irradiation.
Response: FSIS disagrees and will consider any facility that
irradiates meat food or poultry products to be an official
establishment. Sources of radiation used to treat food are defined as
food additives under Sec. 201(s) of the FFDCA. FSIS believes that the
act of using any food additive constitutes processing, and the
processing of meat food and poultry products may only take place in
official establishments subject to FSIS inspection and regulation.
In regard to the freezing of meat food and poultry products to kill
internal parasites, it is true that FSIS has allowed certain warehouses
to freeze beef and pork for this purpose, without being designated as
official establishments. FSIS is now reviewing this policy decision to
determine whether this freezing constitutes processing and will
designate these facilities as official establishments if it concludes
that it does.
Because facilities that irradiate product will be designated as
official establishments, FSIS will not permit such establishments to
operate under other establishments' HACCP plans. Each official
establishment must develop and implement its own.
Comment: Several commenters contended that the validation
requirement for process schedules is inadequate, since irradiation is
so complicated and relatively new to the meat food product industry.
They suggested FSIS require that radiation specialists review process
schedules and HACCP plans. One consumer advocacy organization suggested
that FSIS should validate HACCP plans that include irradiation.
Response: FSIS disagrees. Food irradiation has been practiced in
the United States for over 30 years. Further, the irradiation of
poultry products has been permitted and safely conducted since 1992.
Industry possesses the expertise and the resources to safely and
effectively irradiate meat food products.
FSIS is requiring certain employees of official establishments
conducting irradiation to be trained in various aspects of food
irradiation and radiation safety (new Sec. 424.22(c)(3)(v) and (vi));
FSIS already requires this training for personnel at establishments
that irradiate poultry.
In regard to the proposed requirements for process schedule
validation, because all official meat and poultry establishments will
be operating under the HACCP requirements by the time the regulations
are in effect, FSIS has not carried forward the proposed process
schedule requirements (meant for establishments not yet operating under
HACCP) into this final rule. FSIS does not validate establishment HACCP
plans, regardless of the processing systems employed. In accordance
with Sec. 417.4(a) of the regulations, it is the responsibility of an
establishment to validate its HACCP plan's adequacy in controlling the
identified food safety hazards. FSIS does review HACCP plans for
conformance with the HACCP regulations. Further, FSIS and
establishments are responsible for verifying that HACCP plans are
adequate and working on a day-to-day basis. Establishments must monitor
and verify the performance of the controls in their HACCP plans and
maintain records of this monitoring and verification. FSIS evaluates
the HACCP plan's adequacy and successful operation as part of the
inspection process.
Scope of Meat Food and Poultry Products That May Be Irradiated
Comment: Several commenters requested that FSIS specifically
provide for irradiation as an acceptable treatment for raw, non-intact
beef products contaminated with Escherichia coli O157:H7.
Response: On January 19, 1999, FSIS published a notice in the
Federal Register (54 FR 2803; ``Beef Products Contaminated With
Escherichia Coli
[[Page 72155]]
O157:H7'') clarifying that non-intact beef products, as well as intact
cuts of muscle that are to be further processed into non-intact product
prior to distribution for consumption, that are contaminated with E.
coli O157:H7 are adulterated under the Federal Meat Inspection Act
unless the products are further processed to destroy this pathogen.
Also in that notice, FSIS stated that it was considering irradiation as
an option for effectively eliminating E. coli O157:H7 from contaminated
beef products, since the only type of effective processing available at
the time of the notice was cooking. Now, under the regulations in this
final rule, establishments may use irradiation as a means of
eliminating E. coli O157:H7 from contaminated beef products.
An establishment that irradiates beef product known to be
contaminated with E. coli O157:H7 and intended for distribution as a
non-intact product must have controls in place to ensure that the
pathogen is eliminated from the product prior to its distribution for
consumption. The establishment also must document its actions to
eliminate E. coli O157:H7 from the product in accordance with
applicable regulations. Establishments should refer to the above
mentioned notice, as well as guidance available from the FSIS Internet
site (www.fsis.usda.gov), for further clarification on the Agency's
policy in regard to the treatment of beef products containing E. coli
O157:H7.
Comment: Consumer and industry groups asked FSIS to broaden the
scope of the final rule to provide for the irradiation of processed
products, especially ready-to-eat products. Many commenters believed
that the FDA finding in regard to the Isomedix petition allows FSIS to
do this without petitioning FDA again. Also, several commenters
criticized FSIS and FDA for failing to cooperate more closely in regard
to approving the irradiation for various products. They suggested that:
FSIS should act quickly to petition FDA to make the
regulations for irradiating poultry consistent with those for meat and
to allow for the irradiation of hot-boned meat.
FSIS and FDA should expedite the approval of new packaging
materials for product irradiated while packaged.
FSIS should make final and implement Docket No. 88-026P
(``Substances Authorized for Use in the Preparation of Meat and Poultry
Products''; 60 FR 67459) so as to end the need for duplicative
rulemaking by FDA and FSIS when approving food additives, including the
use of sources of ionizing radiation.
Response: FDA's authority to regulate the uses of ionizing
radiation on food is clear under Sec. 409 of the FFDCA. FDA has
approved the use of sources of ionizing radiation only on the uncooked
meat food products described above. Until FDA approves the use of
ionizing radiation on other meat food products, including processed or
cooked products, FSIS will not provide for the irradiation of such
products.
In August 23, 1999, a consortium of organizations, including the
National Food Processor's Association (NFPA), petitioned FDA to allow
for the use of approved sources of ionizing radiation on processed meat
food and poultry products. Because the irradiation treatment is
intended to significantly reduce the levels of pathogens in food, FDA
is reviewing this petition in an expedited clearance process. FSIS will
cooperate with FDA in reviewing this petition. Further, On August 19,
1999, FSIS petitioned FDA to clarify that sources of ionizing radiation
may be used on ``hot-boned'' (unrefrigerated) meat food products and to
revise the dosage and packaging restrictions on the irradiation of
poultry products for consistency. FDA also is reviewing these petitions
in an expedited clearance process.
FDA is also working to expedite the process for reviewing packaging
materials to be used during food product irradiation and FSIS will
cooperate with FDA in reviews of such packaging for poultry and meat
food products. Under its new Premarket Notification Program, FDA will
continue to review all food contact substances, including food
packaging materials intended for use during irradiation, but will no
longer necessarily list those permitted in the Code of Federal
Regulations.
In regard to the approval of food additives in meat food and
poultry products, elsewhere in this issue of the Federal Register, FSIS
has published a final rule (FSIS Docket No. 88-026F; ``Substances
Authorized for Use in the Preparation of Meat and Poultry Products'')
that ends duplicative approval by both FDA and FSIS. Requests to
approve the use of food additives in or on meat food and poultry
products not permitted now must be sent to FDA. Although FDA will
receive and review such petitions, FDA also intends to amend its
regulations to provide for FSIS review of petitions for uses of food
additives in or on meat food or poultry products. These actions will
eliminate the need for separate FSIS rulemakings. FSIS will limit
substance-specific rulemakings to those necessary to establish
prohibitions or limitations on the use of substances in meat food or
poultry products that are necessary to protect public health or to
achieve other consumer protection benefits, such as to prevent product
misbranding.
In this final rule, FSIS is consolidating its regulations governing
irradiation into a single set of generic regulations under new
Sec. 424.22(c), applicable to the irradiation of all types of meat food
and poultry products (FSIS proposed separate, but identical sets of
regulations for meat and poultry). Therefore, in the future, when FDA
lists new uses of ionizing radiation on various types of meat food and
poultry products, unless FSIS needs to establish a prohibition or
restriction, establishments may immediately take advantage of the newly
approved usage of irradiation without waiting for additional FSIS
rulemaking.
Consumer Acceptance of Irradiation
Comment: Numerous industry groups argued that FSIS should actively
promote irradiation and implement a consumer education program
regarding its benefits.
Response: Recognizing the diversity of meat food and poultry
products and processing environments, FSIS does not mandate or actively
promote any single intervention or antimicrobial technology. The meat
food and poultry product industries, as well as consumer and public
health organizations, have the primary responsibility for promoting
irradiation and educating the public about the benefits and limitations
of irradiation. However, FSIS recognizes the potential of irradiation
to safely and effectively reduce foodborne pathogens in meat food and
poultry products and therefore is eager to provide for its use as one
of the many antimicrobial treatments that may be used within a HACCP
system.
Labeling
Comment: Numerous commenters requested that FSIS make its labeling
requirements for irradiated meat food and poultry products identical
with FDA's requirements. Several commenters noted that the proposed
labeling requirements regarding placement of the statement and radura,
as well as the proposed disclosure requirements for irradiated meat
food or poultry ingredients contained in multi-ingredient products, are
inconsistent with FDA labeling requirements and with the Food and Drug
Administration Modernization Act (FDAMA) of 1997 (Pub. L. 105-115).
Many commenters argued that the proposed requirements are unworkable
and expensive and
[[Page 72156]]
therefore will prevent the wide scale adoption of irradiation. A few
trade associations maintained that establishments producing multi-
ingredient meat food and poultry products will have to maintain two
sets of labeling, since they will not always be using irradiated meat
food or poultry products as ingredients.
Commenters suggested numerous and varied revisions to the proposed
labeling requirements:
One trade association requested that FSIS require the
radura but not the statement on product irradiated in its entirety;
An irradiator suggested that FSIS not require the
irradiation statement to be contiguous to the product name and argued
that the radura should be voluntary;
A few commenters requested that FSIS require
``irradiated'' to be part of the product name. One commenter suggested
that FSIS should then eliminate other labeling requirements, while
another suggested this be an additional requirement;
Several commenters asked that FSIS require the radura with
a qualified statement indicating the beneficial effects of irradiation;
One commenter requested that FSIS allow labeling that
indicates the source of radiation, i.e., gamma or machine source;
One trade association suggested that multi-ingredient
products containing irradiated meat food or poultry product ingredients
be labeled with the radura and statement such as ``contains beef
products treated with irradiation;''
One company maintained that the proposed labeling
requirements for multi-ingredient products are inconsistent with FDA
requirements in 21 CFR 101.100(a)(3)(i), which exempt from labeling
disclosure ``Substances that have no technical or functional effect but
are present in a food by reason of having been incorporated into the
food as an ingredient in another food, in which the substance did have
a functional or technical effect.''
An irradiator suggested that there be no required
disclosure in multi-ingredient products unless the irradiated component
makes up more than 50% of the total product;
One scientific organization argued that no irradiation
labeling should appear on product irradiated before its final
packaging. They contended that the treated product would not maintain
the antimicrobial effects of irradiation and therefore, that any
labeling implying otherwise would be misleading;
Numerous individual consumers and consumer advocacy
organizations commented in favor of explicit and conspicuous labeling
disclosing that product has been irradiated or contains an irradiated
ingredient. Two organizations submitted poll results suggesting that a
majority of consumers are in favor of explicit and conspicuous
disclosure of irradiation. Many of these commenters generally supported
the labeling requirements FSIS proposed and opposed efforts at
consistency with FDA regulations and the requirements of the FDAMA.
Consumer advocacy groups and numerous consumers argued
that, in the interest of the visually impaired, FSIS should not rescind
the existing letter size requirements for the irradiation statement on
treated poultry and should apply this same requirement to irradiated
meat food products.
One consumer advocacy group argued that multi-ingredient
products with an irradiated poultry or meat food product ingredient
making up more than 50% of the total weight should be labeled with the
irradiation statement, as well as disclosure in the ingredient
statement.
Response: FSIS proposed to require that the radura be contiguous to
the irradiation statement and the statement to be contiguous to the
name. In Sec. 317.2(c)(1) of the regulations, FSIS requires that
product names be on the principal display panel. Therefore, under the
proposed regulations the statement and the radura would be required to
be on the principal display panel. FDA, however, in response to the
FDAMA, recently amended its regulations to clarify that the statement
does not have to be any more prominent than the ingredients statement;
that is, the statement and the radura can appear somewhere other than
the principal display panel.
In response to comments and as part of an effort to make FSIS
labeling requirements more consistent with those of FDA, FSIS will not
require, as proposed, that the irradiation statement and the radura be
any more prominent than the ingredients statement on the labeling of
irradiated meat food and poultry products. Thus, the statement and the
radura may appear somewhere other than on the principal display panel.
The requirement in Sec. 317.2(b) that any statement must be placed and
in such terms so as to ``render it likely to be read and understood by
the ordinary individual under customary conditions of purchase and
use'' will still apply to the irradiation statement, however. This
requirement prohibits labeling of irradiated product in a manner that
would intentionally mislead consumers.
FSIS disagrees with the comment that it should have letter size
requirements for irradiation disclosure statements in the interest of
the visually impaired. FSIS is working with FDA and other agencies to
make food labeling regulations consistent. Maintaining the existing or
proposing new letter size requirements solely for irradiated meat food
and poultry products would counter these efforts. However, FSIS will
continue to examine methods for improving the communication of food
safety and other relevant information to all consumers.
Also in response to public comment, FSIS will allow the word
``irradiated'' to be part of the name of irradiated meat food or
poultry product. FSIS will not require the irradiation statement on the
labeling of product that has the word ``irradiated'' as part of its
name. Having ``irradiated'' in a product name will be as meaningful to
consumers as labeling irradiated product with the statement.
Although FDA does not exempt irradiated product from being labeled
with the statement when ``irradiated'' is included in the product name,
it is considering this issue as part of its ongoing reexamination of
labeling requirements for irradiated foods. FDA recently solicited
comment on possible revisions to the labeling requirements for
irradiated food in an advance notice of proposed rulemaking
(``Irradiation in the Production, Processing, and Handling of Food'';
February 17, 1999; 64 FR 7834). During the comment period on for this
notice, FSIS informed FDA of this revision to the labeling requirements
for irradiated meat food and poultry products. If FDA ultimately does
not adopt this labeling approach, FSIS will reassess its labeling
requirements for irradiated products to determine how to best improve
consistency between the requirements of the two agencies.
FSIS will allow labeling statements and claims regarding the
beneficial effects of irradiation, provided they are truthful and not
misleading. FSIS already has approved such claims for the labeling of
irradiated poultry and FDA allows for such claims on the labeling of
other irradiated foods. As proposed, any claims must be substantiated
by processing documentation. The specificity and complexity of the
documentation required will vary and depend on the specificity of the
claim. For example, a general labeling claim, such as a statement that
product was irradiated ``to reduce pathogens such as Salmonella,''
could be easily
[[Page 72157]]
substantiated by the establishment's HACCP plan and monitoring records.
Salmonella and other microbial pathogens would need to be identified as
a hazard in the establishment's HACCP plan and plan validation and
monitoring records would demonstrate the claimed reduction. If an
establishment wished to claim that a particular pathogen had been
eliminated from the product as a result of irradiation, more specific
documentation substantiating this would be required. This type of claim
is discussed further below in the response to comments concerning the
claimed elimination of E. coli O157:H7 from an irradiated product.
FSIS will allow labeling statements disclosing the specific source
of radiation (gamma or machine source). FDA already allows such
statements on irradiated food (e.g. ``Treated by electron beam
irradiation'').
FSIS is making final the proposed requirement that inclusion of an
irradiated meat food product ingredient in any multi-ingredient product
be reflected in the ingredient statement on the finished product
labeling. The FMIA and PPIA, like the FFDCA, require that food labeling
not be false or misleading. In determining whether labeling is false or
misleading under these statutes, FSIS must consider not only
representations made or suggested by elements of the label, but also
the failure to reveal material facts in light of such representations.
FSIS views the irradiation of meat and poultry products as a
``material fact'' that must be disclosed in product labeling, even if
the irradiated meat and poultry products are used as ingredients in
multi-ingredient products. Under this final rule, establishments may
irradiate meat food or poultry products only to control foodborne
pathogens or to extend product shelf-life. In FSIS's view, effects on
pathogen levels or product shelf-life, whether achieved in single-
ingredient or multi-ingredient meat or poultry products, are material
facts that would not be evident to consumers in the absence of
labeling. Moreover, some, and probably much, of the antimicrobial
effect and extension of shelf-life achieved through irradiation is
likely to persist in irradiated meat and poultry used as ingredients in
multi-ingredient products, especially considering that FSIS anticipates
that products in which irradiated meat or poultry are likely to be used
as ingredients are also likely to contain a significant amount of these
ingredients.
Thus, FSIS concludes that irradiation of a meat or poultry
ingredient in a multi-ingredient product must be disclosed. FSIS will,
however, continue to monitor how irradiation is used. As new
information based on experience in the marketplace becomes available,
and should FDA approve other uses of irradiation for meat and poultry
products, FSIS may revisit whether irradiation of ingredients for those
uses is a material fact that requires disclosure.
FSIS disagrees with the comment that disclosure of the irradiated
ingredient will mislead consumers about the product's safety because,
according to the commenter, multi-ingredient products with irradiated
meat or poultry ingredients would be no different microbiologically
than those without. FSIS acknowledges that the antimicrobial effects of
irradiation will be maintained at varying levels in a multi-ingredient
meat food or poultry product, depending on the type of product, how it
is processed, whether it is combined with other non-irradiated
ingredients, or if specific microorganisms are reintroduced. However,
some antimicrobial effect from the irradiation would be maintained in
the irradiated meat food or poultry product ingredient and that would
not be apparent to consumers without labeling.
FSIS disagrees with the comment that the this disclosure
requirement is inconsistent with FDA regulations in 21 CFR
101.100(a)(3)(i), which exempt from labeling disclosure ``Substances
that have no technical or functional effect but are present in a food
by reason of having been incorporated into the food as an ingredient in
another food, in which the substance did have a functional or technical
effect.'' FDA applies this requirement only to food ingredients. FDA
consider sources of radiation to be additives, but not ingredients.
In regard to the possibility of requiring this disclosure on the
basis of the percentage of the irradiated meat food or poultry product
ingredient in a multi-ingredient product, FSIS, in cooperation with
FDA, will continue to examine the issue. Although numerous commenters
suggested labeling disclosure options based on a percentage, no data
was submitted. FSIS is aware that Canada requires labeling disclosure
only if the irradiated ingredient comprises more than 15 percent of a
multi-ingredient product. FSIS is reviewing this Canadian policy.
FSIS could revise the labeling requirements in the future. In fact,
as discussed in the next two comments and response, FSIS and FDA are
considering the option of eventually revising some of the labeling
requirements.
Comment: Numerous industry groups requested that FSIS plan to
sunset all labeling requirements related to irradiation within 5 years
or sooner. They note that FDA discusses this possibility in the recent
notice (64 FR 7834).
Response: FSIS is consulting with FDA on this issue and will review
the comments on the FDA notice. Central to the option of revising any
of the labeling requirements will be consumer awareness and
understanding of food irradiation. FSIS also will continue to assess
the impact and effectiveness of its labeling requirements for
irradiated meat food and poultry products. Interested persons may wish
to submit information on this issue to FSIS.
Comment: A few commenters argued that labeling of irradiated
product should be voluntary. They argued that demand for irradiated
products will give producers and retailers incentive to disclose that
their products were irradiated. Further, numerous commenters claimed
that consumers will regard the statement and radura as a warning and
not purchase the product and argued that irradiation, therefore, will
not be widely adopted by industry. A few commenters claimed that if
irradiation is not widely employed by the food industry as result of
labeling requirements and other perceived regulatory impediments,
significant reductions in foodborne illness will not occur.
Response: As explained above, to prevent misleading labeling, the
FMIA, PPIA, and FFDCA require disclosure of facts material to food
products. Irradiation can affect food in a manner that is not obvious
to consumers in the absence of labeling. Antimicrobial effects, changes
in product shelf-life, and in some cases, changes in characteristics of
food (taste, smell, texture) can result from irradiation. FSIS views
irradiation of meat and poultry, therefore, as a material fact that
must be disclosed in product labeling. However, both FSIS and FDA are
continuing to examine their labeling requirements and the options for
revising these requirements so as to better convey information to
consumers.
Although FSIS acknowledges that labeling may initially have some
effect on consumer acceptance of irradiated meat food and poultry
products, FSIS expects that as consumer awareness increases, the demand
for these products will expand and the labeling will serve to promote
these products. FSIS will continue to examine ways to remove regulatory
impediments to
[[Page 72158]]
advances in food safety technologies, including irradiation, but it is
the responsibility of industry to promote irradiated meat food and
poultry products. FSIS does not agree that its labeling requirements
will decrease the level of possible reductions in foodborne illness
that may result from the use of irradiation. Potential reduction in
foodborne illness are examined in detail below in the discussion of the
economic impact of these regulations.
Comment: FSIS noted in the proposed rule that it had received a
petition from NFPA regarding labeling requirements for irradiated food.
In the petition, NFPA requested that FSIS address whether labeling
requirements concerning the disclosure of irradiation are warranted for
meat food and poultry products and how such labeling affects consumer
acceptance of irradiation. In a subsequent comment on the irradiation
proposal, NFPA demanded that FSIS publicly respond to each issue raised
in its petition and ask for public comment on each issue, although they
added that the FSIS's actions should not delay a final rule.
In its petition and subsequent comment, NFPA requested that FSIS
address several labeling issues discussed elsewhere in this document,
including: whether labeling of irradiated product is
``constitutionally, statutorily, and scientifically unwarranted;''
whether disclosure of radiation would contribute to unfounded
apprehension among consumers and therefore preclude widespread use of
irradiation; and whether FSIS and FDA labeling requirements for
irradiated products should be identical. NFPA cited case law
(International Dairy Food Association v. Amestoy, 92 F.3d 67, 73 (2d.
Cir. 1996) and Central Hudson Gas & Elec. Corp. v. Public Service
Commission, 447 U.S. 557 (1980)) in support of its argument that
consumer desire to know how food was processed is not alone sufficient
to justify mandatory disclosure of the processing. NFPA also requested
that FSIS address whether irradiation is a material fact under section
403(a)(1) of the FFDCA; that is, should irradiated meat food or poultry
products be labeled as such since otherwise, consumers would be unaware
of the material fact that the products had been processed with
radiation?
Response: All the labeling issues raised by NFPA in its petition
and in its subsequent comment were also raised in other comments and
FSIS has responded to them in this document. Furthermore, FDA has
requested comment on these and other labeling issues in its recent
notice and FSIS will review those comments. FSIS sees no need,
therefore, to again solicit public comment on these labeling issues,
and, NFPA did request that the response to their petition not delay any
final regulations.
In response to NFPA questions regarding the legal basis for
requiring disclosure, FSIS has reviewed the Supreme Court standards for
governmental regulation of commercial speech as announced in Central
Hudson Gas & Elec. Corp. v. Public Service Commission and summarized in
the dissenting opinion in International Dairy Food Association v.
Amestoy:
At the outset, commercial speech enjoys no First Amendment
protection at all unless it is not misleading (and related to lawful
activity). If the speech passes that test, it is nonetheless subject
to regulation if the government has a substantial interest in
regulating the speech, the regulation directly advances that
interest, and it is no more intrusive than necessary to accomplish
its goal. 447 U.S. at 566, 100 S.Ct. at 2351. The Supreme Court
later clarified that government's power to regulate commercial
speech includes the power to compel such speech. Zauderer v. Office
of Disciplinary Counsel, 471 U.S. 626, 651, 105 S.Ct. 2265, 2281-82,
85 L.Ed.2d 652 (1985).
International Dairy Food Association v. Amestoy, 92 F.3d 67, 77 (2d.
Cir. 1996).
FSIS does have a substantial interest in requiring the disclosure
that meat or poultry products have been irradiated; such irradiation is
a material fact that must be disclosed to consumers through labeling to
avoid deception, since it can affect the meat or poultry products in a
manner that is not obvious to consumers in the absence of labeling.
Disclosure of irradiation through labeling is the most direct way to
advance this interest. FSIS believes that the labeling requirements
contained in this regulation are the least intrusive possible, but
still accomplish the goal of disclosure. Therefore, FSIS is requiring
labeling that indicates meat and poultry products have been treated
with irradiation.
Comment: Numerous industry and academic commenters requested that
FSIS allow alternative, euphemistic statements on irradiated products
that would be more appealing to consumers, such as ``cold,''
``electronic,'' and ``ionizing'' pasteurization. Several of these
commenters cited or submitted consumer polling data to support the use
of their claims. One food processor suggested that any euphemistic
labeling statements containing the word ``pasteurization'' be
contingent upon specific levels of pathogen reductions. Consumers and
consumer advocacy organizations, for the most part, maintained that
alternative and euphemistic statements would be misleading and
erroneous and opposed them.
Response: FSIS will review, on a case-by-case basis, labels with
alternative or euphemistic statements regarding irradiation. FSIS is
requiring, however, that labels of meat food or poultry products that
have been irradiated in their entirety be labeled with statements such
as ``Treated with irradiation'' or ``Treated by irradiation,'' or, that
the word ``Irradiated'' be part of the product name. FSIS will allow
the terms ``cold,'' ``electronic,'' and ``ionizing'' to be used in
conjunction with term ``irradiation,'' if truthful.
At this time, however, labeling statements or claims for irradiated
product that include the term ``pasteurization'' probably would be
misleading. ``Pasteurization'' implies the destruction of all
vegetative microorganisms in the product as a result of irradiation. At
the maximum dosages allowed by FDA and FSIS, it would be highly
unlikely that all of the vegetative microorganisms in irradiated
product would be destroyed.
For example, an establishment irradiates refrigerated, raw beef
round or chuck using a gamma radiation source. They determine that they
will achieve a 2:1 overdose ratio \1\ using the maximum allowed dosage
of 4.5 kGy. That is, the irradiation treatment will achieve at least a
minimum absorbed dosage of 2.25 kGy throughout the product.
---------------------------------------------------------------------------
\1\ Product shape, density, and its distance from the source of
radiation, as well as other factors, influence the absorbed dosage
in an irradiated product. Therefore, it is difficult to achieve a
uniform absorbed dosage in irradiated products, especially if the
product is densely packed in large quantities. To achieve specific
absorbed dosages of radiation in treated products, irradiators
calculate a maximum/minimum ``overdose ratio.'' Using this ratio
they are able to irradiate product so as to accurately predict that
while some of the treated product will have absorbed the maximum
dosage, all will have absorbed at least the minimum dosage.
---------------------------------------------------------------------------
According to the International Consultative Group on Food
Irradiation \2\, the dosage necessary to eliminate 90 percent of
Salmonella sp. in a gram of product (the ``D value,'' which is
equivalent to 1-log10), ranges from 0.48 kGy to 0.7 kGy.
Therefore, this establishment, by achieving a minimum absorbed dosage
of 2.25 kGy throughout the product, also would effect a minimum
reduction of Salmonella sp. ranging between 4.7-log10 and
3.2-log10 per gram of product, throughout the product. These
hypothetical reductions are significant
[[Page 72159]]
and would greatly reduce the risk of foodborne illness from treated
product. However, these reductions are well below the levels necessary
to achieve a ready-to-eat roast beef product. FSIS recently established
that it is necessary to achieve at least a 6.5-log10
reduction of Salmonella sp. throughout a roast beef product to consider
that product ready-to-eat (64 FR 732; 9 CFR 318.17).
---------------------------------------------------------------------------
\2\ International consultative Group on Food Irradiation,
``Irradiation of red meat: A compilation of technical data for its
authorization and control,'' August 1996.
---------------------------------------------------------------------------
FSIS acknowledges that if an establishment were to greatly minimize
the pathogen load on incoming whole muscle meat product, it could
possibly use irradiation combined with stringent process controls to
produce a ready-to-eat, though uncooked, meat product, such as steak
tartar. In such a case, irradiation would effectively pasteurize the
product. FSIS would allow ``pasteurized'' to be in the labeling
statement on such a product. However, under the current regulations,
FSIS would require that the product also be labeled with statements
such as ``Treated with irradiation'' or ``Treated by irradiation,'' or,
that the word ``Irradiated'' be part of the product name. FSIS will
continue to examine these requirements in light of developments in
irradiation technology and FDA policy.
Comment: Commenters from industry overwhelmingly supported
incentive labeling (labeling claims regarding the benefits of
irradiation) and most suggested that FSIS clarify what types of
substantiating documentation would be required for using it. Most
consumer advocacy groups expressed concerns about incentive labeling
and requested that FSIS require stringent levels of pathogen reduction
as prerequisites for making any claims, as well as regular microbial
testing. One group argued that FSIS should allow claims only on product
irradiated in its final packaging.
All of the consumer advocacy groups that commented, as well as a
few industry commenters, opposed the use of labels claiming that a
product is ``free'' of any pathogen as a result of irradiation
treatment. Many cited concerns about post-processing contamination of
treated and labeled product. Several commenters argued that consumers,
misled by labeling claims, would mishandle treated product, believing
that it is free of all pathogens.
One consumer advocacy organization suggested that FSIS put in place
special ``trace back'' mechanisms for irradiated product. The
organization is concerned that consumers, misled by claims concerning
the efficacy of irradiation, may mishandle irradiated product that
still contains pathogens. Special ``trace back'' mechanisms would
ensure that establishments label irradiated products so as not to
mislead consumers regarding the safety of those products.
Response: As proposed, FSIS will allow labeling statements on
irradiated meat food and poultry products that indicate general or
specific reductions in microbial pathogens, provided they can be
substantiated by processing documentation. The amount and specificity
of the required documentation will vary depending on the statement or
claim.
Also in the proposal, FSIS discussed the possibility of product
being labeled as ``free'' of the pathogen E. coli O157:H7:
Several representatives of the meat and poultry industries have
stated to FSIS that they would like to label product as being free
of certain pathogens as a result of irradiation, e.g., ``Free of E.
coli O157:H7.'' It may be possible for an establishment to determine
the pathogen load on incoming product, irradiate the product to
completely eliminate those pathogens with an appropriate margin of
safety, and ensure that the product remains free of that pathogen
until it reaches the consumer. FSIS requests comment on whether to
allow this type of incentive labeling. Specifically, FSIS is
interested in whether it should establish performance standards for
labeling statements that reflect a specific reduction of pathogens.
For example, FSIS could require that to use such labeling,
establishments must achieve, through a validated HACCP system
incorporating irradiation, a specific reduction of a pathogen of
concern (e.g., an x-log10 reduction of E. coli O157:H7).
(64 FR 9094)
Irradiation, as provided for in this rule, could eliminate E. coli
O157:H7 from products with an appropriate margin of safety. Therefore,
FSIS will allow labeling of sufficiently irradiated product to state
that processing has been conducted to eliminate E. coli O157:H7. As
with any labeling statement that claims a specific reduction of
pathogens resulting from irradiation, FSIS is requiring establishments
claiming that E. coli O157:H7 has been eliminated from their products
to have processing documentation substantiating this.
FSIS agrees with commenters that stringent processing controls
(probably including monitoring of pathogen load on incoming product and
the prevention of product recontamination and post processing
temperature abuse) would be needed to substantiate a label claiming
that a product was ``free'' of E. coli O157:H7. FSIS will expect
establishments that treat product known to be adulterated with E. coli
O157:H7 to implement such controls. FSIS emphasizes that it will
closely assess any requests for labeling that a product is free of E.
coli O157:H7 and, through inspection, will verify that processes to
eliminate the pathogen are under control.
FSIS does not now have the data necessary to establish in the
regulations a minimum level of reduction of E. coli O157:H7 that
establishments must achieve in order to label products as being free of
E. coli O157:H7. The FSIS Office of Public Health and Science currently
is conducting a risk assessment concerning E. coli O157:H7. Using the
results of this risk assessment, as well as other data that may be
developed, FSIS may, in the future, propose to require that any such
labeling claims be used only if establishments achieve a specific,
minimum level of reduction of E. coli O157:H7 within treated product.
In the interim, establishments may want to note that for certain
ready-to-eat products, establishments have been processing to achieve a
5-log10 reduction in E. coli O157:H7. For example, the
cooking requirements for meat patties in Sec. 318.23 of the regulations
achieve an approximate 5-log10 reduction in E. coli O157:H7
and that compliance with the regulations in this section results in the
production of a ready-to-eat meat patty. Further, since 1995, FSIS has
encouraged establishments manufacturing ready-to-eat fermented sausage
products to implement processes validated to achieve at least a 5-
log10 reduction of E. coli O157:H7. Several outbreaks of
food borne illness attributable to E. coli O157:H7 in fermented, shelf-
stable sausage products led FSIS, in cooperation with the Agricultural
Research Service, meat and poultry industry representatives, and
members of the National Advisory Committee on Microbiological Criteria
for Food (NACMCF) to develop a policy for ensuring the safety of ready-
to-eat fermented sausages. This group developed several processing
options that would ensure a 5-log10 reduction of E. coli
O157:H7 in fermented sausages. In an August 21, 1995 correspondence,
FSIS wrote to establishments producing fermented sausages and strongly
encouraged that they implement one of the validated processing options
contained in the document or that they validate their processes to
ensure the processing used achieves at least a 5-log10
reduction of E. coli O157:H7. This specific level of reduction may not
be adequate for all products or processes and establishments should
carefully evaluate the specific product and processes at issue when
developing treatments to eliminate E. coli O157:H7 from meat products.
In regard to consumer perceptions regarding pathogen reduction
claims,
[[Page 72160]]
irradiated raw ground beef still must carry the safe handling
instruction, regardless of the claimed pathogen reduction. FSIS
recognizes that it may be asked to reconsider its requirements
regarding safe handling instructions in the event establishments
develop methods to pasteurize raw meat food and poultry products
through irradiation or other means.
Comment: One commenter requested that FSIS permit irradiated meat
and poultry to be labeled as being ``organic.'' A comment from an
organic food cooperative opposed any such designation.
Response: The Organic Foods Production Act (OFPA) of 1990 requires
USDA to develop national standards and regulations for organically
produced agricultural products and to assure consumers that
agricultural products marketed as ``organic'' are consistent with these
standards. The OFPA also provides for USDA to establish an organic
certification program based on recommendations received from a 14-
member National Organic Standards Board (NOSB). Although the OFPA did
not specifically address the use of irradiation, the NOSB has
recommended, consistent with most existing State and private
certification agency organic standards, that the use of irradiation be
prohibited in handling organic products. This issue is most
appropriately resolved in the agency rulemaking process under OFPA.
Comment: Several industry groups recommended that FSIS explicitly
allow product irradiated at a separate establishment to be fully
labeled before shipment to that facility. One trade organization asked
that FSIS no longer require such product to be shipped under seal.
Several industry commenters requested that FSIS specifically exempt
irradiation facilities from using their marks of inspection over those
of the originating plant and instead allow the irradiator to use a
separate stamp, so as to facilitate trace-back.
Response: Meat food or poultry products may be packaged and labeled
as being irradiated before shipment to an irradiation facility,
provided that the shipping establishment implements controls to prevent
the labeled, but as yet not irradiated, product from being distributed
to consumers. Most establishments could control the shipment of such
product through the maintenance and verification of records, such as
bills of lading. FSIS inspection personnel will verify that these
controls are implemented.
FSIS does not and will not require irradiators or other processors
to place their marks of inspection over those of the establishments
from which the product originated. In regard to which inspection legend
and establishment number would be placed on an irradiated product,
different scenarios are possible. For example, if bulk shippers of
trimmings or cuts are received by an irradiator, irradiated, and then
repackaged in smaller units such as retail trays, the irradiator will
be required to declare its establishment number on the retail package.
However, if an irradiator receives packaged and labeled products for
irradiation, the legend and number of the originating establishment
will be declared on the retail package label. FSIS would expect that
the irradiator would place its legend on the shipper container in which
it packs the product, even if the irradiator uses the same shipper in
which the product was received. In all cases, every establishment that
processes the product must maintain records, as part of its HACCP
paperwork, showing where the product originated, where it was
processed, and where it was distributed for consumption. Any necessary
trace-back will be facilitated by review of these records.
Comment: Numerous consumers requested that FSIS extend required
disclosure to restaurants and institutions that serve irradiated meat
food and poultry products.
Response: Historically, FSIS has not extended its regulations
regarding meat food and poultry product labeling or misbranding to
restaurant and institutional menus. Requiring and enforcing disclosure
that restaurant or institutional food has been irradiated would require
a heavy expenditure of Agency resources for as yet indeterminate
benefits. FSIS will continue to examine this issue. FSIS is aware that
a restaurant in Florida has been disclosing on its menu that it serves
irradiated poultry products. Possibly, other restaurants and
institutions may want to disclose this information for marketing or
other purposes.
Technical Concerns
Comment: One commenter stated that the hypothetical reduction of E.
coli O157:H7 given in the preamble is misleading, as it does not take
minimum/maximum ratios into account.
Response: The example of pathogen reduction given in the preamble
was hypothetical and intended to emphasize the potential effectiveness
of irradiation against pathogens. This level of reduction would be
possible under the permitted dosages, though costly and probably
unnecessary.
Comment: Several commenters requested that FSIS clarify its
proposed training requirements for irradiation facility managers and
``key personnel.'' One commenter claimed that existing short courses
available in North America are inadequate because they either concern
only electron beam irradiation or are too simplistic and argued that
``in-house'' training should satisfy the intent proposed requirement.
Another requested clarification as to who ``key personnel'' are and
suggested that the ``key personnel'' include the facility manager, QC
manager, an external consultant, or corporate management.
Response: FSIS proposed to require establishments that irradiate
meat food products to have on file ``certification by the operator that
the irradiation facility personnel would operate under supervision of a
person who has successfully completed a course of instruction for
operators of food irradiation facilities,'' as well as ``certification
by the operator that the key irradiation personnel have been trained in
food technology, irradiation processing, and radiation health and
safety.'' These requirements already are in effect for poultry
establishments.
The intent of the first training requirement is to ensure that
supervisors of irradiation facilities gain an understanding about the
process controls necessary when irradiating food, as well as the
requirements set forth in FSIS regulations. FSIS is aware of numerous
irradiation facilities that plan to irradiate meat food and poultry
products, but that have previously irradiated only medical devices and
other non-food products. Supervisors of such establishments certainly
need and would benefit from food irradiation training.
The second training requirement is intended to ensure that ``key''
personnel in an establishment also have instruction in the safe and
proper operation of an irradiation facility. Key personnel would
include managers, supervisors, or other personnel of the facility who
monitor or control daily operations. Key personnel must be
knowledgeable about the environmental safeguards and worker safety
precautions necessary in any irradiation facility and required by other
Federal and State agencies. FSIS is revising Sec. 424.22(c)(3)(vi) to
clarify the term ``key irradiation personnel.''
FSIS is aware of several available food irradiation training
courses, but does not intend to review or endorse any specific training
course. Further, FSIS
[[Page 72161]]
agrees that in-house training in food irradiation or radiation safety
could be adequate to meet the requirements. FSIS will verify that
establishments have records confirming that the required training was
received by the establishment personnel.
Comment: One irradiator objected to proposed Secs. ((318.11(b)(6)
and 381.149(b)(6) which appear to prescriptively specify minimum
dosimeter placements. They suggested FSIS instead allow for
statistically based validation and dose mapping to determine the number
and placement of dosimeters.
Response: FSIS agrees and will revise the requirement in
Sec. 424.22(c)(2)(vi) accordingly. FSIS recommends that establishments
consult some of the various technical guides on dosimetry when
developing their systems. The American Society for Testing and
Materials and the International Consultative Group on Food Irradiation
both have published guides on food irradiation dosimetry.
Comment: Another irradiator asked that FSIS revise proposed
Secs. 318.11(b)(7) and 381.149(b)(7) to account for dosimetry from
machine sources of radiation.
Response: The proposed provisions (a single provision in this final
rule, Sec. 424.22(c)(2)(vii)) did account for machine sources of
irradiation in that they required establishments to have in place
``Procedures for verifying the relationship of absorbed dose as
measured by the dosimeter to time exposure of the product unit to the
radiation source.'' The radiation source could be a machine source of
radiation, such as an electron beam accelerator. This requirement
remains unchanged.
Comment: One commenter suggested that establishments employing
irradiation be exempted from pathogen reduction (Salmonella) and
process control microbial testing (generic E. coli) requirements for
raw meat food and poultry products. This commenter argued that
irradiation will reduce pathogens to immeasurable levels and testing
would therefore be unnecessary. The commenter also maintained that such
an exemptions would bring about cost savings to industry in excess of
$100 million.
Response: FSIS disagrees. The microbial testing requirements are
still necessary for measuring an establishment's performance in process
control and pathogen reduction, even if an establishment irradiates its
product. Establishments may irradiate product at any point in their
processing system, including before the required testing for Salmonella
or generic E. coli. Irradiation of raw product before testing could not
only significantly improve a single establishment's performance, but
also could lower the national baselines, compelling improvements in
process control and pathogen reduction by all establishments. Although
rescission of these testing requirements (or any regulatory
requirements, for that matter) might result in cost savings to the
regulated industry, FSIS has determined that these requirements are a
necessary and cost-effective means for improving the safety of meat
food and poultry products.
Costs and Benefits of Irradiation
Comment: A few commenters recommended revisions to the Agency's
cost/benefit and economic impact analyses in the proposal. One
commenter questioned FSIS's estimate of the cost of shipping irradiated
products, arguing that the Agency underestimated the costs by an order
of magnitude. Several commenters maintained that the required labeling
would be perceived by consumers as a warning and, as discussed, would
prevent the wide-scale acceptance of irradiated product. Many of these
commenters argued that labeling should be voluntary, since demand for
irradiated products would create adequate incentives for labeling.
Response: FSIS addresses the comments and reviews the submitted
cost data below in the economic impact analyses.
Summary of the Final Rule
FSIS is amending it regulations to provide for irradiation of
uncooked meat food and poultry products under the following conditions:
Meat food products may be treated with ionizing
irradiation, for purposes of reducing pathogens and extending shelf-
life, at dosages up to 4.5 kiloGrays (kGy), if refrigerated, and 7 kGy,
if frozen.
Establishments may irradiate meat food and poultry
products only in accordance with a HACCP system.
Establishments that irradiate meat food products must have
in place a dosimetry system to measure the absorbed dose of radiation.
Establishments that irradiate meat food products must have
on file documents that relate to other compliance with the requirements
of Federal Agencies with jurisdiction over irradiation, such as NRC and
OSHA.
Labeling of meat food and poultry products irradiated in
their entirety must bear the international radura logo. Also, either
the product name must include the word ``Irradiated'' or the labeling
must bear a disclosure statement such as ``Treated with radiation'' or
``Treated by irradiation.'' The logo must be placed in conjunction with
the disclosure statement, if the disclosure statement is used. The
radiation disclosure statement is not required to be more prominent
than the declaration of ingredients.
The inclusion of irradiated meat food or poultry product
in a multi-ingredient product must be reflected in the ingredient
statement on the finished product labeling.
Optional labeling statements about the purpose for
radiation processing may be included on the product label in addition
to the above stated requirements. Statements that there has been a
specific reduction in microbial pathogens must be substantiated by
processing documentation.
The regulations governing the irradiation of poultry
products are now entirely consistent with the regulations governing the
irradiation of meat food products but for the maximum dosage allowed (3
kGy) and the requirement that if packaged poultry product is
irradiated, that packaging must be air permeable.
Risk Analysis
Section 304 of the Federal Crop Insurance Reform and Department of
Agriculture Reorganization Act of 1994 (P.L. 103-354) requires any
regulation published by USDA concerning human health, safety, or the
environment, and having an annual economic impact of at least $100
million in 1994 dollars, contain a risk assessment and cost-benefit
analysis. The risk assessment and cost-benefit analysis must be
``performed consistently and use reasonably obtainable and sound
scientific, technical, economic, and other data.'' The USDA Office of
Risk Assessment and Cost-Benefit Analysis (ORACBA), also established by
the 1994 Act, must ensure that major rules include such analyses.
ORACBA and FSIS have agreed that FDA has already conducted a
definitive risk analysis concerning the safety of meat food products
treated with ionizing radiation in developing their final rule,
``Irradiation in the Production, Processing and Handling of Food'' (62
FR 64107; December 3, 1997). Therefore, FSIS and ORACBA are adopting
the FDA finding as their risk assessment. Further, FSIS and ORACBA also
have agreed that the cost-benefit and economic impact analyses that
FSIS has performed for this final rule, as required by E.O. 12866 and
the Regulatory Flexibility Act, satisfy the cost-benefit analysis
requirements of the
[[Page 72162]]
Reorganization Act. Consequently, FSIS, with assistance from ORACBA,
has produced only an analytical literature review addressing existing
research and risk assessments on the safety of food irradiation for
consumers and the related risks posed by irradiation, including worker
safety and environmental concerns. This literature review is available
from the FSIS Docket Clerk's Office (see ADDRESSES above) and from the
FSIS Internet world wide web page at http://www.fsis.usda.gov/OA/
topics/irrad-risk.htm.
In this document, FSIS is revising the current regulations
governing the irradiation of poultry to make them more consistent with
the proposed regulations for meat and with HACCP. These revisions to
the poultry regulations would pose no new risks to human health or
worker safety and do not concern the environment. Therefore, FSIS has
not addressed these changes in a separate risk assessment or in the
above mentioned literature review.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. States and local jurisdictions are preempted by
the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) from imposing any marking, labeling, packaging,
or ingredient requirements on federally inspected meat and poultry
products that are in addition to, or different than, those imposed
under the FMIA and the PPIA. States and local jurisdictions may,
however, exercise concurrent jurisdiction over meat and poultry
products that are within their jurisdiction and outside official
establishments for the purpose of preventing the distribution of meat
and poultry products that are misbranded or adulterated under the FMIA
and PPIA, or, in the case of imported articles, that are not at such an
establishment, after their entry into the United States.
This rule is not intended to have retroactive effect.
Under this rule, administrative proceedings will not be required
before parties may file suit in court challenging this rule. However,
the administrative procedures specified in 9 CFR 306.5 and 381.35 must
be exhausted prior to any judicial challenge of the application of the
provisions of this rule, if the challenge involves a decision of an
FSIS program employee relating to inspection provided under the FMIA
and the PPIA.
Compliance With Executive Order 12866--Final Analysis
This action has been reviewed for compliance with Executive Order
12866. As this action is determined to be economically significant for
purposes of Executive Order 12866, the Office of Management and Budget
has reviewed it.
FSIS is amending its meat inspection regulations to allow for the
safe use of ionizing radiation for the treatment of meat, meat
byproducts, and certain other meat food products. FSIS also is revising
the existing regulations governing the irradiation of poultry so as to
render them more consistent with the proposed regulations for meat. In
the proposal preceding this final action, FSIS requested comment
concerning the potential economic effects of the proposed regulations,
as well as data concerning the costs of and benefits from irradiation
of meat and poultry. FSIS received only a few comments that included
economic data or questioned the economic analysis included in the
proposal. These comments are addressed below.
FSIS believes that the net benefits of this action will be
positive. As discussed in the preamble, irradiation can reduce the
levels of pathogens in meat food and poultry products significantly.
Further, the use of irradiation is voluntary. If an establishment
chooses to irradiate its meat food products, it can be assumed from the
establishment's decision to incur the expense of irradiation that it
expects the economic benefits of the investment in irradiation to
exceed the costs of that investment. However, the current lack of
quantification of both the benefits and costs of irradiation make
comparison difficult.
FSIS endeavors to develop regulations that set forth performance
objectives, rather than prescribe specific processing methods. For the
irradiation of meat food products, and where possible, for the
irradiation of poultry products, FSIS proposed requirements that allow
for significant flexibility in integrating irradiation into processing
operations. In this final rule, FSIS has been able to provide for even
greater flexibility through revisions based upon the comments received
in response to proposal.
Although FSIS recognizes the capability of irradiation treatment to
reduce pathogens below current regulatory performance standards for
pathogen reduction, these regulations do not change the existing
performance standards. With standards unchanged, the primary benefit of
the regulations to establishments is the increased processing
flexibility they are allowed with this rule.
Alternatives
Executive Order 12866 requires that FSIS identify and assess
alternative forms of regulation. FSIS considered two alternatives to
the proposed regulation: (1) Not allowing for the irradiation of meat
food products and (2) allowing the irradiation of meat food products
only under very limited conditions, similar to those previously
prescribed for the irradiation of poultry products. FSIS rejected these
two alternatives for reasons explained below.
FSIS did not consider alternatives that would not be permissible
under current FDA regulations, such as allowing irradiation at higher
doses or allowing the irradiation of ready-to-eat meat and poultry
products. FSIS believes that the regulations in this final rule are the
most permissive possible under current FDA regulations. Also, as
explained in the preamble above, FSIS has petitioned FDA to raise the
allowable absorbed dosage for poultry, to remove certain requirements
regarding the packaging for irradiated poultry, and to specifically
allow the irradiation of unrefrigerated (``hot-boned'') meat food
products. Further, an industry consortium has petitioned FDA to allow
the irradiation of processed meat and poultry products.
No Action
Central to the FSIS food safety strategy are efforts to reduce the
level of microbiological pathogens in raw meat and poultry products.
Irradiation has been shown to be a highly effective method for reducing
the levels of microbiological pathogens in raw meat food products.
Further, FDA has concluded that irradiation of meat food products,
under the conditions requested by Isomedix, Inc. and granted by FDA,
would not present toxicological or microbiological hazards and would
not adversely affect the nutritional adequacy of these products. FSIS,
therefore, sees compelling reasons to provide for the irradiation of
meat food products and has rejected the option of disallowing
irradiation.
Notably, the irradiation of meat food products is voluntary.
Although it is an effective antimicrobial treatment, irradiation may
not be appropriate, feasible, or affordable in certain processing
environments. Also, in certain situations, other antimicrobial
treatments may be more effective. FSIS, therefore, is not requiring
that raw meat food products be irradiated.
[[Page 72163]]
Irradiation of Meat Food Products Under Limited Conditions
The previous requirements governing the irradiation of poultry were
fairly prescriptive in that they mandated a minimum dosage and required
that only packaged product be irradiated. FSIS could have proposed
similar requirements for the irradiation of meat food products.
However, as explained above, FSIS believes that the previous
requirements mandating minimum dosages and packaging for irradiated
poultry products, originally intended to ensure that the effects of
irradiation were maintained, are no longer necessary in light of the
new HACCP requirements. Therefore, FSIS is making final no minimum
irradiation dose and no specific packaging requirements for meat food
products, rescinding the minimum dose requirements for irradiated
poultry, and revising the packaging requirements for poultry, where
possible.
Benefits
FSIS has concluded that the meat industry may accrue numerous
benefits from the use of irradiation. As with other antimicrobial
treatments, FSIS is allowing irradiation to be used at any point within
a HACCP system and is requiring no minimum dosage. Establishments
employing irradiation may accrue benefits from this flexibility. For
example, slaughter establishments will gain added flexibility in
treating products so as to meet pathogen reduction performance
standards. Similarly, processors may use irradiated meat in further
processed products.
Further, through the use of irradiation, product shelf-life can be
increased. Andrews, et al. (1998), reviewed five studies encompassing
shelf lives of different types of red meat products.\3\ Their results
suggest that shelf life of products treated with irradiation increase
considerably compared to untreated products.
---------------------------------------------------------------------------
\3\ Andrews, L.S., et al. ``Food Preservation Using Ionizing
Radiation,'' Review of Environmental Contaminant Toxicology, Vol.
154, 1998, pp. 1-53.
---------------------------------------------------------------------------
Society also may realize benefits from these final regulations if
the use of irradiation results in a reduction of illnesses beyond what
is achieved by current technologies. Several types of harmful microbial
pathogens can be present in meat food products, including E. coli
O157:H7, Salmonella, Clostridium perfringens, and the protozoan
parasite Toxoplasma gondii. Irradiation at the dose levels allowed by
this action can reduce the levels of these pathogens substantially.
Economic benefits associated with these reductions would be decreases
in the diseases associated with these pathogens. The reductions in the
disease rates would translate into a reduction in the number of visits
to physicians and hospitals.
FSIS believes that ground beef is likely to be the first meat
product irradiated in great quantity. It is likely that ground beef
will be irradiated in relatively large quantities initially because
irradiation is a means for establishments to effectively eliminate E.
coli O157:H7 from raw ground beef without cooking it. Following a 1993
outbreak of food borne illness associated with E. coli O157:H7 in
hamburger, FSIS implemented a policy under which it considers raw
ground beef containing E. coli O157:H7 to be adulterated. Until now,
establishments could distribute ground beef containing E. coli O157:H7
only after they had thoroughly cooked it, so as to eliminate the
pathogen. Establishments, therefore, are likely to benefit from the
availability of irradiation as an additional treatment for rendering
adulterated raw ground beef product safe. Of course, other types of raw
meat and poultry products also may be irradiated to reduce or eliminate
pathogens.
To give some sense of the potential benefit from the reduction of
illnesses that may occur as a result of the irradiation of ground beef,
a USDA Economic Research Service study on the use of irradiation to
reduce E. coli O157:H7 and Salmonella in ground beef, conducted before
the implementation of HACCP, is instructive. In that study, Morrison,
et al. (1997), estimated the annual pre-HACCP economic value of the
health costs and productivity losses attributable to E. coli O157:H7
and salmonellosis to be between $226 and $552 million.\4\ If 25 percent
of all ground beef were irradiated, the benefits could range between
$56.5 and $138 million.
---------------------------------------------------------------------------
\4\ Morrison, R.M., et al., ``Irradiating Ground Beef to Enhance
Food Safety,'' Food Review, January-April 1997, pp. 33-37.
---------------------------------------------------------------------------
An assumption that only 25% of ground beef will be irradiated may
be conservative in light of a 1993 survey, conducted by the American
Meat Institute Foundation, which reported that 54 percent of
respondents said that they would buy irradiated beef rather than non-
irradiated beef after being told that irradiation can kill pathogens in
raw meat.\5\ This survey also reported that 60 percent of respondents
said that they were willing to pay ten cents more per pound for
hamburger sold at $2/lb. if bacteria levels were ``greatly reduced by
irradiating the meat.''
---------------------------------------------------------------------------
\5\ American Meat Institute Foundation, ``Consumer Awareness,
Knowledge, and Acceptance of Food Irradiation,'' November, 1993.
---------------------------------------------------------------------------
One consumer advocacy organization requested clarification
regarding FSIS use of the estimates of benefits from Morrison (1997).
The group questioned whether Morrison assumed that ground beef would be
irradiated only after final packaging, as was required for poultry
irradiated at the time of the study. The group suggested that if
Morrison made such an assumption, the estimated reductions in foodborne
illness would be inflated if applied to the proposed regulations, which
allow ground beef to be irradiated before final packaging. The group
claimed that because the ground beef could be re-contaminated after
irradiation and before final packaging, reductions in pathogens and
consequently, foodborne illness, would not be so high.
FSIS disagrees. Morrison did not specify whether their estimates of
benefits applied only to ground beef irradiated in its final packaging.
However, FSIS is allowing meat and poultry product to be irradiated
only in accordance with a HACCP system of process controls, regardless
of when it is packaged. HACCP controls will considerably lessen, and
likely prevent, the possibility that meat and poultry product will be
re-contaminated after irradiation and before packaging. Therefore,
these estimates of reductions in foodborne illness are applicable to
these final regulations.
Another commenter suggested that the proposed labeling requirements
could prevent the wide-scale acceptance of irradiated products by
consumers, who will view the required labeling as a warning, and
therefore diminish the potential benefits from reductions in foodborne
illnesses. This commenter suggested the use of voluntary instead of
mandatory labeling and argued that demand for irradiated product will
give producers and retailers incentive to disclose that their products
were irradiated.
As discussed above, disclosure of facts material to food products
is required by the FMIA, PPIA, and the FFDCA. Irradiation can affect
food in a manner that is not obvious to consumers in the absence of
labeling and therefore is a material fact that must be disclosed to
consumers to prevent misleading labeling. FSIS is requiring that
irradiation of meat or poultry products be disclosed in product
labeling. FSIS will consider, however, revising some or all of its
labeling requirements as consumer awareness grows.
FSIS has made some revisions to the proposed labeling requirements
that
[[Page 72164]]
will increase flexibility for processors and could represent some
minimal cost savings. First, FSIS is requiring that single ingredient
meat or poultry products irradiated in their entirety be labeled with a
radura and either a statement indicating that the product was
irradiated or the inclusion of the word ``irradiated'' in the product
name. Allowing establishments to use the word ``irradiated'' as part of
the product name instead of including a labeling statement was
suggested in industry comments as a means of providing more labeling
flexibility.
Also, in response to comments and as part of an effort to make FSIS
labeling requirements more consistent with those of FDA, FSIS will not
require, as proposed, that the irradiation statement and the radura be
any more prominent than the ingredients statement on the labeling of
irradiated meat food and poultry products. Thus, the statement and the
radura may appear somewhere other than on the principal display panel.
Finally, the same commenter estimated the annual net social welfare
gains from irradiation, without HACCP, to be $900 million, i.e., almost
ten times the benefits presented above. This higher estimate of
benefits was based on an assumption that demand for irradiated ground
beef would be similar to the potential demand for irradiated poultry as
estimated by Fox and Olson (1998) from market surveys conducted between
1995 and 1996.\6\ FSIS views this comment as further evidence that
there could be benefits in excess of the health costs savings estimated
by Morrison (1997).
---------------------------------------------------------------------------
\6\ Fox, John A. and Dennis G. Olson, ``Market Trials of
Irradiated Chicken,'' Radiation Physical Chemistry, 52 (1-6), 1998,
pp. 63-66.
---------------------------------------------------------------------------
Incremental Costs
In the proposed rule, using estimates from Morrison (1997) and
other sources, FSIS estimated the incremental costs of irradiation to
range from 2 to 6 cents/lb. of ground beef in 1995 dollars. These
estimates included the cost of labels and of transportation of the
ground beef products from establishments to third-party irradiators.
Assuming that 25 percent of the total annual sales of ground beef (1.75
billion lbs.) would be irradiated, FSIS estimated the annual cost of
irradiation to range from $35 to $105 million in 1995 dollars.
These costs are likely to be overestimated for two reasons. First,
the cost estimates are based on the assumption that irradiation of
ground beef would take place in the smallest plants, which have the
capacity to irradiate only 52 million pounds per year. Second, FSIS
assumed that only 25 percent of ground beef would be irradiated. Any
increase in the irradiated quantity would tend to reduce costs
considerably.
Buzby and Morrison \7\ (1999) recently published updated cost
estimates for ground beef for irradiation. They employed two estimates
of costs, 1.6 cents/lb. and 5.0 cents/lb. in 1996 dollars. Again
assuming that 25 percent of ground beef would be irradiated, they
estimated that the costs of irradiation would range from $28.6 million
to $89.3 million. Their new estimates fall within the range of costs
estimated by FSIS in the proposed rule.
---------------------------------------------------------------------------
\7\ Buzby, Jean C. and Rosanna M. Morrison, ``Food Irradiation--
An Update'' Food Review, May-August 1999, p. 21-22.
---------------------------------------------------------------------------
In the analysis included with the proposal, FSIS assumed the costs
of transporting ground beef from slaughter houses or processing plants
to and from irradiating facilities to be 0.2 cents/lb. A commenter
suggested that this estimate was ``too low by more than one order of
magnitude.'' In response to this comment, FSIS recalculated the
transportation costs to be twice the amount originally estimated, that
is 0.4 cents/lb. instead of 0.2 cents/lb. This assumption would
increase the irradiation costs to range from 2.2 to 6.2 cents/lb. FSIS
believes that these possible cost increases are too small to
significantly decrease the net benefits of meat irradiation.
In conclusion, although FSIS has incomplete data regarding the
costs and benefits of the rule, FSIS believes that the net benefits of
this action will be positive. As discussed above, irradiation can
reduce the levels of pathogens in meat food and poultry products
significantly. Further, the meat industry may accrue numerous benefits
from the use of irradiation.
Compliance With Regulatory Flexibility Act of 1996
The Administrator has determined that, for the purposes of the
Regulatory Flexibility Act (5 U.S.C. 601-612), this final rule will not
have a significant economic impact on a substantial number of small
entities.
Data from the U.S. Bureau of Census, Survey of Industries, 1994,
indicate that the beef industry is predominated by small firms and
establishments. For example, based on the U.S. Small Business
Administration definition of small business by the number of employees
(fewer than 500), 96% of 1,226 firms comprising this industry are
small. Similarly, 90% of individual meat establishments or plants in
this industry are small. In 1994, these small businesses accounted for
19% of total employment in the industry. Their share of payroll was 18%
of the total payroll of $2.8 billion and their revenues were 16% of the
total revenues of $55.8 billion. FSIS believes that these small
businesses will not be affected adversely by the irradiation
requirements because the use of irradiation is voluntary.
The industry may be able to pass through the cost of irradiation to
consumers without losing its market share significantly because demand
for beef products is very inelastic. Huang (1993) analyzed a group of
meats and other animal proteins consisting of products including beef
and veal, pork, other meats, chicken, turkey, fresh and frozen fish,
canned and cured fish, eggs and cheese. He concluded that price
elasticity of demand for this group of products was (-0.3611), i.e., a
one percent increase in price of these products would reduce demand by
only 0.3611 percent.\8\
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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
