[Federal Register: October 23, 2002 (Volume 67, Number 205)]
[Rules and Regulations]
[Page 65016-65029]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc02-2]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Parts 305 and 319
[Docket No. 98-030-4]
RIN 0579-AA97
Irradiation Phytosanitary Treatment of Imported Fruits and
Vegetables
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are establishing regulations providing for use of
irradiation as a phytosanitary treatment for fruits and vegetables
imported into the United States. The irradiation treatment provides
protection against fruit flies and the mango seed weevil. This action
provides an alternative to other currently approved treatments (various
fumigation, cold, and heat treatments, and systems approaches employing
techniques such as greenhouse growing) against fruit flies and the
mango seed weevil in fruits and vegetables.
EFFECTIVE DATE: October 23, 2002.
FOR FURTHER INFORMATION CONTACT: Dr. Inder P. Gadh, Import Specialist,
Phytosanitary Issues Management, PPQ, APHIS, 4700 River Road Unit 140,
Riverdale MD 20737-1236; (301) 734-5210.
SUPPLEMENTARY INFORMATION:
Background
In response to growing commercial interest in the use of
irradiation as a treatment for agricultural products, the Animal and
Plant Health Inspection Service (APHIS) has been developing policies
for evaluating irradiation methods and evaluating research on the
efficacy of irradiation.
To set a framework for developing APHIS'' irradiation policy, we
published a notice entitled ``The Application of Irradiation to
Phytosanitary Problems'' in the Federal Register on May 15, 1996 (61 FR
24433-24439, Docket No. 95-088-1). Among other things, the notice
discussed how APHIS, in collaboration with the Agricultural Research
Service (ARS), would evaluate scientific research to determine the
minimum irradiation doses necessary to kill or render sterile
particular pests associated with particular articles. The notice
emphasized that minimum dose levels are important and necessary, but
that dose levels by themselves do not constitute a complete treatment
schedule or an adequate regulatory framework. Treatment schedules, in
addition to specifying minimum doses, may employ irradiation as a
single treatment, as part of a multiple treatment, or as a component of
a systems approach combined with other pest mitigation measures. The
regulatory framework for employing irradiation treatments must also
address system integrity or quality control issues, including methods
to ensure that the irradiation is properly conducted so that the
specified dose is achieved, and must address matters such as packaging
or safeguarding of the treated articles to prevent reinfestation.
In a proposed rule published in the Federal Register on May 26,
2000 (65 FR 34113-34125, Docket No. 98-030-1), we proposed a framework
for the use of phytosanitary irradiation treatments for imported fruits
and vegetables, and proposed specific standards for an irradiation
treatment for fruit flies and the mango seed weevil (Sternochetus
mangiferae (Fabricus), formerly known as Cryptorhynchus mangiferae) in
imported fruits and vegetables. We solicited comments concerning our
proposed rule for a period of 60 days, ending July 25, 2000. On August
4, 2000, we published a Federal Register notice that reopened and
extended the comment period until August 21, 2000 (65 FR 47908, Docket
No. 98-030-2). By the end of this comment period we received 2,212
comments, including many form letters and form postcards.
The various issues raised in these comments are discussed below by
topic.
Comments Outside the Scope of APHIS' Authority
Approximately 2,000 of the comments we received on the proposed
rule were a form letter, or slight variations of the form letter. In
addition to comments addressing the proposed rule, discussed below,
these form letters raised several issues that concern matters under the
regulatory authority of other Federal and State agencies, not APHIS. We
do not intend to reopen debate over matters that have been resolved
through rulemaking by other agencies that have primary authority in
these areas.
For example, one concern expressed is that irradiation will make
foods unsafe to eat. The Food and Drug Administration (FDA) has primary
regulatory responsibility for ensuring that approved irradiation doses
do not render foods unsafe to eat. FDA regulations (21 CFR 179.26)
establish a limit of 1.0 kilogray for disinfestation of arthropod pests
in food. None of the irradiation doses contained in our rule exceed one
quarter of this approved safe dose limit. A similar concern is whether
irradiation could generate harmful chemicals from the cartons in which
fruits and vegetables are irradiated. FDA has addressed safe packaging
materials in 21 CFR 179.26, where it specifically allows wax-coated
paperboard, the common carton type for fruits and vegetables.
Other comments suggested that irradiation facilities are inherently
unsafe, and that workers and the public may be exposed to dangerous
levels of radiation as the result of accidents at the plants or during
transport of radioisotopes to and from plants. The Nuclear Regulatory
Commission, the Occupational Safety and Health Administration, and the
United States Department of Transportation have the primary regulatory
responsibility for issues including irradiation facility construction,
operation, employee and public safety, and transportation of
[[Page 65017]]
radioisotopes. Their requirements in these areas were established
through public rulemaking by the respective agencies.
Many comments also stated that irradiation would reduce the
nutritional value of fruits and vegetables, particularly through
vitamin depletion, and could also mask the effects of spoilage. Again,
regulation of these matters is outside the scope of the current
rulemaking and outside the statutory authority of APHIS. However, on
these points we do note for the record the following information from
the August 2000 report by the United States General Accounting Office,
``Food Irradiation: Available Research Indicates That Benefits Outweigh
Risks'' (GAO/RCED-00-217):
There is also some vitamin loss associated with irradiation--
with certain vitamins, such as thiamin (B1), ascorbic acid (C), and
alpha-tocopherol (E)--more affected by irradiation than others.
However, according to the Institute of Food Technologists, it is
highly doubtful that there would ever be any vitamin deficiency
resulting from eating irradiated food. For example, thiamin is the
most radiation-sensitive, water-soluble vitamin. With regard to this
vitamin, the American Dietetic Association's position statement on
food irradiation notes that FDA evaluated an extreme case in which
all meat, poultry, and fish were irradiated at the maximum
permissible dose under conditions resulting in the maximum
destruction of thiamin. Even in these circumstances, the average
thiamin intake was above the Recommended Dietary Allowance, leading
FDA to conclude that there was no deleterious effect on the total
dietary intake of thiamin as a result of irradiating foods. In its
1980 evaluation of food irradiation, the Joint Expert Committee
convened by FAO, WHO, and IAEA concluded that irradiation caused no
special nutritional problems in food. Another meeting of experts in
1997--organized by the same three international organizations--
concluded that even high doses of irradiation (i.e., over 10 kGy)
would not result in nutrient losses that could adversely affect a
food's nutritional value.
Irradiation cannot reverse the spoilage process--the bad
appearance, taste, and/or smell will remain the same after
irradiation. In addition, current regulations do not allow food
processors to use doses of irradiation on meat, poultry, fruits, and
vegetables that would be high enough to sterilize extremely
contaminated food. If a processor attempted to use a sterilization
dose on many of these products, the odor, flavor, taste, and texture
would be seriously impaired and the consumer would reject such
products.
APHIS Should Use Treatments and Procedures Other Than Irradiation To
Control Pests
Numerous commenters stated that APHIS should not employ irradiation
as a treatment but should instead use other treatments and procedures
to prevent the introduction of dangerous plant pests associated with
imported fruits and vegetables. They stated that these other methods
were preferable to the human health risks and environmental effects the
commenters believe are associated with irradiation. The suggested
alternatives included fumigation with methyl bromide, cold treatment,
heat treatment, pressure treatment, controlled atmosphere treatments
altering carbon dioxide concentrations, and several developing
technologies such as use of laser ultraviolet light pulses. Some
commenters also suggested that APHIS should only allow articles to be
imported from areas free from significant pests.
We have not made any changes to the rule in response to these
comments. Again, we emphasize that importers are free to choose other
treatments authorized by the regulations in lieu of irradiation. The
reason that irradiation may be attractive to certain importers,
particularly those importing fresh tropical fruits from fruit fly-
infested regions, is that irradiation allows fruits of higher quality
to be imported. Alternative heat, cold, and fumigation treatments often
cause unacceptable phytotoxicity (damage to the fruits). Also, these
alternative treatments often must be used on fruit harvested before it
is fully ripe. The irradiation alternative allows importers to sell
riper, more valuable fruit, with less damage.
In authorizing irradiation treatments, we have considered both the
efficacy and the environmental effects of irradiation compared to other
treatments already authorized by our regulations. The irradiation
treatments in the final rule are effective against the listed plant
pests. As discussed below, an environmental assessment and finding of
no significant impact have been prepared for this rule, documenting the
conclusions that the irradiation methods in this rule would not present
a risk of introducing or disseminating plant pests, would have
environmental effects that are substantially less than those of some
other authorized treatments, and would not have a significant impact on
the quality of the human environment.
It is true that several technologies under development may also
provide effective treatments for various plant pests (e.g., pressure
treatments, controlled atmospheres, and laser ultraviolet light
pulses). To date, we have not seen conclusive scientific documentation
that establishes standard methodologies for these treatments, or that
demonstrates that these treatments effectively control pests of concern
in fruits and vegetables subject to APHIS regulations. APHIS is always
willing to evaluate petitions to add new treatments to our import
regulations. Petitioners should submit a detailed description of the
methodology and standards of the treatment to be evaluated, and should
include any scientific studies that document the effectiveness of the
treatment and related issues (e.g., quality effects on treated
articles).
Prohibition of Irradiation Facilities in Southern States
In the proposed rule, Sec. 305.2(b) provided that irradiation
could be conducted prior to the arrival of articles in the United
States, or after arrival, but limited the location of facilities in the
United States to certain northern States where the climate would
preclude the successful establishment of the targeted fruit flies. We
proposed that irradiation facilities could be located in any State on
the mainland United States except Alabama, Arizona, California,
Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico,
North Carolina, South Carolina, Tennessee, Texas, and Virginia. We
proposed this location restriction as a safeguard against the
possibility that, despite container and movement restrictions designed
to prevent this possibility, fruit flies could escape from regulated
articles in the United States prior to treatment.
Four commenters stated that this restriction should be dropped.
They stated that the restriction was unnecessary because imported
shipments could be successfully safeguarded to prevent the escape of
pests between the time the articles arrive and the time they are
irradiated to destroy any pests associated with them. One commenter
specifically suggested that in lieu of prohibiting irradiation in
southern States, APHIS could impose stringent packaging requirements to
prevent the escape of pests, such as plastic shrouding, banding of
boxes, insect-proof screening, and additional labeling to prevent
misrouting of articles. Another commenter described planned operating
procedures for an irradiation facility to operate at a southern port of
arrival. These procedures would subject containers arriving at the port
to a sanitizing wash upon arrival, then move the unsealed containers
directly into the irradiation facility before they are opened. The
facility would have insect suppression systems to prevent the escape of
insects, including solid walls separating untreated product from
treated product. Another commenter stated that an irradiation facility
in
[[Page 65018]]
Florida had already demonstrated the ability to move high-risk fruits
and vegetables into the facility without escape of pests, treat them,
and move them to their final destinations in Texas and California
without reinfestation. That commenter submitted as evidence the
protocols for moving and irradiating guavas, mangos, and sweet
potatoes.
These commenters, in addition to arguing that irradiation
facilities could safely operate in southern States, maintained that
severe business and economic losses would result from prohibiting
irradiation in southern States. They stated that this action would
prevent the most logical ports from accepting shipments of fruits and
vegetables from South America and Mexico. They also noted that the
South has a large demand for the types of fresh fruits and vegetables
that would enter in accordance with the rule. These commenters also
noted that southern ports are currently allowed to import a large
volume of fruits and vegetables that must be treated after arrival with
treatments other than irradiation--e.g., cold treatment, or fumigation
with methyl bromide--and that the rule would be inconsistent to allow
one kind of trade but not the other.
After careful consideration of these comments, we have decided that
allowing irradiation facilities in all southern States under the
requirements of the proposed rule, or under safeguards described in
general terms by the commenters, would permit an unacceptable risk that
fruit fly populations could become established and flourish in the
southern climate, and therefore we are not changing the proposed
general prohibition of irradiation facilities in southern States
although, as discussed below, we are allowing irradiation facilities to
be established at three ports in southern States if the facilities meet
special conditions. The commenters requesting us to allow irradiation
facilities in other southern States make strong arguments that there
are notable business advantages related to certain port locations and
established trade patterns for imported fruits and vegetables. However,
our primary consideration must be the risk of introduction and
establishment of dangerous plant pests.
The commenters argue that importing fruit fly host materials from
fruit fly-infested regions for irradiation in southern States would be
no riskier than other importations (and interstate movements) that are
currently allowed. However, the examples they cite are not completely
relevant. In the case of the Florida irradiation facility that
irradiates guavas, mangos, and sweet potatoes for movement to Texas and
California, the irradiated articles are of domestic origin. While they
may be exposed to the Caribbean fruit fly, which is established in
certain parts of Florida, they do not represent a risk of spreading
exotic species of fruit flies. Also, even the risks associated with
Caribbean fruit fly have become a concern to other States. In its own
comment on the proposed rule, the California Department of Food and
Agriculture expressed concern over the number of live Caribbean fruit
fly larvae emerging from guavas irradiated in Florida, and was
considering developing a quality control program for such fruit and
reviewing its policy regarding the acceptance of heavily infested
irradiated fruit from Florida. The other pests for which these articles
are irradiated in Florida (weevils and surface pests) do not have the
pest risk potential represented by exotic fruit flies. The argument
that allowing this facility to irradiate imported fruit fly host
material would not increase risks over the level of its current
operations is therefore unconvincing.
We also disagree with the argument that southern ports are
currently allowed to import a large volume of fruits and vegetables
that must be treated after arrival with treatments other than
irradiation--e.g., cold treatment, or fumigation with methyl bromide--
and that this justifies allowing irradiation in all southern States.
Generally, the articles allowed to be imported into southern ports for
fumigation treatment upon arrival are not high-risk fruit fly host
materials; when such articles are allowed to be imported, they must be
treated prior to arrival. Some higher-risk articles (e.g., citrus,
apples, grapes, and pears) are allowed to be imported into three
southern ports (Wilmington, NC; Gulfport, MS; and the Atlanta, GA,
airport) for cold treatment after arrival. Unlike northern ports, at
least two of these three ports (Gulfport and Atlanta) do not have
sufficient biological barriers, including climatic conditions, to
prevent the introduction and establishment of fruit flies and other
insect pests that could escape from shipments of imported fruit after
arrival in the United States. Cold treatment after arrival is allowed
at these three ports because APHIS has imposed special conditions to
mitigate the risk of the introduction of fruit flies and other insect
pests into the United States (see 7 CFR 319.56-2d(b)(5)(iv), (vi), and
(vii)).
The special conditions appropriate for allowing cold treatment
after arrival would also be sufficient to safely allow irradiation
treatment after arrival, although several requirements for cold
treatment facilities (e.g., back-up cooling systems and cold holding
rooms) would not be needed for irradiation facilities at these ports.
Therefore, we are changing this final rule to allow irradiation
facilities to be located at the ports of Gulfport, Wilmington, and
Atlanta. We are accomplishing this change by adding a footnote to Sec.
305.2(b), which lists States where facilities may be located, to read
as follows: ``Irradiation facilities may be located at the maritime
ports of Gulfport, MS, or Wilmington, NC, or the airport of Atlanta,
GA, if the following special conditions are met: The articles to be
irradiated must be imported packaged in accordance with paragraph
(g)(2)(i)(A) of this section; the irradiation facility and APHIS must
agree in advance on the route by which shipments are allowed to move
between the vessel on which they arrive and the irradiation facility;
untreated articles may not be removed from their packaging prior to
treatment under any circumstances; blacklight or sticky paper must be
used within the irradiation facility, and other trapping methods,
including Jackson/methyl eugenol and McPhail traps, must be used within
the 4 square miles surrounding the facility; and the facility must have
contingency plans, approved by APHIS, for safely destroying or
disposing of fruit.''
These special conditions are derived from the special conditions in
Sec. 319.56-2d(b)(5) that are required for cold treatment facilities
in Wilmington, Gulfport, and Atlanta. The purposes of the conditions
are as follows.
Insect-proof packaging; no removal from packaging prior to
treatment. These requirements guard against the possible escape of
adult, larval, or pupal fruit flies or other pests.
Approval of the route by which shipments are allowed to move
between the vessel on which they arrive and the irradiation facility.
This requirement allows APHIS to ensure the articles are not moved
through areas containing crops or wild plants that are good host
material for fruit flies, and to ensure timely, low-risk delivery to
the irradiation facility.
Fruit fly attractants and traps in the irradiation facility and
surrounding areas. The dual purpose is to both kill escaped fruit flies
and to reveal their presence so further control efforts can be planned.
Contingency plans for safely destroying or disposing of fruit. If
irradiation operations are delayed due to equipment failure or for
other reasons, APHIS may order articles
[[Page 65019]]
destroyed to avoid risks that pests might escape them while they are in
storage.
We are not changing the final rule to allow irradiation at other
ports in southern States at this time. Post-arrival cold treatments at
the ports of Wilmington, Gulfport, and Atlanta were initially allowed
in the mid-1990s after APHIS evaluated detailed petitions from port
authorities, State governments, and business interests who worked
jointly to develop detailed proposals for the siting, operations, and
safeguarding of cold treatment facilities at these ports. Requests to
allow irradiation at other southern ports would have to be evaluated in
a similar manner. In each case we would have to thoroughly evaluate the
risk situation of the suggested port, including the individual port's
latitude, microclimate, immediate host availability, and past fruit fly
infestations. After such evaluation, if APHIS determines special
conditions that would allow post-arrival irradiation treatment to occur
without risk of spreading pests, we would initiate rulemaking to allow
such treatment at the designated ports.
Therefore, with the exception noted above for Wilmington, Gulfport,
and Atlanta, this final rule includes the requirement of the proposal
that irradiation facilities in southern States may not treat imported
articles in accordance with the regulations. However, we welcome
detailed petitions from businesses working in concert with port
authorities and State governments who believe that post-arrival
irradiation treatment facilities can safely operate at particular
southern ports.
Recommended Doses
The proposed rule, in Sec. 305.2, set forth the following
irradiation doses:
Irradiation for Fruit Flies and Seed Weevils in Imported Fruits and
Vegetables
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Scientific name Common name Dose (gray)
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(1) Bactrocera dorsalis........ Oriental fruit fly..... 250
(2) Ceratitis capitata......... Mediterranean fruit fly 225
(3) Bactrocera cucurbitae...... Melon fly.............. 210
(4) Anastrepha fraterculus..... South American fruit 150
fly.
(5) Anastrepha suspensa........ Caribbean fruit fly.... 150
(6) Anastrepha ludens.......... Mexican fruit fly...... 150
(7) Anastrepha obliqua......... West Indian fruit fly.. 150
(8) Anastrepha serpentina...... Sapote fruit fly....... 150
(9) Bactrocera tryoni.......... Queensland fruit fly... 150
(10) Bactrocera jarvisi........ (No common name)....... 150
(11) Bactrocera latifrons...... Malaysian fruit fly.... 150
(12) Sternochetus mangiferae Mango seed weevil...... 100
(Fabricus).
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Six commenters made comments suggesting changes to these dose
rates. Four of these commenters suggested specific dose rate changes,
and two addressed the need for research on dose rates more generally.
Several commenters drew attention to the statement in the proposed rule
(pp. 34113-34114) that ``The dose of ionizing radiation, calculated in
gray, must be sufficient to prevent adult emergence of each species of
fruit fly in fruits and vegetables. Each dose is set at the lowest
level that achieves this effect; the dose will not necessarily kill
larvae immediately after treatment.'' Three commenters stated that
APHIS did not set doses at the lowest level that will prevent adult
emergence and cited research reports to support their positions.
The commenters who suggested specific changes to doses suggested
the following doses for the final rule:
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Dose
Scientific name Common name Proposed dose suggested by
(gray) commenters
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(1) Bactrocera dorsalis.................... Oriental fruit fly................. 250 150
(2) Ceratitis capitata..................... Mediterranean fruit fly............ 225 150
(3) Bactrocera cucurbitae.................. Melon fly.......................... 210 150
(4) Anastrepha fraterculus................. South American fruit fly........... 150 100
(5) Anastrepha suspensa.................... Caribbean fruit fly................ 150 100
(6) Anastrepha ludens...................... Mexican fruit fly.................. 150 100
(7) Anastrepha obliqua..................... West Indian fruit fly.............. 150 100
(8) Anastrepha serpentina.................. Sapote fruit fly................... 150 100
(9) Bactrocera tryoni...................... Queensland fruit fly............... 150 100
(10) Bactrocera jarvisi.................... (No common name)................... 150 100
(11) Bactrocera latifrons.................. Malaysian fruit fly................ 150 100
(12) Sternochetus mangiferae (Fabricus).... Mango seed weevil.................. 100 300
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One commenter stated that the new doses were supported by
``numerous sound science based studies,'' but did not identify specific
studies. Two commenters referred to research reports contained in
``Proceedings of the Final Research Coordination Meeting on Use of
Irradiation as a Quarantine Treatment of Food and Agricultural
Commodities'' (IAEA 1992) and ``Report of ICGFI Task Force on
Irradiation as a Quarantine Treatment of Fresh Fruits and Vegetables''
(ICGFI 1991). These studies support the proposition that a 150 gray
treatment for B. dorsalis, B. cucurbitae, and C. capitata is effective
in preventing emergence of adult flies.
Another commenter cited studies by Hallman (1999), Bustos et al.
(1992), and Gould & von Windeguth (1991) to support doses of 100 gray
to treat for A. suspensa, A. ludens, A. obliqua, A. serpentina, B.
jarvisi, and B. tryoni. This commenter also stated that the research
suggests that the doses of 250 gray for B. dorsalis and 225 gray for C.
capitata
[[Page 65020]]
may be too high, but suggested that APHIS seek further research to
demonstrate this rather than changing those doses at this time. This
commenter also suggested that the dose for mango seed weevil, S.
mangiferae, should be raised to 300 gray, because the 100 gray dose was
based on two limited studies that did not fully evaluate the efficacy
of irradiating the weevils in mangoes, rather than in laboratory vials,
and due to the extremely high rate of infestation of many foreign
mangoes by the seed weevil.
Another commenter cited recent research indicating that a dose of
100 gray prevents adult emergence of A. ludens, A. obliqua, and A.
serpentina, and that a dose of 150 gray does so for C. capitata. The
research cited showed no adult emergence at these doses after study of
more than 100,000 irradiated third instar larvae in mangoes.
In addition to suggesting that smaller doses may be effective in
controlling fruit flies, several commenters stated that the proposed
doses, as applied in commercial operation, would cause an unacceptably
high level of damage to the quality of fresh fruit. These commenters
noted that commercial irradiators treating large lots often must expose
some of the lot (e.g., outer layers) to two to three times the minimum
dose in order to ensure that the entire lot receives at least the
minimum dose. Therefore, some of the fruit treated to a minimum dose of
150 gray could receive a dose of up to 450 gray, a dose that
significantly reduces the quality of some fruits. A minimum dose of 250
gray (proposed for B. dorsalis) would result in some of the lot being
exposed to up to 750 gray, a level that would reduce most fruits to an
unsaleable quality. These commenters also noted that there is a direct
relationship between dose and cost of treatment; the higher the dose,
the greater the cost; and suggested that it might not be economically
feasible for commercial irradiators to treat fruit using the proposed
doses.
Based on these comments concerning doses, we have decided to
increase the dose for mango seed weevil from 100 gray to 300 gray, and
to leave all the other doses at their proposed levels. We have
reexamined research on irradiation as a means to control seed weevils,
and the preponderance of it supports using a higher dose than the 100
gray we proposed. The only research that found 100 gray to be effective
against mango seed weevil was a limited study involving a very few
insects; other research by Heather and Corcoran (1990) \1\, Jessup and
Rigney (1990) \2\, and Follett \3\ found that a dose in the 300 gray
range was necessary to effectively control the weevil.
---------------------------------------------------------------------------
\1\ Heather, N.W., and Corcoran, R.J. ``Effects of ionizing
energy on fruit flies and seed weevil in Australian mangoes''.
Proceedings of the IAEA/FAO Research Coordination Meeting on the Use
of Irradiation as a Quarantine Treatment of Food and Agricultural
Commodities, Kuala Lumpur, Malaysia, August, 1990.
\2\ Jessup, A.J., and Rigney, C.J. ``Gamma irradiation as a
commodity treatment against Dacus tryoni, Queensland fruit fly, in
fresh fruit.'' Proceedings of the IAEA/FAO Research Coordination
Meeting on the Use of Irradiation as a Quarantine Treatment of Food
and Agricultural Commodities, Kuala Lumpur, Malaysia, August, 1990.
\3\ Dr. Peter Follett, Agricultural Research Service, USDA.
Personal communication (1999).
---------------------------------------------------------------------------
The comments suggesting lowered doses for other pests, and the
research supporting these comments, may have merit, but such research
must be carefully evaluated and verified before we lower doses below
the proposed levels, which we know are effective. APHIS, in cooperation
with the Agricultural Research Service and others, will evaluate the
lower doses recommended by commenters. If we determine that any or all
of the recommended lower doses are effective, we will initiate
rulemaking in the future to reduce the doses. However, this evaluation
process will take time, and the current final rule maintains the
proposed higher doses so that irradiation treatments may occur while
this evaluation is underway.
Barriers Between Treated and Untreated Articles in Irradiation
Facilities
Several commenters addressed the possibility that, while articles
are in an irradiation facility, pests might move from articles that
have not yet been irradiated to articles that have been irradiated. If
this happens, irradiated articles would pose a risk of spreading these
pests. They noted that if the irradiation facility is outside the
United States, this risk is addressed by the proposed requirement that
articles must be in insect-proof cartons before, during, and after
irradiation. However, the proposal did not require insect-proof cartons
at irradiation facilities in the United States. Also, while the
proposed physical layout for irradiation facilities, with physically
separate locations for treated and untreated articles (Sec.
305.2(e)(2), would prevent mixing of articles, it would not prevent the
self-movement of pests from untreated articles to treated articles in
the facility. The proposal only required that facility areas for
untreated and treated articles ``must be separated by a permanent
physical barrier such as a wall or chain link fence 6 or more feet high
to prevent transfer of cartons.'' While the proposal stated that normal
business practices result in material moving through a facility quickly
for cost reasons, and that untreated material would not remain in a
facility long enough for adult flies to emerge from untreated materials
and move to treated materials, these commenters stated that unforseen
delays and processing backlogs could sometimes allow enough time for
pests to move from untreated to treated articles. They suggested that
for this reason, irradiation facilities in the United States should be
required either to use insectproof cartons, or to have a solid barrier
impervious to fruit flies between areas of the facility where untreated
articles are kept and areas of the facility where treated articles are
kept.
We have not made any change based on these comments because there
is only a slight risk of this scenario occurring, because it is
extremely improbable that larvae could crawl from the untreated to the
treated area of the facility, and articles do not remain in the
untreated section long enough for flies to hatch and move to the
treated area. Section 305.2(c) addresses even these slight risks, by
stating that in the compliance agreement a facility must sign with
APHIS, ``the facility operator must agree to comply with any additional
requirements found necessary by the Administrator to prevent the
escape, prior to irradiation, of any fruit flies that may be associated
with the articles to be irradiated.'' In drawing up that compliance
agreement, we will consider on a case-by-case basis for each facility
whether safeguards are needed to prevent the escape or movement of
pests at that facility.
Monitoring of Foreign Irradiation Facilities by Foreign Plant
Protection Organizations and by APHIS
Several commenters suggested that effective monitoring of
operations at foreign irradiation facilities was crucial to ensure that
treatments were safe and effective. These commenters pointed out that
in some countries the national plant protection organization could
provide most of this monitoring, while in others APHIS would have to
provide most of the monitoring, depending on different situations in
different countries. They suggested that the section of the rule
dealing with monitoring should be flexible enough to let APHIS vary its
level of monitoring as needed, based on the infrastructure and
capabilities of plant protection organizations in different countries.
They also suggested
[[Page 65021]]
that the activities that foreign plant protection services will conduct
to enforce the regulations and monitor compliance should be recorded in
an agreement between the foreign plant protection service and APHIS.
We agree with this comment, and have decided that the monitoring
section of the rule should allow APHIS to target its monitoring as
needed and provide the appropriate level of monitoring, ranging from
intermittent monitoring of operations and inspection of records to a
continual APHIS presence at facilities and regular inspection of
untreated and treated articles for pests. We also believe that
providing this level of monitoring may require APHIS to arrange for
foreign plant protection services to deposit monies into a trust fund
to reimburse APHIS for services, as is common practice under many other
APHIS import regulations (e.g., importing Fuji apples from Japan and
the Republic of Korea under Sec. 319.56-2cc, or importing Hass
avocados from Mexico under Sec. 319.56-2ff). We also agree that the
activities of foreign plant protection services in support of the
regulations should be recorded in a work plan that the foreign plant
protection service submits to APHIS.
Supplemental Proposed Rule
Because the issues of appropriate levels of monitoring, foreign
plant protection service work plans, and another issue mentioned by
commenters--carton irradiation indicators, were not specifically raised
in the proposed rule, we published a supplemental proposed rule to seek
public comment on these issues. That supplemental proposed rule was
published in the Federal Register on March 15, 2002 (67 FR 11610-11614,
Docket 98-030-3). We accepted public comments on the supplemental
proposed rule for 30 days, ending April 15, 2002. We received 67
comments during that period.
In that supplemental proposed rule, we proposed changing the
monitoring section of the rule to allow APHIS to provide an appropriate
level of monitoring at irradiation facilities depending on the
situations in different countries, to establish two kinds of work plans
to document requirements and activities, and to establish trust funds
with national plant protection organizations to reimburse APHIS for its
expenses.
These changes reflect our position that APHIS should sign work
plans with foreign plant protection services to clearly state what
regulatory requirements and levels of inspection, monitoring, and other
activities apply to importation of irradiated articles into the United
States and into the signatory foreign country, and that APHIS should be
able to target its monitoring as needed, ranging from intermittent
monitoring of operations and inspection of records to a continual APHIS
presence at facilities and regular inspection of untreated and treated
articles for target and nontarget pests.
With respect to the work plans, the supplemental proposed rule
provided, in support of the equivalence principle, that APHIS and each
foreign plant protection service will sign an irradiation treatment
framework equivalency work plan that clearly states what legislative,
regulatory, and other requirements must be met, and what monitoring and
other activities must occur, for irradiated articles to be imported
into the United States, or into the foreign country.
Of the approximately 10 comments that addressed this proposed
revision of proposed Sec. 305.2(f), most supported the changes. One
commenter addressed the language in proposed Sec. 305.2(f)(1) that
would require the framework equivalency work plan to include
``citations for any requirements that apply to the importation of
irradiated fruits and vegetables.'' The commenter pointed out that some
countries may not develop or legislate original requirements regarding
irradiation, but may rely on and cite irradiation standards developed
by international bodies such as the International Consultative Group on
Food Irradiation, the International Plant Protection Convention, and
others. APHIS is aware of this, and believes no change to the proposed
language is needed. The framework equivalency work plan can cite
whatever requirements the respective countries apply to irradiated
fruits and vegetables, whether they are laws or regulations of that
country or international guidelines or standards.
One commenter addressed the statement in proposed Sec.
305.2(f)(1)(ii) that the framework equivalency plan must describe ``the
type and amount of inspection, monitoring, or other activities that
will be required in connection with allowing the importation of
irradiated fruits and vegetables.'' This commenter stated that
inspection and monitoring of irradiation processing should not differ
significantly from other treatment methods, e.g., heat or cold
treatments, fumigation, or controlled atmosphere treatments.
APHIS does not believe any change is necessary in regard to this
comment. The proposed language does not set any required level for
inspection and monitoring activities; it merely asks each country to
state the level of such activities it chooses to require in the
framework equivalency plan. We do not agree that all types of treatment
necessarily require the same level of monitoring and inspection to
verify that they are effective. The level required depends on the
nature of the treatments and their technical complexity, including the
number of critical control points to be monitored.
This commenter also noted that the framework equivalency plan is
silent on the role of the irradiation facility, and suggested the
facility should be involved in developing framework equivalency plans
because facilities bear the major responsibility for making effective
monitoring possible.
We do not believe any change is needed in response to this comment.
The point of the framework equivalency plan is to document consistency
in national requirements for importation of irradiated fruits and
vegetables. The proposed regulations present no barrier to
consultations between a foreign plant protection service and an
irradiation facility during development of a framework equivalency
plan, but it is not APHIS' place to require foreign governments to have
such consultations when developing their import requirements. With
regard to documenting the role and specific responsibilities of
irradiation facilities under our regulations, we note that proposed
Sec. 305.2(d) requires that both a compliance agreement and an annual
work plan be developed and signed by APHIS and the foreign irradiation
facility.
One commenter objected to the trust fund agreement in proposed
Sec. 305.2(f)(3), stating that it is unnecessary for APHIS to send
personnel to foreign countries to monitor irradiation processing. He
stated that between the framework equivalency work plan and the
facility preclearance work plan in proposed Sec. 305.2(f), APHIS had
set up a system where equivalency in national requirements existed, in
terms of the Sanitary and Phytosanitary (SPS) Agreement of the World
Trade Organization. Article 4 of that Agreement states that ``Members
shall accept the sanitary and phytosanitary measures of other members
as equivalent, even if these measures differ from those used by other
Members trading in the same product, if the exporting Member
objectively demonstrates to the importing Member that its measures
achieve the importing Member's appropriate level of sanitary
[[Page 65022]]
or phytosanitary protection.'' If this situation applies, the commenter
stated, ``it is more cost effective for both importing and exporting
countries to establish and agree to the ``equivalency work plan,''
including the procedure for operation of irradiation facilities
required for treating fruits and vegetables, than to continue to depend
on inspection and monitoring of operation of quarantine treatments by
officials from importing countries. Exporting countries must ensure
that fruits are produced through Good Agricultural Practices (GAPs),
and handled and processed or treated through proper protocols under
Good Manufacturing Practices (GMPs) to be in compliance with the
requirements of the importing countries. Each step in the production,
handling, processing/treatment must be certified by the competent
authorities in importing countries. The final product must be certified
by the national plant protection organization that proper quarantine
treatment, e.g. irradiation, was done * * *.''
In response to this comment, APHIS understands that equivalency
issues under the SPS Agreement are complex and evolving. First, we note
that USDA collects funds for the foreign activities of its inspectors
in accordance with specific statutory authority, 7 U.S.C. 7753(a),
which states ``The Secretary may enter into reimbursable fee agreements
with persons for preclearance of plants, plant products, biological
control organisms, and articles at locations outside the United States
for movement into the United States.''
Secondly, we disagree that, by jointly developing a framework
equivalency work plan and a facility preclearance work plan, APHIS and
the exporting country will demonstrate that equivalency exists. At
most, developing these plans will help identify to what degree
equivalency exists, and may also identify areas where the procedures
and technical expertise of the exporting country do not meet the United
States' ``appropriate level of sanitary or phytosanitary protection.''
Certainly, the level of inspection and monitoring performed by APHIS
employees under the trust fund agreement will vary depending on the
effectiveness--the equivalency--of the activities of the foreign plant
protection service.
In developing the framework equivalency work plan--a joint
activity--both APHIS and the exporting country will have the
opportunity to negotiate the necessary or appropriate conditions to
establish and run the program. In some cases, there may be concerns
about whether the exporting country has adequate technical expertise,
experience, and oversight capability to ensure an irradiation treatment
program is conducted properly. In other cases, the host government may
have more capability. This final rule does not preclude the exporting
country from proposing alternative approaches or options for meeting
any concerns we may have that might cause us to increase the level of
activities by APHIS inspectors under the trust fund agreement. Also,
the framework equivalency work plan will be subject to annual review,
which allows for the possible reduction of oversight (and associated
costs) as confidence grows in the program.
Thirdly, costs associated with implementing an inspection,
treatment, or other safeguarding program are normal and expected in
agricultural trade. The obligation in the SPS Agreement is that ``* *
*any fees imposed for procedures related to control, inspection, and
approval are equitable in relation to any fees charged on like domestic
products or products originating in any other Member and should be no
higher than the actual cost of the service'' (Annex C). In other words,
APHIS should avoid inconsistent or discriminatory charges or fees, and
we believe the final rule does this.
One commenter stated that the work plans and monitoring provisions
in proposed Sec. 305.2(f) are premature and are subject to challenge,
vis-a-vis pending revisions to the two main General Standards of the
Codex Alimentarius Commission that relate to food irradiation. If and
when these standards are approved, they could become official WTO
guidance addressing operational requirements at irradiation facilities,
including dosimetry, recordkeeping, inventory control, inspections, and
other matters. The commenter stated that any conflict between U.S. food
standards and those of a WTO member nation could be challenged under
the WTO's binding dispute resolution system.
We are making no change based on this comment. The fact that the
Codex Alimentarius Commission is working on developing standards for
the future does not provide any current basis for a challenge to our
regulations. If and when international standards are ready for
adoption, we will examine them to determine whether any of our
regulations should be amended to be consistent with them. We also note
that APHIS has consistently worked with bodies developing international
guidelines for irradiation of fruits and vegetables, and we believe our
final rule is consistent with the anticipated products of these bodies.
One commenter suggested a change to proposed Sec. 305.2(h)(3),
which read ``The utilization of the dosimetry system, including the
number and placement of dosimeters used, must be in accordance with
American Society for Testing and Materials (ASTM) standards.'' This
commenter pointed out that much of the ASTM ``standards'' are actually
guidelines that are meant to be flexible and adaptive, and to state
that they ``must'' be followed is confusing. The commenter also noted
that there are other authoritative sources similar to ASTM standards
regarding dosimetry, such as standards developed by the National
Institute of Standards and Technology, that are in wide use in U.S. and
foreign nuclear industries.
We agree that the reference in proposed Sec. 305.2(h)(3) was too
definite and restrictive, and implied that the ASTM published precise
dosimetry standards that all irradiation facilities could and must
follow exactly. In fact, the ASTM describes its dosimetry guide as a
document that ``covers the basis for selecting and calibrating
dosimetry systems used to measure absorbed dose * * *. It discusses the
types of dosimetry systems that may be employed during calibration or
on a routine basis as part of quality assurance in commercial radiation
processing of products. This guide also discusses interpretation of
absorbed dose and briefly outlines measurements of the uncertainties
associated with the dosimetry. The details of the calibration of the
analytical instrumentation are addressed in individual dosimetry system
standard practices * * *. This guide should be used along with standard
practices and guides for specific dosimetry systems and applications
covered in other standards.''
In fact, the ASTM standards for dosimetry describe basic
principles, effective techniques, and best practices, but do not
provide absolute or mandatory standards for dosimetry systems. To
recognize this, we are changing the statement in Sec. 305.2(h)(3) to
read as follows: ``When designing the facility's dosimetry system and
procedures for its operation, the facility operator must address
guidance and principles from American Society for Testing and Materials
(ASTM) standards or an equivalent standard recognized by the
Administrator.''
Irradiation Indicators and Tests To Identify Irradiated Fruit
Several commenters on the original proposed rule suggested that we
should
[[Page 65023]]
require that prior to irradiation, indicators should be attached to
cartons of articles. These indicators would change color, or undergo
some other obvious change, when exposed to irradiation in the required
dose range for regulated articles. The commenters stated that these
indicators would be a very useful safeguard and could be used by
enforcement personnel and others as a quick check to confirm that a
particular carton had in fact been exposed to the required level of
radiation. Commenters identified several devices and dye-impregnated
labels that react to radiation in the 150-250 gray range.
Because we did not propose to require any such indicators or tests
in the proposed rule, we discussed their use in the supplemental
proposed rule. In the supplemental proposed rule, we proposed to change
the paragraph addressing packaging, Sec. 305.2(g)(1), to state that
``each carton must bear an indicator device, securely attached prior to
irradiation, that changes color or provides another clear visual change
when it is exposed to radiation in the dose range required by this
section for the pests for which the articles are being treated.''
We received more than 20 comments on this proposed change. Several
were mildly supportive of using carton indicators, but the large
majority of comments opposed the requirement for numerous technical,
operational, and cost-benefit reasons. Several commenters cited the
report, ``Standardized methods to verify absorbed dose in irradiated
food for insect control,'' published in 2001 by the International
Atomic Energy Agency, IAEA, Vienna, IAEA-TECDOC-1201. The commenters
stated that the findings of that report indicated that, at present,
color indicator devices are not suitable and not reliable to be used in
phytosanitary applications and should not be used until such devices
are further developed and are thoroughly tested for reliability.
Other commenters cited the document ASTM Standard E 1539-98,
``Standard Guide for Use of Radiation-Sensitive Indicators.'' Section
7.3 of that document states: ``Some irradiation or storage conditions
may result in false positive or negative observations. For these
reasons, indicators should not be used as a criterion for product
release. Also, external environmental influences may make the
interpretation of the indicators meaningless outside the irradiation
facility unless appropriate controls are used.''
One commenter cited several additional research articles \4\ that
evaluate the effectiveness, sensitivity, and vulnerability to
environmental effects of irradiation indicators.
---------------------------------------------------------------------------
\4\ Ehlermann, D.A.E. (Federal Research Centre for Nutrition,
Karlsruhe (DE). Inst. of Process Engineering), ``Validation of a
label dosimeter for food irradiation applications by subjective and
objective means,'' Appl. Radiat. Isot.; v. 48(9), p. 1197-1201;
1997.
Ehlermann, D.A.E. (Federal Research Centre for Nutrition,
Karlsruhe (Germany). Inst. of Process Engineering), ``Validation of
a label dosimeter with regard to dose assurance in critical
applications as quarantine control,'' International Atomic Energy
Agency, IAEA; Vienna (Austria); 1999, p. 265-270; IAEA-TECDOC--1070;
IAEA-SM-356/38.
International Atomic Energy Agency, ``Standardized methods to
verify absorbed dose in irradiated food for insect control,'' IAEA,
Vienna, 2001, IAEA-TECDOC-1201.
Razem, D. (Ruder Boskovic Inst., Zagreb (Croatia)), ``Dosimetric
performance of and environmental effects on sterin irradiation
indicator labels,'' Radiat. Phys. Chem.; v. 49(4) p. 491-495.
---------------------------------------------------------------------------
Several commenters noted that the few indicators currently on the
market were not sensitive enough to properly document the proposed dose
ranges of 100 to 250 gray. They noted that the margin of error for such
indicators appeared to be about 100 gray--meaning that an indicator
designed to change color at a dose of 250 gray might change at a dose
as low as 150 gray, or not change until it received a dose of 350 gray.
These commenters noted that if irradiation facilities concentrate on
indicator color change as a measure of success, they could subject some
articles to unnecessarily high doses, or even pass some articles that
received less than the required doses.
Several commenters suggested that APHIS should concentrate on
ensuring that irradiation facilities conduct and document proper and
effective dosimetry programs and not require carton indicators unless
and until they are proven reliable, useful, and cost-effective at a
later date. They suggested that inspectors at the port of entry, if
they find insects or larvae in an irradiated shipment or have other
questions about the adequacy of the irradiation, could use the required
labeling and documentation to check on the treatment of that shipment--
e.g., by matching carton lot numbers from the port with carton lot
numbers in the facility's records. Inspectors could readily verify with
the facility operator that a particular shipment had been irradiated,
and could also check APHIS monitoring records for that facility. Given
modern communications and databases, such verification would not unduly
delay release of shipments at ports.
Other commenters took issue with a statement in the economic
analysis for the supplemental proposal that use of indicators would
increase the price of imported articles by only ``a few cents per
pound.'' These commenters pointed out that, even if this is true, the
cost of irradiating articles at some facilities could be as low as 5
cents per pound, and increasing this cost to 8 cents by requiring
indicators amounted to a 60 percent cost increase for treatment. They
also noted that a price differential of 3 cents per pound could be a
critical disadvantage in some market situations.
We have carefully analyzed all the data and opinions submitted
recommending against the indicator requirement, and we have decided not
to require indicators at this time. While we believe that a conceivable
indicator could be employed as a possible cross-check at ports of
entry, apparently there is no such indicator that is: (1) Currently
available at low cost; (2) validated to be sensitive and reliable in
the appropriate dose ranges; and (3) validated to be resistant to false
positives and false negatives caused by environmental effects. We also
concur with commenters that, at least during the early implementation
of this program and the first operations of irradiation facilities
under the regulations, it is important to concentrate on effective
dosimetry programs and recordkeeping at facilities, and effective
communications between APHIS inspectors and facilities to backtrack
treatment records for individual shipments, rather than attempting to
use problematic indicator technologies.
One commenter wrote, in support of requiring indicators, that it
was a manufacturer of luminescence technology devices that were
sensitive to irradiation in the dose ranges APHIS proposed. While these
indicators do not change color in a manner visible to the naked eye,
their state change after irradiation can be read by an inexpensive
device similar to a barcode scanner. This commenter claimed that such
indicators have advantages in terms of cost, resistance to
environmental effects, and counterfeit resistance.
While such devices are not consistent with the type of indicator
APHIS proposed--which was for an indicator ``that changes color or
provides another clear visual change''--APHIS will consider such
devices, along with other types of indicator technology, in its future
consideration of whether to require indicators. We wish to emphasize
that we welcome suggestions regarding ways indicators might be used
effectively, and technical descriptions of available indicators. Also,
since irradiation facilities in foreign countries,
[[Page 65024]]
and the government agencies that regulate irradiation in those
countries, ultimately bear a great deal of responsibility for ensuring
that products are irradiated in accordance with APHIS requirements, we
welcome any suggestions from those sources on the use of indicators or
other methods for confirming that products were properly irradiated.
Other Comments on the Supplemental Proposed Rule
We received approximately 50 comments on the supplemental proposed
rule that were similar to the 2000 form-letter comments we received on
the original proposal. These comments generally raised issues that are
outside the scope of the current rulemaking, such as the safety of
irradiation facilities and the nutritional value of irradiated food.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule with the
changes discussed in this document.
Effective Date
This is a substantive rule that relieves restrictions and, pursuant
to the provisions of 5 U.S.C. 553, may be made effective less than 30
days after publication in the Federal Register. Immediate
implementation of this rule is necessary to provide an alternative to
other currently approved treatments against fruit files and the mango
seed weevil in fruits and vegetables, thus relieving restrictions.
Therefore, the Administrator of the Animal and Plant Health Inspection
Service has determined that this rule should be effective upon
publication in the Federal Register.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be significant for the purposes of Executive
Order 12866 and, therefore, has been reviewed by the Office of
Management and Budget.
The economic analysis for the changes in this document is set forth
below. It provides a cost-benefit analysis as required by Executive
Order 12866 and an analysis of the potential economic effects on small
entities as required by the Regulatory Flexibility Act.
In accordance with 5 U.S.C. 604, we have performed a final
regulatory flexibility analysis regarding the effect of this rule on
small entities. In the initial regulatory flexibility analysis in the
proposed rule we stated that we did not have all the data necessary for
a comprehensive analysis of the effects of this rule on small entities,
and we invited comments concerning potential effects. In particular, we
solicited data to help determine the number and kinds of small entities
that may incur benefits or costs from implementation of this proposed
rule. We did not receive any comments challenging our estimates of the
number and kinds of small entities affected, although several comments
did state that the additional cost of requiring carton indicators (a
requirement removed from this final rule, as discussed elsewhere in
this document) would have adverse impacts on both large and small
importers.
Under the Plant Protection Act (7 U.S.C. 7701-7772), the Secretary
of Agriculture is authorized to regulate the importation of plants,
plant products, and other articles to prevent the introduction of
injurious plant pests.
This rule will permit the treatment of imported fruits and
vegetables by irradiation, in place of or in conjunction with existing
phytosanitary treatments or other protocols, for 11 species of fruit
flies and one species of seed weevil. Irradiation could take place
prior to shipment to the United States or after arrival. There are
requirements for certification of the facilities, treatment monitoring,
pallet security, and recordkeeping for irradiation at all facilities,
and packaging and labeling requirements for articles irradiated before
arrival in the United States. Irradiation facilities must use an
approved dosimetry system during treatment and keep records to verify
effective irradiation. For irradiation after arrival, compliance
agreements will impose requirements on the transit from ports to
irradiation facilities, to ensure all shipments requiring irradiation
are delivered to the facility and are not rerouted to sale prior to
treatment.
Firms in the United States primarily affected by this rule will be
ones conducting the irradiation treatments. They could be variously
classified by the Small Business Administration, depending on each
one's particular business enterprises. A firm providing irradiation
services strictly for the treatment of crops, including imported fruits
and vegetables, would be included in the Standard Industry
Classification (SIC) category 0723 (Crop Preparation Services, except
Cotton Ginning). A firm would qualify as a small entity if it had
annual revenues of $5 million or less. If a firm that imports or
wholesales fruits and vegetables were to perform the irradiation
itself, it would be included in SIC 5148 (Fresh Fruits and Vegetables),
since its principal activity would remain importing or wholesaling. In
this case, the firm would be designated as a small entity if it had 100
or fewer employees.
Firms expected to benefit most immediately from this rule, however,
would not belong in either of these SIC categories. They would be
companies that currently provide irradiation services on contract for
decontamination or sterilization purposes and could readily adapt to
perform phytosanitary irradiation. They are classified within SIC 2099
(Food Preparations, N.E.C.) or SIC 2842 (Specialty Cleaning, Polishing,
and Sanitation). The former category includes firms that irradiate food
items, such as spices, seeds, culinary herbs, vegetable seasoning, and
poultry, to destroy harmful pathogens. Included in SIC 2842 are firms
that primarily provide irradiation services for the sterilization of
medical devices, pharmaceutical preparations, and raw materials used in
cosmetic products.
Four firms with SIC 2099 or 2842 designations have been identified
that provide irradiation services on contract. For both categories,
employment of 500 or fewer persons qualifies a firm as a small entity.
Three of the four firms are considered small. (The fourth one had been
a small entity until last year, when it was purchased by another
corporation.)
Of these four companies, the one that is not a small entity is the
only one engaged at present in phytosanitary irradiation. This firm
treats papayas, carambolas, litchis, and other tropical fruits from
Hawaii that are moved interstate to the mainland United States.
Irradiation of the fruit in accordance with 7 CFR 318.13-4f, performed
at facilities in Illinois, removes the risk of Mediterranean, Oriental,
and melon fruit fly introduction, while also lengthening the shelf life
of the fruit. Treatment of the Hawaiian fruit, however, is a small part
of the firm's business; irradiation services are mainly provided for
sterilization purposes through a network of facilities in nine States
and Canada.
Similarly, the second of the four firms has 12 facilities
throughout the United States, 8 of which are used for medical
sterilizations and 4 for other purposes. One of the 12 facilities,
located in southern California, has been adapted for irradiation of
fruits and vegetables for the purpose of lengthening shelf life.
The other two firms that provide irradiation services are single-
facility businesses. One, in Maryland, principally conducts medical and
pharmaceutical sterilizations, and the other, in Florida, has been
irradiating
[[Page 65025]]
poultry products for the retail market and hospitals since 1993.
In addition to these four firms, companies that use irradiation to
sterilize their own products could also benefit from this rule by
contracting their irradiation facilities for phytosanitary purposes.
Location, throughput capacity, the irradiating processes used, and
other characteristics of the facilities would help determine whether
the cost of their services would be competitive in comparison to the
cost of alternative methods of treatments.
While these firms are technologically capable of taking advantage
of treatment opportunities afforded by this rule, any economic effects
on them will ultimately depend on the cost effectiveness of irradiation
when compared to alternative phytosanitary treatments. A 1994 study
sheds light on the benefits and costs of irradiation versus methyl
bromide (MB) fumigation for the treatment of imported fruits and
vegetables.\5\ Economic benefits in this study were estimated in terms
of preventing potential economic losses in U.S. fruit and vegetable
markets that would result from discontinuation of MB as a fumigant for
imports. In fiscal year 1996, 14 percent of imported fruits, nuts, and
vegetables, valued at about $345 million, were treated with MB, 80
percent at U.S. ports and 20 percent in preclearance programs in
foreign locations.\6\ Although temperature-modifying treatments are
possible alternatives for some fruits and vegetables, MB fumigation is
the principal, and sometimes sole, phytosanitary treatment available
for many commodities.
---------------------------------------------------------------------------
\5\ ``Costs and Benefits of Irradiation Versus Methyl Bromide
Fumigation for Disinfestation of U.S. Fruit and Vegetable Imports,''
by Kenneth W. Forsythe, Jr. and Phylo Evangelou, ERS Staff Report
No. AGES 9412, March 1994.
\6\ ``Quarantine Uses of Methyl Bromide by the United States,
Fiscal Year 1996'' (Draft), APHIS-PPD-PAD, April 1997; available in
the APHIS reading room (see ADDRESSES).
---------------------------------------------------------------------------
The 1994 study focused on short- and medium-term costs and benefits
of irradiation treatment in off-season U.S. import markets for grapes,
nectarines, okra, peaches, and plums. Grapes comprise over 80 percent,
by value, of imported fruits and vegetables fumigated with MB, but they
have a low tolerance for irradiation. When grapes were included in the
analysis, irradiation treatment costs, in 1998 dollars, ranged from 1.6
to 3.9 cents per pound. Excluding grapes, irradiation cost estimates
ranged from 3.4 to 3.9 cents per pound.\7\ These unit costs reflect the
substantial economies of size that could be captured by irradiation
facilities, due to the concentration of imported fruit at certain ports
of arrival.
---------------------------------------------------------------------------
\7\ To adjust irradiation unit costs estimated in the 1994 study
from 1987 dollars to 1998 dollars, values are multiplied by a factor
of 1.23 (producer price index for capital equipment, series ID:
WPSSOP3200, Bureau of Labor Statistics, U.S. Dept. of Labor).
---------------------------------------------------------------------------
Preshipment and quarantine uses of MB, along with critical
agricultural and emergency uses, are exempted from the MB phase out
required by the Clean Air Act.\8\ These exemptions essentially segment
the MB market into restricted and unrestricted parts. Demand for MB
used for exempted purposes is expected to remain unaffected as its use
as a soil fumigant is restricted. However, reduced production due to
the phase out may cause the price of MB used for phytosanitary purposes
to rise, due to an increase in the unit cost of production. Most MB in
the world is manufactured by only three companies, two in the United
States and one in Israel. Whether their economies of production can be
maintained will depend on the demand for MB for exempted purposes in
the United States and other developed countries, and overall demand in
developing countries (where final phase out is scheduled under the
Montreal Protocol for 2015).
---------------------------------------------------------------------------
\8\ Ten percent of methyl bromide used annually in agriculture
in the United States is for commodity and quarantine treatment,
compared to 85 percent for soil fumigation and 5 percent for
structural fumigation. The 1999 Omnibus Consolidated and Emergency
Supplemental Appropriations Act (Public Law 105-277) made specific
changes to the Clean Air Act, to harmonize the U.S. phaseout of
methyl bromide with the Montreal Protocol phaseout schedule for
developed countries. This schedule requires U.S. methyl bromide
production and importation reductions (from 1991 levels) of 25
percent in 1999, 50 percent in 2001, 70 percent in 2003, and 100
percent in 2005; exempted from this phaseout schedule are critical
agricultural, emergency, and preshipment and quarantine uses. With
respect to traded commodities, the amendment states that ``the [EPA]
Administrator shall exempt the production, importation, and
consumption of methyl bromide to fumigate commodities entering or
leaving the United States or any State (or political subdivision
thereof) for purposes of compliance with Animal and Plant Health
Inspection Service requirements * * * '' (www.epa.gov/ozone/mbr/
mbrqa.html).
---------------------------------------------------------------------------
The demand for irradiation as a treatment alternative will be
influenced by product quality and phytotoxicity issues. Product shelf
life can be extended by irradiation. Moreover, some fruits and
vegetables that are damaged by fumigation or temperature-modifying
treatments are tolerant of irradiation. On the other hand, as indicated
above for grapes, some fruits and vegetables are considered not very
tolerant of irradiation. Assuming consumers accept irradiation as a
phytosanitary treatment, its use will be determined not only by the
availability of alternative treatments and relative costs but also by
its enhancing or diminishing effects on product quality.
When the latter range of unit costs (3.4 to 3.9 cents per pound)
are applied to fumigated quantities of 11 varieties of fruits imported
in fiscal year 1996 that have a high or medium tolerance of
irradiation, costs of irradiation treatment range, in 1998 dollars,
between $2.7 million and $3.1 million.\9\ Applying MB fumigation costs
assumed in the 1994 study, 0.6 to 1.2 cents per pound in 1998 dollars,
yields a total treatment cost of $0.5 million to $0.9 million for this
same set of imports. It is apparent that the use of irradiation for
phytosanitary purposes is probably not a cost-competitive alternative
to MB fumigation at present. However, the phase-out of MB as a soil
fumigant may result in an increase in its unit cost of production,
thereby making the cost of irradiation and other treatment alternatives
more competitive.
---------------------------------------------------------------------------
\9\ The 11 fruits are apricot, banana/plantain, grapefruit,
orange, papaya, peach/ nectarine, pineapple, plum, strawberry,
tangerine, and tomato. The combined weight of import shipments of
these fruits that were fumigated with MB in fiscal year 1996 was
approximately 78.3 million pounds. This represented only 2.43
percent, by weight, of total imports of these 11 fruits (see, op.
cit., ``Quarantine Uses of Methyl Bromide by the United States,
Fiscal Year 1996'' [Draft], Table 1). The range of costs is probably
underestimated, since it assumes economies of size would be captured
in all cases.
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This rule will broaden the choices among phytosanitary treatment
alternatives for U.S. fruit and vegetable importers. No net societal
gains and losses other than small price-related changes are expected
from this rule if irradiation is used only to treat fruits and
vegetables that would have been imported otherwise using an alternative
treatment. Income earned by firms providing the irradiation services
would be income forgone by the displaced fumigators or other treatment
providers. But if irradiation enables importations that would not
otherwise occur, then societal gains (increased imports) could be
attributed to its phytosanitary use. Irradiation treatment most likely
will both serve as an alternative treatment for a fraction of current
imports and stimulate additional imports for certain fruits and
vegetables, such as papaya, that need to be treated for fruit flies and
have a high tolerance for irradiation.
Allowing irradiation to be used as a phytosanitary treatment for 11
fruit fly species and one seed weevil species would most immediately
benefit four firms, three of which are small entities, that currently
provide irradiation services on contract for sterilization and
decontamination purposes. Participation of these firms, and entry of
other firms, in the treatment of imported
[[Page 65026]]
fruits and vegetables will depend upon the demand that develops for
irradiation in relation to alternative treatments.
The economic effects of the changes adopted from the supplemental
proposed rule result from the establishment of trust fund agreements to
reimburse APHIS for its activities monitoring irradiation facilities in
foreign countries. We are requiring that the inspection and monitoring
activities performed by a foreign plant protection service at
irradiation facilities located overseas be recorded in an agreement
signed by the foreign service and APHIS. The purpose of the agreement
is to ensure appropriate levels of inspection and monitoring at the
facilities, thereby reducing any pest risk due to misunderstandings or
shortcomings in the oversight of irradiation and related processes at
facilities.
When a foreign plant protection service establishes a trust fund
agreement to reimburse APHIS for expenses, that service may or may not
pass along the cost of depositing those funds to producers in that
country, depending on the service's funding mechanisms. If it passes
along that cost to foreign producers, those producers will likely raise
the price of fruits and vegetables exported to the United States to
cover the costs. However, we expect that trust fund agreement costs to
have a negligible effect on the prices paid by U.S. merchants and
consumers for the imported produce.
The benefits of the trust fund agreements accrue because the
agreements will increase the reliability of irradiation as a
phytosanitary treatment. Thus, benefits are evaluated in terms of
preventing potential economic losses in U.S. fruit and vegetable
markets that could occur if pests should enter the United States with
articles that were not properly irradiated because trust fund
agreements to monitor treatments were not in effect. These benefits
cannot be readily quantified. As an example, however, averting the
costs associated with a single fruit fly outbreak in the United States
would save more than the total costs for trust fund agreements over
many years.
The major alternative to this rule would be to not allow these
irradiation treatments. In that case, importers and irradiation
businesses would not accrue the benefits described above, and firms
providing existing treatment alternatives would continue operating as
at present (with MB fumigation becoming less competitive as its supply
is constrained).
This final rule contains information collection requirements, which
have been approved by the Office of Management and Budget (see
``Paperwork Reduction Act'' below).
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. Under this rule: (1) All State and local laws and
regulations that are inconsistent with this rule will be preempted; (2)
no retroactive effect will be given to this rule; and (3)
administrative proceedings will not be required before parties may file
suit in court challenging this rule.
National Environmental Policy Act
An environmental assessment and finding of no significant impact
have been prepared for this rule. The assessment provides a basis for
the conclusion that the irradiation methods in this rule would not
present a risk of introducing or disseminating plant pests and would
not have a significant impact on the quality of the human environment.
Based on the finding of no significant impact, the Administrator of the
Animal and Plant Health Inspection Service has determined that an
environmental impact statement need not be prepared.
The environmental assessment and finding of no significant impact
were prepared in accordance with: (1) The National Environmental Policy
Act of 1969, as amended (NEPA) (42 U.S.C. 4321 et seq.), (2)
regulations of the Council on Environmental Quality for implementing
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS'' NEPA
Implementing Procedures (7 CFR part 372).
Copies of the environmental assessment and finding of no
significant impact are available for public inspection at USDA, room
1141, South Building, 14th Street and Independence Avenue, SW.,
Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday,
except holidays. Persons wishing to inspect copies are requested to
call ahead on (202) 690-2817 to facilitate entry into the reading room.
In addition, copies may be obtained by writing to the individual listed
under ``FOR FURTHER INFORMATION CONTACT.''
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this rule have been approved by the Office of Management
and Budget (OMB) under OMB control number 0579-0155.
List of Subjects
7 CFR Part 305
Irradiation, Phytosanitary treatment, Plant diseases and pests,
Quarantine, Reporting and recordkeeping requirements.
7 CFR Part 319
Bees, Coffee, Cotton, Fruits, Honey, Imports, Logs, Nursery Stock,
Plant diseases and pests, Quarantine, Reporting and recordkeeping
requirements, Rice, Vegetables.
Accordingly, title 7, chapter III, of the Code of Federal
Regulations is amended as follows:
1. A new part 305 is added to read as follows:
PART 305--PHYTOSANITARY TREATMENTS
Sec.
305.1 Definitions.
305.2 Irradiation treatment of imported fruits and vegetables for
certain fruit flies and mango seed weevils.
Authority: 7 U.S.C. 7701-7772; 21 U.S.C. 136 and 136a; 7 CFR
2.22, 2.80, and 371.3.
Sec. 305.1 Definitions.
The following definitions apply for the purposes of this part:
Administrator. The Administrator, Animal and Plant Health
Inspection Service, United States Department of Agriculture, or any
person delegated to act for the Administrator in matters affecting this
part.
APHIS. The Animal and Plant Health Inspection Service, United
States Department of Agriculture.
Dose mapping. Measurement of absorbed-dose within a process load
using dosimeters placed at specified locations to produce a one-, two-,
or three-dimensional distribution of absorbed dose, thus rendering a
map of absorbed-dose values.
Dosimeter. A device that, when irradiated, exhibits a quantifiable
change in some property of the device that can be related to absorbed
dose in a given material using appropriate analytical instrumentation
and techniques.
Dosimetry system. A system used for determining absorbed dose,
consisting of dosimeters, measurement instruments and their associated
reference standards, and procedures for the system's use.
Inspector. Any employee of the Animal and Plant Health Inspection
Service or other person authorized by the Administrator to inspect and
certify the plant health status of plants and products under this part.
[[Page 65027]]
Sec. 305.2 Irradiation treatment of imported fruits and vegetables
for certain fruit flies and mango seed weevils.
(a) Approved doses. Irradiation at the following doses for the
specified fruit flies and seed weevils, carried out in accordance with
the provisions of this section, is approved as a treatment for all
fruits and vegetables:
Irradiation for Fruit Flies and Seed Weevils in Imported Fruits and
Vegetables
------------------------------------------------------------------------
Scientific name Common name Dose (gray)
------------------------------------------------------------------------
(1) Bactrocera dorsalis........ Oriental fruit fly..... 250
(2) Ceratitis capitata......... Mediterranean fruit fly 225
(3) Bactrocera cucurbitae...... Melon fly.............. 210
(4) Anastrepha fraterculus..... South American fruit 150
fly.
(5) Anastrepha suspensa........ Caribbean fruit fly.... 150
(6) Anastrepha ludens.......... Mexican fruit fly...... 150
(7) Anastrepha obliqua......... West Indian fruit fly.. 150
(8) Anastrepha serpentina...... Sapote fruit fly....... 150
(9) Bactrocera tryoni.......... Queensland fruit fly... 150
(10) Bactrocera jarvisi........ (No common name)....... 150
(11) Bactrocera latifrons...... Malaysian fruit fly.... 150
(12) Sternochetus mangiferae Mango seed weevil...... 300
(Fabricus).
------------------------------------------------------------------------
(b) Location of facilities. Where certified irradiation facilities
are available, an approved irradiation treatment may be conducted for
any fruit or vegetable either prior to shipment to the United States or
in the United States. Irradiation facilities certified under this
section may be located in any State on the mainland United States
except Alabama, Arizona, California, Florida, Georgia\1\, Kentucky,
Louisiana, Mississippi1, Nevada, New Mexico, North Carolina1, South
Carolina, Tennessee, Texas, and Virginia. Prior to treatment, the
fruits and vegetables to be irradiated may not move into or through any
of the States listed in this paragraph, except that movement is allowed
through Dallas/Fort Worth, Texas, as an authorized stop for air cargo,
or as a transloading location for shipments that arrive by air but that
are subsequently transloaded into trucks for overland movement from
Dallas/Fort Worth into an authorized State by the shortest route.
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\1\ Irradiation facilities may be located at the maritime ports
of Gulfport, MS, or Wilmington, NC, or the airport of Atlanta, GA,
if the following special conditions are met: The articles to be
irradiated must be imported packaged in accordance with paragraph
(g)(2)(i)(A) of this section; the irradiation facility and APHIS
must agree in advance on the route by which shipments are allowed to
move between the vessel on which they arrive and the irradiation
facility; untreated articles may not be removed from their packaging
prior to treatment under any circumstances; blacklight or sticky
paper must be used within the irradiation facility, and other
trapping methods, including Jackson/methyl eugenol and McPhail
traps, must be used within the 4 square miles surrounding the
facility; and the facility must have contingency plans, approved by
APHIS, for safely destroying or disposing of fruit.
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(c) Compliance agreement with importers and facility operators for
irradiation in the United States. If irradiation is conducted in the
United States, both the importer and the operator of the irradiation
facility must sign compliance agreements with the Administrator. In the
facility compliance agreement, the facility operator must agree to
comply with any additional requirements found necessary by the
Administrator to prevent the escape, prior to irradiation, of any fruit
flies that may be associated with the articles to be irradiated. In the
importer compliance agreement, the importer must agree to comply with
any additional requirements found necessary by the Administrator to
ensure the shipment is not diverted to a destination other than
treatment and to prevent escape of plant pests from the articles to be
irradiated during their transit from the port of first arrival to the
irradiation facility in the United States.
(d) Compliance agreement with irradiation facilities outside the
United States. If irradiation is conducted outside the United States,
the operator of the irradiation facility must sign a compliance
agreement with the Administrator and the plant protection service of
the country in which the facility is located. In this agreement, the
facility operator must agree to comply with the requirements of this
section, and the plant protection service of the country in which the
facility is located must agree to monitor that compliance and to inform
the Administrator of any noncompliance.
(e) Certified facility. The irradiation treatment facility must be
certified by the Administrator. Recertification is required in the
event of an increase or decrease in the amount of radioisotope, a major
modification to equipment that affects the delivered dose, or a change
in the owner or managing entity of the facility. Recertification also
may be required in cases where a significant variance in dose delivery
has been measured by the dosimetry system. In order to be certified, a
facility must:
(1) Be capable of administering the minimum absorbed ionizing
radiation doses specified in paragraph (a) of this section to the
fruits and vegetables;\2\
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\2\ The maximum absorbed ionizing radiation dose and the
irradiation of food is regulated by the Food and Drug Administration
under 21 CFR part 179.
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(2) Be constructed so as to provide physically separate locations
for treated and untreated fruits and vegetables, except that fruits and
vegetables traveling by conveyor directly into the irradiation chamber
may pass through an area that would otherwise be separated. The
locations must be separated by a permanent physical barrier such as a
wall or chain link fence 6 or more feet high to prevent transfer of
cartons, or some other means approved during certification to prevent
reinfestation of articles and spread of pests;
(3) If the facility is located in the United States, the facility
will only be certified if the Administrator determines that regulated
articles will be safely transported to the facility from the port of
arrival without significant risk that plant pests will escape in
transit or while the regulated articles are at the facility.
(f) Monitoring and interagency agreements. Treatment must be
monitored by an inspector. This monitoring will include inspection of
treatment records and unannounced inspections of the facility by an
inspector, and may include inspection of articles prior to or after
irradiation. Facilities that carry out irradiation
[[Page 65028]]
operations must notify the Director of Preclearance, PPQ, APHIS, 4700
River Road Unit 140, Riverdale, MD 20737-1236, of scheduled operations
at least 30 days before operations commence, except where otherwise
provided in the facility preclearance work plan. To ensure the
appropriate level of monitoring, before articles may be imported in
accordance with this section, the following agreements must be signed:
(1) Irradiation treatment framework equivalency work plan. The
plant protection service of a country from which articles are to be
imported into the United States in accordance with this section must
sign a framework equivalency work plan with APHIS. In this plan, both
the foreign plant protection service and APHIS will specify the
following items for their respective countries:
(i) Citations for any requirements that apply to the importation of
irradiated fruits and vegetables;
(ii) The type and amount of inspection, monitoring, or other
activities that will be required in connection with allowing the
importation of irradiated fruits and vegetables into that country; and
(iii) Any other conditions that must be met to allow the
importation of irradiated fruits and vegetables into that country.
(2) Facility preclearance work plan. Prior to commencing
importation into the United States of articles treated at a foreign
irradiation facility, APHIS and the plant protection service of the
country from which articles are to be imported must jointly develop a
preclearance work plan that details the activities that APHIS and the
foreign plant protection service will carry out in connection with each
irradiation facility to verify the facility's compliance with the
requirements of this section. Typical activities to be described in
this work plan may include frequency of visits to the facility by APHIS
and foreign plant protection inspectors, methods for reviewing facility
records, and methods for verifying that facilities are in compliance
with the requirements for separation of articles, packaging, labeling,
and other requirements of this section. This facility preclearance work
plan will be reviewed and renewed by APHIS and the foreign plant
protection service on an annual basis.
(3) Trust fund agreement. Irradiated articles may be imported into
the United States in accordance with this section only if the plant
protection service of the country in which the irradiation facility is
located has entered into a trust fund agreement with APHIS. That
agreement requires the plant protection service to pay, in advance of
each shipping season, all costs that APHIS estimates it will incur in
providing inspection and treatment monitoring services at the
irradiation facility during that shipping season. Those costs include
administrative expenses and all salaries (including overtime and the
Federal share of employee benefits), travel expenses (including per
diem expenses), and other incidental expenses incurred by APHIS in
performing these services. The agreement will describe the general
nature and scope of APHIS services provided at irradiation facilities
covered by the agreement, such as whether APHIS inspectors will monitor
operations continuously or intermittently, and will generally describe
the extent of inspections APHIS will perform on articles prior to and
after irradiation. The agreement requires the plant protection service
to deposit a certified or cashier's check with APHIS for the amount of
those costs, as estimated by APHIS. If the deposit is not sufficient to
meet all costs incurred by APHIS, the agreement further requires the
plant protection service to deposit with APHIS a certified or cashier's
check for the amount of the remaining costs, as determined by APHIS,
before any more articles irradiated in that country may be imported
into the United States. After a final audit at the conclusion of each
shipping season, any overpayment of funds would be returned to the
plant protection service or held on account until needed, at the option
of the plant protection service.
(g) Packaging. Fruits and vegetables that are irradiated in
accordance with this section must be packaged in cartons in the
following manner:
(1) All fruits and vegetables treated with irradiation must be
shipped in the same cartons in which they are treated. Irradiated
fruits and vegetables may not be packaged for shipment in a carton with
nonirradiated fruits and vegetables.
(2) For all fruits and vegetables irradiated prior to arrival in
the United States:
(i) The fruits and vegetables to be irradiated must be packaged
either:
(A) In insect-proof cartons that have no openings that will allow
the entry of fruit flies. The cartons must be sealed with seals that
will visually indicate if the cartons have been opened. The cartons may
be constructed of any material that prevents the entry of fruit flies
and prevents oviposition by fruit flies into the articles in the
carton; \3\ or
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\3\ If there is a question as to the adequacy of a carton, send
a request for approval of the carton, together with a sample carton,
to the Animal and Plant Health Inspection Service, Plant Protection
and Quarantine, Oxford Plant Protection Center, 901 Hillsboro
Street, Oxford, NC 27565.
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(B) In noninsect-proof cartons that are stored immediately after
irradiation in a room completely enclosed by walls or screening that
completely precludes access by fruit flies. If stored in noninsect-
proof cartons in a room that precludes access by fruit flies, prior to
leaving the room each pallet of cartons must be completely enclosed in
polyethylene, shrink-wrap, or another solid or netting covering that
completely precludes access to the cartons by fruit flies.
(ii) To preserve the identity of treated lots, each pallet-load of
cartons containing the fruits and vegetables must be wrapped before
leaving the irradiation facility in one of the following ways:
(A) With polyethylene shrink wrap;
(B) With net wrapping; or
(C) With strapping so that each carton on an outside row of the
pallet load is constrained by a metal or plastic strap.
(iii) Packaging must be labeled with treatment lot numbers, packing
and treatment facility identification and location, and dates of
packing and treatment. Pallets that remain intact as one unit until
entry into the United States may have one such label per pallet.
Pallets that are broken apart into smaller units prior to or during
entry into the United States must have the required label information
on each individual carton.
(h) Dosimetry systems at the irradiation facility. (1) Dosimetry
mapping must indicate the doses needed to ensure that all the commodity
will receive the minimum dose prescribed.
(2) Absorbed dose must be measured using an accurate dosimetry
system that ensures that the absorbed dose meets or exceeds the
absorbed dose required by paragraph (a) of this section (150, 210, 225,
250, or 300 gray, depending on the target species of fruit fly or seed
weevil).
(3) When designing the facility's dosimetry system and procedures
for its operation, the facility operator must address guidance and
principles from American Society for Testing and Materials (ASTM)
standards \4\ or an
[[Page 65029]]
equivalent standard recognized by the Administrator.
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\4\ Designation ISO/ASTM 51261-2002(E) , ``Standard Guide for
Selection and Calibration of Dosimetry Systems for Radiation
Processing,'' American Society for Testing and Materials, Annual
Book of ASTM Standards.
---------------------------------------------------------------------------
(i) Records. An irradiation processor must maintain records of each
treated lot for 1 year following the treatment date and must make these
records available for inspection by an inspector during normal business
hours (8 a.m. to 4:30 p.m., Monday through Friday, except holidays).
These records must include the lot identification, scheduled process,
evidence of compliance with the scheduled process, ionizing energy
source, source calibration, dosimetry, dose distribution in the
product, and the date of irradiation.
(j) Request for certification and inspection of facility. Persons
requesting certification of an irradiation treatment facility must
submit the request for approval in writing to the Animal and Plant
Health Inspection Service, Plant Protection and Quarantine, Oxford
Plant Protection Center, 901 Hillsboro Street, Oxford, NC 27565. The
initial request must identify the owner, location, and radiation source
of the facility, and the applicant must supply additional information
about the facility construction, treatment protocols, and operations
upon request by APHIS if APHIS requires additional information to
evaluate the request. Before the Administrator determines whether an
irradiation facility is eligible for certification, an inspector will
make a personal inspection of the facility to determine whether it
complies with the standards of this section.
(k) Denial and withdrawal of certification. (1) The Administrator
will withdraw the certification of any irradiation treatment facility
upon written request from the irradiation processor.
(2) The Administrator will deny or withdraw certification of an
irradiation treatment facility when any provision of this section is
not met. Before withdrawing or denying certification, the Administrator
will inform the irradiation processor in writing of the reasons for the
proposed action and provide the irradiation processor with an
opportunity to respond. The Administrator will give the irradiation
processor an opportunity for a hearing regarding any dispute of a
material fact, in accordance with rules of practice that will be
adopted for the proceeding. However, the Administrator will suspend
certification pending final determination in the proceeding if he or
she determines that suspension is necessary to prevent the spread of
any dangerous insect. The suspension will be effective upon oral or
written notification, whichever is earlier, to the irradiation
processor. In the event of oral notification, written confirmation will
be given to the irradiation processor within 10 days of the oral
notification. The suspension will continue in effect pending completion
of the proceeding and any judicial review of the proceeding.
(l) Department not responsible for damage. This treatment is
approved to assure quarantine security against the listed fruit flies.
From the literature available, the fruits and vegetables authorized for
treatment under this section are believed tolerant to the treatment;
however, the facility operator and shipper are responsible for
determination of tolerance. The Department of Agriculture and its
inspectors assume no responsibility for any loss or damage resulting
from any treatment prescribed or monitored. Additionally, the Nuclear
Regulatory Commission is responsible for ensuring that irradiation
facilities are constructed and operated in a safe manner. Further, the
Food and Drug Administration is responsible for ensuring that
irradiated foods are safe and wholesome for human consumption.
(Approved by the Office of Management and Budget under control number
0579-0155)
PART 319--FOREIGN QUARANTINE NOTICES
2. The authority citation for part 319 continues to read as
follows:
Authority: 7 U.S.C. 166, 450, 7711-7714, 7718, 7731, 7732, and
7751-7754; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
3. In Sec. 319.56-2, a new paragraph (k) is added to read as
follows:
Sec. 319.56-2 Restrictions on entry of fruits and vegetables.
* * * * *
(k) Any fruit or vegetable that is required by this subpart or the
Plant Protection and Quarantine Treatment Manual to be treated or
subjected to other growing or inspection requirements to control one or
more of the 11 species of fruit flies and one species of seed weevil
listed in Sec. 305.2(a) of this chapter as a condition of entry into
the United States may instead be treated by irradiation in accordance
with part 305 of this chapter.
4. In Sec. 319.56-2x, paragraph (a), the introductory text
preceding the table is revised to read as follows:
Sec. 319.56-2x Administrative instructions; conditions governing the
entry of certain fruits and vegetables for which treatment is required.
(a) The following fruits and vegetables may be imported into the
United States only if they have been treated in accordance with the
Plant Protection and Quarantine (PPQ) Treatment Manual, which is
incorporated by reference at Sec. 300.1 of this chapter. Treatment by
irradiation in accordance with part 305 of this chapter may be
substituted for treatments in the PPQ Treatment Manual for the mango
seed weevil Sternochetus mangiferae (Fabricus) or for one or more of
the following 11 species of fruit flies: Anastrepha fraterculus,
Anastrepha ludens, Anastrepha obliqua, Anastrepha serpentina,
Anastrepha suspensa, Bactrocera cucurbitae, Bactrocera dorsalis,
Bactrocera tryoni, Bactrocera jarvisi, Bactrocera latifrons, and
Ceratitis capitata.
* * * * *
Done in Washington, DC, this 18th day of October, 2002.
Bobby R. Acord,
Acting Under Secretary, Marketing and Regulatory Programs.
[FR Doc. 02-27027 Filed 10-18-02; 4:38 pm]
BILLING CODE 3410-34-P
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