[Federal Register Volume 67, Number 205 (Wednesday, October 23, 2002)]
[Rules and Regulations]
[Pages 65016-65029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27027]


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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
------------------------------------------------------------------------
        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......             100
 (Fabricus).
------------------------------------------------------------------------

    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:

----------------------------------------------------------------------------------------------------------------
                                                                                                       Dose
              Scientific name                            Common name               Proposed dose   suggested by
                                                                                      (gray)        commenters
----------------------------------------------------------------------------------------------------------------
(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
----------------------------------------------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    (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.
---------------------------------------------------------------------------

    (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
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (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.
---------------------------------------------------------------------------

    \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