Treatments for Fruits and Vegetables, 4451-4464 [06-746]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 71, Number 18 (Friday, January 27, 2006)]
[Rules and Regulations]
[Pages 4451-4464]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-746]



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Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules 
and Regulations

[[Page 4451]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 301, 305, 318, and 319

[Docket No. 03-077-2]


Treatments for Fruits and Vegetables

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations by revising the approved doses 
for irradiation treatment of imported fruits and vegetables. This rule 
will establish a new minimum generic dose of irradiation for most plant 
pests of the class Insecta, establish a new minimum generic dose for 
the fruit fly family, reduce the minimum dose of irradiation for some 
specific fruit fly species, add 10 pests to the list of pests for which 
irradiation is an approved treatment at less than the generic dose, and 
provide for the use of irradiation as a treatment for cut flowers and 
foliage. These actions will allow the use of irradiation to neutralize 
more pests and to neutralize some pests at lower doses. Furthermore, we 
are providing for the irradiation of fruits and vegetables moved 
interstate from Hawaii at the pest-specific irradiation doses that are 
now approved for imported fruits and vegetables. We are also providing 
for the use of irradiation to treat fruits and vegetables moved 
interstate from Puerto Rico and the U.S. Virgin Islands. These actions 
will allow irradiation to serve as an alternative to other approved 
treatments for additional commodities moved interstate from Hawaii, 
Puerto Rico, and the U.S. Virgin Islands. Finally, we are adding 
irradiation as a treatment for bananas from Hawaii and adding vapor-
heat treatment as an optional treatment for sweetpotatoes from Hawaii. 
These actions will provide an alternative to the currently approved 
treatments for those commodities while continuing to provide protection 
against the spread of plant pests from Hawaii into the continental 
United States.

EFFECTIVE DATE: February 27, 2006.

FOR FURTHER INFORMATION CONTACT: Dr. Inder P.S. Gadh, Senior Risk 
Manager, Commodity Import Analysis & Operations, PPQ, APHIS, 4700 River 
Road Unit 133, Riverdale, MD 20737-1236; (301) 734-8758.

SUPPLEMENTARY INFORMATION:

Background

    The phytosanitary treatments regulations contained in 7 CFR part 
305 set out standards and schedules for treatments required in 7 CFR 
parts 301, 318, and 319 for fruits, vegetables, and other articles to 
prevent the introduction or dissemination of plant pests or noxious 
weeds into or through the United States. Within 7 CFR part 305, the 
irradiation treatments subpart (Sec. Sec.  305.31 through 305.34, 
referred to below as the regulations) sets out standards and minimum 
doses for irradiation treatment for imported fruits and vegetables and 
for regulated articles moved interstate from quarantined areas within 
the United States, along with other requirements for performing 
irradiation treatments.
    On June 10, 2005, we published in the Federal Register (70 FR 
33857-33873, Docket No. 03-077-1) a proposal to amend the regulations 
by making several amendments to the irradiation treatment regulations 
for imported fruits and vegetables, for fruits and vegetables moved 
interstate from Hawaii, Puerto Rico, and the U.S. Virgin Islands, and 
for regulated articles moved interstate from areas quarantined for 
Mexican fruit fly or Mediterranean fruit fly. We also proposed to 
provide for the use of irradiation treatment for bananas moved 
interstate from Hawaii and to provide for the use of a vapor heat 
treatment for sweetpotatoes moved interstate from Hawaii.
    On June 20, 2005, the Federal Register published a correction (70 
FR 35500) to the table in Sec.  305.31(a) of our proposal in which the 
generic dose for all pests of the phylum Arthropoda, excluding adults 
and pupae of the order Lepidoptera, was corrected to read 400 gray.
    We solicited comments concerning our proposal for 60 days ending 
August 9, 2005. We received 13 comments by that date. They were from 
producers, researchers, representatives of State and foreign 
agricultural departments, an international industry organization, a 
public interest organization, and a private citizen. The comments are 
discussed below by topic.

Issue Outside the Scope of APHIS' Authority

    One commenter raised an issue that concerns a matter under the 
regulatory authority of the Food and Drug Administration (FDA), not the 
Animal and Plant Health Inspection Service (APHIS). Specifically, the 
commenter expressed concern that irradiation will make foods unsafe to 
eat. The commenter stated that irradiation produced 2-
alkylcyclobutanones, which she contended is a dangerous residue 
chemical present in irradiated fruits and vegetables.
    The 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 fresh fruits and vegetables. All 
of the irradiation doses contained in this rule are significantly less 
than this approved safe dose limit.

Use of Irradiation to Treat Cut Flowers and Foliage

    One commenter requested that we also provide for the use of 
irradiation to treat cut flowers and foliage that are subject to 
treatment requirements in the regulations.
    We agree that cut flowers and foliage that are hosts of pests for 
which irradiation is an approved treatment can be treated at the pest-
specific doses provided in this final rule. Therefore, in this final 
rule we have amended the phytosanitary treatment regulations as well as 
the Hawaiian and territorial quarantine regulations to provide for the 
use of irradiation to treat cut flowers and foliage. Specifically, we 
have amended paragraph (a) of Sec.  305.31 to provide that irradiation 
at the pest-specific doses may be used to treat cut flowers and 
foliage. We have also amended Sec.  305.31 by replacing the words 
``fruits and vegetables'' with the word ``article'' each time they 
occur. Sections 305.34, 318.13-4f, and 318.58-4b provide administrative 
instructions for irradiation treatment of certain fruits

[[Page 4452]]

and vegetables from Hawaii, Puerto Rico, and the U.S. Virgin Islands, 
respectively. We have amended these sections by replacing the words 
``fruits and vegetables'' with the word ``article'' each time they 
occur. Finally, we have amended the cut flowers regulations in Sec.  
319.74-2 by adding a new paragraph (d) to indicate that cut flowers may 
be treated at the pest-specific irradiation doses listed in Sec.  
305.31(a). Cut flowers and foliage are also subject to the packaging 
requirements provided in Sec. Sec.  305.31 and 305.34 of the 
regulations.
    Irradiation may have negative effects on the quality of cut 
flowers, and the shipper and facility operator are responsible for 
determining tolerance of cut flowers to treatment. APHIS assumes no 
responsibility for any loss or damage that may result in the use of 
irradiation.

Use of Irradiation To Control Pests

    Two commenters objected to the use of irradiation to treat imported 
fruits and vegetables. One commenter stated that food in the United 
States has been altered so much that it has become inferior to food in 
Europe. A second commenter 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. This second commenter 
added that irradiation has not been shown to be a safe, effective, or 
viable means to eradicate invasive pests and that the U.S. Department 
of Agriculture should cease pursuing irradiation as a treatment for 
plant pests.
    We have not made any changes to the rule in response to these 
comments. 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 can 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. It is true that several technologies under development may also 
provide effective treatments for various plant pests (e.g., pressure 
treatments, controlled atmosphere, 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).
    One commenter stated that the proposed rule could stimulate the 
construction of more irradiation facilities, some of which could use 
radioactive cobalt-60 or cesium-137, which Federal regulations permit. 
The commenter stated that these facilities will pose serious risks to 
the communities where they are built.
    We are not making any changes in response to this comment. The 
safety of operations of irradiation facilities is regulated by the 
Nuclear Regulatory Commission (NRC). NRC ensures that such facilities 
are built and operated according to Federal regulations. To be 
licensed, the facility must have been designed with multiple fail-safe 
measures, and must establish extensive and well-documented safety 
procedures and worker training. With proper design and operating 
procedures, commercial irradiation facilities can be operated safely 
and without posing any significant radiation risk to workers or the 
public.

Recommended Doses

    One commenter presented two studies \1\ which demonstrated that 
Mexican fruit fly (Mexfly) is more radiotolerant than West Indian fruit 
fly, but noted that we proposed an irradiation dose of 100 Gy for West 
Indian fruit fly and only 70 Gy for Mexfly. The commenter recommended 
lowering the dose for West Indian fruit fly to 70 Gy.
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    \1\ Bustos, M.E., Enkerlin, W., Reyes, J., and Toledo, J. 2004. 
Irradiation of mangoes as a postharvest quarantine treatment for 
fruit flies (Diptera: Tephritidae). J. Econ. Entomol. 97: 286-292.
    Hallman, G.J. and Worley, J.W. 1999. Gamma radiation doses to 
prevent adult emergence from immatures of Mexican and West Indian 
fruit flies (Diptera: Tephritidae). J. Econ. Entomol. 92: 967-973.
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    We have reviewed the research submitted by the commenter and agree 
that the dose for West Indian fruit fly (Anastrepha obliqua) should be 
lowered to 70 Gy and have done so in this final rule.
    Two commenters stated that it was unnecessary to list green scale 
in the pest table in Sec.  305.31 because it requires the generic dose 
(400 Gy). One commenter noted that this implied that 400 Gy was the 
lowest possible dose that can control green scale. The second commenter 
added that there has been no large-scale research done on this dose, 
but that preliminary research at the University of Hawaii suggested 250 
Gy would control green scale.
    We agree with these commenters and have amended the table in Sec.  
305.31(a) by removing the entry for Coccus viridis, green scale.
    One commenter recommended adding a statement in the final rule that 
lower irradiation doses might be sufficient for the plant pests being 
added in this rule in order to encourage more research on minimum 
irradiation levels.
    We are not making any changes as a result of this comment. As 
stated previously in this document, APHIS is always willing to evaluate 
research that supports new treatments or changes to existing treatments 
such as lowering the required doses for irradiation. Petitioners should 
submit any scientific studies that document the effectiveness of the 
dose, and APHIS will consider each request as it is presented.
    One commenter recommended rounding irradiation doses to the nearest 
10 Gy increment because dosimeters can vary by 1 to 2 percent in their 
accuracy. The commenter added that it is difficult during research to 
accurately apply doses in less than 10 Gy increments due to variability 
in the density and consistency of the infested fruit or vegetable.
    We are not making any changes in response to this comment. We 
believe that the measures we have in place to monitor and administer 
irradiation treatment will ensure that at least the appropriate minimum 
dose is administered. When applying irradiation treatment, several 
factors are taken into account, including geometry of the source, the 
dimensions of the irradiation container, as well as the bulk-density of 
the load and its distribution. Recording of process parameters and 
dosimetry is required to ensure that the treatments applied are within 
the limits established by APHIS. Further, the available data indicate 
that the doses we proposed are the lowest

[[Page 4453]]

effective doses necessary to achieve phytosanitary security; thus, 
rounding a dose up to the nearest 10 Gy increment would have the effect 
of requiring more than the minimum dose and would be contrary to our 
World Trade Organization (WTO) agreements.

Safeguards on Commodity Movement

    Two commenters noted that we should put in place safeguards, such 
as sealed containers, against plant pest spread for untreated 
commodities that are moved to the mainland United States for treatment. 
One of the commenters suggested prohibiting movement of untreated 
commodities with pretreated commodities and adding protocols for 
transport and containment upon arrival.
    Section 305.34 of the regulations sets forth instructions for 
fruits and vegetables shipped from Hawaii to the mainland United 
States, including safeguards for untreated commodities being shipped to 
the mainland United States for treatment. For imported fruits and 
vegetables, Sec.  305.31, paragraph (g)(1) prohibits packaging 
irradiated fruits and vegetables with nonirradiated fruits and 
vegetables and paragraph (g)(2) provides packaging provisions for 
fruits and vegetables irradiated prior to entering the United States to 
prevent the entry of fruit flies. However, Sec.  305.31 does not 
contain packaging provisions for imported fruits and vegetables to be 
irradiated upon arrival in the United States. Therefore, we are 
amending Sec.  305.31(g) in this final rule by adding a new paragraph 
that requires cartons of untreated regulated articles being imported 
into the United States for treatment to be shipped in shipping 
containers sealed prior to importation with seals that will visually 
indicate if the shipping containers have been opened. These provisions 
we have added regarding imported articles mirror those in Sec.  305.34 
for untreated articles moved from Hawaii to the mainland United States 
for treatment.

Bananas from Hawaii

    One commenter stated that the configuration of bananas on the stalk 
make visual inspections an ineffective detection method. The commenter 
added that the lethal dose for banana moth should be determined before 
including this commodity in the regulations.
    We have determined that the generic dose of 400 Gy would be 
sufficient for banana moth larvae; however inspection is necessary for 
pupae and adults of this pest. Bananas may also undergo irradiation 
treatment at a dose of 150 Gy for fruit flies, which would require 
inspection for banana moth and green scale as an additional mitigation 
measure. We agree with this commenter that the configuration of bananas 
on the stalk makes visual inspection more difficult. Therefore, we have 
amended Sec.  318.13-4i, paragraphs (b)(1) and (b)(2), in this final 
rule to specify that bananas must be removed from the stalk during 
inspection.
    One commenter suggested that we allow green bananas from Hawaii 
grown under the systems approach to be irradiated at 400 Gy if found to 
be infested with green scale or to have certain defects that would 
otherwise trigger rejection upon inspection.
    We agree with this commenter and have amended Sec.  318.13-4i in 
this final rule by revising paragraph (b), introductory text, to state 
that ``Bananas of any cultivar or ripeness that do not meet the 
conditions of paragraph (a) of this section may also be moved 
interstate from Hawaii with irradiation in accordance with the 
following conditions.''

Sweetpotatoes

    One commenter questioned whether early stages of Kona coffee root-
knot nematode could be found by visual inspection.
    We have found inspection to be very effective at detecting 
nematodes of all stages.
    One commenter suggested that the regulations should provide that 
the required probes be placed in the largest roots when applying heat 
treatment to sweetpotatoes.
    We agree that inspectors should locate temperature probes in the 
largest potatoes when applying heat treatment. Therefore, we have 
amended Sec.  305.24(k)(1) in this final rule to provide that 
temperature probes must be placed in the approximate center of the 
``largest individual sweetpotato roots.''
    One commenter stated that recent research \2\ indicates that 
sweetpotato weevil, West Indian sweetpotato weevil, and sweetpotato 
vine borer can all be neutralized with a dose of 150 Gy. The commenter 
asked that we add West Indian sweetpotato weevil and sweetpotato vine 
borer with a dose of 150 Gy and that we change the dose for sweetpotato 
weevil to 150 Gy.
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    \2\ Follett, Peter A. Irradiation for postharvest control of 
Omphisa anastomosalis (Lepidoptera: Pyralidae), Euscepes 
postfaciatus and Cylas formicarius elegantulus (Coleoptera: 
Curculionidae) in sweetpotatoes.
---------------------------------------------------------------------------

    After reviewing the research provided by the commenter, we have 
amended the table in Sec.  305.31(a) in this final rule by adding 
entries for West Indian sweetpotato weevil and sweetpotato vine borer 
and specifying a minimum irradiation dose of 150 Gy for both pests. We 
have also reduced the minimum irradiation dose for sweetpotato weevil 
from 165 Gy to 150 Gy.
    With these changes, all but one of the pests of concern for 
sweetpotatoes from Hawaii for which irradiation is an authorized 
treatment may be treated with a minimum irradiation dose of 150 Gy. The 
exception is the ginger weevil (Elytrotreinus subtruncatus), which 
requires a minimum irradiation dose of 400 Gy. (The regulations also 
require inspection for two other pests for which irradiation is not an 
authorized treatment, i.e., the gray pineapple mealybug [Dysmicoccus 
neobrevipes] and the Kona coffee-root knot nematode [Meloidogyne 
konaensis]). In the proposed rule, we proposed to add a vapor heat 
treatment option for sweetpotato from Hawaii that included provisions 
for the sampling, cutting, and inspection of sweetpotatoes for the 
ginger weevil, and we are adopting those proposed provisions in this 
final rule (see Sec.  318.13-4d in the regulatory text at the end of 
this document). To harmonize the irradiation treatment provisions for 
sweetpotatoes from Hawaii with those new vapor heat provisions, we have 
amended the regulations in Sec.  305.34 in this final rule to offer two 
irradiation treatment options: The existing 400 Gy dose or a 150 Gy 
dose supplemented by sampling, cutting, and inspection for the ginger 
weevil, with the sampling, cutting, and inspection requirements being 
the same as those found in the vapor heat provisions in Sec.  318.13-
4d. The inspection requirements for the gray pineapple mealybug and the 
Kona root-knot nematode will continue to apply to sweetpotatoes treated 
at both the 400 Gy and 150 Gy dose. To effect this change, we have 
amended Sec.  305.34(b)(7)(i) and (ii) in this final rule to reflect 
the new inspection requirement for ginger weevil if sweetpotatoes are 
to be irradiated at 150 Gy; a new footnote in the entry for sweetpotato 
in the table in paragraph (a)(1) of that section directs the reader to 
Sec.  305.34(b)(7)(i) and (ii). Because litchi from Hawaii is also 
subject to additional inspection requirements in Sec.  305.34(b)(7), 
the entry for litchi in the table has also been annotated with a 
reference to that footnote.

Pineapples From Hawaii

    One commenter asked that we delete the reference to ``other than 
smooth Cayenne'' in the entry for pineapples in Sec.  305.34, paragraph 
(a)(1). The commenter noted that this would allow

[[Page 4454]]

all varieties of pineapple to be treated by irradiation for plant pests 
in accordance with Sec.  305.31(a) and Sec.  305.34(a)(2).
    The commenter is correct. We mistakenly included the reference to 
``other than smooth Cayenne'' when in fact, all varieties of pineapple 
are eligible for irradiation. We have amended the entries for pineapple 
in Sec.  305.34(a)(1) and Sec.  318.13-4f by removing the words 
``(other than smooth Cayenne).''

General Comments

    In the supplementary information of our proposed rule, we stated 
that mites are not arthropod plant pests. Two commenters noted that 
mites are arthropod plant pests and that we should not use the term 
``arthropod.''
    We agree with the commenters have amended the last row in the table 
in Sec.  305.31 by changing the words ``phylum Arthropoda'' to ``class 
Insecta.''
    One commenter suggested that we should explain to inspectors what 
they can expect to find with properly irradiated commodities (e.g., 
live fruit flies and perhaps eggs, but no further development from 
either).
    Customs and Border Protection and APHIS inspectors are trained as 
to what they might specifically find in commodities treated by 
irradiation and have been inspecting irradiated fruit moved interstate 
for more than a decade. Therefore, it is unnecessary to include such 
information in this final rule.
    One commenter suggested that we include a provision to prohibit 
irradiation of low-oxygen-stored produce until research on the 
effectiveness of irradiation on such produce can be completed. The 
commenter stated that a recent study showed that four pests showed an 
increase in radiotolerance when stored in such conditions.
    We have no evidence to either support or refute the commenter's 
concern with the response of pests in low-oxygen-stored produce to 
irradiation, but agree that irradiation should be only applied to 
articles that have been stored under certain conditions. Because these 
conditions may vary based on the specific commodity, pest of concern, 
or country of origin, we will address specific storage conditions in 
the operational work plan or the compliance agreement with plant health 
officials in the areas where commodities are produced, packed, and 
treated.
    One commenter stated that we incorrectly classified the dose ranges 
for plant pests in the International Plant Protection Convention 
Guidelines for the Use of Irradiation as a Phytosanitary Measure (ISPM 
Publication No. 18) as recommended minimum dose ranges. The commenter 
stated that these doses are only estimates.
    We acknowledge that we incorrectly characterized the estimates as 
recommended minimum doses. That statement appeared in the supplementary 
information of the proposed rule, however, so there is no need to make 
any changes to the regulations in this document.
    Two commenters stated that research did not demonstrate that all 
fruit flies of the family Tephritidae would be neutralized by a dose of 
150 gray.
    The commenters are correct in that, technically, all fruit flies of 
the family Tephritidae were not tested, but all of the fruit flies that 
were tested in this family were neutralized by this dose. Therefore, we 
consider the results from the fruit flies we tested to be applicable to 
the entire Tephritidae family. However, we agree that it would have 
been clearer to state that ``we consider all fruit flies of the family 
Tephritidae to be neutralized by a dose of 150 gray.''
    In the supplementary information of the proposed rule, we stated 
that required irradiation doses were specific to plant pests rather 
than to the commodities with which they are associated, which reflects 
the fact that the effectiveness of irradiation treatment is dependent 
on the dose that is absorbed by the commodity. One commenter considered 
this statement misleading, noting that it suggests that the radiation 
is absorbed by the commodity thereby killing the insect. The commenter 
added that the doses are specific to the pest rather than commodity 
because the commodity provides limited shielding for the insect from 
the ionizing radiation.
    We agree with this commenter, but because this statement appeared 
in the supplementary information of the proposed rule, there is no need 
to make any changes to the regulations in this document.
    In the proposed rule, we referred to minimum doses as ``pest-
specific.'' One commenter suggested that we use either ``pest species-
specific'' or ``individual pest-specific.''
    We are not making changes in response to this comment. We prefer 
the general term ``pest-specific'' which can apply to both individual 
pests or a pest group (e.g., all fruit flies).
    In the proposed rule, we stated that fruit quality problems 
associated with high irradiation doses prompted us to examine lowering 
doses. One commenter noted that we made no mention of any financial 
considerations taken into account.
    While economic benefits result from our lowering of irradiation 
doses, they are not the reason for our doing so. Under WTO agreements, 
we are obliged to base our regulations on sound science; to ignore 
research that showed lower irradiation doses to be effective would be 
contrary to these agreements.
    One commenter stated that the proposed rule would open up large 
parts of the United States to increased risks of infestation. The 
commenter stated that our reasoning that fruit flies would not survive 
irradiation treatment or weather conditions in many areas of the United 
States was faulty. The commenter added that while the rule only applies 
to 12 species of fruit flies, there are numerous hosts in the United 
States that would be susceptible to those fruit flies.
    We agree that preventing the introduction of exotic fruit flies 
into the United States is of the utmost importance. According to ARS, 
150 Gy will be sufficient to neutralize all fruit flies and that doses 
lower than 150 gray are sufficient to neutralize certain species of 
fruit flies. We believe that treatment of fruits, vegetables, cut 
flowers, and foliage at these doses, when properly administered, will 
be sufficient to prevent the introduction of fruit flies via 
commodities treated by irradiation.

Economic Analysis

    One commenter suggested that our economic analysis should take note 
of some advantages to irradiation, such as the fact that fruit that is 
to be irradiated can be allowed to ripen longer on the tree, resulting 
in higher-quality fruit.
    We have added a paragraph highlighting additional advantages of 
irradiation over some other treatments to the economic analysis in this 
final rule.
    One commenter stated that it is naive to assume that there are 
markets for irradiated fruits and vegetables in the United States. The 
commenter noted that since the FDA legalized the irradiation of fruits 
and vegetables in 1986, very few types of irradiated produce have been 
sold in U.S. grocery stores. The commenter also cited the financial 
troubles of a company that stood to benefit from irradiation as an 
example of the lack of a market for irradiated fruit in the United 
States.
    The proposed rule and this final rule are concerned with the 
phytosanitary security of fruits and vegetables and not their 
marketing. Our regulations offer various treatment options; whether or

[[Page 4455]]

not producers or distributors choose to use irradiation when it is 
available is up to them.

Miscellaneous

    Two commenters pointed out several nonsubstantive editorial errors 
in the proposed rule. We appreciate the commenters bringing these 
errors to our attention and wherever appropriate, have made the 
corrections in this document.

Other Comments

    One commenter suggested that in light of the availability of the 
generic irradiation dose, we reconsider our current pest risk analysis 
process and require evidence only that the few target pests that could 
not be treated effectively with irradiation are not present in a 
particular country or are not pests of concern for a particular 
commodity, rather than requiring that a list all possible pests be 
considered in the pest risk analysis.
    We agree with this commenter that the availability of the generic 
irradiation dose may simplify the pest risk analysis process for 
commodities from countries where pests that can be targeted with the 
generic dose exist. We expect that a pest list would still have to 
assembled in most cases, but the risk management aspect of the risk 
analysis process could be abbreviated if the risks associated with all 
identified quarantine pests could be addressed through the application 
of the generic irradiation dose. If quarantine pests that could not be 
addressed using the generic dose were identified in the pest list, then 
the risk management analysis could be limited to examining mitigation 
measures for those pests alone.
    The commenter also requested that we reconsider the requirement 
that every new commodity must be added to the regulations through 
rulemaking before being eligible for entry into the United States.
    While we are unable to make any changes in this document in 
response to this comment, we are currently developing a proposed rule 
that would redesign the fruits and vegetables regulations to provide 
for the evaluation and approval or denial of new import requests in a 
more expeditious and effective manner.
    One commenter asked that we postpone the comment period for the 
proposed rule because a request submitted by her organization under the 
Freedom of Information Act (FOIA) regarding another rulemaking related 
to irradiation had not yet been fulfilled.
    We do not believe it is necessary or appropriate to delay this 
final rule pending the resolution of commenter's FOIA request 
concerning an entirely separate rulemaking. The APHIS FOIA staff is 
working to address the request referred to by the commenter.
    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.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. For this 
action, the Office of Management and Budget has waived its review under 
Executive Order 12866.
    This rule makes several amendments to the current provisions for 
the use of irradiation as a treatment for various plant pests, allows 
the use of irradiation and inspection as a treatment for bananas moved 
interstate from Hawaii as an alternative to the systems approach 
currently described in the regulations, and allows the use of a vapor 
heat treatment for sweetpotatoes moved interstate from Hawaii as an 
alternative to fumigation with methyl bromide and irradiation. The 
potential economic impacts of the changes are discussed below.

Irradiation Treatment for Fruits, Vegetables, Cut Flowers, and Foliage

    The regulations in Sec.  305.31 set out standards, minimum doses, 
and other requirements for performing irradiation treatments on 
imported fruits, vegetables, cut flowers, and foliage and set out 
minimum doses necessary to neutralize 11 fruit flies and the mango seed 
weevil. This rule adds minimum doses for more pests and lowers the 
minimum doses for others. Specifically, this rule establishes:
     A minimum generic dose of 400 Gy for all plant pests of 
the class Insecta other than pupae and adults of the order Lepidoptera;
     A minimum generic dose of 150 Gy for all fruit flies of 
the family Tephritidae;
     Lower minimum doses for certain fruit flies; and
     New approved minimum doses for 10 plant pests.
    This rule also allows irradiation to serve as an alternative to 
other approved treatments for additional articles moved interstate from 
Hawaii, Puerto Rico, and the U.S. Virgin Islands. Articles from Hawaii, 
Puerto Rico, and the U.S. Virgin Islands that are required to be 
treated by other means for pests listed in Sec.  305.31(a) prior to 
interstate movement will be allowed to be moved interstate if they are 
treated with irradiation at the doses listed in Sec.  305.31(a) and in 
accordance with the other conditions specified in Sec.  305.34.
    Section 305.34 has only provided for irradiation treatment of 
fruits and vegetables from Hawaii; however, we have determined that 
irradiation treatment can be used effectively for commodities from 
Puerto Rico and the U.S. Virgin Islands if the safeguards in Sec.  
305.34 are implemented. Currently, no irradiation facilities exist in 
Puerto Rico or the U.S. Virgin Islands, and no requests have been 
received to approve the construction of such facilities. However, this 
rule provides for the option of moving the commodities under limited 
permit to an irradiation facility on the U.S. mainland for treatment 
prior to entering interstate commerce.

Economic Effects on Small Entities of Changes in Irradiation Treatment 
Provisions

    The Regulatory Flexibility Act requires that agencies specifically 
consider the economic impact of their regulations on small entities. 
The Small Business Administration (SBA) has established size criteria 
using the North American Industry Classification System (NAICS) to 
determine which economic entities meet the definition of a small firm.
    Irradiation facilities affected by this rule will belong to one of 
the following two NAICS categories: (1) Firms providing irradiation 
services for the treatment of fruits and vegetables, which would fall 
within NAICS category 115114, ``Postharvest Crop Activities (except 
Cotton Ginning)''; or (2) firms providing irradiation services for 
decontamination or sterilization purposes, which would fall within 
NAICS category 811219, ``Medical and surgical equipment repair and 
maintenance services.''
    Most treatments of Hawaiian produce are likely to occur at an 
existing irradiation facility on the island of Hawaii. This facility is 
used to treat other fruits and vegetables for which irradiation is an 
approved treatment and can be classified under NAICS category 115114. 
The SBA criteria classify this facility as a small entity, since its 
annual sales are less than $6 million.
    Another firm on the U.S. mainland operates two facilities in 
Illinois and one facility in New Jersey. Its primary service is to 
provide irradiation treatment for the sanitation of medical devices on 
contract. This firm is classified within NAICS category 811219. 
However, since it is part of a larger corporation for which annual 
receipts may exceed $6 million, this

[[Page 4456]]

firm is not classified as a small entity under the SBA criteria. Thus, 
at least one firm that could be affected by this rule is a small 
entity.
    Irradiation facilities, whether large or small, will benefit from 
this rule. The range of commodities imported and moved interstate for 
which irradiation will be an approved treatment will increase. At the 
same time, dosage levels, and therefore operating costs, will decrease 
for many commodities. The changes to irradiation doses and provisions 
allowing the use of pest-specific doses to treat commodities for 
interstate movement will facilitate the importation of fruits, 
vegetables, cut flowers, and foliage and their interstate movement from 
Hawaii, Puerto Rico, and the U.S. Virgin Islands. For certain pests for 
which irradiation is already an approved treatment, required 
irradiation dosages will be lowered to the minimum level necessary. In 
other instances, irradiation will be newly allowed as an alternative 
phytosanitary treatment.
    This rule will result in lower costs and increased flexibility for 
importers, gains that could be expected to be at least partly realized 
by U.S. consumers through lower prices, assuming competitive markets. 
For some commodities, irradiation may also provide quality advantages 
over other treatment methods in terms of increased shelf life. 
Irradiation allows fruits and vegetables of higher quality to be 
imported. Alternative heat, cold, and fumigation treatments can cause 
unacceptable damage to fruits, vegetables, cut flowers, and foliage. At 
this time, we are unsure as to the extent of damage the use of 
irradiation may cause to certain cut flowers and it is entirely the 
importer's or owner's responsibility to assess which treatment should 
be used with each variety of cut flowers. Also, these alternative 
treatments often must be used on fruit harvested before it is fully 
ripe. Irradiation allows importers to sell riper, more valuable fruit, 
with less damage. Choice of irradiation as a treatment alternative 
would rest upon its expected net returns relative to other treatment 
methods.
    Because these changes will have the potential to affect the 
importation or interstate movement of a wide range of commodities, it 
is difficult to predict exactly what economic effects these changes 
will have. However, while affected irradiation firms, large and small, 
are expected to benefit, we do not expect the impacts to be 
significant.

Irradiation and Inspection for Bananas Moved Interstate from Hawaii

    The regulations in Sec.  318.13-4i have provided that green bananas 
(Musa spp.) of the cultivars ``Williams,'' ``Valery,'' ``Grand Nain,'' 
and standard dwarf ``Brazilian'' may be moved interstate from Hawaii 
under a systems approach. At this time, only green bananas of these 
specified cultivars have been eligible for interstate movement under 
those provisions.
    We are adding two combinations of irradiation and inspection as 
treatments for bananas from Hawaii. Specifically, bananas, regardless 
of cultivar or ripeness, from Hawaii will be eligible for interstate 
movement if they have been inspected in Hawaii for adults and pupal 
stages of the banana moth Opogona sacchari (Bojen), and have undergone 
irradiation treatment with a minimum dose of 400 gray at an approved 
facility. Bananas from Hawaii will also be eligible for interstate 
movement if they have been inspected in Hawaii for the banana moth and 
the green scale, Coccus viridis (Green), and have undergone irradiation 
treatment with a minimum dose of 150 gray at an approved facility.

Cost of Irradiation Treatment

    The cost of irradiation is estimated at 15 cents per pound.\3\ We 
expect that most bananas moved interstate from Hawaii under this 
approach will be treated at the existing commercial irradiation 
facility on the island of Hawaii. However, the treatment could be 
performed at the irradiation facilities on the mainland United States 
as well.
---------------------------------------------------------------------------

    \3\ Source: Hawaii Department of Agriculture.
---------------------------------------------------------------------------

Cost of APHIS Inspection

    Monitoring of quarantine treatments conducted during standard 
business hours (weekdays between 8 a.m. and 4:30 p.m.) on the island of 
Hawaii comes at no cost to the facility. APHIS charges for the 
monitoring of treatments conducted before 8 a.m. and after 4:30 p.m. 
and on weekends at a time-and-a-half rate.

Benefits

    The combination of irradiation treatment and inspection will offer 
an alternative to the systems approach for green fruit of the specified 
four banana cultivars, and will allow fruit of any ripeness or cultivar 
to be moved interstate from Hawaii. The approach described in this rule 
can be used to mitigate the pest risk associated with all Hawaiian 
bananas, regardless of cultivar or ripeness. This will allow banana 
producers and parties moving bananas interstate greater flexibility in 
operations, more choices with regard to the types of bananas moved 
interstate, a greater volume of bananas to ship, and less risk of 
facing rejections during inspection under the systems approach and 
Banana Compliance Agreement.
    Growers have been reluctant to ship bananas to U.S. mainland 
markets under the systems approach because Sec.  318.13-4i(c) of the 
regulations has required that bananas to be moved interstate be 
inspected by an inspector and found free of the following defects: 
Prematurely ripe fingers, fused fingers, or exposed flesh (not 
including fresh cuts made during the packing process). Bananas moved 
interstate from Hawaii under this systems approach are required to be 
free of these defects because they are conducive to fruit fly 
infestation. However, growers are concerned about the risk of having 
whole shipments of fruit prohibited from interstate movement as a 
result of a single fault detected when bananas in a random selection of 
boxes are inspected. No commercial container shipments of bananas have 
been made to U.S. mainland markets under the regulations in effect 
prior to this rule. Since the irradiation treatment options provided by 
this rule are sufficient to neutralize fruit flies and other pests of 
concern, irradiation will provide the Hawaiian banana industry with an 
alternative treatment for interstate movement and could open new 
marketing opportunities.
    U.S. consumers will benefit from an increased supply of bananas. 
Growers in Hawaii believe that the U.S. mainland demand for bananas 
from Hawaii may be equivalent to (if not higher than) the existing 
demand for Hawaiian papaya. Hawaiian growers moved approximately 12 
million pounds of papayas to U.S. mainland markets in 2003.\4\ Demand 
may be especially high for the apple banana variety, which has a higher 
sugar content and more aromatic flavor than the standard commercial 
banana varieties currently available in U.S. mainland markets. 
Consumers will benefit from the availability of this specialty product.
---------------------------------------------------------------------------

    \4\ Source: Hawaii Department of Agriculture.
---------------------------------------------------------------------------

    Hawaii accounts for almost all U.S. banana production.\5\ In 2002, 
there were 677 banana farms in Hawaii,\6\ and the value of sales 
amounted to $ 8.6

[[Page 4457]]

million.\7\ Table 1 summarizes production information for bananas and 
papayas in Hawaii. The utilized production of bananas amounted to 19.5 
million pounds in 2002.
---------------------------------------------------------------------------

    \5\ The Census of Agriculture (2002) reports minimal acreage in 
California, Florida, and Texas, which together account for only 131 
acres.
    \6\ National Agricultural Statistics Service, 2002 Census of 
Agriculture.
    \7\ From https://www.nass.usda.gov/hi/fruit/annban.htm. Sales of 
Hawaiian bananas in 2003 were valued at $9.225 million.

Table 1.--Production Statistics for Bananas and Papayas in Hawaii (2002)
------------------------------------------------------------------------
              Item                      Bananas             Papayas
------------------------------------------------------------------------
Bearing acreage (acres).........  1,300.............  1,720.
Utilized production (1,000        19,500............  45,900.
 pounds).
Price (per pound)...............  $0.430............  $0.260.
Value of utilized production....  $8.385 million....  $11.924 million.
Movement to mainland U.S.         None..............  12,000.
 markets (1,000 pounds).
------------------------------------------------------------------------
Sources: Hawaii Department of Agriculture (movement statistics) and
  National Agricultural Statistics Service.

    The United States imported 7,883 million pounds (3,576 million kg) 
of fresh bananas in 2003, valued at $959 million.\8\ Ecuador, Costa 
Rica, Guatemala, Colombia, and Honduras accounted for 97 percent of the 
quantity of imports (table 2). Compared to the 7,883 million pounds of 
bananas currently imported, Hawaii's total production of 20 million 
pounds is extremely small, and it is not likely that 100 percent of the 
State's production will be moved to the mainland United States. Thus, 
as long as phytosanitary mitigation by means of the approved treatments 
is maintained, the interstate movement of bananas from Hawaii is 
unlikely to significantly affect current U.S. trade in fresh bananas.
---------------------------------------------------------------------------

    \8\ World Trade Atlas, 2003.

 Table 2.--Quantity and Value of Fresh Bananas Imported Into the United
          States From the Five Major Exporting Countries (2003)
------------------------------------------------------------------------
                                                                Value
                                                  Quantity     (million
                    Country                       (million       U.S.
                                                    kg)        dollars)
------------------------------------------------------------------------
Ecuador.......................................          902        237.8
Costa Rica....................................          901        247.5
Guatemala.....................................          868        229.1
Colombia......................................          429        117.7
Honduras......................................          388        100.4
                                               --------------
    Total imports.............................        3,576       959.3
------------------------------------------------------------------------
Source: World Trade Atlas (2003).

Economic Effects on Small Entities of Irradiation and Inspection 
Provisions for Bananas

    Most treatments of Hawaiian bananas are likely to occur at the 
existing irradiation facility on the island of Hawaii, which, as noted 
previously, is considered a small entity.
    Banana farming is classified under NAICS category 111339 as ``Other 
Noncitrus Fruit Farming.'' The SBA considers entities in this category 
to be small if their average annual receipts are less than $750,000. 
The 677 banana farms in Hawaii accounted for annual sales of $8.6 
million in total in 2002. Therefore, it is likely that most Hawaiian 
banana farms will be classified as small entities under the SBA 
criteria. The treatment monitoring program will be mainly operated by 
APHIS personnel, and no impact is anticipated on other small entities 
or government agencies.

Vapor Heat Treatment for Sweetpotatoes Moved Interstate From Hawaii

    We are allowing vapor heat treatment, combined with tuber cutting 
and visual inspection, to be used as a treatment for sweetpotatoes 
moved interstate from Hawaii. We believe this treatment will be an 
effective alternative to the methyl bromide and irradiation treatments 
currently prescribed by the regulations to control pests of concern.

Cost of Vapor Heat Treatment

    Hawaii has three packing plants on the Island of Hawaii that 
provide vapor heat treatment services. No other vapor heat treatment 
plants are currently in operation elsewhere in the State. Since APHIS 
has yet to certify a facility for the treatment of sweetpotato by vapor 
heat, the costs of treating this crop specifically cannot be determined 
with certainty at this time. However, one of the packinghouses 
estimated that vapor heat treatment costs could amount to 2 to 3 cents 
per pound for the required treatment protocol. This estimate considered 
the costs of labor, electricity, water, and sewer service. APHIS has 
traditionally certified vapor heat treatment chambers (for example, for 
papaya) in the ``fully loaded configuration.'' The costs of treating 
sweetpotato in smaller batch loads still have to be determined. This 
estimate of treatment cost also does not include a markup for the 
facility. The markup will be determined by the number of plants 
providing service and the demand for service.

Cost of APHIS Inspection for Vapor Heat Treatment or Irradiation

    Monitoring of quarantine treatments conducted during standard 
business hours (weekdays between 8 a.m. and 4:30 p.m.) on the island of 
Hawaii comes at no cost to the facility. APHIS charges for the 
monitoring of treatments conducted before 8 a.m. and after 4:30 p.m. 
and on weekends at a time-and-a-half rate.

Comparison of Vapor Heat Treatment, Irradiation, and Methyl Bromide

    Vapor heat treatment will provide the Hawaiian sweetpotato industry 
with an alternative treatment to irradiation or methyl bromide 
fumigation. If vapor heat treatment can be performed at 2 to 3 cents 
per pound, it will constitute the most cost-effective treatment, 
compared to irradiation at 15 cents per pound and fumigation costs 
ranging from 40.6 cents per pound for 1 pallet to 6.7 cents per pound 
for 12 pallets (table 3). (These are treatment costs only and do not 
include the costs of APHIS monitoring or inspection activities or 
inter-island transportation costs necessary to perform treatments.)

 Table 3.--Estimated Per-Unit Cost of Vapor Heat Treatment, Irradiation,
                      and Methyl Bromide Fumigation
------------------------------------------------------------------------
                                                               Per unit
                                                                 cost
                          Treatment                           (cents per
                                                                pound)
------------------------------------------------------------------------
Vapor heat treatment........................................       2-3
Irradiation.................................................        15
-------------------------------------------------------------

[[Page 4458]]

 
Methyl bromide fumigation: \1\
  One pallet................................................        40.6
  Two pallets...............................................        20.3
  Three pallets.............................................        13.5
  Four pallets..............................................        10.1
  Five pallets..............................................         8.1
  Six pallets...............................................         6.7
  Nine pallets..............................................         7.6
  Twelve pallets............................................         6.9 
------------------------------------------------------------------------
\1\ One pallet contains 1,500 pounds of sweetpotatoes.
Sources: Packinghouse estimate (vapor heat treatment); Hawaii Department
  of Agriculture (irradiation and methyl bromide fumigation).

    The availability of vapor heat treatment thus provides the Hawaiian 
sweetpotato industry with an alternative treatment option at a 
competitive cost. Furthermore, the vapor heat treatment plants in 
Hawaii will benefit if sweetpotatoes are included in the list of 
agricultural products to be treated. The availability of vapor heat 
treatment as an alternative to fumigation might become increasingly 
important in view of the global phaseout of methyl bromide under the 
Montreal Protocol. Irradiation may have positive effects on the quality 
and shelf life of the tubers, and allows flexibility since both small 
and large product lots can be staged for treatment to meet specific 
market demands. Vapor heat treatment is not known to offer quality or 
shelf-life benefits to the product, but some consumers may prefer this 
option above irradiation, especially in Japan, Canada, and Europe.

Impact on U.S. Sweetpotato Production

    Commercial sweetpotato production in Hawaii occurs on the islands 
of Hawaii, Kauai, Maui, and Oahu. In 2002, there were 59 sweetpotato 
farms,\9\ and the value of sales was $989,000.\10\ The utilized 
production of sweetpotatoes in Hawaii was 1.8 million pounds in 2001 
(table 4). The crop is in year-round production in Hawaii.
---------------------------------------------------------------------------

    \9\ National Agricultural Statistics Service, 2002 Census of 
Agriculture.
    \10\ From https://www.nass.usda.gov/hi/vegetble/annveg.htm.

    Table 4.--Production Statistics for Hawaiian Sweetpotatoes (2001)
------------------------------------------------------------------------
                            Item                                Amount
------------------------------------------------------------------------
Harvested acres............................................        220
Yield per acre (1,000 pounds)..............................          8.2
Production (1,000 pounds)..................................      1,800
Farm price (cents per pound) \1\...........................        50
------------------------------------------------------------------------
\1\ The 2001 farm price for sweetpotato was 47.3 cents per pound in
  Hawaii, Honolulu, and the Kauai Counties, and 60 cents per pound in
  the Maui County (Hawaiian Department of Agriculture).
Source: Hawaii Agricultural Statistics Service.

    In the mainland United States, sweetpotato is grown commercially in 
Alabama, California, Georgia, Louisiana, Mississippi, New Jersey, North 
Carolina, South Carolina, Texas, and Virginia. North Carolina, 
Louisiana, Mississippi, and California account for the major proportion 
of production area by State (table 5). In total, the United States 
produced 1,355 million pounds of sweetpotatoes from 93,500 acres in 
2003 (table 6). The Hawaiian sweetpotato production of 1.8 million 
pounds thus comprises a minor proportion of the total production of 
1,355 million pounds in the United States.

  Table 5.--Acres of Sweetpotatoes Planted in the United States (2003)
------------------------------------------------------------------------
                                                                Acres
                           State                               planted
------------------------------------------------------------------------
North Carolina.............................................       42,000
Louisiana..................................................       18,000
Mississippi................................................       14,000
California.................................................       10,100
Texas......................................................        3,400
Alabama....................................................        2,900
Others \1\.................................................        3,100
                                                            ------------
    Total..................................................      93,500
------------------------------------------------------------------------
\1\ Including Hawaii.
Source: Economic Research Service, USDA.


Table 6.--Production and Utilization Statistics for Sweetpotatoes in the
                        United States (2003) \1\
------------------------------------------------------------------------
                           Item                                Amount
------------------------------------------------------------------------
Acres planted.............................................     93,500
Three-year average yield (cwt/acre).......................        150
Production (million pounds)...............................      1,355
Imports (million pounds)..................................         17.0
Exports (million pounds)..................................         53.0
Total utilization (million pounds) \2\....................      1,148.3
Per capita use (pounds)...................................          3.9
Three-year average per capita use (pounds)................          4.0
Current dollars ($/cwt)...................................         15.75
Constant 1996 dollars ($/cwt).............................         13.91 
------------------------------------------------------------------------
\1\ Estimates are for the total United States, and therefore include
  Hawaii. Forecasted estimates are shown.
\2\ Total utilization includes 103 million pounds used for seed and 67.8
  million pounds accruing to feed use, shrink, and loss.
Source: Economic Research Service, United States Department of
  Agriculture. Acres were obtained from Lucier, G. ``Sweet potatoes--
  getting to the root of demand.'' Economic Research Service, USDA,
  2002.

    The Hawaiian sweetpotatoes intended for the U.S. mainland markets 
are of a special purple flesh variety, and they are therefore shipped 
to the mainland as a specialty product intended for niche markets. U.S. 
mainland consumers could, therefore, benefit from an increased supply 
of these specialty sweetpotatoes.
    Interstate movement provides Hawaiian growers and shippers with 
increased marketing opportunities. Sweetpotatoes are in year-round 
production in Hawaii, but some seasonal variation in volume is 
expected. Out-shipment to U.S. mainland markets is estimated at 50,000 
to 60,000 pounds per week. New plantings of the crop have increased on 
the island of Hawaii since irradiation was approved as an alternative 
to methyl bromide fumigation in June 2003. However, plantings are 
likely to increase each year if the market demand increases for 
Hawaiian sweetpotatoes regardless of whether the product is treated by 
methyl bromide fumigation, irradiation, or vapor heat treatment. 
Nevertheless, even if sweetpotato production increases in Hawaii, the 
relative volume of production (1.8 million pounds) remains extremely 
small in comparison to the volume of U.S. mainland sweetpotato 
production (1.36 billion pounds).
    Thus, since Hawaiian production is so small in comparison to U.S. 
mainland production, and as long as phytosanitary mitigation by the 
approved treatments is maintained, sweetpotato shipments from Hawaii 
are unlikely to affect mainland producers. Consumers will benefit from 
the availability of the purple-fleshed specialty sweetpotato product, 
and the Hawaiian sweetpotato industry will gain opportunities to expand 
its mainland U.S. markets.

[[Page 4459]]

Vapor Heat Treatment of Sweetpotatoes Moved Interstate From Hawaii

    The availability of vapor heat treatment at a competitive cost 
could divert some sweetpotatoes moved interstate from Hawaii from the 
existing irradiation facility in Hawaii to a vapor heat treatment 
facility. This will affect the existing irradiation facility in Hawaii, 
which is a small entity. However, it is not known at this time what 
proportion of Hawaiian sweetpotatoes moved interstate will be treated 
with vapor heat instead of irradiation.
    On the other hand, vapor heat treatment facilities could benefit by 
the addition of vapor heat as an approved treatment for sweetpotatoes 
moved interstate from Hawaii. However, since facilities for the vapor 
heat treatment of Hawaiian sweetpotatoes have not been certified yet, 
the businesses cannot be conclusively categorized into small or large 
entities at this time.
    Sweetpotato farming is classified under NAICS category 111219, 
``Other Vegetables (except Potato) and Melon Farming.'' According to 
the SBA's criteria, an entity involved in crop production is considered 
small if it has average annual receipts of less than $750,000. The 59 
sweetpotato farms in Hawaii accounted for annual sales of $989,000 in 
total in 2002. Therefore, it is likely that most of these farms would 
be considered small entities according to the SBA criteria. The 
monitoring and inspection program will be mainly operated by APHIS 
personnel, and no impact is anticipated on other small entities and 
government agencies.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

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 0579-0281.

Government Paperwork Elimination Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the Government Paperwork Elimination Act (GPEA), which 
requires Government agencies in general to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. For information pertinent to GPEA 
compliance related to this rule, please contact Mrs. Celeste Sickles, 
APHIS' Information Collection Coordinator, at (301) 734-7477.

List of Subjects

7 CFR Part 301

    Agricultural commodities, Plant diseases and pests, Quarantine, 
Reporting and recordkeeping requirements, Transportation.

7 CFR Part 305

    Irradiation, Phytosanitary treatment, Plant diseases and pests, 
Quarantine, Reporting and recordkeeping requirements.

7 CFR Part 318

    Cotton, Cottonseeds, Fruits, Guam, Hawaii, Plant diseases and 
pests, Puerto Rico, Quarantine, Transportation, Vegetables, Virgin 
Islands.

7 CFR Part 319

    Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant 
diseases and pests, Quarantine, Reporting and recordkeeping 
requirements, Rice, Vegetables.


0
Accordingly, we are amending 7 CFR parts 301, 305, 318, and 319 as 
follows:

PART 301--DOMESTIC QUARANTINE NOTICES

0
1. The authority citation for part 301 continues to read as follows:

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80, 
and 371.3.
    Section 301.75-15 also issued under Sec. 204, Title II, Pub. L. 
106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 also 
issued under Sec. 203, Title II, Pub. L. 106-224, 114 Stat. 400 (7 
U.S.C. 1421 note).


0
2. In Sec.  301.64-10, paragraph (g) introductory