[Federal Register Volume 60, Number 32 (Thursday, February 16, 1995)]
[Rules and Regulations]
[Pages 8921-8924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3843]



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Rules and Regulations
                                                Federal Register
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Federal Register / Vol. 60, No. 32 / Thursday, February 16, 1995 / 
Rules and Regulations
[[Page 8921]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. 94-042-2]


True Potato Seed From Chile

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are allowing, under certain conditions, the importation of 
true potato seed from Chile. The true potato seed imported from Chile 
under this rule will originate from certified virus-free plantlets from 
the United States, be produced under the supervision of Chilean plant 
protection authorities, and be tested for seedborne viruses prior to 
being offered for entry into the United States. Allowing the 
importation of true potato seed from Chile will give potato producers 
in the United States another means of producing disease-free tubers.

EFFECTIVE DATE: March 20, 1995.

FOR FURTHER INFORMATION CONTACT: Mr. Peter M. Grosser or Mr. Frank E. 
Cooper, Senior Operations Officers, Port Operations, Plant Protection 
and Quarantine, APHIS, USDA, P.O. Drawer 810, Riverdale, MD 20738. The 
telephone number for the agency contact will change when agency offices 
in Hyattsville, MD, move to Riverdale, MD, during February. Telephone: 
(301) 436-6799 (Hyattsville); (301) 734-6799 (Riverdale).

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 7 CFR part 319 prohibit or restrict the 
importation into the United States of certain plants and plant products 
to prevent the introduction of plant pests. The regulations contained 
in ``Subpart--Nursery Stock, Plants, Roots, Bulbs, Seeds, and Other 
Plant Products,'' Secs. 319.37 through 319.37-14 (referred to below as 
the regulations), restrict, among other things, the importation of 
living plants, plant parts, and seeds for propagation.
    One of the articles restricted in the regulations is Solanum 
species (spp.) true seed, also known as true potato seed. ``Solanum 
spp. true seed'' is defined in Sec. 319.37-1 as ``seed produced by 
flowers of Solanum capable of germinating and producing new Solanum 
plants, as distinguished from Solanum tubers, whole or cut, that are 
referred to as Solanum seeds or seed potatoes.''
    On September 9, 1994, we published in the Federal Register (59 FR 
46572-46574, Docket No. 94-042-1) a proposed rule to allow, under 
certain conditions, the importation of true potato seed from Chile. We 
proposed that the true potato seed imported from Chile would have to 
originate from certified virus-free plantlets from the United States, 
be produced in the country's Tenth (X) Region under the supervision of 
Chilean plant protection authorities, and be tested for seedborne 
viruses prior to being offered for entry into the United States.
    We solicited comments concerning our proposal for a 30-day comment 
period ending October 11, 1994. We received 31 comments by that date, 
from State universities and university extension services; plant 
researchers and geneticists; potato breeders, growers, and marketers; 
State agriculture departments; seed companies; an agronomist; a member 
of the U.S. House of Representatives; and the Chilean government trade 
bureau. Twenty one of the commenters supported the proposed rule as 
written, 8 commenters supported the proposed rule but suggested 
changes, and 2 commenters were opposed to the proposed rule. The 
suggested changes and the comments of those opposed to the proposal are 
discussed below.
    Comment: Although the disease is already present in the United 
States, the regulations should include safeguards to prevent the 
introduction of potato spindle tuber viroid (PSTV), which is 
transmitted by true potato seed.
    Response: As discussed in the proposed rule, the plants that would 
produce the true potato seed would originate from plantlets from the 
United States that have been tested for viruses (including PSTV) and 
certified virus-free. Additionally, PSTV is not known to exist in the X 
Region, and, because the X Region is a quarantined area for potatoes, 
the entry of potato seeds, true seed, plants, and tubers is restricted 
in order to prevent the introduction of PSTV and other potato pests or 
diseases. Therefore, we believe that it is unlikely that the true 
potato seed would introduce PSTV into the United States and have made 
no changes in this final rule as a result of that comment.
    Comment: The growing season inspection discussed in the proposed 
rule should be conducted within six weeks of harvest to maximize the 
ability to detect infected plant material. Surveys conducted earlier in 
the growing season might not detect infected plants.
    Response: Diseases with visible symptoms would likely be more 
easily recognized later in the growing season, but the viruses for 
which the plants, tubers, and true potato seed will be tested may be 
asymptomatic in potatoes. The testing protocol presented by Chile's 
ministry of agriculture, the Servicio Agricola y Ganadero (SAG), and 
accepted by the Animal and Plant Health Inspection Service (APHIS) 
calls for plant samples to be collected for testing between 30 days 
after planting up to the flowering phase. APHIS agrees with that time 
frame because we believe that the most accurate testing results would 
be obtained from samples gathered during the active phase of the 
plants' growth. We have, therefore, made no changes in this final rule 
as a result of that comment.
    Comment: Our literature indicates that potato smut occurs in parts 
of Chile. If that disease is present in the X Region, it could be 
carried with the true potato seed as a contaminant.
    Response: Potato smut is not reported to occur in the X Region and, 
as mentioned above, there are quarantine measures in place to prevent 
its introduction into the region. Because we believe that it is 
unlikely that potato smut would be carried into the United States as a 
contaminant on the true potato seed from Chile, we have made no changes 
in this final rule based on that comment. [[Page 8922]] 
    Comment: For the sake of clarity, APHIS should specify ``Solanum 
tuberosum,'' rather than the more general ``Solanum spp.,'' when 
referring to the potato species from which the true potato seed may be 
derived.
    Response: We agree that using ``Solanum tuberosum'' instead of the 
more general ``Solanum spp.'' would be clearer. We have, therefore, 
changed the regulatory text of this final rule to refer to the potato 
species from which the true potato seed may be derived as ``Solanum 
tuberosum.''
    Comment: Specifically requiring that the nitro-cellulose membrane 
(NCM) enzyme-linked immunosorbent assay (ELISA) be used to test for the 
viruses of concern leaves no room for the use of other tests that are 
also recommended by the International Potato Center. Other ELISA tests, 
as well as the nucleic acid spot hybridization (NASH) non-reagent test, 
should be allowed.
    Response: In the testing protocol presented by SAG and accepted by 
APHIS, the NCM ELISA test was specified as the method that would be 
used to test for the viruses of concern. We recognize, however, that 
the other tests recommended by the International Potato Center are 
equally accurate and could be used to test for the viruses of concern 
without compromising the integrity of the testing program in any way. 
Therefore, we have changed the regulatory text of this final rule to 
allow the use of other ELISA tests and the NASH non-reagent test for 
the purposes of testing the tubers, plants, and true potato seed for 
the viruses of concern.
    Comment: With regard to the sample sizes specified in proposed 
paragraph Sec. 319.37-5(h)(iii), the sampling rate should be 500 tubers 
and 500 plantlets per hectare (2.5 acres) rather than per 30 acres in 
order to detect 1 percent contamination with a 99 percent confidence 
level. The sampling level for the true potato seed should be made 
according to International Potato Center's guidelines for laboratory 
tests.
    Response: The 500/500/500 sampling rate discussed in the proposed 
rule for the testing of plants, tubers, and true potato seed actually 
should, as pointed out by the commenter, be 500/500/500 per hectare, 
and not per 30-acre field as stated in the proposed rule. We have 
changed the regulatory text in this final rule to correct that error. 
With regard to the sampling to the true potato seed, the testing 
protocol presented by SAG and accepted by APHIS dictated that the true 
potato seed would be sampled at the same rate as the plants and tubers 
in order to detect 1 percent contamination with a 99 percent confidence 
level. It is the contamination level/confidence level equation that is 
of the greatest importance to APHIS; if SAG would prefer to establish a 
different sampling procedure for true potato seed that could detect the 
same level of contamination with the same level of confidence, APHIS is 
willing to review the new sampling procedure and, if warranted, publish 
a proposal in the Federal Register to add the procedure to the 
regulations.
    Comment: APHIS should recognize Chile's VIII and IX regions as also 
being free from the four viruses of concern and allow the importation 
of true potato seed from those regions as well. Once such recognition 
has been established, APHIS should allow the use of parental material 
from those regions to produce the true potato seed and eliminate the 
requirement for the pre-export inspection and testing of true potato 
seed from the VIII, IX, and X regions of Chile.
    Response: APHIS is open to working with SAG to expand the range of 
areas in Chile from which true potato seed may be imported into the 
United States; similarly, we are open to relaxing or eliminating 
inspection or testing requirements as circumstances warrant. However, 
we must first be able to establish that such actions would not result 
in an increased risk of plant pest introduction or dissemination in the 
United States. Once adequate protocols had been established and agreed 
upon, we could publish a proposal in the Federal Register to add any 
new areas or inspection requirements to the regulations. We cannot, 
however, make any such changes in this final rule.
    Comment: The proposed requirement to test at three levels 
(plantlet, tuber, and true potato seed) for Andean Potato Latent Virus 
(APLV), Arracacha Virus B (AVB), and the Andean Potato Calico Strain of 
Tobacco Ringspot Virus (TRV-Ca) is unnecessarily stringent because 
there is no evidence to confirm that any of the three viruses can be 
transmitted by true potato seed under natural conditions. Additionally, 
the International Potato Center has analyzed true potato seed from the 
Peruvian Andean area--where AVB and TRV-Ca have been found to exist--
and from the Center's own germplasm stock for a continued term of 8 
years and has never found any of the three viruses in the true potato 
seed tested.
    Response: The testing protocol presented by SAG and accepted by 
APHIS prescribed that plants, tubers, and true potato seed would all be 
tested for the viruses of concern. If alternative testing protocols are 
presented by SAG, and APHIS determines that they would not result in an 
increased risk of plant pest introduction or dissemination in the 
United States, we could publish a proposal in the Federal Register to 
relax or replace the requirement to test all three levels (plants, 
tubers, and true potato seed) for all viruses of concern.
    Comment: The proposed criteria of sampling to detect 1 percent 
contamination at a 99 percent confidence level is not adequate for 
quarantine purposes. Zero tolerance is the desired goal of quarantine, 
and anything less creates an unacceptable level of risk that is not in 
the best interest of the potato industry. Under ideal conditions, most 
quarantines only delay the spread of regulated pests. The potato 
industry does not need to face the threat of diseases not currently in 
the United States.
    Response: If ``zero tolerance'' for pest risk was the standard 
applied to international trade in agricultural commodities, it is quite 
likely that no country would ever be able to export a commodity to any 
other country. There will always be some degree of pest risk associated 
with the movement of agricultural products; APHIS' goal is to reduce 
that risk to an insignificant level. In the case of true potato seed 
from Chile, we believe factors such as the low incidence of disease 
transmission by seeds and the absence of potato viruses in the seed 
production area, as well as the origin, certification, and testing 
requirements contained in this final rule, reduce the pest risk 
associated with its importation to an acceptable level.
    Comment: The proposed rule contains a requirement for SAG to 
provide certain phytosanitary certifications. Before further 
consideration is given to the proposal, a formal review of the SAG's 
phytosanitary certification program should be conducted by U.S. 
officials to determine whether SAG can in fact provide reliable and 
credible certification.
    Response: APHIS has a longstanding working relationship with SAG, 
and we are fully confident in their ability to provide reliable and 
credible phytosanitary certification for Chile's agriculture products, 
including true potato seed.
    Comment: Potato producers in the United States do not need another 
means of producing disease-free tubers, especially if that means would 
not provide a genetically pure potato variety. True potato seed is 
already produced in the United States and is available to domestic 
potato research personnel and the seed potato industry. If there is a 
need for additional true potato seed, it could be produced in the 
United States. [[Page 8923]] 
    Response: Whether the domestic potato industry will buy and use the 
true potato seed imported from Chile will be the decision of the 
domestic potato industry. APHIS is concerned with plant pest risk; 
marketing risks would be the concern of the true potato seed's 
producers, exporters, and importers.
    Comment: The economic well-being of pre-nuclear seed potato 
producers and their associated industries may be jeopardized by 
allowing cheaper foreign material to enter the market.
    Response: As discussed in the Regulatory Flexibility analysis in 
the proposed rule and in this final rule, we expect that it will take 
several years before true potato seed imported into the United States 
from Chile and its products will be in a position to capture any 
significant market share. Thus, its potential impact on price and 
competition in the potato seed market remains uncertain. If consumer 
response is favorable and true potato seed imported from Chile becomes 
competitive with the seed potatoes currently available in the United 
States, the price of seed potatoes may be driven down. However, because 
U.S. seed potato prices are influenced more by domestic production and 
market conditions than by imports, it is likely that any economic 
impact on domestic seed potato producers will be small.

Addition of New Virus

    In addition to the comments discussed above, a representative of 
the Food Production and Inspection Branch of Agriculture and Agri-Food 
Canada informed APHIS of recent research that indicated the presence of 
Potato Yellowing Virus (PYV) in Chile. Because PYV can be transmitted 
through true potato seed, SAG informed APHIS that it will include PYV 
testing in its pre-export virus testing. Therefore, we have added PYV 
as a virus of concern in the listings for Solanum spp. and Solanum spp. 
true seed in Sec. 319.37-2(a), and we have added PYV to the list in 
Sec. 319.37-5(o)(3) of viruses for which the samples of Solanum 
tuberosum tubers, plants, and true seed must be tested.

Miscellaneous

    In addition to those changes discussed above, we have also made two 
nonsubstantive changes to the paragraph designations in Sec. 319.37-5. 
First, the regulatory text that we had proposed to add to the section 
as paragraph Sec. 319.37-5(h) are added in this final rule as paragraph 
Sec. 319.37-5(o). Second, the subordinate paragraphs in that same 
paragraph were incorrectly designated in the proposed rule as (i), 
(ii), and (iii); they are now correctly designated as (1), (2), and 
(3).
    Therefore, based on the rationale set forth in the proposed rule 
and in this document, we are adopting the provisions of the proposal as 
a final rule with the changes discussed above.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be not significant for the purposes of Executive 
Order 12866 and, therefore, has not been reviewed by the Office of 
Management and Budget.
    This rule will allow, under certain conditions, the importation of 
true potato seed from Chile. True potato seed imported from Chile under 
this rule will originate from certified virus-free plantlets from the 
United States, will be grown under the supervision of Chilean plant 
protection authorities, and a sample of the plants, tubers, and true 
potato seeds will be tested for seedborne viruses prior to the true 
potato seed being offered for entry into the United States. Allowing 
the importation of true potato seed from Chile will give potato 
producers in the United States another means of producing disease-free 
tubers.
    The United States produced approximately 2,880 million pounds of 
seed potatoes in 1992 (U.S. Department of Agriculture [USDA], Economic 
Research Service). During that same period, the United States imported 
approximately 128 million pounds of seed potatoes, which represents 
about 4.4 percent of U.S. production. Because imports represent such a 
small portion of the domestic seed potato supply, fluctuations in 
import levels and prices do not appear to have a significant effect on 
domestic seed potato prices.
    For example, U.S. imports of seed potatoes declined by more than a 
third between 1990 and 1992, dropping from 201 million pounds in 1990 
to 128 million pounds in 1992. This decline in imports did not, 
however, result in an increase in U.S. grower or retail prices for seed 
potatoes. In fact, the price of imported seed potatoes also fell by 
more than a third during that time, dropping from $11 per 100 pounds in 
1990 to $7 per 100 pounds in 1992 (USDA, ``Agricultural Statistics 
1992,'' Table 371, page 239). Based on the decline in both import 
levels and price during the same 2-year period, it appears that 
domestic seed potato prices are influenced more by the volume of U.S. 
production.
    The import levels and prices discussed above do not reflect any 
imports of true potato seed from anywhere in the world, nor is there 
any record of true potato seed being imported into the United States. 
Our records indicate that true potato seed is a product that has not 
been commercially available in the United States. We expect that it 
will take several years before true potato seed imported into the 
United States from Chile and its products will be in a position to 
capture any significant market share. Thus, its potential impact on 
price and competition in the potato seed market remains uncertain.
    We have identified domestic seed potato producers and seed potato 
importers as the entities potentially affected by this rule. According 
to the Small Business Administration's criteria, an agricultural 
producer with annual sales of less than $500,000 is considered to be a 
small entity; an importer is considered to be a small entity if it 
employs fewer than 100 people. According to the U.S. Department of 
Commerce's ``1987 Census of Agriculture,'' there were about 14,732 
farms that produced potatoes in the United States, and about 96 percent 
of those farms reported sales of less than $100,000. The exact 
percentage of those farms that produced only seed potatoes or a 
combination of seed potatoes and table potatoes is not known, but it is 
likely that the number is small, based on the total production of seed 
potatoes versus table potatoes (2,880 million pounds vs. 42,500 million 
pounds, respectively).
    Information regarding the total number of seed potato importers and 
the percentage of those importers that would be considered small 
entities was unavailable. It is unlikely, however, that allowing the 
importation of true potato seed from Chile will have a significant 
impact on seed potato import levels. The true potato seed imported from 
Chile may be used by potato producers in the United States to produce 
potatoes of a different variety than those potatoes currently grown in 
the United States; the economic impact of the imported true potato seed 
will thus be affected by consumer response to the new variety of 
potatoes. If consumer response is favorable and true potato seed 
imported from Chile becomes competitive with the seed potatoes 
currently available in the United States, the price of seed potatoes 
may be driven down. However, because U.S. seed potato prices are 
influenced more by domestic production and market conditions than by 
imports, it is likely that any economic impact on domestic seed potato 
producers will be small. Any slight negative impact will likely be 
offset by the positive impact on [[Page 8924]] domestic potato 
producers, who will benefit from lower seed potato prices, and 
consumers will benefit from any resulting lower prices.
    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 12778

    This rule has been reviewed under Executive Order 12778, Civil 
Justice Reform. This rule will allow true seed of Solanum spp. to be 
imported into the United States from Chile. State and local laws and 
regulations regarding true seed imported under this rule will be 
preempted while the true seed is in foreign commerce. Seeds are 
generally imported for immediate distribution and sale to the public, 
and remain in foreign commerce until sold to the ultimate consumer. The 
question of when foreign commerce ceases in other cases must be 
addressed on a case-by-case basis. This rule has no retroactive effect 
and does not require administrative proceedings before parties may file 
suit in court.

Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1980 (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), and there are no new requirements. The assigned OMB 
control number is 0579-0049.

List of Subjects in 7 CFR Part 319

    Bees, Coffee, Cotton, Fruits, Honey, Imports, Incorporation by 
reference, Nursery stock, Plant diseases and pests, Quarantine, 
Reporting and recordkeeping requirements, Rice, Vegetables.

    Accordingly, 7 CFR part 319 is amended as follows:

PART 319--FOREIGN QUARANTINE NOTICES

    1. The authority citation for part 319 continues to read as 
follows:

    Authority: 7 U.S.C. 150dd, 150ee, 150ff, 151-167, and 450; 21 
U.S.C. 136 and 136a; 7 CFR 2.17, 2.51, and 371.2(c).


Sec. 319.37-2  [Amended]

    2. In Sec. 319.37-2(a), in the table, the listing for Solanum spp. 
is amended in the third column by adding the words ``; Arracacha Virus 
B; Potato Yellowing Virus'' at the end of the entry, immediately before 
the period.
    3. In Sec. 319.37-2(a), in the table, the listing for Solanum spp. 
true seed is amended in the second column by removing the words 
``Canada and New Zealand'' and adding the words ``Canada, New Zealand, 
and the X Region of Chile (that area of Chile between 39 deg. and 
44 deg. South latitude--see Sec. 319.37-5(o))'' in their place, and in 
the third column by adding the words ``, Arracacha Virus B, Potato 
Yellowing Virus'' at the end of the entry, immediately before the 
period.
    4. In Sec. 319.37-3, paragraph (a)(3) is amended by removing the 
words ``true seed of Solanum spp. (tuber bearing species only--Section 
Tuberarium) from New Zealand;'', and a new paragraph (a)(17) is added 
to read as set forth below:


Sec. 319.37-3  Permits.

    (a) * * *
    (17) Solanum tuberosum true seed from New Zealand and the X Region 
of Chile (that area of Chile between 39 deg. and 44 deg. South 
latitude--see Sec. 319.37-5(o)).
* * * * *
    5. In Sec. 319.37-5, a new paragraph (o) is added to read as 
follows:


Sec. 319.37-5  Special foreign inspection and certification 
requirements.

* * * * *
    (o) Any Solanum tuberosum true seed imported from Chile shall, at 
the time of arrival at the port of first arrival in the United States, 
be accompanied by a phytosanitary certificate of inspection issued in 
Chile by the Servicio Agricola y Ganadero (SAG), containing additional 
declarations that:
    (1) The Solanum spp. true seed was produced by Solanum plants that 
were propagated from plantlets from the United States;
    (2) The Solanum plants that produced the Solanum tuberosum true 
seed were grown in the Tenth (X) Region of Chile (that area of the 
country between 39 deg. and 44 deg. South latitude); and
    (3) Solanum tuberosum tubers, plants, and true seed from each field 
in which the Solanum plants that produced the Solanum tuberosum true 
seed were grown have been sampled by SAG once per growing season at a 
rate to detect 1 percent contamination with a 99 percent confidence 
level (500 tubers/500 plants/500 true seeds per 1 hectare/2.5 acres), 
and that the samples have been analyzed by SAG using an enzyme-linked 
immunosorbent assay (ELISA) test or nucleic acid spot hybridization 
(NASH) non-reagent test, with negative results, for Andean Potato 
Latent Virus, Arracacha Virus B, Potato Virus T, the Andean Potato 
Calico Strain of Tobacco Ringspot Virus, and Potato Yellowing Virus.

(Approved by the Office of Management and Budget under control 
number 0579-0049)

    Done in Washington, DC, this 9th day of February 1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-3843 Filed 2-15-95; 8:45 am]
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