True Potato Seed From Chile

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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