Source: http://www.thefederalregister.com/2007/02/27/07-892.html
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Federal Register | Phytophthora Ramorum; Quarantine and Regulations
[Docket No. 01-054-3]
RIN 0579-AB82
SUMMARY: We are amending thePhytophthora ramorumregulations to establish restrictions on the interstate movement of nursery stock from nurseries in nonquarantined areas in California, Oregon, and Washington. We are also amending the regulations to update conditions for the movement of regulated articles of nursery stock from quarantined areas, to add restrictions on the movement of decorative trees without roots from quarantined areas, as well as to restrict the interstate movement of all other nursery stock from nurseries in quarantined areas. We are also updating the list of plants regulated because ofP. ramorumand the list of areas that are quarantined forP. ramorum, and making other miscellaneous amendments to the regulations. These actions are necessary to prevent the spread ofP. ramorumto noninfested areas of the United States.
DATES: This interim rule is effective February 27, 2007. We will consider all comments that we receive on or before April 30, 2007.
ADDRESSES: *Federal eRulemaking Portal:Go tohttp://www.regulations.gov, select "Animal and Plant Health Inspection Service" from the agency drop-down menu, then click "Submit." In the Docket ID column, select APHIS-2005-0102 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's "User Tips" link.
*Postal Mail/Commercial Delivery:Please send four copies of your comment (an original and three copies) to Docket No. 01-054-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 01-054-3.
FOR FURTHER INFORMATION CONTACT: Mr. Jonathan Jones, NationalPhytophthora ramorumProgram Manager, Pest Detection and Management Programs, PPQ, APHIS, 4700 River Road Unit 160, Riverdale, MD 20737; (301) 734-8247.
Under the regulations in “Subpart-Phytophthora Ramorum” (7 CFR 301.92 through 301.92-11, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) restricts the interstate movement of certain regulated and restricted articles from quarantined areas in California and Oregon to prevent the artificial spread ofPhytophthora ramorum, the pathogen that causes the plant diseases commonly known as sudden oak death, ramorum leaf blight, and ramorum dieback.
The regulations, which were established in February 2002, quarantined 10 counties in California and part of 1 county in Oregon, and restrict the interstate movement of regulated and restricted articles from those areas. Regulated articles, which may be moved interstate from quarantined areas contingent upon the application of certain phytosanitary measures, include soil and nursery stock (except acorns and seeds), unprocessed wood and wood products (including firewood, logs, and lumber), and plant products (including wreaths, garlands, and greenery) of 14 species and 1 genus of plants. Restricted articles from quarantined areas, which are prohibited from moving interstate except under departmental permit, include bark chips, forest stock, and mulch of the same 14 species and 1 genus of plants. The regulations also include provisions for the issuance of certificates and compliance agreements, as well as provisions regarding treatments for regulated articles and inspection and sampling protocols for nurseries shipping host plants interstate.
The regulatory changes codified by this rule are consistent with an order issued by APHIS on December 21, 2004, that restricted the interstate movement of nursery stock from California, Oregon, and Washington nurseries.1 The requirements established by this rule supercede the requirements of the order.
1The emergency order can be viewed on the Internet at:http://www.aphis.usda.gov/ppq/ispm/pramorum/.
In this interim rule, we are amending the regulations to establish restrictions on the interstate movement of nursery stock from nurseries in nonquarantined counties in California, Oregon, and Washington. We are also amending the regulations to update conditions for the movement of regulated articles of nursery stock from quarantined areas, to add restrictions on the movement of decorative trees without roots from quarantined areas, as well as to restrict the interstate movement of all other nursery stock from nurseries in quarantined areas. We are also updating the list of plants regulated because ofP. ramorumand the list of areas that are quarantined forP. ramorum, and making other miscellaneous amendments to the regulations. These actions are necessary to prevent thespread ofP. ramorumto noninfested areas of the United States.
Changes to the Regulations Made by this Rule
Since 2002,P. ramorumhas been confirmed to be established in natural areas in four additional counties in California and a small additional area in Curry County, OR, and many additional plants have been confirmed as hosts of the pathogen. In this document, we are updating the regulations to reflect these developments.
Specifically, we are adding Contra Costa, Humboldt, Lake, and San Francisco Counties in California to the list of quarantined areas and revising the description of the portion of Curry County, OR, that is a quarantined area to reflect the fact that the previously quarantined area has been expanded, and that the area remains under an eradication program. The updated list of quarantined areas appears in § 301.92-3(a)(3) in this rule.
We are also amending the regulations in § 301.92-2 that designate regulated and restricted articles to include additional taxa ofP. ramorumhosts. The complete list of proven host taxa can be found in § 301.92-2(d) in the rule portion of this document. The proven genera, species, or hybrids added by this rule are:
•Acer pseudoplatanusPlanetree maple •Adiantum aleuticumWestern maidenhair fern •Adiantum jordaniiCalifornia maidenhair fern •Aesculus hippocastanumhorse chestnut •Calluna vulgarisScotch heather •Camelliaspp. Camellia—all species, hybrids, and cultivars •Castanea sativaSweet chestnut •Fagus sylvaticaEuropean beech •Frangula purshiana(≡Rhamnus purshiana) Cascara •Fraxinus excelsiorEuropean ash •Griselinia littoralisGriselinia •Hamamelis virginianaWitch hazel •Kalmiaspp. Kalmia-all species, hybrids, and cultivars •Laurus nobilisBay laurel •Maianthemum racemosum(≡Smilacina racemosa) False Solomon's seal •Michelia doltsopaMichelia •Parrotia persicaPersian ironwood •Photinia fraseriRed tip photinia •Pierisspp. Pieris-all species, hybrids, and cultivars •Pseudotsuga menziesiivar.menziesiiDouglas fir and all nursery-grownP. menziesii •Quercus cerrisEuropean turkey oak •Quercus chrysolepisCanyon live oak •Quercus falcataSouthern red oak •Quercus ilexHolm oak •Rosa gymnocarpaWood rose •Salix capreaGoat willow •Sequoia sempervirensCoast redwood •Syringa vulgarisLilac •Taxus baccataEuropean yew •Trientalis latifoliaWestern starflower •Viburnumspp. Viburnum-all species, hybrids, and cultivars
The plant taxa listed above are proven hosts ofP. ramorumbased upon completion, documentation, review, and acceptance of traditional Koch's postulates. Note that several updates have been made to previously listed taxa:
• Black oak is now listed as California black oak;
• The scientific name for California coffeeberry has been corrected;
• Huckleberry is now listed as evergreen huckleberry;
• Arrowwood is now listed as Bodnant viburnum;
• All nursery-grownQuercus parvulaare now regulated;
• All species, hybrids, and cultivars ofPierisspp. are now regulated;
• All species, hybrids, and cultivars ofKalmiaspp. are now regulated;
• All species, hybrids, and cultivars ofRhododendronspp. are now regulated; and
• The listing forUmbellularia californicais clarified to include other recognized common names—pepperwood and Oregon myrtle.
We are also clarifying that firewood, logs, and lumber of specific proven host plant taxa are not regulated because available research shows thatP. ramoruminfections are limited to other parts (i.e., twigs, leaves, and sprouts) of those hosts. These hosts are indicated with an asterisk in revised § 301.92-2(d).
In addition to amending the lists of regulated and restricted articles, we are adding a new category of article to the regulations: Associated articles. Several plant species have been associated withP. ramorumafter symptoms were observed on the plants and culture or polymerase chain reaction (PCR) tests of the plants returned positive results forP. ramorum. Traditional Koch's postulates, which will confirm or exclude them as hosts, have not yet been completed for any of these plant species, but the positive results of culture or PCR tests indicate that they present a risk of transmittingP. ramorum. We are, therefore, imposing restrictions on their interstate movement (discussed in detail later in this document) until the results of the application of Koch's postulates are known. At that time, we will list proven hosts as regulated and restricted articles and remove from the list of associated articles those plant species that are not proven hosts ofP. ramorumvia application of Koch's postulates.
Associated plant taxa are listed in § 301.92-2(e); only nursery stock of these plant taxa are regulated under this rule (i.e., interstate movement of unprocessed wood and wood products, and plant products, including bark chips, mulch, firewood, logs, lumber, wreaths, garlands, and greenery of associated plant taxa are not regulated).
•Abies concolorWhite fir •Abies grandisGrand fir •Abies magnificaRed fir •Acer circinatumVine maple •Acer davidiiStriped bark maple •Acer laevigatumEvergreen maple •Arbutus unedoStrawberry tree •Arctostaphylos columbianaManzanita •Arctostaphylos uva-ursiKinnikinnick, bearberry •Ardisia japonicaArdisia •Calycanthus occidentalisSpicebush •Castanopsis orthacanthaCastanopsis •Ceanothus thyrsiflorusBlueblossom •Cinnamomum camphoraCamphor tree •Clintonia andrewsianaAndrew's clintonia bead lily •Corylus cornutaCalifornia hazelnut •Cornus kousaxCornus capitataCornus Norman Haddon •Distylium myricoidesMyrtle-leafed distylium •Drimys winteriWinter's bark •Dryopteris argutaCalifornia wood fern •Eucalyptus haemastomaScribbly gum •Euonymus kiautschovicusSpreading euonymus •Fraxinus latifoliaOregon ash •Gaultheria shallonSalal, Oregon wintergreen •Hamamelis mollisChinese witch-hazel •Hamamelisxintermedia(H. mollis H. japonica) Hybrid witchhazel •Ilex purpureaOriental holly •Leucothoe axillarisFetter-bush, dog hobble •Leucothoe fontanesianaDrooping leucothoe •Loropetalum chinenseLoropetalum •Magnolia grandifloraSouthern magnolia •Magnolia stellataStar magnolia •Magnolia x loebneriLoebner magnolia •Magnolia x soulangeanaSaucer magnolia •Manglietia insignisRed lotus tree •Michelia maudiaeMichelia •Michelia wilsoniiMichelia •Nerium oleanderOleander •Nothofagus obliquaRoble beech •Osmanthus decorus(≡Phillyrea decora; ≡P. vilmoriniana) Osmanthus •Osmanthus delavayiDelavay Osmanthus, Delavay tea olive •Osmanthus fragransSweet olive •Osmanthus heterophyllusHolly olive •Osmorhiza berteroiSweet Cicely •Parakmeria lotungensisEastern joy lotus tree •Pittosporum undulatumVictorian box •Prunus laurocerasusEnglish laurel, cherry laurel •Prunus lusitanicaPortuguese laurel cherry •Pyracantha koidzumiiFormosa firethorn •Quercus acutaJapanese evergreen oak •Quercus petraeaSessile oak •Quercus rubraNorthern red oak •Rosa(specific cultivars) hybrid roses Royal Bonica (tagged: “MEImodac”), Pink Meidilland (tagged: “MEIpoque”), Pink Sevillana (tagged: “MEIgeroka”) •Rosa rugosaRugosa rose •Rubus spectabilisSalmonberry •Schima wallichiiChinese guger tree •Taxus brevifoliaPacific yew •Taxus x mediaYew •Torreya californicaCalifornia nutmeg •Toxicodendron diversilobumPoison oak •Vancouveria planipetalaRedwood ivy Nurseries Located Outside Quarantined Areas
A primary purpose of this rule is to address the discovery ofP. ramorumin nurseries in California, Oregon, and Washington that are outside quarantined areas. Nurseries outside the quarantined area were not previously covered by the regulations. WhileP. ramorumis present and in some cases widespread in the natural environment in the quarantined areas of California and Oregon, the detections ofP. ramorumin the nonquarantined areas of California and Oregon and in the State of Washington have been limited to commercially produced nursery plants. These nurseries are a proven source ofP. ramorummoved in the interstate trade of nursery stock, therefore, we are regulating the interstate movement of nursery stock from nurseries in nonquarantined areas in California, Oregon, and Washington (referred to elsewhere in this document and in the amended regulations as regulated areas2 ) in order to prevent the spread ofP. ramorumto noninfested areas of the United States. As stated in the previous section, we are not regulating the interstate movement of any other restricted or regulated articles from regulated areas because positive finds in regulated areas have been limited to nursery stock.
2Note the distinction between regulated areas and quarantined areas. Quarantined areas include the 14 counties in California and a portion of 1 county in Oregon listed in § 301.92-3(a)(3). Regulated areas include all remaining areas of California and Oregon, and the entire State of Washington.
Specifically, any nursery located in a regulated area that contains regulated articles of nursery stock or associated articles is prohibited from moving nursery stock interstate until certain conditions are met. In some cases, nurseries may also be prohibited from shipping non-host nursery stock3 until the same or similar conditions are met. These conditions, which are contained in § 301.92-11 of the regulations, are described below.
3Non-host nursery stock is defined as any taxa of nursery stock not listed in § 301.92-2 as a regulated or associated article.
Requirements for Moving Regulated Articles of Nursery Stock and Associated Articles Interstate From Regulated Areas
Paragraph (c) of § 301.92-11 pertains to nurseries located in regulated areas that ship regulated articles of nursery stock or associated articles interstate. Under paragraph (c), such nurseries must be inspected for symptoms ofP. ramorumby an APHIS, State, or county inspector.4 Inspection will focus on, but not be limited to, regulated articles of nursery stock and associated articles.
4Persons operating under compliance agreements in accordance with § 301.92-6 are eligible to issue certificates for the interstate movement of regulated and associated articles, but only APHIS, State, and county inspectors are authorized to conduct nursery inspections required by the regulations.
Samples must be taken from all symptomatic plants. If fewer than 40 symptomatic plants are present, each symptomatic plant must be sampled and additional samples must be taken from asymptomatic plants so that the minimum number of plants sampled totals 40. If no symptomatic plants are present, 40 asymptomatic plants must be sampled. Each sample may contain more than one leaf, and may come from more than one plant, but all plants in the sample must be from the same lot.5 If the samples are collected from asymptomatic plants, the samples must be taken from regulated and associated articles and nearby plants. Inspectors must conduct inspections at times when the best expression of symptoms is anticipated (typically within 30-90 days of bud break) and must take nursery fungicide programs into consideration to maximize the opportunity to observe symptoms. We recommend that inspections be performed 2 to 9 weeks after any application of fungicides that are efficacious forPhytophthoraspp. or oomycetes, (depending on the type of fungicide used and the plant treated), and prior to any subsequent applications of such fungicides. Nursery owners must also keep records of fungicide applications for 2 years and must make them available to inspectors upon request.
5“Lot” is defined as a contiguous block of plants of the same species or cultivar, of the same container size and from the same source, if known.
Annual Certification and Recordkeeping
All plant samples must be tested in accordance with § 301.92-12. If samples return negative results forP. ramorum, an inspector may certify that the nursery is free of evidence ofPhytophthora ramoruminfestation at the time the plants were inspected. Nurseries in a regulated area must have current and valid certification to ship regulated articles of nursery stock and associated articles interstate. If annual certification expires prior to reinspection, all plants in the nursery are prohibited interstate movement until the nursery is inspected, tested, and re-certified in accordance with the regulations.
All nurseries that are operating under compliance agreements must maintain records of all incoming shipments of plants for a minimum of 24 months and must make them available to inspectors upon request. In addition, all nurseries that are operating under compliance agreements, except retail dealers, must maintain records of outgoing shipments for a minimum of 24 months. This recordkeeping will help to facilitate tracebacks and traceforwards in the event that articles infected withP. ramorumare discovered upon inspection.
Requirements for Moving Non-Host Nursery Stock Interstate From Regulated Areas
Paragraph (d) of § 301.92-11 pertains to nurseries in regulated areas that contain only non-host nursery stock. If a nursery located in a regulated area moves non-host nursery stock interstate but the nursery contains regulated articles of nursery stock or associated articles, the nursery must meet the requirements of § 301.92-11(c), which are described above, even if the nursery only ships non-host nursery stock interstate. Alternately, under paragraph (d), if there are no regulated or associated articles in the nursery, a nursery in a regulated area may ship non-host nursery stock interstate if the following conditions are met:
• The nursery must be visually inspected annually and found free of symptoms ofP. ramorumat the timewhen the best expression of symptoms is anticipated (typically within 30-90 days of bud break).
• If symptomatic plants are found upon inspection, all such plants must be tested, and the following plants must be withheld from interstate shipment until testing is completed and the nursery is found free of evidence ofP. ramorumby an inspector: All symptomatic plants, any plants located in the same lot as the symptomatic plant, and any plants located within 2 meters of the affected lot(s) of plants.
• If no symptomatic plants are found, an inspector may certify that the nursery is free of evidence ofP. ramorum, and non-host nursery stock will be eligible for interstate movement. Note that no certificate is required for non-host plants moving interstate in accordance with § 301.92-11(d).
The States of California, Oregon, and Washington, and local governments cooperate with APHIS in enforcing the requirements of this rule. The States have agreed to maintain on the Internet a current list of nurseries that have been certified as free of evidence ofP. ramoruminfestation in accordance with this rule. Links to the States' lists can be found athttp://www.aphis.usda.gov/ppq/ispm/pramorum/resources.html.
In the December 2004 Federal Order, the provisions described above pertaining to nurseries located in regulated areas and the interstate movement of nursery stock from regulated areas were scheduled to expire three years from the effective date, unless APHIS issued another rule before that time to extend or revise that aspect of theP. ramorumregulatory program. That expiration date only pertained to regulated areas in California, Oregon, and Washington that are outside quarantined areas. We have decided that the sunset clause included in the Federal Order is no longer necessary or appropriate, therefore we are not including it in this rule and are continuing the provisions described above pertaining to nurseries located in regulated areas and the interstate movement of nursery stock from regulated areas until further notice.
Additional Restrictions on the Movement of Associated Articles and Non-Host Nursery Stock From Quarantined Areas
This rule also restricts the interstate movement of associated articles6 and non-host nursery stock from quarantined areas. Associated articles must meet the same conditions for interstate movement from a quarantined area that apply to regulated articles of nursery stock; those conditions can be found in revised § 301.92-11(a). Non-host nursery stock must typically meet the same conditions for interstate movement from a quarantined area that apply to regulated articles of nursery stock, but if a nursery in a quarantined area contains no regulated articles of nursery stock or associated articles, non-host nursery stock may be moved interstate from that nursery provided the nursery is inspected and found free of evidence ofP. ramorumin accordance with revised § 301.92-11(b), which contains essentially the same inspection and sampling protocol described above under the heading “Requirements for Moving Non-Host Nursery Stock Interstate from Regulated Areas.” Note that to be eligible for interstate movement, non-host nursery stock that is rooted in soil or growing media requires certification that the soil or growing media meets the requirements of § 301.92-5(a)(1)(iii).
6As described earlier in this document, associated articles include only nursery stock of plant taxa listed in § 301.92-2(e).
Most revisions made to the regulations by this rule pertain to inspection and sampling protocols for nursery stock moving interstate from California, Oregon, and Washington. In order to eliminate confusion over what provisions apply in a given situation, we have prepared the following table.
Type(s) of plants in the nursery Type(s) of plants shipped interstate Inspection and certification protocol Origin: Quarantined areas Origin: Regulated areas Regulated articles only None Not regulated Not regulated. Regulated articles only Regulated articles § 301.92-11(a) § 301.92-11(c). Associated articles only None Not Regulated Not Regulated. Associated articles only Associated articles § 301.92-11(a) § 301.92-11(c). Regulated and associated articles only Regulated or associated articles, or both § 301.92-11(a) § 301.92-11(c). Regulated and associated articles and non-hosts None Not regulated Not regulated. Regulated and associated articles and non-hosts Regulated or associated articles, or both § 301.92-11(a) § 301.92-11(c). Regulated and associated articles and non-hosts Non-hosts only § 301.92-11(a) § 301.92-11(c). Non-hosts only None Not regulated Not regulated. Non-hosts only Non-hosts § 301.92-11(b)1 § 301.92-11(d). Decorative trees without roots (e.g., Christmas trees) Proven host plant taxa § 301.92-11(a) Not regulated. Decorative trees without roots (e.g., Christmas trees) Associated plant taxa Not regulated Not regulated. 1Under § 301.92-4, non-host nursery stock from a nursery in a quarantined area that contains no regulated or associated articles does not require a certificate for interstate movement, provided that the plants are moved bare-root; if soil or growing media is attached to non-host nursery stock, to be eligible for interstate movement, the soil or growing media must be certified in accordance with § 301.92-5(a)(1)(iii).
This rule also amends certain existing provisions pertaining to inspection and testing of nurseries in quarantined areas. Prior to the effective date of this interim rule, the inspection and sampling protocol contained in § 301.92-11 required nurseries that ship regulated articles of nursery stock interstate to be inspected and tested annually forP. ramorum, and each shipment intended for interstate movement to be inspected for symptoms ofP. ramorum, and ifnecessary, tested. This rule amends the text of those provisions in order to clarify them and improve their effectiveness. Specifically, in this rule:
• The provisions for inspecting nurseries are revised. We are requiring the inspections to be focused on the detection and identification of symptomatic regulated articles of nursery stock and associated articles, and are requiring that all symptomatic plants be sampled and tested. We believe inspecting the entire nursery and focusing on all proven host nursery stock and associated plant taxa will best enable us to determine ifP. ramorumis present in the nursery being inspected.
• The testing protocol is specified. The regulations in effect prior to this rule simply required samples to be sent to an APHIS-approved laboratory for testing. This rule requires samples to be tested and evaluated using an APHIS-approved method at an APHIS-approved laboratory in order to ensure that the tests produce accurate and consistent results. This rule also describes the only currently approved test protocol. The protocol is described in detail later in this document under the heading “Testing.”
• We are clarifying that nurseries in quarantined areas must have a current and valid annual certification of freedom from evidence ofP. ramorumin order to submit individual shipments of nursery stock for inspection.
• We are specifying conditions under which nurseries in quarantined and regulated areas may continue to move articles interstate if the nursery receives articles from an uncertified nursery in a quarantined or regulated area. These conditions are located in § 301.92-5, paragraphs (a)(1)(iv)(D) and (b)(1)(ii), respectively.
New Proven Hosts or Associated Plants and Effects on Regulated Nurseries
New hosts ofP. ramorumare being identified on a monthly, sometimes weekly, basis. As such, the regulations may not always reflect all known proven hosts and associated plant taxa. Under the regulations in § 301.92-2, an inspector may notify a person that a given product or article is subject to the regulations, even if the product or article is not specifically listed in the regulations. This might occur if the product or article (i.e. non-host nursery stock, pots, or potting tools) was associated with other products or articles that are likely infected withP. ramorum.In those instances, the product or article would be held until determined free fromP. ramorumusing official, APHIS-approved testing. APHIS inspectors provide notice to affected States and stakeholders when new hosts are confirmed and associated plants are identified. Such plants and their products then become subject to the regulations. Hosts are added when official samples (samples taken by Federal, State, or county inspectors and submitted to APHIS) are confirmed to be infected withP. ramorum.National plant protection organizations (NPPO) of foreign countries are also recognized as credible sources for the identification of new hosts, as well as knownP. ramorumresearchers who publish their new host findings in peer reviewed journals or report their findings. When researchers report new host finds, these finds are verified either by the NPPO of the country in which the researcher resides or by APHIS.
In this rule, we clarify that the following provisions apply when APHIS informs a nursery owner that additional proven hosts or associated plants have been confirmed:
• Nurseries operating under a compliance agreement in accordance with § 301.92-6 may continue to ship plants interstate in accordance with the regulations.
• Nurseries that had not previously contained any regulated or associated articles, and that had been inspected in accordance with § 301.92-11(b)(3) and allowed to ship plants interstate without a certificate, but that contain a newly identified proven host or associated plant must cease interstate shipments of regulated and associated articles until the nursery is reinspected and found free of evidence ofP. ramorumin accordance with § 301.92-11. Nurseries that come under regulation during winter dormancy periods and that are not able to be inspected in accordance with § 301.92-11 prior to desired shipments of non-host nursery stock may be allowed to ship non-host nursery stock interstate at the discretion of an inspector.
These provisions provide clear guidance to affected persons as to how they will be affected by additions to the lists of proven hosts and associated plant taxa.
We are also amending the regulations to clearly describe the testing protocols that must be used to determine whether plant samples taken in accordance with the regulations are infected withP. ramorum.These testing requirements are located in a new § 301.92-12. Under this section, samples must be analyzed using a methodology approved by APHIS at a laboratory approved by APHIS. The process for testing and analyzing samples is described below.7
7Detailed descriptions of testing and sample analysis procedures can be viewed on the Internet athttp://www.aphis.usda.gov/ppq/ispm/pramorum/.
Any samples collected in accordance with the regulations may be prescreened using an APHIS-approved enzyme-linked immunosorbent assay (ELISA) to determine the presence ofPhytophthoraspp. ELISA tests are optional; however, if all samples collected from a single nursery or a single shipment are found to be negative through ELISA prescreening, no further testing of the plants sampled is required. A nursery or shipment of plants may be considered free of evidence ofP. ramorumbased on negative results of ELISA tests, and provided all other applicable requirements are met, the plants are eligible for interstate movement.8
8Nurseries in quarantined areas require both current annual certification and certification of individual interstate shipments of regulated articles of nursery stock and associated articles.
If ELISA prescreening is not performed, or if results of ELISA prescreening are positive forPhytophthoraspp. in any sample, the sample must be analyzed using an APHIS-approved9 test. Samples will be considered positive forP. ramorumbased on positive results of any approved test. Positive PCR or other molecular tests do not require confirmatory culture tests, nor do positive culture tests require confirmatory PCR or other molecular tests; however, if culture tests return other than positive results, an APHIS-approved PCR or other molecular test must be conducted, as described below. No culture test is required if an APHIS-approved PCR or other molecular test returns negative results. Plants in the nursery must be withheld from interstate movement pending negative test results in accordance with applicable provisions of § 301.92-11.
PCR and Other Molecular Tests
If the results of PCR or other molecular tests are negative for all samples from a nursery or single shipment, no further testing is required. The nursery or shipment sampled may be considered free of evidence ofP. ramorum.
If any samples tested using the PCR protocol or another approved protocol return positive results forP. ramorum, the nursery from which they originate is prohibited from moving plants interstate until an inspector determines that plants intended for interstate movement are free of evidence ofP. ramorum infection. When an inspector determines that a nursery in a regulated area is free of evidence ofP. ramoruminfestation, the nursery will be eligible to move plants interstate under certificate. Nurseries in quarantined and regulated areas that contain only non-host nursery stock are eligible to move plants interstate in accordance with § 301.92-11(b) and (d).
Similarly, when an inspector determines that a shipment of nursery stock intended for interstate movement from a nursery in a quarantined area is free of evidence ofP. ramoruminfection, and provided the nursery has current and valid annual certification in accordance with the regulations, the shipment of nursery stock is eligible for interstate movement under certificate.
If the results of culture tests are other than positive for any samples taken from a nursery or a single shipment, each plant sample that returns other than positive culture results must be tested again using an approved PCR or other molecular test, and plants from the nursery or shipment are only eligible for interstate movement if results of such tests are negative for all samples taken.
If any culture tests return positive results forP. ramorum, the movement of nursery stock is restricted under the same conditions described above for positive PCR and other molecular tests.
Restrictions on the Interstate Movement of Decorative Trees Without Roots From Quarantined Areas
We are restricting the interstate movement of decorative trees without roots (e.g., Christmas trees) of provenP. ramorumhost taxa. Under the regulations, locations where trees are grown for sale as decorative trees without roots, and locations where decorative trees without roots are stored or distributed are considered nurseries. As such, any such location that ships trees interstate and that grows decorative trees without roots of provenP. ramorumhost taxa is subject to the same inspection, testing, and certification requirements as any other nursery. Thus, decorative trees without roots that are shipped interstate from quarantined areas must originate from a nursery that has current, valid annual certification of freedom from evidence of infestation byP. ramorumin accordance with § 301.92-11(a)(1) and individual shipments must also be inspected and certified in accordance with § 301.92-11(a)(2).
Note that locations that grow, store, or distribute decorative trees without roots that are not proven hosts ofP. ramorumare not regulated under this rule unless the location contains proven hosts. If the nursery ships interstate and contains any proven hosts, the nursery is subject to the regulations.
The interstate movement of decorative trees without roots from regulated areas is not regulated under this rule.
Additional Provisions for the Interstate Movement of Wreaths, Garlands, and Greenery of Proven Host Taxa From Quarantined Areas
Prior to this rule, the regulations only allowed the movement of regulated articles of wreaths, garlands, and greenery from a quarantined area if the articles were treated in accordance with a treatment listed in 7 CFR part 305 or a treatment listed in § 301.92-10. In this rule, we are amending the regulations to allow wreaths, garlands, and greenery of provenP. ramorumhost taxa to be moved interstate from a quarantined area if the articles originate from a nursery that has current, valid annual certification of freedom from evidence of infestation byP. ramorum, in accordance with § 301.92-11(a)(1), and provided that individual shipments of such articles are inspected and certified in accordance with § 301.92-11(a)(2).
The regulations in § 301.92-4 have provided for the interstate movement of restricted articles via departmental permit.10 APHIS does issue permits for the movement of restricted articles for research purposes, but technically not via a departmental permit. Therefore, we are amending the regulations in § 301.92-4 to provide that we will issue permits for such movements in accordance with the requirements of 7 CFR part 330, which provides for the movement of plant pests and material that may be infected or infested with plants pests.
10Permits are not required for the interstate movement of regulated or associated articles, or non-host nursery stock. A certificate issued in accordance with § 301.92-5 is required for those articles.
We are clarifying in revised § 301.92 that the interstate movement of regulated, restricted, or associated articles, or nursery stock that has been tested with a test approved by APHIS and found infected withP. ramorum, or that is part of a plant that was found infected withP. ramorum, is prohibited, unless such movement is in accordance with the plant pest regulations in 7 CFR part 330.
In conjunction with the changes described in this document, we are adding definitions for the termsassociated article, from, lot, non-host nursery stock, nursery, andregulated areato § 301.92-1. The definitions forassociated article, lot, non-host nursery stockandregulated areaare described earlier in this document. The termfromis defined in order to clarify when a particular nursery requires inspection. An article is considered to be “from” a specific site or location if it was grown or propagated in, stored or sold, or distributed from the site or location.
The termnurseryis defined in order to clarify what types of businesses are subject to the regulations pertaining to the interstate movement of nursery stock.Nurseryis defined as any location where nursery stock is grown, propagated, stored, or sold; or any location from which nursery stock is distributed. Also, as described earlier in this document, locations that grow trees for sale without roots (e.g., as Christmas trees) are considered to be nurseries for the purpose of the regulations.
In addition, we are revising the definitions ofcertificate, forest stock, mulch, nursery stock,andsoilin § 301.92-1. The definition ofcertificateis revised to reflect the fact that certificates issued in accordance with the regulations may be in the form of a stamp or imprint that looks like this:
ER27FE07.007
The definition formulchis revised to clarify that plant material meeting the definition of mulch (bark chips, wood chips, wood shavings, or sawdust, or a mixture thereof) is regulated as mulch if used as part of a growing media mixture.
The definition ofnursery stockis revised to (1) ensure that it applies to all potentialP. ramorumhost materials, bedding plants, and other herbaceous plants, bulbs, and roots, (2) clarify that it applies to tree seedlings being used for reforestation, and (3) remove references to seeds and fruit pits, as those articles are not subject to regulation under the quarantine. In conjunction with this change, and with the addition of a definition fornursery, we are also revising the definition forforest stockto reflect that forest stock includes all flowers, trees, shrubs, vines, scions, buds, or other plants that are wild-grown, backyard-grown, or naturally occurring.
The definition forsoilis revised to reflect the definition used by the International Plant Protection Convention glossary of phytosanitary terms:11 The loose surface material of the earth in which plants grow, in most cases consisting of disintegrated rock with an admixture of organic material. As a result of revising the definition ofsoil, we also need to add provisions to the regulations to ensure the regulations continue to cover growing media mixtures that were clearly regulated under the prior regulations assoil. As such, we are adding a definition ofgrowing mediato the regulations, as well as updating the regulations so that growing media is regulated in the same fashion as soil.Growing mediais defined as any material in which plant roots are growing or intended for that purpose.
11Available at http://www.ippc.int/.
We are revising the provisions pertaining to quarantined areas in § 301.92-3 to make it clear that APHIS will quarantine an area based on confirmed detections ofP. ramorumin the natural environment, not based on detections in artificial environments such as nurseries.
We are also clarifying provisions throughout the regulations regarding certifications of freedom fromP. ramorum. The regulations in effect prior to this interim rule restricted the interstate movement of regulated articles from nurseries until such a time as an inspector could determine that the nurseries are free of evidence ofP. ramorum. This rule provides that nurseries must be free of evidence ofP. ramoruminfestation; certification of “pest freedom” can only be made if each individual plant is tested for the pathogen.
We are also updating § 301.92-7 regarding advance notice for the services of an inspector to require that a person wishing to move plants that require a certificate for interstate movement must notify the inspector as far in advance of the desired interstate movement as possible, but no less than 48 hours before the desired time of inspection. This section had previously stated that we require 14 days' advance notice, but we are able to respond with 48 hours' notice.
We are updating § 301.92-10 pertaining to treatments to make it clear that soil treated forP. ramorummust be heated such that the temperature at the center of the load reaches at least 180 °F for 30 minutes. We are also clarifying that the hot water dip for wreaths, garlands, and greenery is applicable to all regulated articles, including newly listed ones, as well as referencing the approved treatment for bay leaves listed in 7 CFR part 305.
Need for Additional Revisions to the Regulations
The study ofP. ramorumis constantly producing new information that allows us to better regulate the interstate movement of plant material to prevent the spread of the diseases caused by the pathogen. APHIS and the Forest Service, USDA, have been conducting annual national surveys to determine whether and whereP. ramorumexists in other areas of the United States. If additional hosts ofP. ramorumare identified during the course of the national survey or by other scientific research, we will add those hosts to the list of regulated and restricted articles as appropriate. Detection ofP. ramorumon other species through PCR or culture tests could result in those species being added to the list of associated articles. Completion of Koch's postulates would prove them as hosts.
This rule is being promulgated on an emergency basis to address specific imminent risks. We recognize that several facets of the regulations require additional revision to bring them up to date with current operational practices and the state of scientific knowledge regardingP. ramorum.We intend to publish another document for public comment in the future that will focus on treatments. We also intend to update the conditions for interstate movement for certain articles other than nursery stock, including wreaths and garlands, leaves, stems and branches, green waste, and other articles.
We will continue to review ourP. ramorumregulatory program and evaluate the new restrictions on nurseries in regulated areas upon receipt of comments on this rule, and upon evaluation of data derived from the program so far. We will provide public notification of any changes to the regulations via a document published in theFederal Register.
This rulemaking is necessary on an emergency basis to prevent the spread ofP. ramorumoutside quarantined areas in California and Oregon and infected nursery sites in California, Oregon, and Washington. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in theFederal Register.
We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in theFederal Register. The document will include a discussion of any comments we receive and any amendments we are making to the rule.
We have prepared an economic analysis for this interim rule. It provides a cost-benefit analysis as required by Executive Order 12866, as well as an initial regulatory flexibility analysis, which considers the potential economic effects of this interim rule on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below. The full economic analysis may be viewed on the Regulations.gov Web site (seeADDRESSESat the beginning of this document for instructions for accessing Regulations.gov). You may request paper copies of the economic analysis by calling or writing to the person listed underFOR FURTHER INFORMATION CONTACT. Please refer to Docket No. 01-054-3 when requesting copies. The economic analysis is also available for review in our reading room (information on the location and hours of the reading room is listed under the headingADDRESSESat the beginning of this document).
We do not currently have all of the data necessary for a comprehensive analysis of the effects of this interim rule on small entities. Therefore, APHIS welcomes public comment that would enable us to more fully consider impacts of the rule, specifically information on costs that may be incurred due to complying with the interstate movement restrictions.
This interim rule places restrictions on the interstate movement of nursery stock from California, Oregon, and Washington. This economic analysis will focus primarily on the effects of restricting nursery stock from the regulated and quarantined areas. While there are other articles regulated besides nursery stock, such as trees without roots (i.e., Christmas trees), the economic impacts of restricting the movement of these other articles are expected to be relatively smaller, and therefore are not a primary focus of the analysis.12
12The only species of Christmas tree that is affected by the rule is the Douglas fir, which reportedly is not a high volume product in the quarantined area. As such, we do not believe this particular aspect of the interim rule will cause significant impact on affected nurseries.
Those nurseries wishing to engage in interstate movement of nursery stock of proven and associated hosts ofP. ramorummay only do so if it is accompanied by a certificate issued under an APHISPhytophthora ramorumcompliance agreement. Nurseries located in the quarantined area that are planning to ship host articles must undergo annual inspection, as well as inspection of individual shipments, prior to being certified to ship interstate. In order to ship non-host articles interstate, nurseries in the quarantined area must follow these same protocols, with the exception that nurseries containing no proven or associated host stock may receive certification to ship after undergoing annual inspection and will not be required to inspect individual shipments. On the other hand, nurseries in the regulated area that intend to ship nursery stock of proven or associated host taxa must undergo annual inspection to be certified to ship interstate. Only those nurseries that contain only non-host nursery stock can ship without certification, provided that they have undergone annual inspection. In order to enter into a compliance agreement and obtain certification to ship regulated articles, the nursery must take certain steps, such as undergoing annual inspection and sampling of nursery stock, and testing plant samples at a USDA approved laboratory using federally approved laboratory protocols. Thus, there are two major components to certification: Inspection and testing. It is important to note that the costs associated with entering into and maintaining a compliance agreement were covered by regulating agencies, specifically USDA and State departments of agriculture in 2005 and 2006. Funding for entering into and maintaining a compliance agreement in 2007 will transition and have to be borne by the entity under the compliance agreement for any amount not covered by available Federal or State funding. APHIS will provide affected entities with advance notice and guidance before we change the way we fund—including the possibility of requiring additional funding support from program participants and other cooperators—the specific activities associated with entering into and maintaining compliance agreements.
Nurseries will be required to undergo annual inspection and be certified free ofP. ramorum.This inspection and sampling will be provided by Federal and State inspectors, the cost of which was covered by USDA in 2005 and 2006, when conducted during normal business hours. Individual nursery operators are responsible for all costs and charges arising from inspection and other services provided outside normal business hours. In addition, for those nurseries that must undergo inspection and sampling of individual shipments, the costs of those services were also covered by USDA in 2005 and 2006. Likewise, Federal funds are expected to cover the costs for these inspection and sampling activities in 2007, to the extent that funds are available. APHIS will provide affected entities with advance notice and guidance before we change the way we fund those inspection and sampling activities.
The interim rule will further amend the regulations by specifically describing the testing protocols that must be used to determine whether plant samples are infected withP. ramorum.While samples are being tested, nurseries must withhold shipments from movement until negative results are returned. The actual cost impact on nurseries will vary, depending on the classification of article shipped and/or the type of testing performed. Nurseries may choose to prescreen samples by usingthe optional APHIS-approved ELISA test to determine the presence ofPhytophthoraspp. If all samples collected from a single nursery or a single shipment are found to be negative through ELISA prescreening, no further testing of the plants sampled is required. If ELISA prescreening is not performed, or if results of the prescreening are positive forPhytophthoraspp. in any sample, the sample must be analyzed using APHIS-approved testing such as PCR or other molecular tests, or a culture test. Samples will be considered positive forP. ramorumbased on positive results of any approved test. If the results of PCR assay or other molecular tests are negative for all samples in a nursery, no further testing is required, and the nursery may be considered free ofP. ramorum.In the case of any of the samples tested using PCR or other molecular tests, or a culture test, returning a positive result forP. ramorum,the nursery from which they originated is prohibited from moving plants interstate until an inspector determines that those plants are free of evidence ofP. ramorum.In the event a nursery opts to test samples using a culture test, and the results are negative forP. ramorum,it is important to note that these samples must continue to be withheld from shipment until they return a negative result to a PCR or other molecular test. General estimates approximate the cost of ELISA, PCR and other molecular tests to be $15 per test, whereas the approximate cost of a culture test is about $10 per test.13 This testing has been provided by Federal and State inspectors, the cost of which was covered by USDA or States in 2005 and 2006. Funding for testing activities in 2007 and beyond will transition to the nursery for costs not covered by any available Federal or State funding. APHIS will provide affected entities with advance notice and guidance before we change the way we fund those testing activities.
13 Source:Phillip Berger, National Science Program Leader—Molecular Diagnostics Biotechnology, USDA APHIS PPQ (Raleigh, NC).NOTE:These estimates would cover the cost of materials and supplies, and some but possibly not all labor. These estimates do not consider the cost of instrumentation, service contracts, maintenance, etc.
TheP. ramorumprogram was fully funded for the fiscal year (FY) 2006, with the total available funds being $8.353 million.14 In FY 2006, we estimated spending approximately $6.35 million inP. ramorumactivities in California, Washington, and Oregon, of which approximately $4.15 million was allocated to inspection, sampling, testing, and certification activities. The remainder of the spending was allocated to national survey, trace forwards and trace backs, eradication, and enforcement activities of the regulation.
14 Source:Jonathan Jones, APHIS/PPQ, and Rick Lewis, APHIS/PPD.
In addition to the monetary costs of compliance agreements and nursery and shipment certifications borne by the public sector, there are also indirect costs to the nurseries as a result of regulation. For example, there could be potential costs associated with lost sales while withholding plants for shipment during inspection and testing. Further, the presence ofP. ramorum, and the accompanying movement restrictions where there were none previously could result in a potential loss in consumer confidence for nursery stock from the regulated area. These potential indirect losses are not quantifiable; however, we examine them to the extent possible in the sections that follow. In researching the possible impacts of the rule on nurseries, we solicited comments from State departments of agriculture, as well as industry associations. In some cases, no information was provided, either because it was unavailable and/or unidentifiable, or because it was considered to be confidential business information. We welcome public comment on the impacts of the interim rule.
As of July 2005, there were 861 nurseries in California that have been inspected and determined to be free ofP. ramorum, and were authorized to ship non-host nursery stock interstate without a certificate. In addition, there were 81 locations in the quarantined area authorized to ship host material underP. ramorumcompliance agreements, and 323 locations in the regulated area operating underP. ramorumcompliance agreements.15 As mentioned earlier, the majority of direct enforcement costs of the regulation associated with entering into compliance agreements, such as inspection, sampling, and testing, have been paid for by regulatory agencies. In 2005, $4.2 million in regulatory funds were allocated toP. ramorumquarantine and survey activities in California. In 2006, this amount increased to $5.4 million. It is important to note that these allocated funds do not include costs associated with trace back, trace forward, or eradication activities in the event of an infestation of nurseries as a result of interstate trade.16
15 Source:California Department of Food Agriculture, Quarantine and Survey Information (http://www.cdfa.ca.gov/phpps/pe/sod_survey/).
16 Source:Jonathan Jones, APHIS/PPQ.
In addition, there are other costs of the regulation, many of which are indirect and more difficult to quantify. For example, in the case of a nursery in Azusa County found to be infected withP. ramorum, there were both direct and indirect losses. Direct losses due to plants being destroyed at cost, not at the wholesale value, as well as custom