Permits and Procedures for Fieldwork

Transcription

1 Permits and Procedures for Fieldwork OVERVIEW The following handout was prepared by Irene Liu and Paul Durst for a Responsible Conduct of Research (RCR) seminar held on 19 October We developed the seminar to introduce biology graduate students to the logistics of establishing a field-based project. Our goals were to familiarize students with the general permit process; to outline the permits and shipping policies most commonly encountered in field research; and to compile a list of forms and resources others can use to maximize the likelihood that their samples arrive safely at Duke. We consulted with Duke students, staff and faculty, as well as outside contacts who had previously helped us with permit applications, to write this list. Contents are separated into two categories: permit requirements for animal research, and permit requirements for plant research. DISCLAIMER This document is not meant to be comprehensive, as specific projects require specific permits. But if you notice a mistake or glaring absence, please send an to irene.liu@duke.edu, and we will modify the list as appropriate. 1

2 Permits and Procedures for Animal Research THE BOTTOM LINE Always, always call each agency to ask about your project s permit requirements. Keep a log of your correspondence with your contacts. Plan and get started early! Level of permits International (CITES, host country) Federal (USFWS, USDA, USNPS, CDC) State Site Institutional (Duke, collaborating institutions) Permits concerned with animal populations Convention on International Trade in Endangered Species (CITES): by species and country USFWS Endangered Species: by species USFWS Migratory Birds: by species Banding or marking individuals: by species State-level Endangered Species: by species Institutional Animal Care and Use Committee (IACUC): all vertebrates and select cephalopods. Duke requirements are listed here: Permits concerned with human health USDA Animal and Plant Health Inspection Service (APHIS): by species and country CDC: by species Biological Use Authorization (BUA): by institution Shipping animal products (general) All documents must be in English. Sign all paperwork in blue ink. If packages are temperature-sensitive, ship as early in the week as possible (NOT on Friday) and keep federal holidays in mind. Suggestions for minimizing the risk of sample spoilage: (a) Under regulations and permit conditions, you must notify your shipper (e.g., Fed- Ex) 72 hours in advance that a perishable package is coming their way. (b) Use containers made especially for shipping sensitive specimens. (c) Write PERISHABLE on the outside of the box. Fed-Ex can set you up with its Custom Critical service costly, but worth it. Again, find out in advance whether the nearest Fed-Ex to your field site provides this service. (d) Fed-Ex considers dry ice a dangerous good because of its explosive abilities, so you will need to follow the instructions for indicating that your package contains dry ice, United Nations hazardous substance no (UN 1845). (e) Not all Fed-Ex locations ship perishable or dangerous goods. Make sure to check which locations near you will accept your specimens. 2

3 (f) Dry ice sublimates faster under lower pressure, such as in an airplane cabin. For international and larger domestic shipments, consider replacing dry ice with dry shippers, which contain liquid nitrogen and last longer. (g) More info here: Shipping animal products (international) Make sure the shipper you plan to use ships biological specimens! For international shipments: You must include USFWS form 3-177, the Declaration for Importation or Exportation of Fish or Wildlife ( 1.pdf). When filling out customs forms, use Harmonized Tariff Code (collections and collectors pieces of zoological, botanical, mineralogical, anatomical, historical, archaeological, palaeontological, or ethnographic interest). While counterintuitive, this code is the best catch-all code with which to ship specimens. Include a cover letter to inspectors listing all enclosed documents and your contact information. Better yet, contact them before you even leave the U.S. You can send them copies of your documents and tell them your plans, and they can tell you if they spot any problems. Write WILDLIFE: extra copies of documents in box on multiple sides of the box. Insert originals in the clear exterior envelope and another copy inside. Keep a third set for yourself. Call, or fax the USFWS Office of Law Enforcement in Memphis to let them know to expect a package. Unless you specify an outside customs broker, all packages stay under Fed-Ex s control as they are cleared by the USDA and USFWS. Each package is assigned a Fed-Ex customs broker. You can get his/her name and number from the sales rep if you need details beyond the information on the tracking page. For those whose projects also require exporting biological specimens out of the States, procedures for export and import are not the same. When importing samples, ship directly from the international address to Duke. As long as you have indicated the package contains wildlife products and have the appropriate documents in the pouch and Harmonized Tariff Code on the waybill, Fed-Ex will automatically route it through a USFWS designated wildlife port. When exporting samples that require a permit, you need to mail the package first to the USFWS Office of Law Enforcement in Memphis. Contact them first to let them know about the package. Package the entire shipment for export, but don t seal it. Then place the unsealed package and all the paperwork inside a second box. Include an international air waybill that the inspectors can attach after clearance to send it to its final destination. Shipping animal products in flammable liquids The International Air Transport Association (IATA) has specific requirements for shipping samples that are preserved in alcohol or formaldehyde. Special Provision A180 states that noninfectious specimens, such as specimens of mammals, birds, amphibians, reptiles, fish, insects and other invertebrates containing small quantities of ethanol, formaldehyde, alcohols or isopropyl alcohol are not subject to Dangerous Goods Regulations if specific packing and 3

4 marking requirements are met. You can find those requirements here: Certificates of treatment/origin An APHIS permit, if applicable, must be accompanied by a signed and dated certificate of origin, printed on institutional letterhead of an in-country government/academic agency or institution. (CDC has similar requirements for the animal imports it regulates.) Your text will read something like this: I certify that the exported material contained in shipment [number on air waybill] was collected from [animals] that originated in [host country] and was not commingled with or exposed to any other animal origin material. The person who signs the certificate must be the person identified as shipper on the APHIS permit. If your host country is known to be affected with the diseases listed here ( and if your lab is not approved as USDA-certified Biosafety Level (BSL)-II, you will generally need to (a) treat your samples prior to bringing them in and (b) enclose a signed certificate of treatment. A certificate of treatment can read the same as a certificate of origin, but you need to add an additional sentence vouching for the treatment. Contact USDA for a list of the approved treatments for your sample type. Hand-carrying animal products Very general advice: Customs officers are understandably strict about bringing samples into the States. If you are bringing anything in that requires a USFWS permit, you must arrive Monday- Friday, 9-5, and not on a federal holiday, and you must arrive at a designated wildlife port ( You will need to declare your samples and have them inspected by the host country (typically by the agriculture department) and by U.S. Customs Agricultural Quarantine Inspectors. Check the appropriate yes box on the blue Customs form, and tell the inspector you re carrying wildlife products. Depending on where officials are stationed, you might complete both inspections before you board the plane, or once before you board and once after you arrive in the States. Contact the appropriate parties at least 48 hours before your flight, and give yourself plenty of time. Sample checklist 1: Domestic mammals of special concern United States National Parks Service (USNPS) Scientific Collecting Permit ( California Department of Fish and Game (DFG) Scientific Collecting Permit ( California DFG Memorandum of Understanding (MOU) for species of special concern ( Catalina Island Conservancy Research Permit ( UC Natural Reserve System ( US Navy Scientific Collecting Permit (on-base contact required) Duke IACUC approval ( 4

5 University of California IACUC approval ( University of California BUA ( Sample checklist 2: International, non-endangered birds that are not bald/golden eagles Bahamas Ministry of the Environment Scientific Research permit Bahamas Ministry of Agriculture Export Permit Bahamas Ministry of Agriculture Approved Specimen Export Form (no online resources; phone/ contact required) USFWS Migratory Bird Import/Export Permits ( USFWS Bird Banding Permit ( USFWS Declaration for Importation or Exportation of Fish or Wildlife (Sample: USDA APHIS permit for birds, equids, ruminants or swine ( Certificate of treatment accompanying APHIS permit (Sample: Commercial invoice for Customs (enclosed with shipment) Duke IACUC approval Cover letter with permit list and contact information 5

6 Permits and Procedures for Plant Research THE BOTTOM LINE Always, always call each agency to ask about your project s permit requirements. Keep a log of your correspondence with your contacts. Plan and get started early! Checklist of common permits I. Non-endangered species A. Domestic 1) Site collecting permit B. International 1) Host country s collection permit 2) Host country s export permit, if applicable 3) For plants: USDA Animal and Plant Health Inspection Service (APHIS) Plant Protection and Quarantine (PPQ) permit (see below) 4) For soil: USDA APHIS permits for organic soil, PPQ 525 (see below) Non-organic soil like clay, sand and rocks are not regulated. II. Threatened or endangered species A. Domestic 1) USFWS collecting permit 2) State collecting permit 3) Site collecting permit B. International 1) Host country s collection permit 2) Host country s export permit, if applicable 3) Convention on International Trade in Endangered Species (CITES) Permit 4) USDA APHIS standard PPQs and PPQ 621 for importing protected plants Applying for permits There is a newish online system called epermits that speeds up the application process. Users are required to sign up for an eauthentication account ( to access epermits. The process of signing up is fairly straightforward, though you will need Biosafety Level (BSL)-II Access, which requires visiting the nearest USDA office (Hillsborough) to show your ID. Apply for permits at: This website has links for online application via epermits as well as PDFs you can print out to applying the old-fashioned way. One advantage of the epermit system is that APHIS representatives can help guide you through the process. For example, if you apply for PPQ 587 and it turns out the study plant is on the prohibited list, they ll let you know that you need to fill out a PPQ 588 instead. Importing plants, arthropods and soil PPQ 525 Application for permit to receive soil PPQ 526 Application for permit to move live plant pests, biological control agents, or noxious weeds 1

7 PPQ 546 Agreement for postentry quarantine PPQ 585 Application for permit to import timber or timber products PPQ 586 Application for permit to transit plants and/or plant products through the United States PPQ 587 Application for permit to import plants or plant products (e.g., seeds for planting) PPQ 588 Application for permit to import prohibited plants or plant products for experimental purposes PPQ 621 Application for protected plant permit to engage in the business of importing, exporting or re-exporting terrestrial plants or plant products that are protected There are a small number of plants species and genera (e.g., crops, certain weeds) that have specific regulations regarding their importation. Consult the USDA website to see if your plants are on this list. Alternatively, a host institution can send the material to you under their permits as a herbarium exchange. This is often much easier, but also slower. Importing live plants Plants for planting must be free of soil, sand, or other growing media. The only exception is for plants growing solely in agar or agar-like tissue culture medium. Some plants, such as small batches of Arabidopsis seeds, may not need a permit, just a phytosanitary certificate. For details, see This site also links to the list of restricted plants. If in doubt, apply for a permit and they ll let you know if it isn t needed. After you apply for the permit, USDA agents may come to inspect the facilities to make sure you can adequately contain and dispose of the regulated items. After about 2-3 months, your permit application should be approved, if you ve done everything right. The permit will include exact details on requirements for how to ship the samples, how to store them, and how to dispose of them. Importing arthropods, earthworms, snails and slugs, plant pathogens, soil and other potential plant pests For information about what permits are required for the importation, interstate movement and environmental release of plant pests (this covers most insects, soil, soil microorganisms), see Importing genetically modified plants If you re importing genetically modified plants, you ll also need to fill out a very detailed BRS (Biotechnology Regulatory Services) notification request via epermits. If all goes well, you will receive an acknowledgment letter for your notification request, which must accompany the permit on all shipments. If you re planning to grow genetically modified organisms using Duke facilities such as the Phytotron or research greenhouses, you ll also need to obtain approval from the Duke Institutional BioSafety Committee (IBC) before importing the plants. Shipping live plants 2

8 Note: An option to shipping live plants is arranging for dead plant/seed specimens to be shipped via host institutions under an inter-herbarium exchange. This is often much easier than going through the USDA. Likewise, institutions or labs can apply for a soil importation permit, which would allow for soil samples to be sent to the lab directly. Importation of plant and soil samples under a PPQ permit must pass through a USDA quarantine station, where it is inspected and shipped on to its final destination. The researcher is expected to include a paid envelope for shipment from the quarantine station. To ship live plants, the sender will need to fill out and enclose a phytosanitary certificate to get the plants through Customs. A detailed list of the package contents is also required, as well as a copy of the permit. The USDA will send address labels for you to place on the outside of the package. The label will have the address on the designated Plant Inspection Station - do not place your address on the outside of the package. You will need a customs broker to get the plants through USDA customs and on its way to you, for an additional fee (>$100). Usually the shipper, such as FedEx, can act as the customs broker. It s best if the sender arranges for a customs broker before shipping the samples. The customs broker may require you to fill out and fax them a Customs Power of Attorney, which will need to be signed by a higher-up Duke official, such as the Dean of Natural Sciences. If all goes well, your plants should be through customs and delivered to Duke within a week. They may or may not still be alive at this point, but that s not the USDA s problem. For herbaceous plants, seeds are probably the best way to go. Dormant stem cuttings may work for woody plants. Shipping soil There are a large number of regulations for importing, storing, and disposing of soil for analysis, which will be spelled out in the permit. In general, soil must be well-labelled, securely stored (e.g., in a securely closed, watertight or leak-proof primary container (test tube, vial, etc.) that must be enclosed in a second, durable watertight or leak-proof secondary container). Each container must be able to contain the soil independently. Soil is required to be sterilized upon arrival in the U.S. The USDA can sterilize samples upon request for 3lbs of soil. Otherwise, the host institution is required to sterilize the soil according to UDSA procedure. An exemption to sterilize soil can be requested for experimental purposes. Similarly, under PPQ526 permit, imported soil samples can be cultured, following special request. Soil samples must be disposed of by heat treatment (baking or autoclaving). Put the destination address on the outside and inside of the package, attach a PPQ form 550 sticker on the outside of the package, which will route the shipment to customs (they will send these), include the permit, include a detailed list of the contents, and make sure the contents are properly packaged. You should need to arrange for FedEx to serve as customs broker for an additional fee, as with plants. There is also an option to hand-carry soil. There are further restrictions on this, but, in general, customs agents at the airport will let you get through if you have any kind of soil permit. Sample checklist 1: International seed collection Bahamas Ministry of the Environment Scientific Research permit 3

9 Bahamas Ministry of Agriculture Export Permit Bahamas Ministry of Agriculture Approved Specimen Export Form USDA APHIS PPQ 587 Application for permit to import viable seeds Sample checklist 2: Importing genetically modified poplars for experimental purposes USDA APHIS PPQ 588 Application for permit to import prohibited plants or plant products for experimental purposes (poplars are prohibited) USDA APHIS Biotechnology Regulatory Services (BRS) Notification Acknowledgment Letter for introduction of genetically engineered plants Sender needs to include a phytosanitary certificate and detailed list of contents with the shipment Duke Institutional BioSafety Committee (IBC) registration should be completed before shipment, but no need to include with shipment Sample checklist 3: Domestic, threatened plant species endemic to the southwestern US USFWS Endangered/Threatened Species Scientific Collection Permit ( New Mexico Department of Energy, Minerals, and Natural Resources State Collection Permit Verbal or written letters of permission from private landowners 4