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• Import into the U.S.
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• Regulated Organism and Soil Permits
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Importation of Soil Amendments or Plant Health Enhancers, (Including Fertilizers, Compost, Sludge, and Other Materials Used to Enhance Plant Growth

The Animal and Plant Health Inspection Services (APHIS) of the United States Department of Agriculture (USDA) is charged with protecting the health and value of American agriculture and natural resources from the introduction of destructive plant and animal diseases and pests. USDA-APHIS processes permit applications for a variety of organic soil amendments/plant health enhancers from various countries for commercial purposes. These commodities have numerous names that typically are descriptive of their intended use, but the products typically contain living microorganisms and plant and/or plant parts that may have been composted or mechanically processed. Permits or other documentation may be required for entry of these products into the U.S. from foreign countries, and in the absence of these documents, shipments can be denied entry. The following guidance is intended to assist potential importers of these commodities. Individuals wishing to import these commodities must also follow the statutes of other regulatory agencies and programs such as the Environmental Protection Agency (EPA), Centers for Disease Control (CDC), Food and Drug Administration (FDA), and Fish and Wildlife Services (FWS), etc.  State Departments of Agriculture may regulate fertilizers, and they may issue permits or other documentations authorizing the use of domestic products within their States.  Please note that State Departments of Agriculture do not regulate foreign commerce, and their documentation is not sufficient for the entry of these products into the U.S.

What are soil amendments/ plant health enhancers?
Soil amendments/plant health or growth enhancers are materials that typically are added to soil, plants, or the plant-growth environment to enhance plant growth. These include fertilizers, compost, sludge, manure, microbes, additives, and others or combinations thereof. For regulatory purposes any material that meets this definition will be called ‘Plant Growth Enhancer.’

Plant Growth Enhancers (PGEs)
PGEs may enhance plant growth by various mechanisms. These include: providing supporting nutrients (fertilizers), and improving soil condition (i.e., adjusting the pH of the soil, improving soil structure and texture, aeration adjustment, and moisture conservation among others), or controlling or suppressing plant pests. These PGEs could contain organic and inorganic components, and could be of natural or synthetic origin. Inorganic PGEs are composed of synthetic chemicals and/or minerals, while organic PGEs are often composed of organic matter from plant/animal sources, and/or microbes. Thus, organic amendments may include materials such as manure, earthworm castings, soil, sphagnum peat, grass clippings, straw, wood chips, various composts, seaweed, guano, or naturally occurring mineral deposits (e.g. saltpeter), and living microorganisms among others.

Regulatory policy pertaining to the importation of PGEs into the U.S
PGEs have the potential to contain pests or plants and plant parts that present a risk to American agriculture and the environment. Therefore, release of these commodities into the environment could be detrimental to U.S. agriculture and the environment. APHIS regulates living organisms that could impact animal and plant health. These products could contain human and animal pathogens, which may be regulated by other agencies.  APHIS has the authority to regulate microbial organisms that are biocontrol organisms or have biopesticidal properties. More information can be obtained from the Permits and Certifications APHIS Web site.  Select link entitled, “Guidelines and Regulations for Microbial Pathogens Used to Control Invertebrate Plant Pests”

APHIS may also regulate many of the following components: microbial organisms, mollusks, arthropods, nematodes, plants and plant parts, noxious weed seeds, soil, earthworm castings and animal products such as manure and bedding materials. Animal products that may present a risk to animal health are regulated by APHIS Veterinary Services (VS). VS may be contacted by email at AskNCIE.Products@usda.gov or by phone at 301-851-3300. For information pertaining to soil, plant and plant products, organisms, and biocontrol/microbial biopesticides, contact APHIS Plant Protection and Quarantine (PPQ) by email at pest.permits@usda.gov, or by phone at 866-524-5421. Other Federal, State, and local Agencies may also regulate these products.

Permitting policy pertaining to the importation of PGEs into the U.S

• APHIS can either authorize importation through the issuance of a permit, or deny the application, because there is no acceptable safeguard to mitigate the risk associated with a commodity that contains plant pests or biocontrol/biopesticide organism, if the application is for environmental release.
• APHIS could authorize importation of the commodity into containment for further research, but deny its release into the environment.
• Permit applications for environment release require rigorous evaluation and may be subject to regulations of other Agencies.  Permits for research that includes environmental release can only be authorized for field studies of 10 acres or less. See below for a questionnaire that will enable importers to provide required information to APHIS.
• APHIS also evaluates the media in which the organisms are contained to ensure that it is free of plant or animal health risk.
• If APHIS determines that the PGEs do not represent a pest risk to American agriculture or the environment, APHIS is still required to meet the requirements of the National Environmental Policy Act (NEPA) and the FWS Endangered Species Act (ESA) prior to authorization of the entry and release of these commodities into the U.S. APHIS will issue letters of decision on a case-by-case basis following the evaluation of the risk associated with the components of the product.
• Letters of decision include; “letters of denial,” “letters of no permit required,” or “letters of no jurisdiction.”  Letters of no permit required or letters of no jurisdiction should accompany shipments in order to facilitate entry into the U.S.  A letter of denial will indicate that APHIS will not issue a permit, based on the risk to American agriculture.
• If a product is authorized to enter the U.S., certificates of purity and identity may be required.

What is not regulated?

• PGEs that are free of organic material; organic materials that are exempt from USDA regulations are described in the soil circular. These include volcanic rock, pumice, and peat (if processed to uniform consistency and are free of plant parts and seed). Sterile media is not regulated, and certification of the sterilization process is required.
• PGEs that only contain pure cultures of organisms of known identity that are not human, animal, or plant pests or pathogens or biocontrol organisms/biopesticides.

From what locations are the PGEs regulated?

• All foreign sources, Hawaii, and all U.S. territories.
• Parts of U.S. under Federal quarantine as authorized under 7CFR 301 regulations and quarantines.

What information is required by APHIS to facilitate the evaluation and decision process? [Questionnaire]

Please provide answers to the following questions as well as the additional information requested below:

1. If your product contain live organisms, please:
    
   • Provide a complete scientific name and strain for each microbe; the country where the organism was originally isolated; and the environment where it was isolated (e.g., soil, water, animal, plant, detritus, etc.).
   • Indicate if the presence of each microbe was confirmed in your final product as determined by an analysis. If so, please describe the method used and provide a copy of the results.
   • Provide data and scientific literature citations addressing whether each microbe is pathogenic (or non-pathogenic) to plants, humans, animals, and non-target organisms likely to be present in the environment where the material will be released, if applicable.
      
2. Please provide a complete list of all ingredients in each product.
3. Please indicate whether your product is for research or commercial purposes (sale / distribution). If for research, please specify if for field, laboratory, growth chamber, and/ or greenhouse use.
4. Does your product contain soil? Does your product contain earthworm castings, sludge, manure, farm waste, or other organic materials? Please describe.
5. Does your product contain plant matter including decaying materials? Please describe where the plant matter was obtained and/ or what it was derived from.
6. Has your product been processed or treated? If so, please describe such processing or treatment and provide a detailed protocol for each method.
7. Please describe the mechanism of action by which the product enhances plant growth. Provide the scientific basis for such mechanism of action.
8. Does it target and/ or control a plant pest(s) or noxious weed? If so, what is the target pest(s) and/ or noxious weed?
9. Have the microbes been reported in the scientific literature to produce toxins or antibiotics? If yes, do you believe these have a role in providing the intended plant health benefit? Please describe.

Please Note: Answers to the questions can be supplemented with file attachments, photos etc. Also, follow-up questions may be asked.

Commercial sale of imported PGEs containing organic matter and/or organisms of unknown identity is not authorized unless the material has been treated to destroy all organisms, Federal noxious weed seeds, and other contaminants. These treatments are similar to those approved for soil. For additional information, see the APHIS Regulated Organism and Soil Permits Web site.  Please contact APHIS before shipment of such materials.

Contact Information
For further guidance and permit requirements, please contact: 

APHIS/PPQ 
Email:  pest.permits@usda.gov 
Telephone 866-524-5421. 

For PPQ/VS 
Email: AskNCIE.Products@usda.gov
Telephone:  301-851-3300.