Ralstonia Exclusion Program

The Ralstonia Exclusion Program (REP) is a certification program for offshore facilities that produce Ralstonia solanacearum race 3 biovar 2 (Rs R3bv2) host plants for export to the United States under a systems approach. The REP intends to mitigate risks of importing propagative plant material that can host select agent Rs R3bv2 into the continental United States from countries where Rs R3bv2 is known to occur. The minimum phytosanitary measures include, but are not limited to, protocols for commodity production, packing, safeguarding, diagnostic testing, treatment, export certification, and shipping to the United States. Commodities regulated for this select agent are eligible for import when program participants comply with this framework and with an operational work plan (OWP) signed with the National Plant Protection Organization (NPPO) of the country of origin. OWP agreements with each NPPO may describe in greater detail mitigation measures necessary at specific production sites to meet REP program standards.

The select agent Rs R3bv2 (7 CFR 331.3) is a damaging pathogen of important US agricultural commodities such as tomatoes, potatoes, and eggplants. In production greenhouses, spread of this pathogen can occur through transplanting infected plants, pinching buds off plants without sanitizing, using contaminated tools between cuttings, and irrigating with sub-irrigation or ebb-and-flow systems. Growing plants in certified greenhouses under a systems approach can effectively mitigate most of the pest risk associated with these practices.

The Minimum Sanitation Protocol for Offshore Geranium Cutting Production was last updated by APHIS in 2007. In updating this protocol, APHIS developed the Ralstonia Exclusion Program to incorporate sanitation protocols and program requirements for all Rs R3bv2 host plants, including Pelargonium spp. and Solanum spp., into a single framework.

Yes, participation in the REP is mandatory, unless imported from a country where Rs R3bv2 is known not to occur. Currently only Canada and Israel are known to be free of Rs R3bv2.

Any offshore producer that meets the program requirements and is approved to participate by their NPPO may participate in the program.

• There must be a bilateral agreement between APHIS and the NPPO of the exporting country.
• Rs R3bv2 host plants must be produced in an APHIS-certified facility.
• Consignments must meet all the permit and import requirements stated in 7 CFR 319.37, the Plants for Planting Manual, Agricultural Commodities Import Requirements database, and relevant operational work plans.
• Consignments must be represented by a customs entry that was filed with APHIS CORE Message Set and which includes the NPPO-assigned facility code.

No. Pelargonium spp. and Geranium spp. are two separate genera of plants in the geranium family. A common name for both species is geranium. Only Pelargonium spp. is regulated as a host of Rs R3bv2. 

The REP framework outlines requirements to become an approved participating facility. Please refer to Section 4.4 Requirements for Approved Facilities.

• Interested offshore producers must send an official request to APHIS through the NPPO expressing their interest in participating in the REP.
• The NPPO of the country of export must approve the facility to participate in the REP prior to notifying APHIS of their readiness for an initial certification audit.
• The NPPO must sign a Cooperative Service Agreement (CSA) between APHIS and the NPPO-designated cooperator.
• The facility must work with the NPPO-designated cooperator to reimburse APHIS for certification and inspection services using a trust fund established under the CSA agreement.

No, Pelargonium spp. cuttings cannot be shipped in the same consignment with OGCP approved plant taxa if an importer wishes to benefit from reduced inspection rates associated with the OCGP program. For example, if you are importing a consignment with Pelargonium spp. (not approved for the OGCP), and Mandevilla sp. (approved for the OGCP) that cargo will not be eligible for OGCP and will be inspected at the full rate at the port of entry.

There is information on the APHIS website about Ralstonia solanacearum, including symptoms and pest status.

• Visit ACIR for specific import requirements for Pelargonium spp. cuttings and tomato plantlets in growing media from Mexico.
• View the ACIR List of facilities approved to ship under this program. 
• Send questions or requests for more information in an email to pop.rep@usda.gov.

Please email APHIS-PPQCPHSTBeltsvilleSampleDiagnostics@usda.gov to request a copy of the work instruction for methods for concentrating and detecting Ralstonia solanacearum in irrigation water using a filter funnel system. Please include the title of the work instruction in the subject line of the email: WI-B-T-1-112.  

The work instruction is titled “Sample processing and molecular detection of Ralstonia solanacearum (Rs) in irrigation water using a Filter funnel and real time PCR.”
 

Commodities regulated for this select agent are eligible for import when program participants comply with this framework and with an OWP signed with the NPPO of the exporting country of origin. OWP agreements with each NPPO may describe in greater detail mitigation measures necessary at specific production sites to meet REP program standards.

Facility certification takes place during the active plant production and harvesting period.

The lead auditor will evaluate the facility against criteria from the REP framework, associated operational work plans and an audit checklist.

A certified APHIS auditor in collaboration with an NPPO representative and, if available, a local APHIS staff. In some circumstances, two or more certified auditors might be needed to complete the audit.

The cost of certification and inspection services includes the salary, benefits, overtime (if applicable), travel, accommodations, and overhead for the auditor(s). If APHIS audits several facilities in one trip the travel costs can be divided among the facilities visited.

No, there are no application fees to participate in the program.

No, importers do not need to register with APHIS. However, they must register with the NPPO of the exporting country.

The certification is valid for 1 year. To maintain certification, a full system certification audit is required every year for production facilities and a maximum of every third year for elite facilities.

If corrective action requests (CAR) are issued during the audit, the facility cannot be certified until all CARs are closed.

The certification process can take up to 12 months from planning the site visit to the final certification decision. APHIS will notify the facility of the certification audit outcome by an official letter to the NPPO.

• The NPPO-assigned facility number or code
• Producer name

Please contact ace.itds@usda.gov.

The deviation request process allows an REP participant to propose an alternative way to meet an REP requirement for APHIS evaluation. A deviation could include a change from the stated process in the framework, or a request for a new chemical or treatment. Follow the guidance below to request a deviation from the framework.

Process to Request Deviations from the REP Framework

1. The Producer must communicate with the NPPO of the exporting country about their deviation request, and identify the associated section and paragraph number in the REP.
2. The Producer must propose an alternative mitigation practice in detail and show how the alternative meets the safeguarding goals.
3. The NPPO must assess if the alternative mitigation is acceptable.
4. The NPPO must submit a formal letter to APHIS with the following information:
   1. A request for APHIS to assess a deviation to the REP framework for the place of production.
   2. Identification of the associated sections and paragraph numbers in the REP framework. 
   3. An explanation of the reason, purpose, or need for the deviation.
   4. A detailed description of the proposed deviation. 
   5. A proposed implementation plan for the deviation. 
   6. Scientific evidence (i.e. peer-reviewed journals) or experimental data from the production site and any other information that supports the proposed mitigation measures for the deviation.
5. APHIS will acknowledge receipt and begin evaluation the deviation request package.
6. After receiving the deviation request package from the NPPO, APHIS may request more information. Once the deviation request package is complete, evaluation may take a minimum of 60 days.
7. If approved, APHIS will send official correspondence to the NPPO and will notify the requesting place of production via email.
8. An approval for a deviation request could be temporary and is not guaranteed.

For additional information please refer to the Ralstonia Exclusion Program Framework, review the frequently asked questions, or email questions to pop.rep@usda.gov.