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Ralstonia Exclusion Program

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USDA regulates Ralstonia solanacearum race 3 biovar 2 (Rs R3bv2), a select agent

pathogen that poses a severe threat to important U.S. agricultural commodities such

as tomatoes, potatoes, and eggplants. 

Rs R3bv2 was listed as a select agent in the USDA Agricultural Bioterrorism

Protection Act of 2002. In 2005, APHIS amended the regulations (70 FR 61351) to

establish a certification program for articles of Pelargonium spp. and Solanum spp.

imported from countries where the bacterium (Rs R3bv2) is known to occur. For

Pelargonium spp. imports, the certification program followed the Minimum

Sanitation Protocol for Offshore Geranium Cutting Production.

In 2024, APHIS is implementing an updated framework for all Rs R3bv2 host

commodities under the Ralstonia Exclusion Program (REP). The REP framework will

be a basis for bilateral operational work plans allowing imports of Rs R3bv2 host

plants under the REP from countries where the select agent is known to occur. The

framework closes known sanitation and testing gaps in earlier protocols and clarifies

roles and responsibilities of all program participants. It also provides updated

standard operating procedures to execute following an Rs R3bv2 detection. APHIS

plans to roll out the REP in June 2024. 
Open for Comment

APHIS is seeking comment on the draft Ralstonia Exclusion Program (REP)

framework. The REP provides unified offshore facility standards to address Ralstonia

solanacearum race 3 biovar 2 (Rs R3bv2) for all propagative hosts. Please email your

comments to ppq.nappra@usda.gov. The comment period closes April 5, 2024.

View 2024 Ralstonia Exclusion Program Framework

General Requirements

To import into the United States Rs R3bv2 host plants from countries where the

select agent is known to occur, exporters must work with their National Plant

Protection Organization (NPPO) to participate in the REP. Participants may export

Rs R3bv2 host plants such as Pelargonium spp. cuttings or tomato plantlets in

growing media to the United States if they meet the following criteria: 

Consignments meet all requirements of an operational work plan between

APHIS and the NPPO of the exporting country.

REP host plants are produced in an APHIS-certified facility.

Consignments are represented by a customs entry that was filed with APHIS

CORE Message Set.

APHIS Facility Certification

APHIS must physically visit and certify all interested offshore facilities before they

may participate in the program. APHIS will provide certification services to facilities

that meet or exceed the minimum standards for facility construction, security,

production and sanitation, pest management, scouting, diagnostic testing, training,

treatments and record-keeping as described in the Ralstonia Exclusion Program

Framework. APHIS will work with the exporting NPPOs to coordinate certification

audits once a year. Participation in the REP requires the establishment of a trust

fund through a signed cooperative service agreement to cover the cost of

certification services and other site visits. 
For additional information please refer to the Ralstonia Exclusion Program

Framework, review the frequently asked questions below, or email questions to

pop.rep@usda.gov.

Frequently Asked Questions

The following questions and answers provide guidance and general information

about the implementation of the REP.

General Questions

What is the 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.

What happened to the Minimum Sanitation Protocol for Offshore Geranium Cutting Production?
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.

Is participation mandatory to export Pelargonium spp. cuttings or tomato plantlets in growing

media from Mexico to the United States?

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.

Who can participate?

Any offshore producer that meets the program requirements and is approved to

participate by their NPPO may participate in the program.

What are the program’s eligibility criteria?

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.

Are Pelargonium spp. and Geranium spp. both regulated under the program?

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. 

What is the process of joining the program?

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.

I also participate in the Offshore Greenhouse Certification Program (OGPC). Is my

consignment eligible for the OGCP if I commingle Pelargonium spp. cuttings and OGCP

approved plant taxa in the same consignment?

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.

Where can I find information about Ralstonia solanacearum?

There is information on the APHIS website about Ralstonia solanacearum, including

symptoms and pest status.

Where can I find additional information about the REP?

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.

Diagnostic Testing

Where can I obtain a copy of the APHIS work instruction for diagnostic water testing?
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.”

Information for National Plant Protection Organizations

When are commodities regulated for this select agent eligible for import?

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.

Information for Participating Offshore Producers

When is the annual facility certification audit?

Facility certification takes place during the active plant production and harvesting

period.

What will be evaluated during the annual certification audit?

The lead auditor will evaluate the facility against criteria from the REP framework,

associated operational work plans and an audit checklist.

Who performs the annual facility certification audit?

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.
What is included in the cost of a certification audit or site visit?

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.

Are there any application fees?

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

Do importers need to register?

No, importers do not need to register with APHIS. However, they must register with

the NPPO of the exporting country.

How long is the certification valid for?

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.

How long is the certification process?

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.

Information for Brokers

What information is required in the APHIS Core message set for the program?

The NPPO-assigned facility number or code

Producer name

Who should I contact for questions about the APHIS Automated Commercial Environment?
Please contact ace.itds@usda.gov.