Animal and Plant Health Inspection Service, USDA.
We are amending the regulations governing the importation of plants for planting to authorize the importation of tomato plantlets from Mexico in approved growing media, subject to a systems approach. The systems approach consists of measures currently specified for tomato plants for planting not imported in growing media, as well as measures specific to all plants for planting imported into the United States in approved growing media. Additionally, the plantlets must be imported into greenhouses in the continental United States and the importers of the plantlets from Mexico or the owners of the greenhouses in the continental United States must enter into compliance agreements regarding the conditions under which the plants from Mexico must enter and be maintained within the greenhouses. This rule allows for the importation into the continental United States of tomato plantlets from Mexico in approved growing media, while providing protection against the introduction of plant pests. The rule also allows the imported greenhouse plantlets to produce tomato fruit for commercial sale within the United States.
Effective November 2, 2015.
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FOR FURTHER INFORMATION CONTACT:
Ms. Lydia E. Colon, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236; (301) 851-2302.
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The regulations in 7 CFR part 319 prohibit or restrict the importation of certain plants and plant products into the United States to prevent the introduction of quarantine plant pests. The regulations contained in “Subpart—Plants for Planting,” §§ 319.37 through 319.37-14 (referred to below as the regulations), prohibit or restrict, among other things, the importation of living plants, plant parts, and seeds for propagation or planting.
The regulations differentiate between prohibited articles and restricted articles. Prohibited articles are plants for planting whose importation into the United States is not authorized due to the risk the articles present for introducing or disseminating plant pests. Restricted articles are articles authorized for importation into the United States, provided that the articles are subject to measures to address such risk.
Section 319.37-5 of the regulations lists restricted articles that may be imported into the United States only if they are accompanied by a phytosanitary certificate that contains an additional declaration either that the restricted articles are free of specified quarantine pests or that the restricted articles have been produced in accordance with certain mitigation requirements. Within the section, paragraph (r) contains requirements for the importation of restricted articles (except seeds) of Pelargonium or Solanum spp. into the United States. Solanum spp. restricted articles include tomato (Solanum lycopersicum) plantlets, in addition to other species and cultivars within the genus.
Paragraph (r)(1) of § 319.37-5 authorizes the importation into the United States of Pelargonium or Solanum spp. restricted articles from Canada under the provisions of a greenhouse-grown restricted plant program. Paragraph (r)(3) contains conditions for the importation into the United States of Pelargonium or Solanum spp. restricted articles that do not meet the conditions in paragraph (r)(1), and are from a country in which Ralstonia solanacearum race 3 biovar 2 is known to occur.
Conditions for the importation into the United States of restricted articles in growing media are specifically found in § 319.37-8. Within that section, the introductory text of paragraph (e) lists taxa of restricted articles that may be imported into the United States in approved growing media, subject to the mandatory provisions of a systems approach. In § 319.37-8, paragraph (e)(1) lists the approved growing media, and paragraph (e)(2) contains the provisions of the systems approach. Within paragraph (e)(2), paragraphs (i) through (viii) contain provisions that are generally applicable to all the taxa listed in the introductory text of paragraph (e), and paragraphs (ix) through (xi) contain additional taxon-specific conditions.
In response to a request from the national plant protection organization (NPPO) of Mexico, in a proposed rule 
published in the Federal Register (80 FR 11946-11950, Docket No. APHIS-2014-0099) on March 5, 2015, we proposed to amend the regulations to authorize the importation into the continental United States of tomato (Solanum lycopersicum) plantlets from Mexico in growing media, subject to a systems approach. Because we considered R. solanacearum race 3 biovar 2 to exist in Mexico, the proposed systems approach included the measures specified in paragraph (r)(3) of § 319.37-5. Because the plantlets would be imported in growing media, the systems approach also included the general conditions in § 318.37-8 for all taxa of plants for planting imported into the United States in growing media. Finally, we also proposed that the plantlets would have Start Printed Page 59558to be imported into greenhouses in the continental United States and the importers of the plantlets from Mexico or the owners of the greenhouses in the continental United States would have to enter into compliance agreements regarding the conditions under which the plants from Mexico must enter and be maintained within the greenhouses.
We solicited comments concerning our proposal for 60 days ending May 4, 2015. We received 19 comments by that date. They were from an NPPO, two State departments of agriculture, an organization representing State departments of agriculture, U.S. tomato producers, importers of tomato plantlets, professors who specialize in U.S. tomato production, a U.S. Senator, local and municipal governments, and a private citizen.
Most of the commenters urged us to finalize the proposed rule, as written. Several commenters were generally supportive of the rule, but requested clarifications regarding the provisions of the rule, or modification to those provisions. Finally, several commenters did not support the rule. We discuss the comments that we received below, by topic.
Comments Regarding the Presence of Ralstonia Solanacearum Race 3 Biovar 2 in Mexico
In the request that we received from the NPPO of Mexico to authorize the importation of tomato plantlets into the continental United States in approved growing media, the NPPO specified that the plantlets would be produced from certified seed, would be produced in greenhouses constructed and maintained to be pest-exclusionary, would be shipped in growing media maintained under similar conditions, and would be safeguarded during movement to the continental United States to prevent plant pests from being introduced to the plantlets.
To evaluate this request, we prepared a pest risk assessment (PRA) that analyzed the potential pest risks associated with the importation of tomato plantlets from Mexico produced under such conditions. The PRA concluded that a number of quarantine pests of tomato plantlets exist in Mexico, including R. solanacearum race 3 biovar 2, but that, if the plantlets are produced in accordance with the conditions specified by the NPPO, they would present a negligible risk of quarantine pests being introduced into the continental United States through their importation in approved media.
Based on the findings of the PRA, a risk management document (RMD) that also accompanied the proposed rule recommended that, among other requirements, the plantlets should be authorized importation subject to paragraph (r)(3) of § 319.37-5 because of the presence of R. solanacearum race 3 biovar 2 in Mexico.
A commenter disputed the presence of R. solanacearum race 3 biovar 2 in Mexico. The commenter stated that, of the ten references 
that APHIS cited in the PRA regarding the presence of R. solanacearum race 3 biovar 2 in Mexico, five only stated that R. solanacearum race 3 is present in Mexico, and did not identify the biovar; three isolated R. solanacearum from samples obtained from Mexico, but did not state that the samples became infected in Mexico or delineate where in Mexico the samples originated; and the remaining two suggested that plantlets affected with R. solanacearum race 3 biovar 2 have been detected in Mexico, but did not rule out that the plantlets were germinated from infected, imported seed. The commenter also stated that most of the references cited could be classified as “unreliable” pursuant to the International Plant Protection Convention's International Standards for Phytosanitary Measures (ISPM) No. 8, and that ISPM No. 8 prohibits importing countries from assessing the pest status of a foreign region based on unreliable records.
For these reasons, the commenter concluded that APHIS should state that the presence of R. solanacearum race 3 biovar 2 in Mexico is unknown because of unreliable pest detection records, and remove the R. solanacearum race 3 biovar 2-specific provisions from the systems approach.
Similarly, another commenter pointed out that R. solanacearum race 3 biovar 2 has been detected in the United States on two occasions, yet there are no R. solanacearum race 3 biovar 2-specific restrictions on the interstate movement of tomato plantlets within the United States. The commenter asked us to explain or address this discrepancy.
Unlike other phytopathogenic bacteria, race classifications for R. solanacearum are not based on gene-for-gene interactions across host species, but rather on pathogenicity in different types of host plants. Biovars of R. solanacearum, in contrast, do cross species. There is, accordingly, generally no correlation between races and biovars of R. solanacearum, and, in general, one cannot presume a specific biovar of R. solanacearum has been detected in a host plant based on knowledge of the race isolated.
However, this is not true of race 3 and biovar 2 of R. solanacearum. There exists a distinct and close correlation between this race and biovar of the disease, such that, in the international taxonomic community, references to race 3 of R. solanacearum are presumed to refer to biovar 2, and references to biovar 2 of R. solanacearum are presumed to refer to race 3. The five references in the PRA that referred to the presence of R. solanacearum race 3 in Mexico (CABI 1999, CABI 2012, EPPO 1997, EPPO 2012, and Hernández-Romano et al.) used this common taxonomic practice, and thus do refer to R. solanacearum race 3 biovar 2.
Of the three articles that the PRA referenced in which R. solanacearum was isolated from samples obtained from Mexico (Meng et al., Milling et al., and Sanchez-Perez et al.), one (Meng et al.) explicitly states that the isolate of R. solanacearum race 3 biovar 2 used in the study is from Mexico. The other two state that the isolates were obtained from a collection that is housed at the University of Wisconsin, and is identified as being of Mexican origin. While none of the references identify Start Printed Page 59559the exact location in Mexico where the isolates originated, that location is not germane to determining whether or not R. solanacearum race 3 biovar 2 is present in Mexico.
Of the remaining two articles, we agree that one (Xu et al.) does not conclude that R. solanacearum race 3 biovar 2 is present in Mexico, and will no longer use it as a reference in future discussions of the presence of R. solanacearum race 3 biovar 2 in Mexico.
We disagree, however, that the other article (Perea et al.) could merely provide evidence that infected imported seed was used to germinate tomato plantlets within Mexico. Seed transmission of R. solanacearum race 3 biovar 2 is extremely rare; soil, water, and plant debris are far more common pathways for the disease. Additionally, the infected plantlets identified by Perea et al. exhibited no signs of infection during the early stages of production, when they were potted and housed in greenhouses; the plantlets only appeared symptomatic well after they were planted in an outdoor field. When potted plants are infected with R. solanacearum race 3 biovar 2, however, they tend to appear symptomatic within 30 days. This suggests that the seed from which the plantlets were germinated was not infected with R. solanacearum race 3 biovar 2. Rather the evidence provided in Perea et al. strongly suggests that the plantlets became infected in an outdoor field through contact with infected soil, water, or debris.
We agree with the commenter that the references are of varying reliability, but disagree with the commenter's interpretation of ISPM No. 8. ISPM No. 8 does not distinguish between reliable and unreliable records, but rather provides criteria by which an importing country should assess the relative reliability of a record in comparison to other records. The ISPM acknowledges that determining whether a particular plant pest exists in a foreign region is, however, ultimately a subjective “expert judgment” made by the importing country.
After reviewing the records available to us in light of the commenter's concerns, we have determined that there is significant evidence that R. solanacearum race 3 biovar 2 exists in the natural environment within Mexico. This differs from the United States, where outbreaks of R. solanacearum race 3 biovar 2 have been limited to greenhouses and arisen from the importation of infected plants.
Accordingly, we consider it appropriate to maintain R. solanacearum race 3 biovar 2-specific provisions as part of our systems approach for the importation of tomato plantlets in growing media from Mexico, and have made no changes to the provisions of the proposed rule in response to this comment.
In a similar vein, a commenter asked us why the proposed rule had contained R. solanacearum race 3 biovar 2-specific provisions, given that the PRA found that it “highly unlikely” that tomato plantlets from Mexico would become infected with the disease.
The PRA found such transmission to be highly unlikely, provided that the plantlets are produced under the provisions of the systems approach. The PRA did not evaluate the likelihood that plantlets produced under different conditions would become infected with R. solanacearum race 3 biovar 2. Because we consider that disease to exist in the natural environment within Mexico, the risk would be considerably higher, and thus the need for the required provisions.
Comments Regarding Organic Certification
Several tomato producers within the United States supported the proposed rule, and stated that they would like to import tomato plantlets in growing media from Mexico if the rule is finalized. However, the commenters stated that they are certified organic by the United States Department of Agriculture (USDA), and expressed concern that several of the mitigation measures specified in the risk management document (RMD) that accompanied the proposed rule appeared to require fumigation with methyl bromide and the use of disinfectants that are not approved by USDA for organic production. The commenters noted, however, that the proposed rule itself did not appear to require either fumigation or the use of such disinfectants. The commenters inquired whether there was a discrepancy between the RMD and the proposed rule, and, if so, which provisions they would be expected to adhere to.
Paragraph (r)(3)(viii) of § 319.37-5 requires Solanum spp. plants for planting from countries in which R. solanacearum race 3 biovar 2 is known to occur to be grown in growing media that is free of R. solanacearum race 3 biovar 2. In order for growing media to be considered free of R. solanacearum race 3 biovar 2, guidance that we have developed for producers states that the growing media should either be fumigated with methyl bromide at 3 grams per liter of media for 72 hours at 21° Celsius or above, or steam sterilized so that the media reaches a temperature of 80° Celsius for at least 2 hours. The RMD referred to both of these options, and either option would fulfill the requirements of the regulations.
Paragraph (r)(3)(vi) of § 319.37-5 requires all equipment that comes in contact with articles of Solanum spp. within a production site to be adequately sanitized so that R. solanacearum race 3 biovar 2 cannot be transmitted between plants or enter from outside the production site via equipment, while paragraph (r)(3)(vii) of § 319.37-5 requires production site personnel to adequately sanitize their clothing before entering the production site to prevent the entry of R. solanacearum race 3 biovar 2 into the production site.
APHIS has determined that several disinfectants may be used to meet these sanitation requirements. One of them, hydrogen peroxide, is approved by USDA for organic production.
General Comments on the Proposed Rule
One commenter suggested that we should authorize the importation of tomato seeds from Mexico, rather than tomato plantlets in growing media.
The regulations already authorize the importation of tomato seeds from Mexico. The market access request from the NPPO of Mexico was for tomato plantlets in growing media.
One commenter suggested that we consider authorizing the importation of tomato plantlets from Mexico under “Good Seed and Plant Production Practices” (GSPPPs), an international accreditation standard for pest-free production of plants for planting.
Generally applicable standards such as the GSPPPs may not always address taxon-specific plant pest risks. Additionally, the regulations are currently written in a manner which does not facilitate the use of such generally applicable standards. However, if finalized, a proposed rule 
published in the Federal Register on April 25, 2013 (78 FR 24634-24663; Docket No. APHIS-2008-0011) would restructure the regulations to facilitate the potential use of GSPPPs.
Two commenters stated that certain areas of the continental United States are more hospitable to the establishment of quarantine pests of tomatoes than others, and the rule should be amended to prohibit the importation of tomato plantlets in growing media from Mexico into those areas.Start Printed Page 59560
If the provisions of the proposed rule are adhered to, the plantlets will present a negligible risk of introducing quarantine pests into any area of the continental United States. Therefore, the relative likelihood of establishment of these pests in a particular part of the continental United States is not germane, and we are making no changes to the provisions of the systems approach based on these comments.
Comments Regarding Specific Provisions of the Systems Approach
We proposed that the production site where the plantlets were produced would have to test for R. solanacearum race 3 biovar 2 and maintain records regarding such testing for at least two growing seasons.
A commenter stated that indoor production facilities have growing cycles, rather than growing seasons, and inquired whether maintaining the records for two growing cycles would suffice to meet this requirement.
Operationally, we rely on the definition of “growing season” provided in ISPM No. 5, “Glossary of Phytosanitary Terms.” 
This definition considers a growing season to be the period or periods of the year when plants actively grow in an area, place of production, or production site.
The commenter did not specify what they meant by “growing cycle.” However, if the commenter meant the time period during which a particular set of tomato plantlets are in active growth within the producer's facility, from establishment to harvest, then the term “growing season” is equivalent to the term “growing cycle.”
We proposed that the greenhouses in which the plantlets are produced in Mexico would have to be surrounded by a 1-meter sloped buffer.
One commenter asked whether the buffer had to be around the perimeter of each of the greenhouses, or whether the greenhouses could collectively be surrounded by the buffer.
Either type of buffer suffices to meet this requirement.
We proposed that the plantlets would have to be handled and packed in a manner which precludes the introduction of R. solanacearum race 3 biovar 2 to the articles.
One commenter asked whether these procedures would prevent insect pests from being introduced onto the plantlets during movement to the United States.
Safeguarding procedures which prevent the introduction of R. solanacearum race 3 biovar 2 onto host plants are also sufficient to prevent the introduction of insect pests.
Finally, we proposed that the plantlets would have to be imported directly into a pest-exclusionary greenhouse in the continental United States.
One commenter asked whether the plantlets could be offloaded into a pest-exclusionary docking station at the same production site in the United States that contains the pest-exclusionary greenhouses, then resealed and moved to the greenhouses at a further stage of production.
Provided that the docking station has been evaluated by APHIS and provides an equivalent level of pest exclusion as do the greenhouses themselves, they may.
Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, without change.
Executive Orders 12866 and 13563 and Regulatory Flexibility Act
This rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
In accordance with 5 U.S.C. 604, we have performed a final regulatory flexibility analysis, which is summarized below, regarding the economic effects of this rule on small entities. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.
The rule will allow the importation of tomato plantlets in approved growing media from Mexico into the continental United States. Currently, tomato plantlets in growing media are not admissible into the United States except from Canada. The imported plantlets will be allowed to be imported only to APHIS-approved facilities under compliance agreements, and will be used only for fruit production.
Data are not available on the production or trade of tomato plantlets. However, U.S. greenhouse (more generally termed protected-culture) tomato production and import levels provide evidence of the expanding derived demand for tomato plantlets. In 2011, protected-culture tomatoes made up 40 percent of the U.S. tomato supply, up from less than 10 percent in 2004; they now dominate retail tomato sales. The value of protected-culture tomato imports by the United States grew by two-thirds between 2009 and 2013, in response to expanding consumer demand, from $795 million to $1.33 billion.
Reportedly, there are few nurseries in the United States that produce tomato plantlets and their volume of production is relatively small. The final rule will enable U.S. producers of protected-culture tomatoes to draw upon Mexican plantlet suppliers in addition to imports from Canada, and is expected to have a positive economic impact on the protected-culture tomato industry.
Protected-culture tomato producers are classified in the North American Industry Classification System within Other Vegetable (except Potato) and Melon Farming (NAICS 111219), for which the Small Business Administration small-entity standard is annual receipts of not more than $750,000. The average market value of agricultural products sold by operations in this industry in 2012 was about $314,000. While we are unable to determine the number of businesses that will be affected by the final rule, we can assume that at least some of them are small entities.
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.
National Environmental Policy Act
An environmental assessment and finding of no significant impact have been prepared for this final rule. The environmental assessment provides a basis for the conclusion that the importation into the continental United States of tomato plantlets in growing media from Mexico, subject to a required systems approach, will not have a significant impact on the quality of the human environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.
The environmental assessment and finding of no significant impact were prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA Start Printed Page 59561(7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).
The environmental assessment and finding of no significant impact may be viewed on the Regulations.gov Web site. Copies of the environmental assessment and finding of no significant impact are also available for public inspection at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead on (202) 799-7039 to facilitate entry into the reading room. In addition, copies may be obtained by writing to the individual listed under FOR FURTHER INFORMATION CONTACT.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this final rule, which were filed under 0579-0431, have been submitted for approval to the Office of Management and Budget (OMB). When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action we plan to take.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to compliance with the EGovernment Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this final rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
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- Nursery stock
- Plant diseases and pests
- Reporting and recordkeeping requirements
Accordingly, we are amending 7 CFR part 319 as follows:
PART 319—FOREIGN QUARANTINE NOTICES
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1. The authority citation for part 319 continues to read as follows: End Amendment Part
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2. Section 319.37-1 is amended by adding, in alphabetical order, a definition for compliance agreement to read as follows:End Amendment Part
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Compliance agreement. A written agreement between APHIS and a person (individual or corporate) engaged in the production, processing, handling, or moving of restricted articles imported pursuant to this subpart, in which the person agrees to comply with the subpart and the terms and conditions specified within the agreement itself.
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3. Section 319.37-8 is amended as follows: End Amendment Part
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a. In paragraph (e), introductory text, by removing the period after the entry for “ Schlumberga spp. from the Netherlands and Denmark” and adding, in alphabetical order, an entry for “Solanum lycopersicum from Mexico.”.End Amendment Part
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b. By adding paragraph (e)(2)(xii). End Amendment Part
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c. By revising the OMB citation at the end of the section. End Amendment Part
The addition and revision read as follows:
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(e) * * *
(2) * * *
(xii) Plantlets of Solanum lycopersicum from Mexico must also meet the following conditions:
(A) The plantlets must be produced in accordance with § 319.37-5(r)(3);
(B) The plantlets can only be imported into the continental United States, and may not be imported into Hawaii or the territories of the United States; and
(C) The plantlets must be imported from Mexico directly into a greenhouse in the continental United States, the owner or owners of which have entered into a compliance agreement with APHIS. The required compliance agreement will specify the conditions under which the plants must enter and be maintained within the greenhouse, and will prohibit the plantlets from being moved from the greenhouse following importation, other than for the appropriate disposal of dead plantlets.
(D) If all of the above requirements are correctly complied with, then the tomato fruit produced from the imported greenhouse plantlets may be shipped from the greenhouses for commercial sale within the United States.
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(Approved by the Office of Management and Budget under control numbers 0579-0266 and 0579-0431)
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Done in Washington, DC, this 28th day of September 2015.
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-25100 Filed 10-1-15; 8:45 am]
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