Amendments to the Pale Cyst Nematode Regulations

Citation85 FR 85497
Record Number2020-26962
Published date29 December 2020
SectionRules and Regulations
CourtAnimal And Plant Health Inspection Service
Federal Register, Volume 85 Issue 249 (Tuesday, December 29, 2020)
[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
                [Rules and Regulations]
                [Pages 85497-85503]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-26962]
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                Rules and Regulations
                 Federal Register
                ________________________________________________________________________
                This section of the FEDERAL REGISTER contains regulatory documents
                having general applicability and legal effect, most of which are keyed
                to and codified in the Code of Federal Regulations, which is published
                under 50 titles pursuant to 44 U.S.C. 1510.
                The Code of Federal Regulations is sold by the Superintendent of Documents.
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                Federal Register / Vol. 85, No. 249 / Tuesday, December 29, 2020 /
                Rules and Regulations
                [[Page 85497]]
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                DEPARTMENT OF AGRICULTURE
                Animal and Plant Health Inspection Service
                7 CFR Part 301
                [Docket No. APHIS-2018-0041]
                RIN 0579-AE48
                Amendments to the Pale Cyst Nematode Regulations
                AGENCY: Animal and Plant Health Inspection Service, USDA.
                ACTION: Final rule.
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                SUMMARY: We are amending the domestic quarantine regulations for pale
                cyst nematode by adding procedures that allow persons to review and
                comment on the protocols for regulating and deregulating quarantined
                and associated areas. As part of this action, we have made the
                protocols available online. We are taking these actions in response to
                a court order requiring the Animal and Plant Health Inspection Service
                to provide a means for public input on the protocols we use to
                deregulate fields for pale cyst nematode and to make the protocols
                publicly available. These changes make the protocols accessible to all
                and give persons the opportunity to comment on them.
                DATES: Effective January 28, 2021.
                FOR FURTHER INFORMATION CONTACT: Ms. Lynn Evans-Goldner, National
                Policy Manager, Office of the Deputy Administrator, PPQ, APHIS, 4700
                River Road, Unit 137, Riverdale, MD 20737; (301) 851-2286; [email protected].
                SUPPLEMENTARY INFORMATION:
                Background
                 The pale cyst nematode (PCN, Globodera pallida) is a major pest of
                potato crops in cool-temperature areas throughout the world, causing
                significant yield losses if left uncontrolled. Other hosts of this
                destructive pest include tomatoes, eggplants, peppers, and some weeds.
                The spread of PCN in the United States could result in a significant
                loss of domestic and foreign markets for U.S. potatoes and other host
                commodities.
                 Section 414 of the Plant Protection Act (PPA, 7 U.S.C. 7714)
                provides that the Secretary of Agriculture may, under certain
                conditions, hold, seize, quarantine, treat, apply other remedial
                measures to destroy or otherwise dispose of any plant, plant pest,
                plant product, article, or means of conveyance that is moving, or has
                moved into or through the United States or interstate if the Secretary
                has reason to believe the article is a plant pest or is infested with a
                plant pest at the time of movement.
                 On March 4, 2019, we published in the Federal Register (84 FR 7304-
                7306, Docket No. APHIS-2018-0041) a proposal \1\ to amend the domestic
                quarantine regulations for PCN by adding procedures that allow persons
                to review and comment on the protocols for regulating and deregulating
                infested and associated areas. We took this action in response to a
                court order requiring the Animal and Plant Health Inspection Service
                (APHIS) to facilitate public input into the development of protocols
                for deregulating fields for PCN.
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                 \1\ To view the proposal and comment period reopening documents,
                the comments we received, and supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0041.
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                 We solicited comments concerning our proposal for 60 days ending
                May 3, 2019. We reopened the comment period for 30 days ending July 26,
                2019,\2\ in response to commenters who experienced technical
                difficulties with accessing the protocols online.
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                 \2\ 84 FR 30040.
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                 One commenter stated that, in the proposed rule, we did not
                adequately include scientific support and source material for our
                confirmatory and deregulatory field protocols as mandated by the court
                order. To provide the public with an opportunity to review this
                material, we published another document \3\ on June 5, 2020, in the
                Federal Register announcing a second reopening of the comment period
                for another 30 days, ending July 6, 2020. In that document, we
                explained the science underlying each of the field protocols and
                referenced the significant sources we consulted for developing them.
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                 \3\ 85 FR 34537-34541.
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                 We received a total of 25 comments during the initial and reopened
                comment periods. They were from State agricultural officials, potato
                producers and producer organizations, agronomists, attorneys, and
                members of the public. A few comments we received expressed general
                agreement with the rule, while the remainder questioned or criticized
                specific provisions of the rule, the deregulation protocols, and PCN
                program activities. Some commenters raised topics concerning PCN
                program operations outside the scope of the proposal and deregulation
                protocols. We discuss the relevant comments we received below.
                Comment Period
                 A few commenters stated that web links to the protocols, which we
                had included in the proposed rule and in a mailing sent to affected
                growers, were not connecting them to the protocol pages.
                 We acknowledge that the protocol links were not working during part
                of the initial comment period, so we reopened the comment period as
                noted above and provided working protocol links to ensure that
                stakeholders would have ample opportunity to comment.
                 One commenter asked that the proposed rule be republished, with the
                protocols included in the body of the rule.
                 As we made the protocols available for comment on Regulations.gov
                and the APHIS website throughout the reopened comment periods, we see
                no need for including them in a republished proposed rule. We also note
                that in the Federal Register document announcing the second comment
                period reopening, we included details of the scientific support and
                sources we used to develop the protocols.
                Changes to the Regulations
                 We proposed revising Sec. 301.86-3(c)(1), which designates fields
                with viable pale cyst nematodes present as being infested, by adding
                information for accessing the APHIS protocol for designation of
                infested fields in accordance with criteria established by the
                Administrator.
                 We also proposed revising Sec. 301.86-3(d)(1) to read that an
                infested field will be removed from quarantine for PCN upon a
                determination that no viable
                [[Page 85498]]
                PCN is detected in the field. We stated that the determination for
                removing the field from quarantine will be made in accordance with
                criteria established by the Administrator and sufficient to support
                removal of infested fields from quarantine, and that the removal
                criteria will be presented in an online deregulation protocol.\4\ We
                also proposed revising paragraph (d)(2) for associated fields so that
                it refers to the deregulation protocol for those fields, also available
                online.
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                 \4\ The deregulation protocols are available on the APHIS PCN
                page at https://www.aphis.usda.gov/planthealth/pcn.
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                 In paragraph (d)(4), we included the website address for accessing
                the infested and associated field deregulation protocols and indicated
                that any subsequent changes we make to them will be announced in a
                Federal Register notice and open to public comment. We proposed these
                changes to the regulations as a response to the court-mandated
                requirement that the deregulation protocols be publicly accessible and
                open to notice and comment in accordance with the Administrative
                Procedure Act.
                Deregulation Biosurvey
                 Our proposed deregulation protocol for infested and associated
                fields includes a 3-year biosurvey. Two commenters representing State
                departments of agriculture disagreed with using the 3-year biosurvey
                (equivalent to 3 consecutive susceptible potato crops) to evaluate for
                deregulation of infested and associated fields. Both commenters stated
                that a 3-year biosurvey of infested fields fails to sufficiently
                mitigate the risk of PCN spreading to uninfested fields in Idaho and in
                the commenters' respective States. As support, both commenters cited
                the results of a study conducted in Norway showing that PCN cysts
                survived for 12 years in infested fields free of PCN host plants, and
                one cited a study from Northern Ireland claiming a 30-year survival
                period for PCN cysts in fields that were out of potato production for
                42 years.
                 We are making no changes to the regulations based on the
                information provided by these commenters as they appear to be referring
                to an APHIS deregulation protocol no longer in use. Additionally, these
                commenters did not consider the effects of eradication treatments on
                infested fields, which shorten the survival period for PCN. As noted in
                the proposed rule, we originally included a 3-year deregulation
                biosurvey as part of an eradication program in a 2007 interim
                rulemaking \5\ that quarantined certain areas of Idaho due to the
                presence of PCN. The biosurvey required planting PCN host crops in soil
                from an infested field, in a greenhouse, and sampling the soil for PCN
                following each of three crop cycles. Negative results for all three
                cycles would be necessary for APHIS to deregulate the field. In the
                2007 interim rulemaking, this biosurvey was the sole criterion for
                deregulation of infested and associated fields.
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                 \5\ September 12, 2007 (72 FR 51975-51988, Docket No. APHIS-
                2006-0143).
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                 However, in response to public comments and subsequent scientific
                input, we supplemented the 3-year biosurvey requirement with the in-
                field bioassay test for evaluating infested fields for deregulation.
                The in-field bioassay requires growing three susceptible host crops in
                a field with no detections of viable PCN following each crop. Under
                this current deregulation protocol, infested fields are required to
                pass a series of laboratory-based viability tests that take at least 3
                years to complete. Once a field passes the laboratory-based tests,
                APHIS requires three host crops to be grown over the entire field while
                it remains under regulatory control. A field has met requirements for
                deregulation when full field surveys following each of the host crops
                are negative for viable PCN.
                 We do not dispute the studies cited by commenters that PCN cysts
                can remain viable for years in the absence of a host crop. However, we
                have determined that the current deregulation protocol, which requires
                growing a host crop in the field as part of the evaluation, will
                effectively detect and mitigate viable PCN and ensure that fields are
                not deregulated prematurely.
                 Another commenter objected to the deregulation protocol requirement
                that three potato crops be planted in ``hot spots'' (infestation foci)
                of a regulated field and that those spots be sampled for viable PCN
                cysts with each crop, even if the initial sampling of the field
                indicated no viable cysts. According to the commenter, his field
                revealed no cysts after APHIS conducted an initial sampling, and on
                those grounds questioned why a grower whose field showed no cysts after
                testing could not skip over the required iterations of ``hot spot''
                planting and sampling, and instead move directly to the next phase of
                the protocol.
                 We are making no changes in response to the commenter. The
                deregulation protocol provides an alternate testing strategy when cysts
                are not detected in soil samples for use in laboratory-based tests.
                Three crops of potatoes over the entire area of the field or within the
                infestation foci can be substituted for the viability and greenhouse
                bioassay testing to achieve the same level of detection confidence as
                the laboratory and in-field bioassay tests together.
                 Two commenters stated that APHIS has been successful to date in
                delimiting the extent of PCN infestation in Idaho potato fields under
                the existing survey and sanitation requirements. Both commenters noted
                that several fields in Idaho are in the process of completing bioassays
                this production season that could make them eligible for removal from
                quarantine under the current deregulation protocol. They asked that
                APHIS make no bioassay protocol changes until the results of the third
                bioassay on these fields are determined after the growing season, and
                added that the results of these bioassays should be used to inform any
                future consideration of modifications to the bioassay protocol with
                respect to removal of quarantine status. If the results cast doubt on
                the ability of three bioassays to detect the presence of viable PCN
                cysts, they suggested that APHIS consider increasing the number of
                bioassays required for release from quarantine.
                 The current deregulation protocol is effective at detecting
                extremely small populations and APHIS is considering no changes to the
                bioassay at this time. The commenters are referring to several infested
                fields in Idaho being evaluated under the greenhouse bioassay to
                determine whether such fields are eligible to return to potato
                production. To date, no infested fields have met the testing
                requirements to be fully deregulated. At this stage in the eradication
                testing process, the fields remain regulated, with measures in place to
                mitigate the movement of soil off the field until or unless three crops
                of potatoes have been grown on the field and no viable nematodes are
                detected following harvest of each crop. If APHIS finds it necessary to
                change the deregulation protocol in the future, we would first provide
                the background and scientific basis for those changes and solicit
                public comment on the matter. Regardless of the deregulation method, if
                viable nematodes are detected in the bioassay of a particular field,
                the field will remain regulated.
                 A commenter stated that the infested field deregulation protocol
                includes ``optional PCN program-sponsored eradication treatments'' but
                that the protocol does not explain what these additional eradication
                treatments are and whether they are an option for APHIS or for the
                regulated entity. The
                [[Page 85499]]
                commenter suggested that we clarify this explanation in a new proposed
                rule.
                 The optional PCN program-sponsored eradication treatments listed in
                the protocol documents are available at the option of regulated
                entities, as long as APHIS has sufficient funding and a ready supply of
                treatment materials. At present, the treatment options are the soil
                fumigant 1,3-dichloropropene (Telone II) and the trap crop Solanum
                sisymbriifolium (litchi tomato). We do not agree with the commenter's
                suggestion that a new proposed rule is necessary for explaining this
                information further.
                 A few commenters expressed concerns that practices required in the
                deregulation protocols could adversely affect the environment. One
                commenter stated that if PCN eradication treatments include a
                nematicide such as Telone II, additional environmental analysis should
                be undertaken regarding its use. Another commenter stated that in-field
                pressure washing, steam sanitation, soil sampling, and host and trap
                crop planting have environmental implications and noted that issuance
                of a final rule in the absence of an environmental analysis will
                violate the National Environmental Policy Act (NEPA, 42 U.S.C. 4321 et
                seq.) and its implementing regulations.
                 We are making no changes in response to the commenters. This rule
                does not require such an analysis under NEPA requirements. The rule
                adds no provisions and makes no changes to the protocols themselves or
                how they are applied. We note, however, that we have conducted several
                environmental assessments \6\ to evaluate the use of fumigants, trap
                crop planting, and other field treatments and mitigations with regard
                to PCN.
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                 \6\ Available at https://www.aphis.usda.gov/aphis/ourfocus/planthealth/plant-pest-and-disease-programs/ea/ct_pcn.
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                Deregulation of Associated Fields
                 As noted above, we proposed revising Sec. 301.86-3(d) to indicate
                that, as with infested fields, criteria for deregulating associated
                fields are included in a protocol available on the PPQ website. For
                associated fields remaining in host crop production, the deregulation
                protocol requires that two host crops be grown, each followed by a full
                field soil survey. If lab results are negative for PCN in both surveys,
                the field will be deregulated. Statistical analyses have shown that
                APHIS' delimiting survey rate of 8,000 cubic centimeters of soil
                (approximately 20 pounds (lbs) per acre) has a greater than 95 percent
                probability of detecting small populations of PCN after one host crop,
                and closer to 99 percent probability of detecting PCN after two host
                crops.
                 A commenter expressed concern about inconsistencies in how APHIS
                determines what land should be regulated for PCN and stated that he has
                never heard of a clear deregulation plan for associated fields where no
                nematodes have ever been found.
                 Complete deregulation protocols for infested and associated fields,
                including associated fields where no nematodes have been found, are
                available at https://www.aphis.usda.gov/planthealth/pcn. Under Sec.
                301.86-3(c)(2) of the regulations, APHIS may designate a field as an
                associated field if host crops have been grown in that field in the
                past 10 years and if the field came into contact with a regulated
                article from a PCN-infested field in the past 10 years. Included among
                the regulated articles listed in Sec. 301.86-2 is any equipment or
                conveyance used in an infested or associated field that can carry soil
                if moved out of the field. Although we proposed no changes to these
                sections of the regulations, provisions for deregulating associated
                fields are included in the protocols and for this reason we are
                responding to comments we received regarding farm equipment and field
                quarantine status.
                 A commenter asked if potato seed farms should be regulated when
                they have an association with an infested field.
                 If a field used as a potato seed source is suspected of having or
                confirmed to have a PCN infestation, it will be regulated accordingly.
                Potato seed produced on a regulated field is considered to be a
                regulated article and as such is subject to movement restrictions. Any
                field that has come into contact with a regulated article (such as seed
                produced on an infested field) will be regulated as an associated
                field. Any fields that are identified as a seed source for an infested
                field will be prioritized for survey but are not included as part of
                the regulated area until or unless survey results are suspect or
                positive for PCN.
                Field Borders and Barriers
                 Under Sec. 301.86-3(c)(2)(i) of the regulations, APHIS will
                designate a field as an associated field on the basis of adjacency when
                PCN host crops have been grown in the field in the last 10 years and
                the field borders an infested field. Although we proposed no changes to
                this paragraph, we are responding to comments received regarding field
                borders and regulatory status because the status of such fields is
                contingent on the deregulation protocol for associated fields.
                 To deregulate an associated field under this process, the field
                owner must establish a buffer zone of uncultivated ground at least 15
                yards wide along the entire interface with the infested field. The
                buffer zone must include a physical barrier, such as a ditch, berm, or
                fence to discourage transfer of soil or other regulated articles
                between the two fields. The field must also meet the soil survey
                requirement for deregulation of an associated field. Establishing a
                field buffer zone is entirely voluntary for the owner of an adjacent
                field seeking to expedite the process to deregulate a field.
                 One commenter stated that the border buffer requirements constitute
                a taking of the neighbor's property and another commenter agreed,
                stating that farmers should be compensated for having to take land out
                of production for buffers. Another commenter noted instances in which
                APHIS required trenches or other barriers between fields on bordering
                farms even after a field was released from regulation and stated that
                barriers encroach on the land of innocent neighbors.
                 We disagree that establishing buffer zones to mitigate the spread
                of PCN between fields constitutes a taking of property, particularly as
                establishing such a zone in an associated field is voluntary on the
                part of the landowner. Creating an uncultivated buffer zone between an
                adjacent field and an infested field is a scientifically established
                means for expediting deregulation of the adjacent field before the
                infested field is deregulated.
                Deregulation of Fields no Longer in Host Crop Production or
                Agricultural Use
                 We have made publicly available the deregulation protocols for
                fields no longer in host crop production and fields no longer in
                agricultural use. We received comments regarding the deregulation of
                such fields.
                 One commenter asked if a change in the use of regulated fields to
                non-agricultural use--such as for housing or pasture--would allow
                regulation of those fields to be lifted. Another commenter objected to
                APHIS continuing to designate a field as associated for PCN even though
                the property includes a home and grass lawn and is too small for
                growing a profitable host crop, and cysts have never been found there.
                The commenter asked whether a change in the use of the property to a
                non-agricultural use, such as a gravel pit, would be sufficient for
                APHIS to deregulate it. Another commenter cited the case of a
                [[Page 85500]]
                homeowner who asked APHIS to remove land connected to his yard from
                associated field status but was told he would need to follow the
                deregulation protocol. The commenter suggested that APHIS allow growers
                to opt out of the deregulation program for a portion of their ground if
                they choose to subdivide the property for housing.
                 We are making no changes based on the comments. The protocols
                already include provisions for deregulating fields that will not return
                to host crop production and will transition to other uses such as
                residential or commercial development or pasture. The exact
                requirements for deregulating a field that has been taken out of host
                crop production depend upon the nature of the land's intended future
                use and the level of PCN risk in the field at the time of deregulation.
                 Another commenter asked if a former large farming operation on
                regulated fields now functioning as a hobby farm still needs to be
                regulated for PCN, particularly as the host crops grown are only sold
                locally.
                 As all regulated fields can pose a PCN risk, hobby farms
                established on regulated fields that produce host crops must follow the
                same deregulation protocol as large-scale agricultural fields remaining
                in commercial host crop production.
                Sampling and Testing Procedures
                 We received several comments regarding the soil sampling and
                testing procedures we use in the field deregulation protocols. We have
                established in the protocols specific soil sampling rates per acre, the
                findings of which are used to map the distribution and population of
                cysts in infested fields. Cysts discovered during sampling are tested
                for viability.\7\
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                 \7\ More information about sampling rates and cyst viability is
                included in the comment period reopening document (85 FR 34537-
                34541, Docket No. APHIS-2018-0041, June 5, 2020), which can be
                accessed through the link in footnote 1.
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                 One commenter asked how we determined soil testing rates, noting
                that any rates determined from an agreement between the United States
                and Canada are not based on scientific testing rates.
                 While survey rates are often listed in agreements between
                countries, the rates themselves are based primarily on scientific
                research within APHIS and data from the scientific community.
                 A commenter asked if soil testing rates were determined by the
                Technical Working Group, noting that any rates based on the work of
                that group violate the District Court's order that APHIS may not rely
                upon the advice or recommendations of the Technical Working Group in
                any future actions.
                 As we noted in the document reopening the comment period for the
                proposal, the methodology for soil testing under the PCN program was
                drawn from scientific best practices and experience gained from our
                work in the APHIS Golden Nematode Program.
                 A commenter stated that our methods of proof of a PCN find are
                flawed, noting instances of fields where small numbers of nematodes
                were initially found but which subsequently disappeared without
                receiving any field treatments.
                 We disagree with the commenter that our methods for detecting PCN
                are flawed. The detection and subsequent absence of nematodes in a
                sample from an untreated field is not an unusual occurrence and cannot
                be ascribed to a problem with our methodology. Several factors can
                influence detection of PCN, including the aggregate distribution and
                infestation level of the pest in a field.
                 One commenter recommended that the protocol survey regimen of 40
                lbs per acre on associated fields could be reduced to the European
                protocol of 1.28 lbs per acre. Another commenter stated that APHIS'
                soil sampling requirements for the deregulation protocol are 10 times
                the world standards and recommended that we use the world standard of 2
                lbs maximum. Similarly, a commenter stated that since PCN is on the
                world eradication list, then Idaho should use the same lower level of
                soil testing that our trading partners use.
                 We are making no changes in response to the comments. APHIS' goal
                is to contain and eradicate PCN in Idaho to protect all U.S. growers
                from the yield losses experienced by growers in other countries that
                take different approaches to managing PCN. PCN is managed in Europe
                because it is endemic and widespread and therefore less intensive
                surveys are sufficient if the goal is management and not eradication.
                However, PCN populations in Europe continue to increase and seed potato
                acreages are reduced annually as a result. The purpose of this program
                is to ensure the same thing does not occur in the United States. We
                determined that the current soil testing procedures we use are
                necessary and appropriate to achieve program goals.
                 A commenter stated we did not indicate the soil depth at which
                field samples are to be collected for the deregulation protocol,
                resulting in uncertainty about APHIS' ability to mitigate the PCN risk.
                The commenter cited soil samples in Norway and Northern Ireland surveys
                that were taken at depths of 9 to 17 centimeters and 70 centimeters,
                respectively. Similarly, two other commenters expressed concern that
                the methods used to collect samples for testing in APHIS-approved
                laboratories are scientifically invalid because soil samples are only
                collected from the top 2 inches of the soil.
                 Soil samples are collected at the field surface; however, tillage
                and potato harvest practices in southeast Idaho thoroughly mix the top
                30 centimeters (cm) of the soil profile. Therefore, subsequent surface
                sampling effectively represents the top 30 cm of the soil profile. We
                consider this soil sampling depth to be adequate to detect the presence
                of PCN in Idaho, the only State in which PCN is known to exist.
                 A commenter stated that the nematode soil extraction methods
                required by APHIS in PCN laboratories are expedited, causing very low
                recovery rates and further invalidating the confirmatory policy.
                 We are uncertain as to what specific problem the commenter is
                citing. APHIS follows extraction protocols based on best practices
                described in scientific literature, which include a minimum 2-week soil
                drying period and a quality-controlled laboratory environment in which
                the samples are processed.
                 Two commenters stated that growers should be able to have an
                independent lab conduct soil testing and compare their results with
                APHIS' findings, with one commenter expressing doubts about the
                reliability of DNA testing conducted by APHIS.
                 We do not prohibit a field operator or owner from employing
                independent PCN testing of their fields. However, we note that as soil
                in regulated fields is considered a regulated article, it cannot be
                moved from such fields without APHIS authorization. Moreover, soil
                testing can only be administered at APHIS-permitted facilities under
                methods approved by APHIS. For any third-party sampling effort to be
                recognized by APHIS as a valid comparison, we must provide oversight of
                field sampling and laboratory extraction to ensure APHIS protocols are
                followed.
                 A commenter requested that we no longer require tare dirt testing
                for exotic nematodes, adding that if APHIS does not require testing
                from our trading partners then APHIS should not be doing it
                domestically.
                 We are making no changes in response to the commenter. Tare soil
                sampling has never been a requirement of the APHIS PCN domestic
                program.
                [[Page 85501]]
                Farm Machinery and Nonfarm Conveyances in Regulated Fields
                 As a regulated article under Sec. 301.86-2, farm equipment and
                conveyances used in an infested or associated field that can carry soil
                out of the field are subject to pressure washing and steam sanitation
                requirements. These requirements constitute part of the deregulation
                protocols for infested and associated fields.
                 A few commenters stated these requirements have resulted in damage
                to the paint and computer components of their farming equipment and
                requested that APHIS provide them with compensation for damages.
                 We acknowledge that in the past there have been instances in which
                sanitation measures necessary for mitigating PCN have impacted farming
                equipment. However, through years of experience we have developed and
                applied approaches to sanitizing equipment that minimize or prevent
                instances of damage.
                 A commenter stated that equipment sanitation requirements were
                burdensome because it takes time to sanitize equipment and APHIS will
                not verify completion in a timely way. One commenter recommended that
                APHIS employ two sets of equipment cleaning teams at earlier and later
                hours so the whole day is covered.
                 We are aware of the time and effort required of growers to fulfill
                the sanitation requirements but note that doing so is essential to
                mitigating the spread of PCN. We have worked to make it easier for
                growers to meet these requirements by expanding our hours of service
                and implementing a central hotline for requesting sanitation services
                and scheduling appointments after hours, Saturdays, and on Federal
                holidays.
                 Some commenters stated that APHIS is inconsistent and arbitrary in
                how it establishes and enforces PCN regulations with respect to moving
                equipment and conveyances in and out of regulated fields. One such
                commenter noted that straw and alfalfa can be moved off an infested
                field while combines and other equipment used for harvesting must
                undergo sanitation as a regulated article, and yet power company
                equipment and third-party vendors move vehicles in and out of
                quarantined fields without regulation. Another commenter stated that
                pressure washing and steam sanitation requirements for infested and
                associated fields are arbitrarily applied. The commenter stated that
                his organization has provided APHIS with evidence of arbitrary
                application, including failure of APHIS to require sanitation of non-
                farm vehicles and equipment entering regulated fields. Finally, a
                commenter stated, without providing details, that APHIS has allowed
                trucks to travel unimpeded in infested fields and onto public roads
                without being washed or inspected, although harvesters could not do the
                same.
                 We disagree with the commenters' contention that APHIS applies
                sanitation requirements for infested and associated fields
                ineffectively and arbitrarily. Sanitation and limited permitting are
                required and enforced for all equipment and vehicles that exit a
                regulated field. We pursue all reports we receive of equipment moved in
                violation of the requirements and take action when there is enough
                evidence to warrant it. We use all records and other information
                available to us to establish regulated areas and to enforce sanitation
                requirements for all equipment and vehicles, while recognizing that
                farm equipment poses the greatest risk for spreading PCN, given its
                exposure to soil and frequent movement between fields.
                 A commenter asked how many times a field can be re-associated with
                an infested field.
                 There is no limit to the number of times a field can be re-
                associated. The regulatory status of a field for PCN is dependent on
                that field meeting any of the criteria for designation of fields as
                associated fields in Sec. 301.86-3(c)(2).
                 A commenter noted that a number of external environmental factors,
                including host plant root diffusates, soil temperature and moisture,
                soil oxygen, soil microorganisms, minerals, and organic substances can
                induce or influence cyst hatching, and asked why these options are not
                used in place of sanitizing equipment.
                 We acknowledge that these factors can influence cyst hatching but
                note they are currently in the research phase and not ready to be tried
                on a production scale. Moreover, the factors listed are not actually
                sanitizing agents but more allied with pest eradication practices.
                While we always seek new approaches to controlling pests, sanitation is
                required to adequately address the risk of spreading PCN on equipment
                used in infested fields.
                 One commenter expressed concerns about the difficulty of moving
                deregulated equipment between fields. The commenter noted an instance
                in which APHIS told a grower that it was a holiday and their grain
                combine would have to remain in the field for 3 to 4 days before it
                could be washed and released.
                 APHIS understands the impacts of the sanitation requirement on
                growers and works to minimize delays while still providing services at
                no cost to growers. We note that sanitation and inspection services
                have been made available to growers on Federal holidays since 2011. In
                2012, we developed a self-certification option with program oversight
                so growers could work autonomously. Stakeholders have the option of
                entering into a compliance agreement enabling them to meet washing,
                inspection, and certification requirements themselves.
                 A commenter stated that pressure washing equipment on the edge of a
                regulated field creates muddy conditions, which actually enhances the
                movement of soil out of the field as the mud clings to the tires of the
                equipment.
                 The commenter has provided no evidence that APHIS washes equipment
                in such a way that enhances movement of soil on equipment. We note that
                APHIS has broad experience with ensuring that vehicles and equipment
                that have been in PCN regulated fields are washed appropriately.
                Non-Compliance With Court Order
                 According to one commenter, the proposed rule, economic analysis,
                and protocols violate the District Court's order that APHIS may not
                rely upon the advice or recommendations of the Technical Working Group
                in any future actions, including this rulemaking. The commenter noted
                that in the Court's 2018 Memorandum Decision and Order in Mickelsen
                Farms v. APHIS, there are many instances of APHIS' reliance on the
                recommendations and findings of the Technical Working Group in the
                development of the protocols. The commenter stated that the Technical
                Working Group recommended that farm implements used on any known
                infested field must be completely sanitized and noted that the
                deregulation protocols call for pressure washing and steam sanitation.
                The commenter also pointed out that the Technical Working Group
                recommended using stain viability assays on eggs, as does the infested
                field deregulation protocols. Finally, the commenter noted that the
                Technical Working Group recommended post-eradication treatment
                monitoring using fixed grid patterns, and the infested field protocol
                also calls for fixed grid pattern field sampling.
                 Although we disagree with the commenter's contention that the
                deregulation protocols were developed based on the work of the
                Technical Working Group, we acknowledge that the March 2019 proposed
                rule could have provided the public with a more
                [[Page 85502]]
                detailed explanation to draw its own conclusions on this matter. For
                this reason, we reopened the comment period on the proposed rule a
                second time and provided in this June 2020 reopening document \8\
                additional information about the science and sources we used to develop
                the protocols. We have responded to comments addressing that
                information in this final rule.
                ---------------------------------------------------------------------------
                 \8\ See footnote 1 for a link to the document.
                ---------------------------------------------------------------------------
                Other Comments
                 One commenter said that we provided no evidence to support our
                statement in the proposal that unmanaged PCN infestations can cause
                potato yield losses of between 20 and 70 percent, adding that no yield
                losses have ever been documented as a result of PCN in the State of
                Idaho.
                 The percentage range we cited in the proposed rule collectively
                refers to potato yield losses from a few types of potato cyst
                nematodes, including PCN. Several studies from around the globe cite
                similar yield losses in countries where potato cyst nematodes have
                multiplied unchecked.\9\ We note that no losses in potato yields have
                been documented for PCN in Idaho as in other countries because the
                infestation was detected and addressed before the pest level could
                reach the threshold for significant crop yield loss.
                ---------------------------------------------------------------------------
                 \9\ Studies on this topic include: ``Scientists: Unless PCN is
                eliminated, `there will be no Scottish potato sector left in 25
                years' time.'' Potato News Today, August 9, 2019; otton, J. 2014,
                ``The genome and life-stage specific transcriptomes of Globodera
                pallida: key aspects of plant parasitism by a cyst nematode.''
                Genome Biology 15: https://doi.org/10.1186/gb-2014-15-3-r43; Greco,
                N. 1988, ``Potato cyst nematodes: Globodera rostochiensis and G.
                pallida.'' Nematology Circular 149, Florida Department of
                Agriculture and Consumer Services, Division of Plant Industry,
                Gainesville, FL, USA; Dale, M.F.B., 1988, ``The assessment of the
                tolerance of partially resistant potato clones to damage by the
                potato cyst nematode Globodera pallida at different sites and in
                different years.'' Annals of Applied Biology 113, pp. 79-88; and
                Mai, J. 1977, ``Worldwide Distribution of Potato-Cyst Nematodes and
                Their Importance in Crop Production.'' Journal of Nematology, 9:1,
                January 1977.
                ---------------------------------------------------------------------------
                 Several commenters suggested that APHIS should remove PCN from the
                U.S. and global quarantine lists.
                 There are currently 85 countries in addition to the United States
                that regulate G. pallida and 127 other countries that also regulate G.
                rostochiensis. Each of these countries determines its own import
                requirements for commodities entering their country. We agree with the
                regulatory and scientific communities that find PCN is capable of
                threatening Idaho \10\ and the global potato industry with costs
                associated with managing unrestricted PCN populations.
                ---------------------------------------------------------------------------
                 \10\ See Koirala, S., Watson, P., McIntosh, C.S. et al.
                ``Economic Impact of Globodera Pallida on the Idaho Economy.''
                American Journal of Potato Research. 97, 214-220 (2020). https://doi.org/10.1007/s12230-020-09768-2.
                ---------------------------------------------------------------------------
                 Several commenters questioned the U.S. Department of Agriculture's
                (USDA's) ability to contain or eradicate PCN, citing instances in which
                viable nematodes have been dispersed broadly by wind, water, and
                animals.
                 While we acknowledge that water, wind, or animals are possible
                mechanisms for spreading PCN, our experience as well as scientific
                studies indicate that human-assisted spread is the primary mechanism
                for spreading PCN between fields. Natural PCN movement within soil, in
                contrast, has been shown to be generally no greater than 1-2 meters
                annually.\11\ Although some infested fields in Idaho have been detected
                within close proximity to one another, all such fields to date have
                been shown to have a history of shared equipment or other human-
                assisted means of soil movement from another infested field.
                ---------------------------------------------------------------------------
                 \11\ See, for example, N.C. Banks, et al., ``Dispersal of Potato
                Cyst Nematodes Measured Using Historical and Spatial Statistical
                Analyses.'' Phytopathology 102(6):620-6, June 2012: https://apsjournals.apsnet.org/doi/pdfplus/10.1094/PHYTO-08-11-0224; and
                Lambert, K. and S. Bekal, ``Introduction to Plant-Parasitic
                Nematodes.'' The Plant Health Instructor (2002, revised 2009). DOI:
                10.1094/PHI-I-2002-1218-01.
                ---------------------------------------------------------------------------
                 We note, moreover, that APHIS regulates associated fields on the
                basis of adjacency to infested fields for the purpose of detecting any
                PCN spread by natural means. Our survey data have not supported that
                PCN is spread in Idaho by wind, water, or animals. APHIS has collected
                over half a million soil samples outside of infested fields, many from
                fields adjacent to infested fields, with no detections of PCN.
                 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 13771 and Regulatory Flexibility Act
                 This final 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. This rule is not an Executive
                Order 13771 regulatory action because this rule is not significant
                under Executive Order 12866.
                 In accordance with the Regulatory Flexibility Act, we have analyzed
                the potential economic effects of this action on small entities. The
                analysis is summarized below. Copies of the full analysis are available
                on the Regulations.gov website (see footnote 1 in this document for a
                link to Regulations.gov) or by contacting the person listed under FOR
                FURTHER INFORMATION CONTACT.
                 According to the Small Business Administration, entities whose main
                activity is potato farming (classified under NAICS 111211) are
                considered small if they have $750,000 or less in annual receipts.
                Based on the 2017 Census of Agriculture, there were about 25,000 farms
                in Idaho, of which around 700 were considered to be primarily potato
                farms. Bingham and Bonneville Counties had 108 and 40 potato farms,
                respectively. There were about 1,800 farms in Idaho with farm sales
                greater than $500,000, of which around 1,070 farms had farm sales
                greater than $1 million. According to the 2017 Census, 108 of Bingham
                County's 1,177 farm operations (about 9 percent) had farm sales greater
                than $500,000, while Bonneville County, 40 of the 1,109 farm operations
                (about 4 percent) had farm sales greater than $500,000. Although the
                distribution of potato farms with farm sales above $500,000 (or
                $750,000) is not known, it is reasonable to conclude that many of the
                potato farms in northern Bingham and southern Bonneville Counties are
                small business entities.
                 However, the final rule would not impose new or additional burdens
                on small entities as this is an administrative action for which there
                would be no additional costs.
                 Under these circumstances, the Administrator of the Animal and
                Plant Health Inspection Service has determined that this action will
                not have a significant economic impact on a substantial number of small
                entities.
                Executive Order 12372
                 This program/activity is listed in the Catalog of Federal Domestic
                Assistance under No. 10.025 and is subject to Executive Order 12372,
                which requires intergovernmental consultation with State and local
                officials. (See 2 CFR chapter IV.)
                Executive Order 12988
                 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.
                [[Page 85503]]
                Congressional Review Act
                 Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
                the Office of Information and Regulatory Affairs designated this rule
                as not a major rule, as defined by 5 U.S.C. 804(2).
                Paperwork Reduction Act
                 This final rule contains no reporting, recordkeeping, or third
                party disclosure requirements under the Paperwork Reduction Act of 1995
                (44 U.S.C. 3501 et seq.).
                List of Subjects in 7 CFR Part 301
                 Agricultural commodities, Plant diseases and pests, Quarantine,
                Reporting and recordkeeping requirements, Transportation.
                 Accordingly, we are amending 7 CFR part 301 as follows:
                PART 301--DOMESTIC QUARANTINE NOTICES
                0
                1. The authority citation for part 301 continues to read as follows:
                 Authority: 7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80,
                and 371.3. Section 301.75-15 issued under Sec. 204, Title II, Public
                Law 106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16
                issued under Sec. 203, Title II, Public Law 106-224, 114 Stat. 400
                (7 U.S.C. 1421 note).
                0
                2. Section 301.86-3 is amended as follows:
                0
                a. In paragraph (a), by removing ``http://www.aphis.usda.gov/
                plant_health/plant_pest_info/potato/pcn.shtml'' and adding ``https://www.aphis.usda.gov/planthealth/pcn'' in its place; and
                0
                b. By revising paragraphs (c)(1) and (d).
                 The revisions read as follows:
                Sec. 301.86-3 Quarantined areas.
                * * * * *
                 (c) * * *
                 (1) Infested fields. A field will be designated as an infested
                field for pale cyst nematode upon a determination that viable pale cyst
                nematode is present in the field. The determination will be made in
                accordance with the criteria established by the Administrator for the
                designation of infested fields. The criteria are presented in a
                protocol document that may be viewed at https://www.aphis.usda.gov/planthealth/pcn. The protocol may also be obtained by request from any
                local office of Plant Protection and Quarantine; local offices are
                listed in telephone directories. Any substantive changes we propose to
                make to the protocol will be published for comment in the Federal
                Register. After we review the comments received, we will publish
                another notice in the Federal Register informing the public of any
                changes to the protocol.
                * * * * *
                 (d) Removal of fields from quarantine. (1) Infested fields. An
                infested field will be removed from quarantine for pale cyst nematode
                upon a determination that no viable pale cyst nematode is detected in
                the field. The determination will be made in accordance with criteria
                established by the Administrator and sufficient to support removal of
                infested fields from quarantine. The criteria are presented in a
                protocol document as provided in paragraph (d)(4) of this section along
                with information for viewing the protocol.
                 (2) Associated fields. An associated field will be removed from
                quarantine for pale cyst nematode once surveys are completed and pale
                cyst nematode is not detected in the field. The determination will be
                made in accordance with criteria established by the Administrator and
                sufficient to support removal of associated fields from quarantine. The
                criteria are presented in a protocol document as provided in paragraph
                (d)(4) of this section along with information for viewing the protocol.
                 (3) Removal of other areas from quarantine. If the Administrator
                has quarantined any area other than infested or associated fields
                because of its inseparability for quarantine enforcement purposes from
                infested or associated fields, as provided in paragraph (a) of this
                section, that area will be removed from quarantine when the relevant
                infested or associated fields are removed from quarantine.
                 (4) Protocol for removal of fields from quarantine. The
                Administrator will remove infested and associated fields, and other
                areas as provided in this section, from quarantine for pale cyst
                nematode in accordance with the protocols published on the Plant
                Protection and Quarantine website at https://www.aphis.usda.gov/planthealth/pcn. The protocols may also be obtained by request from any
                local office of Plant Protection and Quarantine; local offices are
                listed in telephone directories. Any substantive changes we propose to
                make to the protocols will be published for comment in the Federal
                Register. After we review the comments received, we will publish
                another notice in the Federal Register informing the public of any
                changes to the protocols.
                 Done in Washington, DC, this 1st day of December 2020.
                Michael Watson,
                Acting Administrator, Animal and Plant Health Inspection Service.
                [FR Doc. 2020-26962 Filed 12-28-20; 8:45 am]
                BILLING CODE 3410-34-P
                

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