Amendments to the Pale Cyst Nematode Regulations, 34537-34541 [2020-11792]

Download as PDF 34537 Proposed Rules Federal Register Vol. 85, No. 109 Friday, June 5, 2020 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 301 [Docket No. APHIS–2018–0041] RIN 0579–AE48 Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule; reopening of comment period. AGENCY: We are reopening the comment period for our proposed rule that would amend the domestic quarantine regulations for pale cyst nematode by adding procedures to allow persons to review and comment on the protocols for regulating and deregulating infested and associated areas. We are taking this action to allow persons to comment on the science on which we have established our infested and associated field protocols and on the sources we have used to develop the protocol principles and methods currently used. This action will allow interested persons additional time to prepare and submit comments. DATES: The comment period for the proposed rule published on March 4, 2019 (84 FR 7304–7306), is reopened. We will consider all comments that we receive on or before July 6, 2020. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to http://www.regulations.gov/ #!docketDetail;D=APHIS-2018-0041. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2018–0041, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road, Unit 118, Riverdale, MD 20737–1238. Supporting documents and any comments we receive on this docket may be viewed at http:// www.regulations.gov/ lotter on DSK9F5VC42PROD with PROPOSALS VerDate Sep<11>2014 17:12 Jun 04, 2020 Jkt 250001 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 Globodera pallida (pale cyst nematode, or PCN) by adding procedures that allow persons to review and comment on the protocols for regulating and deregulating quarantined and associated areas. We took this action in response to a court order 2 requiring the Animal and Plant Health Inspection Service (APHIS) to solicit public input into the development of the protocols used for deregulating fields for PCN. 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, in response to commenters who experienced technical difficulties with accessing the protocols online. During the comment period, we made available for comment six documents: The Infested Field Confirmatory Policy, the Regulated Field Survey and Laboratory Result Definitions, the Infested Field Deregulation Protocol (if remaining in host crop production), the Associated Field Deregulation Protocol (if remaining in host crop production), the Deregulation Protocol for Agricultural Land No Longer in Host Crop Production, and the Analysis in SUPPLEMENTARY INFORMATION: Amendments to the Pale Cyst Nematode Regulations SUMMARY: #!docketDetail;D=APHIS-2018-0041 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799–7039 before coming. 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; lynn.evans-goldner@ usda.gov. 1 To view the proposed rule, supporting documents, and the comments we received, go to http://www.regulations.gov/ #!docketDetail;D=APHIS-2018-0041. 2 Memorandum Decision and Order, Mickelsen Farms, LLC, et al. v. APHIS, et al., March 20, 2018. https://www.gpo.gov/fdsys/pkg/USCOURTS-idd-1_ 15-cv-00143/pdf/USCOURTS-idd-1_15-cv-001432.pdf. PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 Support of Certification that the Rule will not have a Significant Economic Impact on a Substantial Number of Small Entities. We received a total of 19 comments, 2 of which were submitted twice. One person commented that we did not adequately explain the science and sources for our confirmatory and deregulatory field protocols contained in the applicable documents. Out of an abundance of caution and transparency, and in deference to the court which directed us to provide ‘‘requisite public notice and commenting on the Deregulation Protocols,’’ APHIS is providing the public with an additional opportunity to comment on the science supporting the protocols, including the sources of the methods informing their content. Accordingly, we are including more information about the protocols in this document and are reopening the comment period for 30 days. APHIS’ prompt response to finding PCN in Idaho, which resulted in the drafting and publication of the interim rule in 2007,3 drew extensively upon the U.S. Department of Agriculture (USDA) Emergency Programs Manual (EPM) (February 2002).4 The EPM lays out in general form the procedures necessary for addressing plant pest emergencies, including development of an interim rule that establishes survey activities, quarantines, movement restrictions, and other pest measures intended to mitigate or eradicate the pest. APHIS has implemented similar plant pest responses throughout the United States in other programs to address golden nematode, spotted lanternfly, potato wart, gypsy moth, and fruit flies. Similar types of early detection and rapid response efforts are employed by other Federal, State, and international plant protection organizations. Based on the initial regulations for controlling PCN that we finalized through rulemaking, we subsequently developed protocols for regulating and deregulating PCN-infested and associated fields.5 APHIS has harmonized its regulations and enforcement efforts with those of the Idaho State Department of Agriculture 3 Docket No. APHIS–2006–0143; 72 FR (51975– 51988), September 12, 2007. 4 To view the manual on regulations.gov, see footnote 1. 5 See footnote 1 for a link to the protocols. E:\FR\FM\05JNP1.SGM 05JNP1 34538 Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Proposed Rules and the Canadian Food Inspection Agency. The protocol mitigations work collectively as a systems approach and have significantly reduced the rate of PCN spread by regulating infested and associated fields and establishing sanitation requirements for equipment and vehicles leaving infested and associated fields. In the absence of such regulatory measures, we note that statistical analysis of human-assisted spread of PCN estimates a mean spread rate of 3.29 miles/year.6 This suggests that in the 14 years since PCN was first detected in Idaho, the pest could have spread more than 46 miles from the first infested field identified. With regulatory controls in place, PCN is limited to an area within an 8.5-mile radius, only 11.5 miles in straight line distance. Below, we list the procedures used in the protocols and explain the scientific rationale and background we relied upon as grounds for including them. As noted above, many, if not most, of these procedures have been employed by USDA and State pest programs for decades across the United States, in various forms and for many different plant pests and crops, including nematodes on potatoes. Internationally, Australia and Japan, which also do not have widespread PCN infestations, have also relied on these and similar best practices to help them respond to PCN detections in their respective countries.7 lotter on DSK9F5VC42PROD with PROPOSALS Containment Measures for PCN Different types of farming equipment can spread Globodera cysts,8 with potato diggers representing the greatest potential risk. The risk is high because of the large amount of soil that adheres to the digger and because PCN population densities are highest at harvest time following production of a susceptible cultivar. Additionally, the new cysts present at harvest contain a large number of viable eggs that provide a greater chance of successful population establishment.9 Consequently, every precaution should be taken to prevent the spread of potato cyst nematodes. Nematologists advise 6 Banks, N.C., et. al. Dispersal of Potato Cyst Nematodes Measured Using Historical and Spatial Statistical Analyses. Phytopathology, Vol. 102, No. 6, 2012. 7 IPPC reports are located at https://www.ippc.int/ en/countries/australia/pestreports/2010/09/ eradication-of-potato-cyst-nematode-pcn-fromwestern-australia/ and at https://www.ippc.int/en/ countries/japan/pestreports/2016/10/outbreak-ofglobodera-pallida-4/. 8 Brodie, B.B., Probability of Globodera rostochiensis Spread on Equipment and Potato Tubers. Journal of Nematology 25(2):291–296. 1993. 9 Brodie, B.B., and M.L. Brucato. Relation of Cyst Age and Egg Density to Establishment of Globodera Rostochiensis populations. Journal of Nematology 21:4 October 1989. VerDate Sep<11>2014 17:12 Jun 04, 2020 Jkt 250001 those who work in the fields to clean equipment of soil before entering noninfested sites.10 Based on these established best practices, the PCN program protocols include requirements for pressure washing or using steam to clean all farm equipment, vehicles, or other conveyances that have been in a PCN infested or associated field. These procedures ensure that nematodes are not carried into new fields via soil or equipment. Washing and steam sterilization of equipment has been a phytosanitary standard for nematode and other plant pest control for decades, and the techniques required in the PCN deregulation protocols are similar to plant pest sanitation protocols used throughout the United States and the world. More specifically, the PCN sanitation practices are modeled in part after those employed by the USDA Golden Nematode program for controlling the spread of that pest in New York State. A 2006 version of the USDA Golden Nematode Manual requires that all soil be removed by cleaning farm equipment, mechanized soil moving equipment, farm tools, used containers, and other similar articles using pressure washing and steam treatment.11 Soil Sampling and Detection Strategies for PCN Soil sampling rates used by the PCN program for associated and infested fields are supported by a model that combines the medium scale distribution of cysts and the small scale distribution of cysts within square meters. The medium scale distribution provides the expected population densities at each position within the focus and refers to the size and shape of a focus resulting from farming practices. The small scale distribution represents the multiplication of Globodera on the roots of evenly spaced potato plants. A computer program, SAMPLE, analyzes soil sampling methods.12 The 10 Stienstra, W.C., and D.H. McDonald. The Soybean Cyst Nematode. Minnesota Extension Service AG–FO–3935 1990. 11 Golden Nematode Program Manual (2006): 2– 8–18. Similar steam and pressure cleaning requirements are included in earlier versions of the manual published in 1968 and 1992. All versions are available via the link to regulations.gov in footnote 1 of this document. 12 Additional descriptions of these sampling methods are: (1) Been, T.H. and Schomaker, C.H. 1998. Sampling methods for fields with patchy infestations of the potato cyst nematode (Globodera spp.): A simulation model to develop and evaluate sampling methods. In Quantitative studies on the management of potato cyst nematodes (Globodera spp.) in the Netherlands. p. 319; and (2) Been, T.H. and Schomaker, C.H. 2000. Development and evaluation of sampling methods for fields with PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 parameters of the model include gradient length and width, which represent the medium scale distribution and the aggregation factor of the negative binomial distribution (small scale distribution). Terms of the soil sampling method are also factored into the program. The terms are maximum grid cell size, sampling points per hectare (ha), core size cubic centimeters (cc), soil sample size (cc) per ha, and bulk sample size (gram). In this program, the selected average detection probability is set at 90 percent. The following sampling rates were calculated to detect extremely small infestations at three critical phases of the program: Deregulation of associated fields, monitoring eradication progress on infested fields, and deregulation of infested fields (in-field bioassay). The Canadian and United States Guidelines on Surveillance and Phytosanitary Actions for the potato cyst nematodes Globodera rostochiensis and Globodera pallida recommend a minimum sample size of 20,000 cc per ha (approximately 8,000 cc per acre) taken either manually or mechanically. When a similar method was analyzed with the SAMPLE program using 15,000 cc/ha (approximately 6,000 cc per acre) with a bulk sample size of 22.5 kilogram (kg), it had a detection probability of 99 percent with a central population density (CPD) of 50 cysts per kg of soil. For small infestation foci where the CPD is 5 cysts per kg of soil, the method has a detection probability of only 22 percent. The delimiting rate for associated fields is 8,000 cubic centimeters (cc)/ acre (ac), approximately 20 pounds (lbs)/ac. According to the SAMPLE model, for an infestation with a CPD of 50 cysts/kg in a field, the model shows a detection probability of 98.55 percent at the delimiting survey rate. Associated fields are required to undergo two surveys at the delimiting rate, each following a host crop. At a CPD of 50 cysts/kg, the second sampling detection should remain high. To calculate the cumulative detection probabilities with repetitive sampling, the product of both non-detection probabilities are combined. The probability of no detection each year is 1 ¥ 0.9855 = 0.0145. If this happens twice, the combined probability of no detection equals 0.01452 = 0.00021025. Detection after two crops surveyed by this method is 1 ¥ 0.00021025 = 0.9998, or 99.98 percent. For small infestations of 5 cysts/kg (approximately 2 cysts per infestation foci of potato cyst nematodes (Globodera rostochiensis and G. pallida). Phytopathology 90:647–656. E:\FR\FM\05JNP1.SGM 05JNP1 lotter on DSK9F5VC42PROD with PROPOSALS Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Proposed Rules pound) of soil, however, repetitive sampling is even more important because the detection probability starts at 22 percent but increases with each host crop. The infested field monitoring survey rate is 80,000 cc/ac, approximately 200 lbs/ac. Because of the small infestation foci in Idaho, a declining cyst population from the absence of host crops, and the application of eradication treatments, intensive sampling increases the chance of detection and the accuracy of population estimation. As a result, the intense monitoring survey rate of 80,000 cc/ac for infested fields is scientifically supported. The infested field in-field bioassay rate is 20,000 cc/ac, approximately 50 lbs/ac. This rate is scientifically justified by the model where a small infestation with a CPD of 5 cysts/kg has a detection probability of 22 percent. As described for the delimiting survey method, the model shows that when the CPD increases, the detection probability also increases. Because the in-field bioassay reintroduces host crops and requires soil surveys following each of three host crops, the incipient population increases; therefore, detection probability also significantly increases. Soil samples are collected at the field surface; however, potato harvest machinery and annual tillage practices effectively mix the top layer of the soil such that soil samples represent at least the top 30 centimeters of the soil profile. PCN program sampling rates are higher than those used by many other countries where PCN infestations are widespread and have been present for decades. Lower sampling rates are generally used for managing high infestations and reducing economic impacts of the pest, not for eradicating nor limiting spread of the pest. Details of APHIS’ use of DNA and morphological/morphometric identification of PCN are described in a 2007 scientific article,13 which is provided via a link in the confirmatory protocol. In the 1990s, nematologists began using DNA technology extensively for identification purposes, while morphological identification of nematodes has been widely in practice for decades. The technical minimum threshold for declaring a field infested/ positive for PCN is met by detecting a minimum of two cysts from two samples that were identified as PCN by morphological/morphometric analysis, and at least one of the cysts was viable and confirmed as PCN by molecular (DNA) analysis. It is not necessary for the two samples to come from the same survey event. Infested Field Confirmatory Policy To evaluate a field for PCN under the confirmatory protocol, a soil sample is required. Sanitary requirements for entering a field (boots, washing of tools), soil bagging and labeling, and vehicle disinfection are longstanding and widely observed practices used by APHIS to prevent the spread of plant pests from infected fields. The protocol for determining infested field regulation for PCN is based on our knowledge about the biology and epidemiology of PCN. Specimens from a soil sample must be definitively identified and confirmed by an APHISapproved laboratory using morphological and molecular DNAbased methods. Molecular methods provide an additional, confirmatory step along with morphological methods. Fields that APHIS has determined to be infested with PCN are eligible for release under a deregulation protocol if the field is used for host crop production. The infested field deregulation protocol employs strategies that have been used for decades to control nematodes on potatoes and other crops. VerDate Sep<11>2014 17:12 Jun 04, 2020 Jkt 250001 Regulating Associated Fields The protocol for determining associated field regulation is modeled in part after the USDA Golden Nematode Program and its criteria for determining ‘‘exposed land’’ as described in the USDA Golden Nematode Manual (2006 version).14 Unlike the Golden Nematode Program approach of regulating large blocks of land or entire counties, the PCN Program adopted a more conservative field-by-field regulatory approach in which only confirmed infested fields and those at high risk for infestation are regulated. Associated fields are identified through the process of researching an infested field’s history, going back 10 years, to identify other fields that may have been exposed to infested field soil. Infested Field Deregulation Protocol (if Remaining in Host Crop Production) 13 Skantar, et al., Morphological and Molecular Identification of Globodera pallida Associated with Potato in Idaho. Journal of Nematology, 2007 Jun; 39(2): 133–144. http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC2586493/. In addition, a diagnostic protocol for Globodera rostochiensis and Globodera pallida (PM 7/40 (4)) was approved as an European Plant Protection Organization Standard in 2003 and last revised in 2017: https:// onlinelibrary.wiley.com/doi/full/10.1111/ epp.12391. 14 To view the manual on regulations.gov, see footnote 1. PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 34539 Fixed Grid Pattern Field Sampling In the Infested Field Deregulation Protocol, APHIS conducts an initial full field survey in a fixed grid pattern at an 80,000 cc of soil per acre sampling rate. The sampling results (number of cysts per sample) are used to map the relative distribution and population of cysts in the field, and infestation foci are located. The fixed grid survey is a standard industry practice for monitoring several types of field activities, including mapping infestations and monitoring pest eradication treatments. For instance, one study APHIS drew upon in developing the protocols describes a method for PCN soil sampling by which a field is divided into 20 x 20 meter grid squares, then soil samples are collected from each grid. The samples are processed to separate cysts from the soil, and the number of cysts per grid is determined by counting. The results of the cyst counts are plotted to produce a map of the infestation across the field.15 Identifying infestation foci informs soil treatment decisions and cost-effective monitoring of treatment efficacy over time. This method is the basis for the PCN program’s mapping surveys and subsequent grid monitoring surveys. The PCN sampling method for infested fields is based on a 2 x 2 grid pattern method (subsamples are collected 2 paces apart, every 2 paces) modeled in part after a grid survey method described in GN program manuals from 1992 and 2006. The 2006 manual describes the steps for such a survey, beginning with measuring the dimensions of the field, dividing the field into a grid, and sampling the soil following the grid pattern. If nematodes are located in a sample, the grid makes it possible to trace that sample back to a location in the field.16 After sampling results are determined, a field may undergo a series of optional, PCN program-sponsored eradication treatments, which are monitored according to initial grid survey results. These treatments are conducted at the discretion of the grower. Eradication treatments have included Telone® II fumigation and the trap crop litchi tomato. Telone® and Telone® II have been widely employed as a nematicide for control of all major species of nematodes throughout the United States, as has litchi tomato as a trap crop 15 See Evans. K., et al., Mapping Infestations of Potato Cyst Nematodes and the Potential for Spatially Varying Applications of Nematicides. Precision Agriculture 4 (2003) 149–162. 16 Golden Nematode Program Manual (2006): 2– 3–7. To view the manual on regulations.gov, see footnote 1. E:\FR\FM\05JNP1.SGM 05JNP1 34540 Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Proposed Rules in other countries. Trap crops, which have been used for decades to control nematodes, can be effective in reducing yield loss in potatoes and other crops when used as part of a crop rotation, or in conjunction with the use of nematicides.17 Host crops may be grown consecutively or in a crop rotation. A field is eligible for full deregulation if no viable cysts are detected after each of three host crops are harvested.18 The scientific rationale for requiring three crops is to allow multiplication and detection of any low-level PCN populations prior to release. lotter on DSK9F5VC42PROD with PROPOSALS Viability Testing, Staining, and Bioassays In the Infested Field Deregulation Protocol, initial cyst viability is assessed using a live/dead staining assay. The staining assay to determine viability is a standard procedure in nematology as it allows for clearer visual identification of the organism. To evaluate the efficacy of a treatment for cyst nematode control, determining if a nematode is dead or alive is important. The lack of movement of a nematode does not signify death in species like Heterodera spp. (cyst nematodes).19 Since the egg is protected in a resistant structure, living (viable) and dead (nonviable) eggs cannot be distinguished by direct observation. Various dyes and stains have been used to visualize and then ascertain viability of nematode eggs. To become deregulated, a field must complete a series of tests to demonstrate that the infestation has been fully eradicated. In classical nematology, the standard method to determine PCN viability is based on a staining assay, using Meldola’s blue dye (MB) followed by microscopic visualization of MB-treated nematodes. Nematode staining techniques are widely accepted by the majority of nematology laboratories and have been for decades.20 One study presents a novel hatching bioassay technique developed for golden nematode, in which the authors illustrated the feasibility and 17 See Sparkes, Jessica, Potential trap crops for the control of Potato Cyst Nematode (PCN). ADAS UK Ltd. 2013: https://potatoes.ahdb.org.uk/sites/ default/files/publication_upload/ PCN%20trap%20crops%20review_ for%20publication.pdf. 18 See Greco N., et al., The Effect of Globodera Pallida and G. Rostochiensis On Potato Yield. Nematologica 28.4: January 1982: https://brill.com/ view/journals/nema/28/4/article-p379_2.xml. 19 Shepherd, A.M. 1962. New blue R, a stain that differentiates between living and dead nematodes. Nematologica 8: 201–208. 20 Perry, R. and Feil, J., Observations on a Novel Hatching Bioassay for Globodera Rostochiensis Using Fluorescence Microscopy. Revue Ne´matologie 9 (31): 280–282 (1986). VerDate Sep<11>2014 17:12 Jun 04, 2020 Jkt 250001 advantages of a hatching bioassay system using staining and fluorescence microscopy. Another study 21 published in 1996 discusses the results of PCN infectivity assays using staining techniques similar to those we prescribe in the deregulation protocol. We also note that the 1968 USDA Golden Nematode Program Manual includes viability testing to monitor efficacy of chemical treatments. As part of the infested field protocol, we also assess cyst viability using a greenhouse bioassay method (equivalent to three consecutive susceptible potato crops) or an in-field bioassay method (three consecutive crops grown in infestation foci or over the entire field). Greenhouse and field bioassays are used throughout the world to evaluate pest viability and other biological characteristics.22 APHIS emergency response manuals and used by several APHIS, State, and international programs. For example, a Japanese Beetle Harmonization plan, adopted by the National Plant Board in 1998, uses the same concept as the PCN deregulation protocol of conducting detection surveys followed by a more robust delimiting survey. This Japanese beetle harmonization plan was implemented by the Idaho State Department of Agriculture in Boise, Idaho in 2013 after detection of the beetle in 2012.23 Deregulation Protocol for Agricultural Land No Longer in Host Crop Production and Non-Agricultural Land Associated Field Deregulation Protocol (if Remaining in Host Crop Production) The primary determination for a field to become regulated as an associated field is exposure of that field to soil or other regulated articles from an infested field. Pressure washing sanitation requirements, explained above, are implemented for all equipment in contact with field soil. These requirements are necessary to mitigate the potential spread of PCN from associated fields that are considered high risk for PCN infestation. Other regulatory requirements are implemented for movement of commodities and articles from the field that cannot be sanitized. For PCN, a full-field delimiting survey at a sampling rate of 8,000 cc of soil per acre (equivalent to approximately 20 pounds of soil per acre) is used to determine its presence in associated fields. A series of two negative delimiting surveys, each following harvest of two host crops grown on the field, is required to deregulate an associated field. The current deregulation protocol was adopted by APHIS in 2012 at the request of cooperators and stakeholders that were impacted, including the Idaho State Department of Agriculture, Idaho Potato Commission, and owners and operators of infested and associated fields. Delimiting surveys are a common practice that have been included in A deregulation option exists for regulated fields where agriculture still occurs but where all host crop production was prohibited or has ceased for a minimum of 30 years. This could include infested or associated status fields. During the 30-year time period, the fields may have been used for various purposes, including but not limited to hobby farms, fallow fields, forage crops, grain fields, nurseries, or pasture. PCN can remain viable for approximately 30 years in the absence of a host crop.24 To become deregulated, fields no longer in host crop production must complete a two-step process. Records must be made available to APHIS to demonstrate that the land has been out of host crop production for the last 30 years. APHIS then surveys the entire field at a rate of 8,000 cc soil per acre (equivalent to approximately 20 pounds of soil per acre). This dual approach establishes a 30-year period in which the field is out of host production, making it much less likely that PCN is present, and in the present establishes whether any viable PCN remains. A deregulation option also exists for regulated fields that have been converted to non-agricultural uses. This could include infested or associated status fields. Examples of nonagricultural uses include such things as highways and other paved roads and commercial, industrial or residential development. To become deregulated, fields converted to non-agricultural uses must have records available to determine the land has been out of agricultural use for 21 Zanna, Muhammad, Diapause in the nematode Globodera pallida. European Journal of Plant Pathology 100: 413–423, 1994. 22 See McKenzie, M.M. and S.J. Turner, Assessing reproduction of potato cyst nematodes (Globodera rostochiensis and G. pallida) on potato cultivars for National Listing. EPPO Bulletin 17:3: September 1987. https://onlinelibrary.wiley.com/doi/abs/ 10.1111/j.1365-2338.1987.tb00048.x. 23 See Idaho Japanese Beetle Project at https:// invasivespecies.idaho.gov/cooperative-agriculturalpest-surveys-caps. 24 Turner, Susan. Population decline of potato cyst nematodes (Globodera rostochiensis, G. pallida) in field soils in Northern Ireland. Annals of Applied Biology, October 1996: https:// onlinelibrary.wiley.com/doi/abs/10.1111/j.17447348.1996.tb05754.x. PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\FR\FM\05JNP1.SGM 05JNP1 Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Proposed Rules at least the last 20 years and will not return to production, or construction for non-agricultural proposes has rendered the land non-tillable and is not likely to return to agricultural production. The risk of PCN spread and establishment from these non-agricultural fields is lower than those remaining in non-PCN host agricultural production, resulting in the lower number of years required for release. In the APHIS Karnal Bunt Program, which has been in place since 1996, a similar provision in the regulations 25 has been used successfully to lower or eliminate the risk of Karnal Bunt if the land cannot be farmed. In order to give the public an opportunity to consider the science on which we have established the field protocols and the sources we have used to develop them, we are reopening the comment period on Docket No. APHIS– 2018–0041 for an additional 30 days. This action will allow interested persons additional time to prepare and submit comments. Done in Washington, DC, this 21st day of May 2020. Michael Watson, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2020–11792 Filed 6–4–20; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF ENERGY 10 CFR Part 431 [EERE–2019–BT–TP–0025] RIN 1904–AE55 Energy Conservation Program: Test Procedure for Commercial Prerinse Spray Valves Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Request for information. AGENCY: The U.S. Department of Energy (DOE) is requesting information and data through this request for information (‘‘RFI’’) to consider whether to amend DOE’s test procedures for commercial prerinse spray valves. Specifically, DOE seeks data and information pertinent to whether amended test procedures would (1) more accurately or fully comply with the requirement that the test procedure be reasonably designed to produce test results that measure water use during a representative average use cycle or period of use without being unduly lotter on DSK9F5VC42PROD with PROPOSALS SUMMARY: 25 See 7 CFR 301.89–3(f)(1). VerDate Sep<11>2014 17:12 Jun 04, 2020 Jkt 250001 burdensome to conduct, or (2) reduce test burden. DOE welcomes written comments from the public on any subject within the scope of this document (including topics not raised in this RFI), as well as the submission of data and other relevant information. DATES: Written comments and information will be accepted on or before July 6, 2020. ADDRESSES: Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at http://www.regulations.gov. Follow the instructions for submitting comments. Alternatively, interested persons may submit comments, identified by docket number EERE–2019–BT–TP–0025, by any of the following methods: 1. Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. 2. Email: to CPSV2019TP0025@ ee.doe.gov. Include docket number EERE–2019–BT–TP–0025 in the subject line of the message. 3. Postal Mail: Appliance and Equipment Standards Program, U.S. Department of Energy, Building Technologies Office, Mailstop EE–5B, 1000 Independence Avenue SW, Washington, DC 20585–0121. Telephone: (202) 287–1445. If possible, please submit all items on a compact disc (‘‘CD’’), in which case it is not necessary to include printed copies. 4. Hand Delivery/Courier: Appliance and Equipment Standards Program, U.S. Department of Energy, Building Technologies Office, 950 L’Enfant Plaza SW, Suite 600, Washington, DC 20024. Telephone: (202) 287–1445. If possible, please submit all items on a CD, in which case it is not necessary to include printed copies. No telefacsimilies (‘‘faxes’’) will be accepted. For detailed instructions on submitting comments and additional information on this process, see section III of this document. Docket: The docket for this activity, which includes Federal Register notices, comments, and other supporting documents/materials, is available for review at http:// www.regulations.gov. All documents in the docket are listed in the http:// www.regulations.gov index. However, some documents listed in the index, such as those containing information that is exempt from public disclosure, may not be publicly available. The docket web page can be found at https://www1.eere.energy.gov/buildings/ appliance_standards/standards.aspx? productid=69&action=viewcurrent. The docket web page contains instructions on how to access all documents, PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 34541 including public comments, in the docket. See section III for information on how to submit comments through http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE–5B, 1000 Independence Avenue SW, Washington, DC 20585–0121. Telephone: (202) 287– 1604. Email: ApplianceStandardsQuestions@ ee.doe.gov. Ms. Kathryn McIntosh, U.S. Department of Energy, Office of the General Counsel, GC–33, 1000 Independence Avenue SW, Washington, DC 20585–0121. Telephone: (202) 586– 2002. Email: Kathryn.McIntosh@ hq.doe.gov. For further information on how to submit a comment or review other public comments and the docket, contact the Appliance and Equipment Standards Program staff at (202) 287– 1445 or by email: ApplianceStandardsQuestions@ ee.doe.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction A. Authority and Background B. Rulemaking History II. Request for Information A. Scope and Definitions B. Test Procedure 1. Industry Standard 2. Water Pressure C. Other Test Procedure Topics III. Submission of Comments I. Introduction DOE’s test procedures for commercial prerinse spray valves are prescribed at Subpart O of 10 CFR part 431. The following sections discuss DOE’s authority to establish and amend test procedures for commercial prerinse spray valves and relevant background information regarding DOE’s consideration of test procedures for this equipment. A. Authority and Background The Energy Policy and Conservation Act, as amended (‘‘EPCA’’),1 among other things, authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. (42 U.S.C. 6291– 6317) Title III, Part B 2 of EPCA 1 All references to EPCA in this document refer to the statute as amended through America’s Water Infrastructure Act of 2018, Public Law 115–270 (October 23, 2018). 2 For editorial reasons, upon codification in the U.S. Code, Part B was redesignated Part A. E:\FR\FM\05JNP1.SGM 05JNP1

Agencies

[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Proposed Rules]
[Pages 34537-34541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11792]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Proposed 
Rules

[[Page 34537]]



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: Proposed rule; reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: We are reopening the comment period for our proposed rule that 
would amend the domestic quarantine regulations for pale cyst nematode 
by adding procedures to allow persons to review and comment on the 
protocols for regulating and deregulating infested and associated 
areas. We are taking this action to allow persons to comment on the 
science on which we have established our infested and associated field 
protocols and on the sources we have used to develop the protocol 
principles and methods currently used. This action will allow 
interested persons additional time to prepare and submit comments.

DATES: The comment period for the proposed rule published on March 4, 
2019 (84 FR 7304-7306), is reopened. We will consider all comments that 
we receive on or before July 6, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0041.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0041, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2018-
0041 or in our reading room, which is located in Room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW, Washington, DC. 
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

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: 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 Globodera 
pallida (pale cyst nematode, or PCN) by adding procedures that allow 
persons to review and comment on the protocols for regulating and 
deregulating quarantined and associated areas. We took this action in 
response to a court order \2\ requiring the Animal and Plant Health 
Inspection Service (APHIS) to solicit public input into the development 
of the protocols used for deregulating fields for PCN.
---------------------------------------------------------------------------

    \1\ To view the proposed rule, supporting documents, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0041.
    \2\ Memorandum Decision and Order, Mickelsen Farms, LLC, et al. 
v. APHIS, et al., March 20, 2018. https://www.gpo.gov/fdsys/pkg/USCOURTS-idd-1_15-cv-00143/pdf/USCOURTS-idd-1_15-cv-00143-2.pdf.
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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, in response to commenters who experienced technical difficulties 
with accessing the protocols online.
    During the comment period, we made available for comment six 
documents: The Infested Field Confirmatory Policy, the Regulated Field 
Survey and Laboratory Result Definitions, the Infested Field 
Deregulation Protocol (if remaining in host crop production), the 
Associated Field Deregulation Protocol (if remaining in host crop 
production), the Deregulation Protocol for Agricultural Land No Longer 
in Host Crop Production, and the Analysis in Support of Certification 
that the Rule will not have a Significant Economic Impact on a 
Substantial Number of Small Entities.
    We received a total of 19 comments, 2 of which were submitted 
twice. One person commented that we did not adequately explain the 
science and sources for our confirmatory and deregulatory field 
protocols contained in the applicable documents. Out of an abundance of 
caution and transparency, and in deference to the court which directed 
us to provide ``requisite public notice and commenting on the 
Deregulation Protocols,'' APHIS is providing the public with an 
additional opportunity to comment on the science supporting the 
protocols, including the sources of the methods informing their 
content. Accordingly, we are including more information about the 
protocols in this document and are reopening the comment period for 30 
days.
    APHIS' prompt response to finding PCN in Idaho, which resulted in 
the drafting and publication of the interim rule in 2007,\3\ drew 
extensively upon the U.S. Department of Agriculture (USDA) Emergency 
Programs Manual (EPM) (February 2002).\4\ The EPM lays out in general 
form the procedures necessary for addressing plant pest emergencies, 
including development of an interim rule that establishes survey 
activities, quarantines, movement restrictions, and other pest measures 
intended to mitigate or eradicate the pest. APHIS has implemented 
similar plant pest responses throughout the United States in other 
programs to address golden nematode, spotted lanternfly, potato wart, 
gypsy moth, and fruit flies. Similar types of early detection and rapid 
response efforts are employed by other Federal, State, and 
international plant protection organizations.
---------------------------------------------------------------------------

    \3\ Docket No. APHIS-2006-0143; 72 FR (51975-51988), September 
12, 2007.
    \4\ To view the manual on regulations.gov, see footnote 1.
---------------------------------------------------------------------------

    Based on the initial regulations for controlling PCN that we 
finalized through rulemaking, we subsequently developed protocols for 
regulating and deregulating PCN-infested and associated fields.\5\ 
APHIS has harmonized its regulations and enforcement efforts with those 
of the Idaho State Department of Agriculture

[[Page 34538]]

and the Canadian Food Inspection Agency. The protocol mitigations work 
collectively as a systems approach and have significantly reduced the 
rate of PCN spread by regulating infested and associated fields and 
establishing sanitation requirements for equipment and vehicles leaving 
infested and associated fields. In the absence of such regulatory 
measures, we note that statistical analysis of human-assisted spread of 
PCN estimates a mean spread rate of 3.29 miles/year.\6\ This suggests 
that in the 14 years since PCN was first detected in Idaho, the pest 
could have spread more than 46 miles from the first infested field 
identified. With regulatory controls in place, PCN is limited to an 
area within an 8.5-mile radius, only 11.5 miles in straight line 
distance.
---------------------------------------------------------------------------

    \5\ See footnote 1 for a link to the protocols.
    \6\ Banks, N.C., et. al. Dispersal of Potato Cyst Nematodes 
Measured Using Historical and Spatial Statistical Analyses. 
Phytopathology, Vol. 102, No. 6, 2012.
---------------------------------------------------------------------------

    Below, we list the procedures used in the protocols and explain the 
scientific rationale and background we relied upon as grounds for 
including them. As noted above, many, if not most, of these procedures 
have been employed by USDA and State pest programs for decades across 
the United States, in various forms and for many different plant pests 
and crops, including nematodes on potatoes. Internationally, Australia 
and Japan, which also do not have widespread PCN infestations, have 
also relied on these and similar best practices to help them respond to 
PCN detections in their respective countries.\7\
---------------------------------------------------------------------------

    \7\ IPPC reports are located at https://www.ippc.int/en/countries/australia/pestreports/2010/09/eradication-of-potato-cyst-nematode-pcn-from-western-australia/ and at https://www.ippc.int/en/countries/japan/pestreports/2016/10/outbreak-of-globodera-pallida-4/.
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Containment Measures for PCN

    Different types of farming equipment can spread Globodera cysts,\8\ 
with potato diggers representing the greatest potential risk. The risk 
is high because of the large amount of soil that adheres to the digger 
and because PCN population densities are highest at harvest time 
following production of a susceptible cultivar. Additionally, the new 
cysts present at harvest contain a large number of viable eggs that 
provide a greater chance of successful population establishment.\9\ 
Consequently, every precaution should be taken to prevent the spread of 
potato cyst nematodes. Nematologists advise those who work in the 
fields to clean equipment of soil before entering non-infested 
sites.\10\
---------------------------------------------------------------------------

    \8\ Brodie, B.B., Probability of Globodera rostochiensis Spread 
on Equipment and Potato Tubers. Journal of Nematology 25(2):291-296. 
1993.
    \9\ Brodie, B.B., and M.L. Brucato. Relation of Cyst Age and Egg 
Density to Establishment of Globodera Rostochiensis populations. 
Journal of Nematology 21:4 October 1989.
    \10\ Stienstra, W.C., and D.H. McDonald. The Soybean Cyst 
Nematode. Minnesota Extension Service AG-FO-3935 1990.
---------------------------------------------------------------------------

    Based on these established best practices, the PCN program 
protocols include requirements for pressure washing or using steam to 
clean all farm equipment, vehicles, or other conveyances that have been 
in a PCN infested or associated field. These procedures ensure that 
nematodes are not carried into new fields via soil or equipment. 
Washing and steam sterilization of equipment has been a phytosanitary 
standard for nematode and other plant pest control for decades, and the 
techniques required in the PCN deregulation protocols are similar to 
plant pest sanitation protocols used throughout the United States and 
the world. More specifically, the PCN sanitation practices are modeled 
in part after those employed by the USDA Golden Nematode program for 
controlling the spread of that pest in New York State. A 2006 version 
of the USDA Golden Nematode Manual requires that all soil be removed by 
cleaning farm equipment, mechanized soil moving equipment, farm tools, 
used containers, and other similar articles using pressure washing and 
steam treatment.\11\
---------------------------------------------------------------------------

    \11\ Golden Nematode Program Manual (2006): 2-8-18. Similar 
steam and pressure cleaning requirements are included in earlier 
versions of the manual published in 1968 and 1992. All versions are 
available via the link to regulations.gov in footnote 1 of this 
document.
---------------------------------------------------------------------------

Soil Sampling and Detection Strategies for PCN

    Soil sampling rates used by the PCN program for associated and 
infested fields are supported by a model that combines the medium scale 
distribution of cysts and the small scale distribution of cysts within 
square meters. The medium scale distribution provides the expected 
population densities at each position within the focus and refers to 
the size and shape of a focus resulting from farming practices. The 
small scale distribution represents the multiplication of Globodera on 
the roots of evenly spaced potato plants.
    A computer program, SAMPLE, analyzes soil sampling methods.\12\ The 
parameters of the model include gradient length and width, which 
represent the medium scale distribution and the aggregation factor of 
the negative binomial distribution (small scale distribution). Terms of 
the soil sampling method are also factored into the program. The terms 
are maximum grid cell size, sampling points per hectare (ha), core size 
cubic centimeters (cc), soil sample size (cc) per ha, and bulk sample 
size (gram). In this program, the selected average detection 
probability is set at 90 percent. The following sampling rates were 
calculated to detect extremely small infestations at three critical 
phases of the program: Deregulation of associated fields, monitoring 
eradication progress on infested fields, and deregulation of infested 
fields (in-field bioassay). The Canadian and United States Guidelines 
on Surveillance and Phytosanitary Actions for the potato cyst nematodes 
Globodera rostochiensis and Globodera pallida recommend a minimum 
sample size of 20,000 cc per ha (approximately 8,000 cc per acre) taken 
either manually or mechanically. When a similar method was analyzed 
with the SAMPLE program using 15,000 cc/ha (approximately 6,000 cc per 
acre) with a bulk sample size of 22.5 kilogram (kg), it had a detection 
probability of 99 percent with a central population density (CPD) of 50 
cysts per kg of soil. For small infestation foci where the CPD is 5 
cysts per kg of soil, the method has a detection probability of only 22 
percent.
---------------------------------------------------------------------------

    \12\ Additional descriptions of these sampling methods are: (1) 
Been, T.H. and Schomaker, C.H. 1998. Sampling methods for fields 
with patchy infestations of the potato cyst nematode (Globodera 
spp.): A simulation model to develop and evaluate sampling methods. 
In Quantitative studies on the management of potato cyst nematodes 
(Globodera spp.) in the Netherlands. p. 319; and (2) Been, T.H. and 
Schomaker, C.H. 2000. Development and evaluation of sampling methods 
for fields with infestation foci of potato cyst nematodes (Globodera 
rostochiensis and G. pallida). Phytopathology 90:647-656.
---------------------------------------------------------------------------

    The delimiting rate for associated fields is 8,000 cubic 
centimeters (cc)/acre (ac), approximately 20 pounds (lbs)/ac. According 
to the SAMPLE model, for an infestation with a CPD of 50 cysts/kg in a 
field, the model shows a detection probability of 98.55 percent at the 
delimiting survey rate. Associated fields are required to undergo two 
surveys at the delimiting rate, each following a host crop. At a CPD of 
50 cysts/kg, the second sampling detection should remain high. To 
calculate the cumulative detection probabilities with repetitive 
sampling, the product of both non-detection probabilities are combined. 
The probability of no detection each year is 1 - 0.9855 = 0.0145. If 
this happens twice, the combined probability of no detection equals 
0.0145\2\ = 0.00021025. Detection after two crops surveyed by this 
method is 1 - 0.00021025 = 0.9998, or 99.98 percent. For small 
infestations of 5 cysts/kg (approximately 2 cysts per

[[Page 34539]]

pound) of soil, however, repetitive sampling is even more important 
because the detection probability starts at 22 percent but increases 
with each host crop.
    The infested field monitoring survey rate is 80,000 cc/ac, 
approximately 200 lbs/ac. Because of the small infestation foci in 
Idaho, a declining cyst population from the absence of host crops, and 
the application of eradication treatments, intensive sampling increases 
the chance of detection and the accuracy of population estimation. As a 
result, the intense monitoring survey rate of 80,000 cc/ac for infested 
fields is scientifically supported.
    The infested field in-field bioassay rate is 20,000 cc/ac, 
approximately 50 lbs/ac. This rate is scientifically justified by the 
model where a small infestation with a CPD of 5 cysts/kg has a 
detection probability of 22 percent. As described for the delimiting 
survey method, the model shows that when the CPD increases, the 
detection probability also increases. Because the in-field bioassay 
reintroduces host crops and requires soil surveys following each of 
three host crops, the incipient population increases; therefore, 
detection probability also significantly increases.
    Soil samples are collected at the field surface; however, potato 
harvest machinery and annual tillage practices effectively mix the top 
layer of the soil such that soil samples represent at least the top 30 
centimeters of the soil profile. PCN program sampling rates are higher 
than those used by many other countries where PCN infestations are 
widespread and have been present for decades. Lower sampling rates are 
generally used for managing high infestations and reducing economic 
impacts of the pest, not for eradicating nor limiting spread of the 
pest.

Infested Field Confirmatory Policy

    To evaluate a field for PCN under the confirmatory protocol, a soil 
sample is required. Sanitary requirements for entering a field (boots, 
washing of tools), soil bagging and labeling, and vehicle disinfection 
are longstanding and widely observed practices used by APHIS to prevent 
the spread of plant pests from infected fields.
    The protocol for determining infested field regulation for PCN is 
based on our knowledge about the biology and epidemiology of PCN. 
Specimens from a soil sample must be definitively identified and 
confirmed by an APHIS-approved laboratory using morphological and 
molecular DNA-based methods. Molecular methods provide an additional, 
confirmatory step along with morphological methods.
    Details of APHIS' use of DNA and morphological/morphometric 
identification of PCN are described in a 2007 scientific article,\13\ 
which is provided via a link in the confirmatory protocol. In the 
1990s, nematologists began using DNA technology extensively for 
identification purposes, while morphological identification of 
nematodes has been widely in practice for decades. The technical 
minimum threshold for declaring a field infested/positive for PCN is 
met by detecting a minimum of two cysts from two samples that were 
identified as PCN by morphological/morphometric analysis, and at least 
one of the cysts was viable and confirmed as PCN by molecular (DNA) 
analysis. It is not necessary for the two samples to come from the same 
survey event.
---------------------------------------------------------------------------

    \13\ Skantar, et al., Morphological and Molecular Identification 
of Globodera pallida Associated with Potato in Idaho. Journal of 
Nematology, 2007 Jun; 39(2): 133-144. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2586493/. In addition, a diagnostic protocol for 
Globodera rostochiensis and Globodera pallida (PM 7/40 (4)) was 
approved as an European Plant Protection Organization Standard in 
2003 and last revised in 2017: https://onlinelibrary.wiley.com/doi/full/10.1111/epp.12391.
---------------------------------------------------------------------------

Regulating Associated Fields

    The protocol for determining associated field regulation is modeled 
in part after the USDA Golden Nematode Program and its criteria for 
determining ``exposed land'' as described in the USDA Golden Nematode 
Manual (2006 version).\14\ Unlike the Golden Nematode Program approach 
of regulating large blocks of land or entire counties, the PCN Program 
adopted a more conservative field-by-field regulatory approach in which 
only confirmed infested fields and those at high risk for infestation 
are regulated. Associated fields are identified through the process of 
researching an infested field's history, going back 10 years, to 
identify other fields that may have been exposed to infested field 
soil.
---------------------------------------------------------------------------

    \14\ To view the manual on regulations.gov, see footnote 1.
---------------------------------------------------------------------------

Infested Field Deregulation Protocol (if Remaining in Host Crop 
Production)

    Fields that APHIS has determined to be infested with PCN are 
eligible for release under a deregulation protocol if the field is used 
for host crop production. The infested field deregulation protocol 
employs strategies that have been used for decades to control nematodes 
on potatoes and other crops.

Fixed Grid Pattern Field Sampling

    In the Infested Field Deregulation Protocol, APHIS conducts an 
initial full field survey in a fixed grid pattern at an 80,000 cc of 
soil per acre sampling rate. The sampling results (number of cysts per 
sample) are used to map the relative distribution and population of 
cysts in the field, and infestation foci are located. The fixed grid 
survey is a standard industry practice for monitoring several types of 
field activities, including mapping infestations and monitoring pest 
eradication treatments. For instance, one study APHIS drew upon in 
developing the protocols describes a method for PCN soil sampling by 
which a field is divided into 20 x 20 meter grid squares, then soil 
samples are collected from each grid. The samples are processed to 
separate cysts from the soil, and the number of cysts per grid is 
determined by counting. The results of the cyst counts are plotted to 
produce a map of the infestation across the field.\15\ Identifying 
infestation foci informs soil treatment decisions and cost-effective 
monitoring of treatment efficacy over time. This method is the basis 
for the PCN program's mapping surveys and subsequent grid monitoring 
surveys.
---------------------------------------------------------------------------

    \15\ See Evans. K., et al., Mapping Infestations of Potato Cyst 
Nematodes and the Potential for Spatially Varying Applications of 
Nematicides. Precision Agriculture 4 (2003) 149-162.
---------------------------------------------------------------------------

    The PCN sampling method for infested fields is based on a 2 x 2 
grid pattern method (subsamples are collected 2 paces apart, every 2 
paces) modeled in part after a grid survey method described in GN 
program manuals from 1992 and 2006. The 2006 manual describes the steps 
for such a survey, beginning with measuring the dimensions of the 
field, dividing the field into a grid, and sampling the soil following 
the grid pattern. If nematodes are located in a sample, the grid makes 
it possible to trace that sample back to a location in the field.\16\
---------------------------------------------------------------------------

    \16\ Golden Nematode Program Manual (2006): 2-3-7. To view the 
manual on regulations.gov, see footnote 1.
---------------------------------------------------------------------------

    After sampling results are determined, a field may undergo a series 
of optional, PCN program-sponsored eradication treatments, which are 
monitored according to initial grid survey results. These treatments 
are conducted at the discretion of the grower. Eradication treatments 
have included Telone[supreg] II fumigation and the trap crop litchi 
tomato. Telone[supreg] and Telone[supreg] II have been widely employed 
as a nematicide for control of all major species of nematodes 
throughout the United States, as has litchi tomato as a trap crop

[[Page 34540]]

in other countries. Trap crops, which have been used for decades to 
control nematodes, can be effective in reducing yield loss in potatoes 
and other crops when used as part of a crop rotation, or in conjunction 
with the use of nematicides.\17\
---------------------------------------------------------------------------

    \17\ See Sparkes, Jessica, Potential trap crops for the control 
of Potato Cyst Nematode (PCN). ADAS UK Ltd. 2013: https://potatoes.ahdb.org.uk/sites/default/files/publication_upload/PCN%20trap%20crops%20review_for%20publication.pdf.
---------------------------------------------------------------------------

    Host crops may be grown consecutively or in a crop rotation. A 
field is eligible for full deregulation if no viable cysts are detected 
after each of three host crops are harvested.\18\ The scientific 
rationale for requiring three crops is to allow multiplication and 
detection of any low-level PCN populations prior to release.
---------------------------------------------------------------------------

    \18\ See Greco N., et al., The Effect of Globodera Pallida and 
G. Rostochiensis On Potato Yield. Nematologica 28.4: January 1982: 
https://brill.com/view/journals/nema/28/4/article-p379_2.xml.
---------------------------------------------------------------------------

Viability Testing, Staining, and Bioassays

    In the Infested Field Deregulation Protocol, initial cyst viability 
is assessed using a live/dead staining assay. The staining assay to 
determine viability is a standard procedure in nematology as it allows 
for clearer visual identification of the organism. To evaluate the 
efficacy of a treatment for cyst nematode control, determining if a 
nematode is dead or alive is important. The lack of movement of a 
nematode does not signify death in species like Heterodera spp. (cyst 
nematodes).\19\ Since the egg is protected in a resistant structure, 
living (viable) and dead (nonviable) eggs cannot be distinguished by 
direct observation. Various dyes and stains have been used to visualize 
and then ascertain viability of nematode eggs.
---------------------------------------------------------------------------

    \19\ Shepherd, A.M. 1962. New blue R, a stain that 
differentiates between living and dead nematodes. Nematologica 8: 
201-208.
---------------------------------------------------------------------------

    To become deregulated, a field must complete a series of tests to 
demonstrate that the infestation has been fully eradicated. In 
classical nematology, the standard method to determine PCN viability is 
based on a staining assay, using Meldola's blue dye (MB) followed by 
microscopic visualization of MB[hyphen]treated nematodes. Nematode 
staining techniques are widely accepted by the majority of nematology 
laboratories and have been for decades.\20\ One study presents a novel 
hatching bioassay technique developed for golden nematode, in which the 
authors illustrated the feasibility and advantages of a hatching 
bioassay system using staining and fluorescence microscopy. Another 
study \21\ published in 1996 discusses the results of PCN infectivity 
assays using staining techniques similar to those we prescribe in the 
deregulation protocol. We also note that the 1968 USDA Golden Nematode 
Program Manual includes viability testing to monitor efficacy of 
chemical treatments.
---------------------------------------------------------------------------

    \20\ Perry, R. and Feil, J., Observations on a Novel Hatching 
Bioassay for Globodera Rostochiensis Using Fluorescence Microscopy. 
Revue N[eacute]matologie 9 (31): 280-282 (1986).
    \21\ Zanna, Muhammad, Diapause in the nematode Globodera 
pallida. European Journal of Plant Pathology 100: 413-423, 1994.
---------------------------------------------------------------------------

    As part of the infested field protocol, we also assess cyst 
viability using a greenhouse bioassay method (equivalent to three 
consecutive susceptible potato crops) or an in-field bioassay method 
(three consecutive crops grown in infestation foci or over the entire 
field). Greenhouse and field bioassays are used throughout the world to 
evaluate pest viability and other biological characteristics.\22\
---------------------------------------------------------------------------

    \22\ See McKenzie, M.M. and S.J. Turner, Assessing reproduction 
of potato cyst nematodes (Globodera rostochiensis and G. pallida) on 
potato cultivars for National Listing. EPPO Bulletin 17:3: September 
1987. https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2338.1987.tb00048.x.
---------------------------------------------------------------------------

Associated Field Deregulation Protocol (if Remaining in Host Crop 
Production)

    The primary determination for a field to become regulated as an 
associated field is exposure of that field to soil or other regulated 
articles from an infested field. Pressure washing sanitation 
requirements, explained above, are implemented for all equipment in 
contact with field soil. These requirements are necessary to mitigate 
the potential spread of PCN from associated fields that are considered 
high risk for PCN infestation. Other regulatory requirements are 
implemented for movement of commodities and articles from the field 
that cannot be sanitized. For PCN, a full[hyphen]field delimiting 
survey at a sampling rate of 8,000 cc of soil per acre (equivalent to 
approximately 20 pounds of soil per acre) is used to determine its 
presence in associated fields. A series of two negative delimiting 
surveys, each following harvest of two host crops grown on the field, 
is required to deregulate an associated field. The current deregulation 
protocol was adopted by APHIS in 2012 at the request of cooperators and 
stakeholders that were impacted, including the Idaho State Department 
of Agriculture, Idaho Potato Commission, and owners and operators of 
infested and associated fields.
    Delimiting surveys are a common practice that have been included in 
APHIS emergency response manuals and used by several APHIS, State, and 
international programs. For example, a Japanese Beetle Harmonization 
plan, adopted by the National Plant Board in 1998, uses the same 
concept as the PCN deregulation protocol of conducting detection 
surveys followed by a more robust delimiting survey. This Japanese 
beetle harmonization plan was implemented by the Idaho State Department 
of Agriculture in Boise, Idaho in 2013 after detection of the beetle in 
2012.\23\
---------------------------------------------------------------------------

    \23\ See Idaho Japanese Beetle Project at https://invasivespecies.idaho.gov/cooperative-agricultural-pest-surveys-caps.
---------------------------------------------------------------------------

Deregulation Protocol for Agricultural Land No Longer in Host Crop 
Production and Non-Agricultural Land

    A deregulation option exists for regulated fields where agriculture 
still occurs but where all host crop production was prohibited or has 
ceased for a minimum of 30 years. This could include infested or 
associated status fields. During the 30-year time period, the fields 
may have been used for various purposes, including but not limited to 
hobby farms, fallow fields, forage crops, grain fields, nurseries, or 
pasture. PCN can remain viable for approximately 30 years in the 
absence of a host crop.\24\
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    \24\ Turner, Susan. Population decline of potato cyst nematodes 
(Globodera rostochiensis, G. pallida) in field soils in Northern 
Ireland. Annals of Applied Biology, October 1996: https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1744-7348.1996.tb05754.x.
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    To become deregulated, fields no longer in host crop production 
must complete a two-step process. Records must be made available to 
APHIS to demonstrate that the land has been out of host crop production 
for the last 30 years. APHIS then surveys the entire field at a rate of 
8,000 cc soil per acre (equivalent to approximately 20 pounds of soil 
per acre). This dual approach establishes a 30-year period in which the 
field is out of host production, making it much less likely that PCN is 
present, and in the present establishes whether any viable PCN remains.
    A deregulation option also exists for regulated fields that have 
been converted to non-agricultural uses. This could include infested or 
associated status fields. Examples of non-agricultural uses include 
such things as highways and other paved roads and commercial, 
industrial or residential development.
    To become deregulated, fields converted to non-agricultural uses 
must have records available to determine the land has been out of 
agricultural use for

[[Page 34541]]

at least the last 20 years and will not return to production, or 
construction for non-agricultural proposes has rendered the land non-
tillable and is not likely to return to agricultural production. The 
risk of PCN spread and establishment from these non-agricultural fields 
is lower than those remaining in non-PCN host agricultural production, 
resulting in the lower number of years required for release. In the 
APHIS Karnal Bunt Program, which has been in place since 1996, a 
similar provision in the regulations \25\ has been used successfully to 
lower or eliminate the risk of Karnal Bunt if the land cannot be 
farmed.
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    \25\ See 7 CFR 301.89-3(f)(1).
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    In order to give the public an opportunity to consider the science 
on which we have established the field protocols and the sources we 
have used to develop them, we are reopening the comment period on 
Docket No. APHIS-2018-0041 for an additional 30 days. This action will 
allow interested persons additional time to prepare and submit 
comments.

     Done in Washington, DC, this 21st day of May 2020.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-11792 Filed 6-4-20; 8:45 am]
 BILLING CODE 3410-34-P