[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; <a href="/cdn-cgi/l/email-protection#2e42574040004b584f405d034941424a404b5c6e5b5d4a4f00494158"><span class="__cf_email__" data-cfemail="91fde8ffffbff4e7f0ffe2bcf6fefdf5fff4e3d1e4e2f5f0bff6fee7">[email protected]</span></a>.

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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