[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Rules and Regulations]
[Pages 16189-16195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07798]



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 Rules and Regulations
                                                 Federal Register
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 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 
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  Federal Register / Vol. 84, No. 75 / Thursday, April 18, 2019 / Rules 
and Regulations  

[[Page 16189]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 301

[Docket No. APHIS-2015-0101]
RIN 0579-AE30


Phytophthora ramorum; Regulated Areas, Regulated Establishments, 
and Testing Protocols

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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

SUMMARY: We are amending the Phytophthora ramorum regulations to remove 
regulated areas for P. ramorum from the regulations, as well as all 
regulatory requirements specific to such areas. We are revising the 
inspection and sampling requirements for certain nurseries that are in 
areas quarantined for P. ramorum and that ship regulated nursery stock 
interstate to have them take into consideration additional potential 
sources of P. ramorum inoculum at the nurseries. Finally, we are 
establishing conditions under which we would regulate nurseries located 
outside of the quarantined areas for P. ramorum, if sources of P. 
ramorum inoculum are detected at those nurseries and the nurseries ship 
certain articles interstate. These changes will provide regulatory 
relief to nurseries in areas that are regulated for P. ramorum, while 
also ensuring that nurseries that may pose a risk of disseminating P. 
ramorum through the interstate movement of regulated nursery stock are 
subject to measures that address this risk.

DATES: Effective May 20, 2019.

FOR FURTHER INFORMATION CONTACT: Mr. William Wesela, National Policy 
Manager, Pest Management, PPQ, APHIS, 4700 River Road, Riverdale, MD 
20737-1238; (301) 851-2229.

SUPPLEMENTARY INFORMATION: 

Background

    Under section 412(a) of the Plant Protection Act (7 U.S.C. 7701 et 
seq., referred to below as the PPA), the Secretary of Agriculture may 
prohibit or restrict the movement in interstate commerce of any plant 
or plant product, if the Secretary determines that the prohibition or 
restriction is necessary to prevent the dissemination of a plant pest 
within the United States.
    Phytophthora ramorum, the cause of sudden oak death, ramorum leaf 
blight, and ramorum dieback, is a harmful pathogen that can cause 
mortality in several oak tree species and also causes twig and foliar 
diseases in numerous native and non-native ornamental plants, shrubs, 
and trees within the United States.
    Since its initial discovery in Marin County, CA, in 1995, the P. 
ramorum pathogen has been confirmed on various native hosts in Curry 
County, OR, and 15 California counties. In 2001, the States of Oregon 
and California restricted intrastate movement of certain articles from 
known infested areas at the time to prevent the spread of P. ramorum 
within those States. Because infected plants and plant products that 
move interstate could serve as a pathway for the introduction of P. 
ramorum to other areas of the United States, the Animal and Plant 
Health Inspection Service (APHIS) issued an interim rule published in 
the Federal Register on February 14, 2002 (67 FR 6827-6837, Docket No. 
01-054-1) to quarantine portions of the States of California and Oregon 
where P. ramorum was confirmed to exist (at the time, 10 counties in 
California and a portion of Curry County, OR). The interim rule 
established a new subpart, ``Subpart X--Phytophthora ramorum'' (7 CFR 
301.92 through 301.92-12, referred to below as the regulations), which 
contains APHIS' regulations to address the spread of P. ramorum. 
Subsequent detections of the pathogen from two large southern 
California nurseries in 2004 that had shipped potentially infested 
plants throughout the United States led to the additional 
implementation of a Federal Order in 2005 requiring inspection of 
nurseries in California, Oregon, and Washington that ship host plants 
or associated host plants. As new findings emerged since that time, 
APHIS revised its protocols and expanded its quarantined areas to 
manage P. ramorum infections in the United States.
    In a Federal Order issued on January 10, 2014, and a Federal Order 
issued on April 3, 2015, we restructured the domestic quarantine 
program for Phytophthora ramorum.\1\ On June 25, 2018, we published in 
the Federal Register (83 FR 29465-29472, Docket No. APHIS-2015-0101), a 
proposal \2\ to amend the regulations to reflect the changes made by 
the 2014 and 2015 Federal Orders to the Phytophthora ramorum domestic 
quarantine program. Additionally, we proposed to update the lists of 
hosts and associated hosts for P. ramorum, and to establish conditions 
for the interstate movement of soil samples from areas quarantined for 
P. ramorum.
---------------------------------------------------------------------------

    \1\ https://www.aphis.usda.gov/aphis/ourfocus/planthealth/plant-pest-and-disease-programs/pests-and-diseases/phytophthora-ramorum/ct_phytophthora_ramorum_sudden_oak_death.
    \2\ To view the proposal, supporting documents, and the comments 
we received, go to https://www.regulations.gov/docket?D=APHIS-2015-0101.
---------------------------------------------------------------------------

    We solicited comments on the proposal for 60 days ending August 24, 
2018. We received 10 comments on our proposal. Comments were from 
researchers, State agricultural and conservation agencies, 
environmental advocacy groups, research foundations, and private 
citizens. Of these, one was fully supportive of the proposed action. 
Another objected to the proposal generally on the grounds that it would 
increase the spread of disease, but did not address specific concerns 
with the proposal. Others supported some aspects of the proposal, but 
raised several issues of concern. These issues are discussed below by 
topic.

Interstate Movement of Regulated Articles

    An issue of concern to several commenters was the risk posed by 
interstate movement of nursery stock and other regulated articles under 
the proposed regulations. One commenter representing a State Department 
of Agriculture objected to the interstate shipment of plants from 
quarantine zones regardless of host status. The commenter stated that 
the proposal's method of evaluating plants in regulated establishments 
on a nursery-by-nursery basis prior to interstate shipment could lead 
to the P. ramorum pathogen moving with the shipment, if sampling is 
done during a latent period or if lots

[[Page 16190]]

testing free of the pathogen are contaminated prior to shipment. The 
commenter also noted that nurseries within a P. ramorum quarantined 
area remain at risk for contamination due to P. ramorum existing in the 
natural environment. In addition to objecting to the interstate 
shipment of plants from quarantine zones, the commenter asked that 
conditions for the shipment of plants from regulated establishments 
outside quarantine zones be clarified in the details of proposed 
compliance agreements, including mitigation measures, to ensure that 
there is no evidence of the pathogen in the natural environment, or the 
possibility of contamination from positive plant material in the 
nursery.
    APHIS has been operating under the current P. ramorum domestic 
quarantine program, as implemented by Federal Orders, since 2014. We 
have found the existing testing protocols and conditions in place for 
interstate movement of regulated, restricted, and associated articles 
from quarantined areas and from regulated establishments, which this 
rule codifies, are sufficient to mitigate the risk of transmission of 
the pathogen. Additionally, we note in response to the commenter's 
concerns regarding sampling that the regulations require that annual 
inspections and sampling take place at times most conducive to 
detection of the pathogen.
    Compliance agreements between regulated establishments and APHIS 
ensure that appropriate standards for individual establishments are 
implemented to prevent the spread of the P. ramorum pathogen. As the 
Agency responsible for Federal oversight of regulated establishments, 
APHIS will continue to ensure that requirements specified in individual 
compliance agreements meet stringent Agency standards to prevent the 
spread of the pathogen.
    Another commenter representing a State Department of Food and 
Agriculture raised concerns regarding the proposed sampling requirement 
for nurseries in quarantined areas to be set on a nursery-by-nursery 
basis. The commenter stated that Federal Order DA-2014-02, used as a 
justification in the proposed rule for changing these sampling 
standards, does not actually address the number of samples to be 
collected during the annual quarantine compliance inspection of a 
nursery, only the number of samples for the Federal Order's compliance 
sampling that occurs biannually at previously positive nurseries. The 
State expressed concern that its regulators under this proposal would 
be placed under a substantial burden, and requested clarification 
regarding the minimum number of samples to be taken during an annual 
inspection in quarantined counties not previously testing positive for 
P. ramorum, as well as guidance in the form of a table or guide in the 
proposal to determine the number of samples to be collected from each 
nursery. The commenter also requested that APHIS re-examine Federal 
Order DA-2014-02 to determine if the Order's intent supports the 
proposed nursery-by-nursery basis for sampling, and asked that APHIS 
add a regulatory requirement for the inspection of nurseries that 
supply interstate shippers.
    We agree with the commenter's assessment of the proposed sampling 
requirements for nurseries in quarantined areas and will not be making 
that proposed change in this final rule. Sampling requirements for 
annual inspections of nurseries in quarantined areas not previously 
testing positive for P. ramorum will continue as implemented under 
existing regulations and Federal Orders. We have also taken the 
commenter's request for additional nursery inspections under 
consideration, and will keep it in mind for future updates to domestic 
quarantine program operations. APHIS meets annually with the National 
Plant Board to discuss the program and any changes in protocol that may 
be needed, and will continue to engage with stakeholders when making 
operational decisions.
    Two commenters stated that the risk of inadvertent shipment of the 
P. ramorum pathogen, and subsequent risk to forests and nurseries, 
would be reduced with additional mitigations in the proposed rule 
including more rigorous inspections, surveys, or monitoring. The 
commenters noted that any nursery with host plants in any location 
should be considered as a potential source of infested plants. Another 
commenter also highlighted the risk that any nursery plant poses in 
transmitting P. ramorum, adding that APHIS should institute a system 
for detecting the pathogen in any nursery that contains host plants. 
The commenter indicated that such a system should include mandatory 
inspection and monitoring using techniques for detecting P. ramorum 
beyond visual inspection alone, and that enhanced regulatory scrutiny 
should be applied to nurseries in geographic areas that are conducive 
to survival of P. ramorum or that sell plants to be planted in such 
geographic areas. The commenter also suggested resources for research 
that support amended testing protocols for P. ramorum.
    We appreciate the commenters' concerns regarding the potential for 
additional infestation of P. ramorum. While our regulations focus on 
establishments that participate or intend to participate in interstate 
shipping, based on our experience in administering the domestic 
quarantine program, we believe the conditions currently in place for 
testing and inspections--which will be codified under this rule--are 
sufficient for preventing further spread of the pathogen and for 
protecting American agriculture. As mentioned above, the regulations 
require that annual inspections and sampling take place at times most 
conducive to detection of P. ramorum, which mitigates the risk of 
inadvertent shipment of the pathogen. Additionally, this rule will 
codify the use of measures beyond visual inspection for detecting the 
pathogen in regulated establishments and nurseries in quarantined areas 
shipping regulated articles interstate, including testing of soil and 
standing water. As in past practice, we will continue to monitor 
detection of the pathogen, and will reevaluate program protocols should 
the need arise.
    One commenter questioned where the proposal would leave `opt-out' 
nurseries that had tested positive for P. ramorum since March 31, 2011, 
but decided not to ship interstate under the DA-2014-02 Federal Order. 
The commenter asked if such nurseries would be considered a regulated 
establishment under the proposed rule if they choose to ship interstate 
in the future, or if the rule creates a loophole for these opt-out 
nurseries to begin shipping interstate without sampling or 
certification.
    In Sec.  301.92-3(b) of the proposed rule and this final rule, we 
indicate that the Administrator will designate a nursery that is not 
located in a quarantined area for P. ramorum as a regulated 
establishment if the nursery ships regulated, restricted, or associated 
articles interstate and sources of P. ramorum are detected on nursery 
stock, or in soil, growing media, pots used for nursery stock, water 
sources, or any other regulated, restricted, or associated articles at 
the nursery. A nursery outside of a quarantined area that has tested 
positive for P. ramorum and wishes to begin shipping interstate will 
need to meet the requirements of Sec. Sec.  301.92-4 and 301.92-5, as 
well as the inspection and sampling requirements in Sec.  301.92-11(c).
    Any nurseries located in quarantined areas in which P. ramorum has 
been detected since March 31, 2011, wishing

[[Page 16191]]

to ship interstate under the requirements of Sec.  [thinsp]301.92-
11(a)(2) in this rule will need to meet the requirements therein for 
inspection, sampling, and testing prior to shipment.
    Two commenters representing different Departments of the same State 
also expressed concerns about interstate movement of P. ramorum, and 
asked for additional Federal oversight measures to address this. They 
asked that the U.S. Department of Agriculture (USDA) not relax 
regulations to protect against P. ramorum infestation and requested 
that USDA allow receiving States more flexibility in their ability to 
protect State resources. They also expressed concern that nurseries 
testing positive for P. ramorum are placed under Federal compliance 
agreements, which are then left to the States for oversight without 
stated minimum standards for mitigation processes.
    Ongoing cooperation between Federal and State regulators is 
essential to the proper functioning of the domestic quarantine program 
for P. ramorum. States play an important role in this relationship to 
enforce regulatory requirements, for which Federal funding is provided. 
APHIS remains committed to its ongoing partnership with States, and 
intends to set minimum standards for mitigation processes through the 
codification of this rule. Additionally, we note that this rule does 
not relax any regulatory operations, but rather updates the regulations 
to codify existing protocols that have been in place since 2014, and 
will remain in place following publication of this rule.

Discrepancies in Background Information and Host List

    Several commenters noted discrepancies in the background 
information of the proposed rule. Two commenters highlighted specific 
passages where suggestions for rewording were included to clarify the 
history and background associated with the P. ramorum pathogen. Several 
commenters also noted that the proposed rule's statement that 14 
counties in California are under quarantine for P. ramorum should read 
as 15. A few commenters also took issue with the APHIS host list, 
finding it to exclude a number of hosts and also finding the length of 
time between a host's identification and its addition to the list to be 
unsatisfactory. Specifically, commenters cited concerns regarding the 
placement of the Japanese larch (Larix kaempferi) on the list of 
associated hosts, as literature in the United Kingdom has documented 
that this is a proven host of the pathogen. The commenters requested 
that APHIS re-evaluate its determination of hosts, including the speed 
with which hosts are evaluated, in addition to adding Japanese larch to 
the host list.
    We appreciate the commenters' concerns and have in this final rule 
clarified background information that may have been inadvertently 
imprecise regarding the historical progression of P. ramorum detections 
and response protocols in the United States. The reference to 14 
quarantined counties in the preamble of the proposed rule was made in 
the context of describing the list of counties in the existing 
regulations (first implemented by the 2002 interim rule). We have 
clarified this reference in this final rule, and note that all 15 
counties quarantined under subsequent Federal Orders were included in 
the regulatory text of the proposal.
    Regarding the host list, we agree with commenters as to the 
challenges of maintaining an updated host list in its current form. To 
address this issue, we plan in the near future to restructure the lists 
of proven P. ramorum hosts and associated plant taxa, and to move the 
lists from the regulations to the APHIS website to allow for more 
timely updates. Part of the restructuring plan would likely include 
merging the lists of proven and associated hosts into a single host 
list, which would address commenters' concern regarding placement of 
specific taxa within the existing lists. Any such plans would be 
proposed via rulemaking with a public comment period provided.
    One commenter stated that the background information in the 
proposed rule understated the risk of P. ramorum infection to 
nurseries, pointing out that the annual 3 percent level of detection 
cited in the proposal is not a low level of risk, that spread of the 
pathogen to nurseries from the natural environment still occurs despite 
regulatory efforts, and that new infections in nurseries are likely to 
continue absent mandated surveys of all nurseries selling host or 
associated host plant material.
    We wish to clarify that the 3 percent level of detection indicated 
in the preamble text was referring to the number of nurseries, not the 
number of overall plants, where P. ramorum was detected. Also, we note 
that we are bound by statutory authority to regulate based on 
interstate commerce, and therefore cannot mandate regulatory 
requirements that extend beyond this authority. However, based on our 
experience in administering the domestic quarantine program and the 
relatively low number of infestations discovered during its 
implementation, we believe that the proposed methods are sufficient to 
mitigate risks of further spread of the pathogen. As we have done in 
past practice with making program enhancements--including with this 
final rule that codifies program updates that were made to existing 
regulations--we note that we will continue to monitor detections of P. 
ramorum and will update program protocols should it become necessary to 
do so.

Lack of Transparency

    Citing a lack of publicly-available data, several commenters noted 
the difficulty for non-regulators to be able to adequately evaluate the 
existing efficacy of the P. ramorum program and the provisions to 
codify them in the proposed rule. The commenters requested that APHIS 
reinstate the P. ramorum quarterly program updates that were 
discontinued in 2014.
    We appreciate the commenters' concerns and will be reinstating the 
P. ramorum program updates beginning in April of 2019.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Orders 12866 and 13771 and Regulatory Flexibility Act

    This rule is not an Executive Order 13771 regulatory action because 
this rule is not significant under Executive Order 12866. Further, 
APHIS considers this rule to be a deregulatory action under Executive 
Order 13771 as the action would remove regulated areas for P. ramorum 
from the regulations, as well as the regulatory requirements specific 
to such areas, thus relieving restrictions on affected entities living 
in those areas. 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.
    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 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov website (see ADDRESSES above for instructions 
for accessing Regulations.gov).
    This rule revises the Phytophthora ramorum domestic regulations in 
accordance with Federal Orders issued 2013-2015. The Federal Orders 
have allowed APHIS and State regulatory agencies to focus regulatory 
controls on the nurseries that present a significant

[[Page 16192]]

risk of spreading the pathogen and away from those nurseries that pose 
a negligible risk of contributing to its artificial spread, thereby 
more efficiently apportioning resources and the regulatory burden.
    The rule removes the designation of P. ramorum regulated areas, as 
well as all restrictions and protocols specific to those areas. It will 
relieve the regulatory burden on approximately 1,500 nurseries where 
the pathogen is not present in the environment. As an alternative to 
regulated areas, this action codifies the concept of regulated 
establishments that will be required to enter into compliance agreement 
with APHIS.
    The annual cost of complying with the P. ramorum management 
requirements in the regulations ranges from $14,000 to $16,000 per 
nursery. Thus, the cost savings for the 1,500 operations that will be 
relieved of these management requirements range from $21 million to $24 
million per year. In accordance with guidance on complying with 
Executive Order 13771, the single primary estimate of the cost savings 
of this rule is about $22.5 million ($15,000 per nursery), the mid-
point estimate of cost savings annualized in perpetuity using a 7 
percent discount rate. In addition, by not requiring annual 
certification by APHIS or State officials, there will be public cost 
savings of about $363,000 per year.
    This rule will not deregulate the current P. ramorum quarantine 
areas, nor will it deregulate interstate shipping nurseries located 
within these quarantined areas. For regulated establishments and 
establishments located within quarantined areas, compliance costs may 
increase or decrease depending on amended best management practices, 
but any related change in operational costs is not expected to be 
significant.
    The majority of establishments that will be affected by this rule 
are small entities. The rule codifies current Federal Orders, and will 
not have a significant economic impact on a substantial number of small 
entities.
    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.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the reporting, recordkeeping, and 
third party disclosure requirements included in this final rule have 
already been approved by the Office of Management and Budget (OMB) 
under OMB control numbers 0579-0088 and 0579-0310.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this final rule, please contact Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

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 301.92 is amended as follows:
0
a. By revising paragraph (b); and
0
b. In paragraph (c), by removing the words ``quarantined or regulated 
area'' and adding the words ``quarantined area or regulated 
establishment'' in their place.
    The revision reads as follows:


Sec.  301.92  Restrictions on interstate movement.

* * * * *
    (b) No person may move interstate from any regulated establishment 
any regulated, restricted, or associated articles except in accordance 
with this subpart.
* * * * *

0
3. Section 301.92-1 is amended by removing the definition for Regulated 
area and by adding, in alphabetical order, a definition for Regulated 
establishment to reads as follows:


Sec.  301.92-1   Definitions.

* * * * *
    Regulated establishment. Any nursery regulated by APHIS pursuant to 
Sec.  301.92-3(b).
* * * * *

0
4. Section 301.92-2 is amended as follows:
0
a. In paragraph (d), by adding entries in alphabetical order for 
Cinnamomum camphora and Gaultheria procumbens; and
0
 b. In paragraph (e), by adding entries in alphabetical order for Ilex 
cornuta, Illicium parviflorum, Larix kaempferi, Magnolia denudata, 
Mahonia nervosa, Molinadendron sinaloense, Trachelospermum jasminoides, 
and Veronica spicata Syn. Pseudolysimachion spicatum.
    The additions read as follows:


Sec.  301.92-2   Restricted, regulated, and associated articles; lists 
of proven hosts and associated plant taxa.

* * * * *
    (d) * * *
    * Cinnamomum camphora Camphor tree
* * * * *
    * Gaultheria procumbens, Eastern teaberry
* * * * *
    (e) * * *
    Ilex cornuta Buford holly, Chinese holly
* * * * *
    Illicium parviflorum Yellow anise
    Larix kaempferi Japanese larch
* * * * *
    Magnolia denudata Lily tree
* * * * *
    Mahonia nervosa Creeping Oregon grape
* * * * *
    Molinadendron sinaloense
* * * * *
    Trachelospermum jasminoides Star jasmine, confederate jasmine
* * * * *

[[Page 16193]]

    Veronica spicata Syn. Pseudolysimachion spicatum Spiked speedwell

0
5. Section 301.92-3 is revised to read as follows:


Sec.  301.92-3  Quarantined areas and regulated establishments.

    (a) Quarantined areas. (1) Except as otherwise provided in 
paragraph (a)(2) of this section, the Administrator will designate as a 
quarantined area in paragraph (a)(3) of this section each State, or 
each portion of a State, in which Phytophthora ramorum has been 
confirmed by an inspector to be established in the natural environment, 
in which the Administrator has reason to believe that Phytophthora 
ramorum is present in the natural environment, or that the 
Administrator considers it necessary to quarantine because of its 
inseparability for quarantine enforcement purposes from localities in 
which Phytophthora ramorum has been found in the natural environment. 
Less than an entire area will be designated as a quarantined area only 
if the Administrator determines that:
    (i) The State has adopted and is enforcing restrictions on the 
intrastate movement of regulated, restricted, and associated articles 
that are substantially the same as those imposed by this subpart on the 
interstate movement of regulated, restricted, and associated articles; 
and
    (ii) The designation of less than the entire State as a quarantined 
area will prevent the interstate spread of Phytophthora ramorum.
    (2) The Administrator or an inspector may temporarily designate any 
nonquarantined area as a quarantined area in accordance with paragraph 
(a)(1) of this section. The Administrator will give a copy of this 
regulation along with a written notice for the temporary designation to 
the owner or person in possession of the nonquarantined area. 
Thereafter, the interstate movement of any regulated, restricted, or 
associated article from an area temporarily designated as a quarantined 
area will be subject to this subpart. As soon as practicable, this area 
will be added to the list in paragraph (a)(3) of this section or the 
designation will be terminated by the Administrator or an inspector. 
The owner or person in possession of an area for which designation is 
terminated will be given notice of the termination as soon as 
practicable.
    (3) The following areas are designated as quarantined areas:
California
    Alameda County. The entire county.
    Contra Costa County. The entire county.
    Humboldt County. The entire county.
    Lake County. The entire county.
    Marin County. The entire county.
    Mendocino County. The entire county.
    Monterey County. The entire county.
    Napa County. The entire county.
    San Francisco County. The entire county.
    San Mateo County. The entire county.
    Santa Clara County. The entire county.
    Santa Cruz County. The entire county.
    Solano County. The entire county.
    Sonoma County. The entire county.
    Trinity County. The entire county.
Oregon
    Curry County. The following portion of Curry County that lies 
inside the area starting at the point where the mouth of the Rogue 
River meets the Pacific Ocean and continuing east along the Rogue River 
to the northeast corner of T35S R12W section 31; then south to the 
northeast corner of T38S R12W section 18; then east to the northeast 
corner of T38S R12W section 13; then south to northeast corner of T38S 
R12W section 25; then east to the northeast corner of T38S R11W section 
29; then south to the northeast corner of T40S R11W section 8; then 
east to the northeast corner of T40S R11W section 10; then south to the 
State border with California; then west to the intersection of the 
State border and U.S. Highway 101; then northwest along U.S. Highway 
101 to the intersection with West Benham Lane; then west along West 
Benham Lane to the Pacific Coastline; then following the Pacific 
Coastline northwest to the point of beginning.
    (b) Regulated establishments--(1) Designation. The Administrator 
will designate a nursery that is not located in a quarantined area for 
Phytophthora ramorum as a regulated establishment for Phytophthora 
ramorum if the nursery ships regulated, restricted, or associated 
articles interstate and sources of Phytophthora ramorum are detected on 
nursery stock, or in soil, growing media, pots used for nursery stock, 
standing water, drainage water, water used for irrigation, or any other 
regulated, restricted, or associated articles at the nursery.
    (2) Deregulation. The Administrator will withdraw regulation of a 
regulated establishment if, for 3 consecutive years, each time the 
nursery is inspected by an inspector, it is found free of sources of 
Phytophthora ramorum inoculum.

(Approved by the Office of Management and Budget under control number 
0579-0310)

0
6. Section 301.92-4 is amended by revising the section heading and 
paragraphs (a)(2) and (d) to read as follows:


Sec.  301.92-4  Conditions governing the interstate movement of 
regulated, restricted, and associated articles, and non-host nursery 
stock from quarantined and regulated establishments.

    (a) * * *
    (2) Without a certificate. (i)(A) The regulated article or 
associated article originated outside the quarantined area and the 
point of origin of the article is indicated on the waybill of the 
vehicle transporting the article; and
    (B) The regulated or associated article is moved from outside of 
the quarantined area through the quarantined area without stopping 
except for refueling or for traffic conditions, such as traffic lights 
or stop signs, and the article is not unpacked or unloaded in the 
quarantined area.
    (ii) Soil samples may be moved from a quarantined area for 
Phytophthora ramorum for chemical or physical (compositional) analysis 
provided that they are moved to a laboratory; and that laboratory:
    (A) Has entered into and is operating under a compliance agreement 
with APHIS in accordance with Sec.  301.92-6;
    (B) Is abiding by all terms and conditions of that compliance 
agreement; and
    (C) Is approved by APHIS to test and/or analyze such samples.
* * * * *
    (d) Interstate movement of regulated, restricted, and associated 
articles from regulated establishments. Regulated, restricted, and 
associated articles may be moved interstate from a regulated 
establishment if the regulated establishment has entered into a 
compliance agreement with APHIS in accordance with Sec.  301.92-6, and 
the articles are accompanied by a certificate issued in accordance with 
Sec.  301.92-5.

0
7. Section 301.92-5 is amended by revising paragraphs (a)(1)(iv)(A) and 
(b) to read as follows:


Sec.  301.92-5  Issuance and cancellation of certificates.

    (a) * * *
    (1) * * *
    (iv) * * *
    (A)(1) Are shipped from a nursery that has been inspected in 
accordance with the inspection and sampling protocol described in Sec.  
301.92-11(a)(1), and the nursery is free of evidence of Phytophthora 
ramorum infestation; or
    (2) Are shipped from a nursery that has been inspected in 
accordance with the inspection and sampling protocol

[[Page 16194]]

described in Sec.  301.92-11(a)(2), and the nursery is free of evidence 
of Phytophthora ramorum infestation; or
    (3) Are shipped from a nursery that has been inspected in 
accordance with the inspection and sampling protocol described in Sec.  
301.92-11(a)(2), is not free of evidence of Phytophthora ramorum 
infestation, but has entered into and is operating under a compliance 
agreement with APHIS, and is determined by an inspector to be abiding 
by all terms and conditions of that agreement; and
* * * * *
    (b) Movements from regulated establishments. An inspector may issue 
a certificate for the movement of regulated, restricted, and/or 
associated articles from a regulated establishment if the inspector 
determines that:
    (1) The nursery has entered into a compliance agreement APHIS in 
accordance with Sec.  301.92-6 and is abiding by all terms and 
conditions of that agreement; and
    (2) The nursery has been inspected in accordance with Sec.  301.92-
11(c); and
    (3) The articles to be shipped interstate are free from 
Phytophthora ramorum inoculum; and
    (4) The movement of the articles is not subject to additional 
restriction under section 414 of the Plant Protection Act (7 U.S.C. 
7714) or other Federal domestic plant quarantines and regulations.
* * * * *


Sec.  301.92-6  [Amended]

0
8. Section 301.92-6 is amended as follows:
0
a. By redesignating footnote 15 as footnote 12; and
0
b. In the OMB citation at the end of the section, by adding the words 
``0579-0088 and'' after the word ``numbers''.


Sec.  301.92-7  [Amended]

0
9. In Sec.  301.92-7, footnote 16 is redesignated as footnote 13.

0
10. Section 301.92-11 is revised to read as follows:


Sec.  301.92-11  Inspection and sampling protocols.

    (a) Nurseries in quarantined areas shipping regulated articles of 
nursery stock and associated articles interstate--(1) Nurseries in 
which Phytophthora ramorum has not been detected since March 31, 2011. 
To meet the requirements of Sec.  301.92-5(a)(1)(iv), nurseries that 
are located in quarantined areas, that move regulated articles of 
nursery stock, decorative trees without roots, wreaths, garlands, or 
greenery, associated articles, or non-host nursery stock interstate, 
and in which Phytophthora ramorum has not been detected since March 31, 
2011, must meet the following requirements. Any such nurseries in 
quarantined areas that do not meet the following requirements are 
prohibited from moving regulated articles and associated articles 
interstate. Any such nurseries in quarantined areas that do not meet 
the following requirements or those in paragraph (b) of this section 
are prohibited from moving non-host nursery stock interstate.
    (i) Annual inspection, sampling, and testing--(A) Inspection. The 
nursery must be inspected annually for symptoms of Phytophthora ramorum 
by an inspector. Inspectors will visually inspect for symptomatic 
plants throughout the nursery, and inspection will focus on, but not be 
limited to, regulated articles and associated articles.
    (B) Sampling. A minimum of 40 plant samples must be tested per 
nursery location. Samples must be taken from all symptomatic plants if 
symptomatic plants are present. If fewer than 40 symptomatic plants are 
present, each symptomatic plant must be sampled and the remainder of 
the 40 sample minimum must be taken from asymptomatic plants. If no 
symptomatic plants are present, 40 asymptomatic plants must be sampled; 
biased toward proven hosts. Each sample may contain more than one leaf, 
and may come from more than one plant, but all plants in the sample 
must be from the same lot. Asymptomatic samples, if collected, must be 
taken from regulated and associated articles and nearby plants. 
Inspectors must conduct inspections at times when the best expression 
of symptoms is anticipated and must take nursery fungicide programs 
into consideration. Nursery owners must keep records of fungicide 
applications for 2 years and must make them available to inspectors 
upon request.
    (C) Testing. Samples must be labeled and sent for testing to a 
laboratory approved by APHIS and must be tested using a test method 
approved by APHIS, in accordance with Sec.  301.92-12.
    (D) Annual certification. If all plant samples tested in accordance 
with this section and Sec.  301.92-12 return negative results for 
Phytophthora ramorum, an inspector may certify that the nursery is free 
of evidence of Phytophthora ramorum infestation at the time of the 
inspection, and the nursery is eligible to enter into or maintain its 
compliance agreement in accordance with Sec.  301.92-6.
    (ii) Pre-shipment inspection, sampling, and testing--(A) 
Inspection. During the 30 days prior to interstate movement from a 
nursery in a quarantined area, regulated articles or associated 
articles intended for interstate movement must be inspected for 
symptoms of Phytophthora ramorum by an inspector. Inspection will focus 
on, but not be limited to, regulated articles and associated articles. 
No inspections of shipments will be conducted unless the nursery from 
which the shipment originates has a current and valid annual 
certification in accordance with this section.
    (1) If no symptomatic plants are found upon inspection, the 
shipment may be considered free from evidence of Phytophthora ramorum 
and is eligible for interstate movement, provided that the nursery is 
operating under a compliance agreement with APHIS in accordance with 
Sec.  301.92-6.
    (2) If symptomatic plants are found upon inspection, the inspector 
will collect at least one sample per symptomatic plant, and one sample 
per regulated article or associated article that is in close proximity 
to, or that has had physical contact with, a symptomatic plant.
    (B) Testing and withholding from interstate movement. Samples taken 
in accordance with this paragraph (a)(1) must be labeled and sent for 
testing to a laboratory approved by APHIS and must be tested using a 
test method approved by APHIS, in accordance with Sec.  301.92-12. The 
interstate movement of plants in the shipment is prohibited until the 
plants in the shipment are determined to be free of evidence of 
Phytophthora ramorum infection in accordance with Sec.  301.92-12.
    (2) Nurseries in which Phytophthora ramorum has been detected since 
March 31, 2011. To meet the requirements of Sec.  301.92-5(a)(1)(iv), 
nurseries that are located in quarantined areas, that move regulated 
articles of nursery stock, decorative trees without roots, wreaths, 
garlands, or greenery, associated articles, or non-host nursery stock 
interstate, and in which Phytophthora ramorum has been detected since 
March 31, 2011, must meet the following requirements. Any such 
nurseries in quarantined areas that do not meet the following 
requirements are prohibited from moving regulated articles and 
associated articles interstate. Any such nurseries in quarantined areas 
that do not meet the following requirements or those in paragraph (b) 
of this section are prohibited from moving non-host nursery stock 
interstate.
    (i) Inspections. The nursery must be inspected at least twice 
annually for symptoms of Phytophthora ramorum infestation by an 
inspector. The

[[Page 16195]]

inspection will focus on regulated plants and other potential sources 
of Phytophthora ramorum inoculum.
    (ii) Sampling. Samples must be taken from host plants, soil, 
standing water, drainage water, water for irrigation, and any other 
articles determined by the inspector to be possible sources of 
Phytophthora ramorum inoculum. The number of samples taken may vary 
depending on the possible sources of inoculum identified at the 
nursery, as well as the number of host articles in the nursery.
    (iii) Testing. Samples must be labeled and sent for testing to a 
laboratory approved by APHIS and must be tested using a test method 
approved by APHIS in accordance with Sec.  301.92-12.
    (iv) Negative results; certification. If all samples tested in 
accordance with this section and Sec.  301.92-12 return negative 
results for Phytophthora ramorum, an inspector may certify that the 
nursery is free of Phytophthora ramorum at the time of the inspection. 
If the nursery is inspected and determined by an inspector to be free 
of Phytophthora ramorum inoculum each time it is inspected for 3 
consecutive years, the nursery will thereafter be inspected in 
accordance with paragraph (a)(1) of this section.
    (v) Positive results. If any samples tested in accordance with this 
section and Sec.  301.92-12 return positive results for Phytophthora 
ramorum, the nursery may ship lots of regulated, restricted, and 
associated articles interstate pursuant to Sec.  301.92-5(b) only if 
the lot is determined to be free from Phytophthora ramorum inoculum. 
The method for this determination will be specified in the nursery's 
compliance agreement with APHIS.
    (b) Nurseries in quarantined areas shipping non-host nursery stock 
interstate. Nurseries located in quarantined areas and that move non-
host nursery stock interstate must meet the requirements of this 
paragraph or the requirements of paragraph (a) of this section. If such 
nurseries contain any regulated or restricted articles, the nursery 
must meet the requirements of paragraph (a) of this section. This 
paragraph (b) only applies if there are no regulated or associated 
articles or nursery stock at the nursery. Nurseries that do not meet 
the requirements of paragraph (a) of this section or this paragraph (b) 
are prohibited from moving non-host nursery stock interstate.
    (1) Annual visual inspection. The nursery must be visually 
inspected annually for symptoms of Phytophthora ramorum. Inspections 
and determinations of freedom from evidence of Phytophthora ramorum 
infestation must occur at the time when the best expression of symptoms 
is anticipated.
    (2) Sampling. All plants showing symptoms of infection with 
Phytophthora ramorum upon inspection will be sampled and tested in 
accordance with Sec.  301.92-12. If symptomatic plants are found upon 
inspection, the following plants must be withheld from interstate 
shipment until testing is completed and the nursery is found free of 
evidence of Phytophthora ramorum in accordance with this paragraph (b) 
and Sec.  301.92-12: All symptomatic plants, any plants located in the 
same lot as the suspect plant, and any plants located within 2 meters 
of this lot of plants.
    (3) Certification. If all plant samples tested in accordance with 
this section and Sec.  301.92-12 return negative results for 
Phytophthora ramorum, or if an inspector at the nursery determines that 
plants in a nursery exhibit no signs of infection with Phytophthora 
ramorum, the inspector may certify that the nursery free of evidence of 
Phytophthora ramorum infestation at the time of inspection. 
Certification is valid for 1 year and must be renewed each year to 
continue shipping plants interstate.
    (c) Regulated establishments shipping regulated, restricted, or 
associated articles of interstate--(1) Inspections. To meet the 
conditions of Sec.  301.92-5(b), the regulated establishment must be 
inspected at least twice annually for symptoms of Phytophthora ramorum 
infestation by an inspector. The inspection will focus on regulated 
plants and other potential sources of Phytophthora ramorum inoculum.
    (2) Sampling. Samples must be taken from host plants, soil, 
standing water, drainage water, water for irrigation, growing media, 
and any other articles determined by the inspector to be possible 
sources of Phytophthora ramorum inoculum. The number of samples taken 
may vary depending on the possible sources of inoculum identified at 
the nursery, as well as the number of host articles in the nursery.
    (3) Testing. Samples must be labeled and sent for testing to a 
laboratory approved by APHIS and must be tested using a test method 
approved by APHIS in accordance with Sec.  301.92-12.
    (4) Negative results; certification. If all samples tested in 
accordance with this section and Sec.  301.92-12 return negative 
results for Phytophthora ramorum, an inspector may certify that the 
nursery is free of Phytophthora ramorum at the time of the inspection. 
For purposes of Sec.  301.92-5(b), regulated, restricted, and 
associated articles at a certified nursery are considered free from 
Phytophthora ramorum until the time of the next inspection.
    (5) Positive results. If any samples tested in accordance with this 
section and Sec.  301.92-12 return positive results for Phytophthora 
ramorum, the nursery may ship lots of regulated, restricted, and 
associated articles interstate pursuant to Sec.  301.92-5(b) only if 
the lot is determined to be free from Phytophthora ramorum inoculum. 
The method for this determination will be specified in the nursery's 
compliance agreement with APHIS.


(Approved by the Office of Management and Budget under control number 
0579-0310)


Sec.  301.92-12  [Amended]

0
 11. In Sec.  301.92-12, paragraph (a) introductory text is amended by 
removing the words ``prescreen plant samples'' and adding the words 
``prescreen samples'' in their place.

    Done in Washington, DC, this 12th day of April 2019.
 Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-07798 Filed 4-17-19; 8:45 am]
BILLING CODE 3410-34-P