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

Published date18 April 2019
Citation84 FR 16189
Record Number2019-07798
SectionRules and Regulations
CourtAnimal And Plant Health Inspection Service
Federal Register, Volume 84 Issue 75 (Thursday, April 18, 2019)
[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
                ________________________________________________________________________
                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.
                ========================================================================
                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
                

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