[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Rules and Regulations]
[Pages 63060-63066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25291]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 301

[Docket No. APHIS-2005-0103]
RIN 0579-AB98


Special Need Requests Under the Plant Protection Act

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending our domestic quarantine regulations to 
establish a process by which a State or political subdivision of a 
State could request approval to impose prohibitions or restrictions on 
the movement in interstate commerce of specific articles that are in 
addition to the prohibitions and restrictions imposed by the Animal and 
Plant Health Inspection Service. The Plant Protection Act provides that 
States or political subdivisions of States may make such special need 
requests, but there are currently no procedures in place for their 
submission or consideration. This action establishes a process by which 
States may make a special need request.

DATES: Effective Date: November 24, 2008.

FOR FURTHER INFORMATION CONTACT: Mr. Osama El-Lissy, Director, 
Emergency Management, Emergency and Domestic Programs, PPQ, APHIS, 4700 
River Road Unit 134, Riverdale, MD 20737-1237; (301) 734-5459.

SUPPLEMENTARY INFORMATION: 

Background

    The Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) gives 
authority to the Secretary of Agriculture to prohibit or restrict the 
importation, entry, exportation, or movement in interstate commerce of 
any plant, plant product, biological control organism, noxious weed, 
article, or means of conveyance if the Secretary determines that the 
prohibition or restriction is necessary to prevent the introduction of 
a plant pest or noxious weed into the United States, or the 
dissemination of a plant pest or noxious weed within the United States. 
The Secretary has delegated this authority to the Administrator of the 
Animal and Plant Health Inspection Service (APHIS).
    Under section 436 of the PPA (7 U.S.C. 7756), no State or political 
subdivision of a State may regulate the movement in interstate commerce 
of any article, means of conveyance, plant, biological control 
organism, plant pest, noxious weed, or plant product in order (1) to 
control a plant pest or noxious weed; (2) to eradicate a plant pest or 
noxious weed; or (3) to prevent the introduction or dissemination of a 
biological control organism, plant pest, or noxious weed if the 
Secretary has issued a regulation or order to prevent the dissemination 
of the biological control organism, plant pest, or noxious weed within 
the United States. The only exceptions to this prohibition are when a 
State or political subdivision of a State imposes regulations which are 
consistent with and do not exceed the regulations or orders issued by 
the Secretary, or when the State or political subdivision of a State 
demonstrates to the Secretary, and the Secretary finds, that there is a 
special need for additional prohibitions or restrictions based on sound 
scientific data or a thorough risk assessment.
    On April 4, 2006, we published in the Federal Register (71 FR 
16711-16716, Docket No. APHIS-2005-0103) a proposal \1\ to amend the 
regulations by adding a new ``Subpart--Special Need Requests'' (7 CFR 
301.1 through 301.1-3) in which we set out procedures for the 
submission and handling of special need requests.
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    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2005-0103.
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    We solicited comments concerning our proposal for 60 days ending 
June 5, 2006. We received 17 comments by that date. They were from 
representatives of State agriculture departments, environmental groups, 
industry organizations, and private citizens. While the majority of 
these commenters supported the establishment of criteria for the 
submission of special need requests, all of the commenters expressed 
some reservations, which are discussed below by topic. We are

[[Page 63061]]

making only minor changes in response to those comments.
    Several commenters were concerned that the timeframe for APHIS to 
review and make a decision to grant or deny a special need request 
would be too long and could potentially hinder rapid response to the 
introduction or spread of a pest. Several of these commenters proposed 
their own timelines for each step in the review and decisionmaking 
process or suggested publishing the receipt of a special need request 
as an interim rule.
    We disagree that the special need request process would hinder 
timely response to the introduction or spread of pests. The special 
need request process is intended as a way for States to request 
authorization to establish additional prohibitions or restrictions for 
pests that APHIS already currently regulates. There are other processes 
in place for responding to new pests. In addition, the review and 
decisionmaking process for special need requests would not be a 
rulemaking process, as we would not be amending the regulations to 
reflect our granting of a request. As stated in the proposed rule, upon 
receipt of a complete special need request, we would publish a notice 
in the Federal Register announcing the availability for review and 
comment of the request along with all materials submitted in support of 
the request. Following the comment period, we would publish another 
notice advising the public of the Administrator's decision to either 
grant or deny the special need request based upon his or her review and 
evaluation of the information submitted in support of the request and 
of any comments received. If a special need request is time sensitive, 
the State making the request should give APHIS an idea of its urgency 
so that we may prioritize our review and decisionmaking regarding that 
request.
    One commenter stated that a special need exception should 
automatically expire after a certain period of time unless a State can 
successfully demonstrate that there is a continued need for the 
exemption.
    We agree that a special need exception may no longer be necessary 
after a certain period of time. Therefore, this final rule provides 
that a special need exception, if granted, would be applicable for 2 
years, after which the State or political subdivision of a State must 
submit a request for renewal of the exemption. If a renewal is 
submitted, it would need to address the same criteria as the initial 
request (an updated risk analysis, survey, etc.) and would have to show 
that a special need still exists. The renewal would have to be 
submitted no sooner than 6 months and no later than 3 months prior to 
the end of the 2-year applicability period for the initial exception. 
Once we have received a request for a renewal, we would follow the same 
notice and comment process we used for the initial granting of the 
special need exception. If, by the end of the 2-year applicability 
period, the State or political subdivision of a State does not submit a 
renewal, the State or political subdivision of a State's special need 
exception will lapse and the State or political subdivision of a State 
will have to reapply for the special need exception.
    Several commenters were concerned about the process used in 
circumstances where there may be insufficient data regarding the pest 
potential of a specific species or expressed concern regarding the 
burden on States to answer the criteria for the special need request 
comprehensively, particularly with respect to the cost of surveys. 
Several commenters suggested that, similar to the process used by the 
World Trade Organization (WTO), a State or political subdivision of a 
State be allowed to adopt temporary restrictions until APHIS has had 
time to evaluate whether such restrictions are valid.
    As stated above, the special need request process is intended as a 
way for States to request additional prohibitions or restrictions for 
pests that APHIS already currently regulates. Therefore, we would 
expect that only in rare instances would there not be sufficient data 
present about a certain pest. We will take lack of data into account in 
such instances. With respect to temporary restrictions, the PPA 
requires that special need exceptions be based on sound scientific data 
or a thorough risk assessment; therefore we do not believe that special 
need exceptions should be granted until a full review of the available 
data has been conducted.
    Several commenters requested clarification or definitions of terms 
used within the rule, such as ``special need,'' ``sound scientific 
data,'' and ``risk assessment.'' Several commenters also asked for 
specific criteria regarding the type of data we would accept in 
consideration of a special need request or whether both ``sound 
scientific data'' and a ``thorough risk assessment'' are needed to make 
a special need request. Some commenters suggested that it would be 
helpful to adopt the definitions and standards used by international 
organizations such as the WTO, the International Plant Protection 
Convention (IPPC), or the Food and Agriculture Organization.
    These terms are drawn from the text of the Plant Protection Act 
(``* * * a State demonstrates to the Secretary, and the Secretary 
finds, that there is a special need for additional prohibitions or 
restrictions based on sound scientific data or a thorough risk 
assessment''), and we do not consider them to have any specialized 
meaning beyond their commonly understood meanings. Section 301.1-2 of 
the regulations clearly outlines the type of information required for 
consideration of a special need request and provides for the submission 
of risk analyses or other scientific data in support of a special need 
request.
    Another commenter asked whether States may petition USDA to conduct 
risk assessments or whether States would be required to conduct their 
own assessments.
    We believe that States would be in a better position to come up 
with the information required under Sec.  301.1-2 than APHIS, as they 
would be more aware of the special circumstances that led them to apply 
for additional measures. However, given that special need requests only 
apply to pests that APHIS is already currently regulating, we welcome, 
and will accommodate, requests from States for any information we have 
gathered on such pests.
    Two commenters expressed concern that the proposed rule promotes 
economic protectionism by allowing States to restrict interstate 
movement in order to protect a specific crop or commodity.
    We disagree that the proposed rule promotes economic protectionism. 
Our process for deciding to either grant or deny a special need request 
will be determined exclusively on the basis of the best available 
science and the need to take the least restrictive action. In addition, 
the decision to grant or deny a special need request will be based on 
several specific criteria and each of those criteria will need to be 
satisfied through the presentation of compelling, science-based 
evidence. However, we have revised our criteria in order to clarify 
that we will not grant a special need request based solely on economic 
factors.
    Another commenter suggested that, in the event of the withdrawal of 
a special need exception, the special need exception be continued 
through the comment period and up to and until a withdrawal decision by 
the Administrator.
    As stated in Sec.  301.1-3(d), if the Administrator determines that 
there is the need for the withdrawal of a special need exception before 
the renewal date of the exception, APHIS will publish a

[[Page 63062]]

notice in the Federal Register to inform the public of the withdrawal 
and to make the information supporting the withdrawal available for 
review and public comment for at least 60 days. A withdrawal of a 
special need exception will not come into effect until the close of the 
comment period and evaluation of all comments received, after which 
APHIS will publish another notice announcing the Administrator's 
decision to either withdraw or uphold the special need exception.
    One commenter was concerned that a special need request involving a 
potentially weedy plant might be rejected by APHIS on the grounds that 
the plant is ``present'' in a State or political subdivision of a 
State, when in fact the plant is present only in nursery or garden 
settings.
    Our policies for determining when a weed is considered to be 
``present'' are consistent with IPPC guidelines, specifically 
International Standards for Phytosanitary Measures No. 8, 
``Determination of Pest Status in an Area''. We do not envision 
circumstances under which we would cite the mere presence of a plant in 
a nursery or garden setting as grounds for denying a special need 
request.
    One commenter expressed concern that States may not be aware of 
what they may regulate and when and suggested that we state what States 
may regulate with respect to species that are and are not subject to a 
domestic quarantine.
    We believe that the PPA adequately describes the powers of States 
with respect to interstate movement. As noted, States may regulate any 
plant, plant product, biological control organism, noxious weed, 
article, or means of conveyance if their regulations are consistent 
with or do not exceed the regulations or orders issued by APHIS or when 
there are no Federal regulations in place for any such plant, plant 
product, biological control organism, noxious weed, article, or means 
of conveyance.
    Several commenters stated that special need requests should not be 
limited to States, and that political subdivisions of States should be 
able to make special need requests independently from States.
    We believe that political subdivisions of States might not have the 
resources to submit special need requests on their own and we also do 
not want to usurp the power of the States. In addition, we wish to 
clarify that Tribes may make special need requests independent from 
States as they are considered to be sovereign nations.
    One commenter suggested that States that have violated Federal 
regulations by imposing prohibitions or restrictions on interstate 
movement that are in addition to current APHIS prohibitions or 
restrictions should be excluded from making special need requests.
    We do not believe that the commenter's suggestion is appropriate. 
Instances of States acting contrary to the PPA have been very rare. In 
addition, prohibiting States that have acted contrary to Federal 
regulations from ever making special need requests may prevent us from 
granting legitimate special need requests and thus impair our ability 
to protect American agriculture.
    One commenter stated that a special need request should only be 
made when a State can demonstrate that there is something ``truly so 
unusual within the State'' and ``that APHIS is incapable of regulating 
for that risk''. Further, the commenter stated that a special need 
request should not be used as a way to appeal regulations that a State 
does not agree with. Two other commenters stated that the granting of a 
special need request should be rare.
    We agree with the commenters that the special need request process 
is not meant as an appeals process for APHIS regulations. Our granting 
of a special need request will be based upon the soundness of the 
scientific evidence provided by the State in support of its request; 
special need requests may be granted frequently or infrequently 
depending on that evidence.
    Several commenters asked that we outline who it is in APHIS that 
will be reviewing the special need requests.
    Appropriate and knowledgeable reviewers will be selected based on 
the nature and scope of the request. We employ experts for each pest 
that we regulate in both the field and at our headquarters who are 
involved on a daily basis in the running of the regulatory program. We 
expect that these experts, along with other experts as needed, would be 
reviewing material submitted in support of special need requests.
    One commenter suggested that States should demonstrate that the 
protection requested in their special need request would not come at 
the expense of neighboring States or political subdivisions. A second 
commenter was concerned by this suggestion, stating that a State or 
political subdivision is inherently unable to provide data or 
information on behalf of another State or political subdivision.
    We agree that States or political subdivisions of States should be 
mindful of neighboring States when developing their own special need 
requests. However, we would not require States to provide specific data 
showing that their special need request would not negatively impact 
other States or political subdivisions. Such considerations will be 
taken into account during review of a special need request. States may 
also collaborate with other States in submitting multi-State special 
need requests. However, the special need request must include 
sufficient, detailed information to allow APHIS to evaluate and make a 
determination to either grant or deny the special need request for each 
State on an individual basis. In order to explicitly provide for multi-
State special need requests, we are adding this information to the 
introductory text of proposed Sec.  301.1-2(a).
    Several commenters questioned whether a special need request would 
be applicable to a pathway rather than to just individual pests.
    As stated in the proposed rule, the PPA gives authority to the 
Secretary of Agriculture to prohibit or restrict, among other things, 
the importation, entry, exportation, or movement in interstate commerce 
of any article or means of conveyance if the Secretary determines that 
the prohibition or restriction is necessary to prevent the introduction 
of a plant pest or noxious weed into the United States, or the 
dissemination of a plant pest or noxious weed within the United States. 
We believe that the special need criteria allow for flexibility in what 
a State considers to be a factor that makes it ``particularly 
vulnerable'' by allowing States to provide information regarding ``any 
other special basis for the request for additional restrictions or 
prohibitions.''
    One commenter suggested that proposed Sec.  301.1-2(a)(4) be 
changed to include contiguous borders with an area infested with a pest 
as a circumstance that renders a State ``particularly vulnerable.''
    We do not believe it is necessary to change proposed Sec.  301.1-
2(a)(4) as suggested because States will have the opportunity to 
include such information in their responses to the criteria in 
paragraphs (a)(1) and (a)(2) of that section.
    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 
change discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. This rule 
has

[[Page 63063]]

been determined to be significant for the purposes of Executive Order 
12866 and, therefore, has been reviewed by the Office of Management and 
Budget.
    This rule amends our domestic quarantine regulations to establish a 
process by which a State or political subdivision of a State could 
request approval to impose prohibitions or restrictions on the movement 
in interstate commerce of specific articles that are in addition to the 
prohibitions and restrictions imposed by APHIS. The PPA provides that 
States or political subdivisions of States may make such special need 
requests. This action establishes a process by which States may make a 
special need request.
    For this rule, we have prepared an economic analysis. The economic 
analysis provides a cost-benefit analysis as required by Executive 
Order 12866, as well as an analysis of the potential economic affects 
of this final rule on small entities, as required under 5 U.S.C. 604. 
The economic analysis is set forth below.

Expected Benefits

    The principal benefit for entities in a special need area would be 
the pest risk reduction attributable to the action. The risk of entry 
and establishment of a pest of concern with and without the granting of 
a special need request would need to be estimated before the benefit of 
the reduced risk could be determined. However, the risk of a pest of 
concern entering and becoming established in an area may be difficult 
to estimate.
    Other possible benefits of a special need request would be easier 
to calculate. Reduced pest risk due to additional restrictions or 
prohibitions may mean that certain mitigation measures in the special 
need area would no longer be considered necessary. There may be less 
need for inspections, special permits, certain pesticide applications, 
special handling or packaging, or other safeguards practiced or 
required prior to the granting of the special need request. Costs 
forgone once the request has been granted would represent benefits of 
the action.
    Agricultural and other entities in a special need area may also 
benefit from the reduced availability of articles restricted or 
prohibited because of the special need request. Restricted supplies 
from sources outside the special need area could create increased 
market opportunities for suppliers within the area. If quantities 
normally purchased could not be provided by suppliers within the 
special need area (or from outside sources that do not present a pest 
risk), then suppliers likely would benefit from an increase in price.

Expected Costs

    Costs would be incurred both in the special need area and in the 
area placed under additional restrictions or prohibitions. In each 
case, the size of the impact would depend upon the volume of supply 
affected by a special need request. As just described, prices in a 
special need area may increase if the available quantity of an article 
is reduced because of restrictions or prohibitions. But gains for 
suppliers within the special need area from price increases would come 
at the expense of the area's consumers, and overall there would be a 
net loss in social welfare. Losses may be incurred not only by end-
users, but also by intermediary entities. Stores selling the restricted 
articles (nurseries, landscaping companies, grocery stores) may face 
declining demand, depending upon the response of consumers to the price 
increase, and reduced net revenues.
    For the area placed under additional restrictions or prohibitions 
because of a special need request, sales of affected articles may 
decline if other replacement markets are not found. Even if shipments 
to the special need area can be maintained, additional costs may be 
incurred. For example:
     Growers may be required to have inspections conducted more 
frequently than APHIS would otherwise require (a cost that may be borne 
by the State or political subdivision).
     Growers (or the State or political subdivision) may be 
required to pay for special phytosanitary certificates or permits.
     Growers may incur costs related to additional risk 
mitigations, such as particular pesticide applications or treatments, 
netting, or special greenhouse equipment.
     Additional inspections or restrictions may result in 
shipping delays.
     Shipping companies may experience reduced business or may 
face additional costs related to container or sealing requirements of 
the special need request.

Expected Net Effects

    The overriding benefit for an area granted a special need request 
would be the reduced risk of pest entry and establishment. Other 
market-related benefits are likely to be outweighed by costs incurred 
in the special need area and in the area placed under additional 
restrictions or prohibitions. Costs, including those associated with 
additional risk mitigation requirements, may be borne by agricultural 
entities, the public sector, or, most likely, a combination of the two.

Final Regulatory Flexibility Analysis

    Need for and objectives of the rule. Section 436(b) of the Plant 
Protection Act requires that a State demonstrate to the Secretary that 
it has a special need for additional restrictions or prohibitions, that 
the Secretary agree that there is a special need, and that the 
additional restrictions and prohibitions requested by the State be 
based on sound scientific data or a thorough risk assessment. This rule 
establishes specific criteria by which a special need request from a 
State will be evaluated.
    The desirability of specific criteria for evaluating special need 
requests has become apparent from requests received by the Agency from 
several States for additional restrictions or prohibitions on the 
interstate movement of articles that would be more restrictive than 
those currently imposed, for example, by the Phytophthora ramorum 
regulations in 7 CFR 301.92 through 301.92-12.
    Summary of significant issues raised in public comment in response 
to the initial regulatory flexibility analysis and any changes made in 
the proposed rule as a result of such comments. APHIS did not receive 
any comments regarding the initial regulatory flexibility analysis for 
the proposed rule.
    Small entities that may be affected. Agricultural and other 
entities would not be affected by this rule, per se, but rather by the 
special need requests that follow. This rule simply establishes a 
process by which States may make a special need request and provide the 
Agency with a specific set of evaluation criteria.
    U.S. agricultural businesses are predominantly small entities. At 
all stages of economic activity--production, transportation, 
processing, and wholesale and retail sales--agricultural industries are 
generally composed of a large number of small firms and a small number 
of large firms (with the latter usually generating the major share of 
industry revenue). Given this prevailing pattern, any impacts that 
special need requests may have on agricultural businesses can be 
expected generally to affect a large if not substantial number of small 
entities. The number of affected small entities would vary by request, 
and would depend on the particular circumstances in the affected States 
or political subdivisions.
    Reporting, recordkeeping and other compliance requirements. This 
rule contains various recordkeeping and reporting requirements. These 
requirements were described in the proposed rule under the heading

[[Page 63064]]

``Paperwork Reduction Act'' and have been approved by the Office of 
Management and Budget. (See the ``Paperwork Reduction Act'' section 
below.)
    We expect that costs related to preparing a special need request 
would be borne by the public sector, but it is possible that 
agricultural industries (and therefore small entities) could incur 
indirect costs depending on arrangements for generating the required 
information. Also, the Regulatory Flexibility Act's definition of small 
entities includes small governmental jurisdictions, that is, 
``governments of cities, counties, towns, townships, villages, school 
districts, or special districts, with a population of less than fifty 
thousand.'' Thus, it is possible that special need areas could 
correspond to or include small governmental jurisdictions.
    Of greater impact than costs associated with the preparation of a 
request will be the costs and benefits of complying with the additional 
restrictions or prohibitions, once a special need request is granted by 
the Agency. Types of benefits and costs that may result from a special 
need request are identified at the beginning of this document.
    A description of the steps the agency has taken to minimize any 
significant economic impact on small entities, and reasons for 
selecting the alternative adopted in the final rule. This rule 
establishes a set of criteria for APHIS to use in evaluating special 
need requests submitted by special need areas. In and of itself, this 
rule does not impact entities, large or small. Alternatives to this 
rule would be to either leave the regulations unchanged, or to require 
a different set of criteria than is proposed. Leaving the regulations 
unchanged would be unsatisfactory for the public and for APHIS. The 
evaluation process for special need requests is currently not as 
effective as it might be due to the lack of an explicit set of criteria 
that States and political subdivisions are required to address in 
applying for a special need exception. The criteria adopted by this 
rule will provide, we believe, well-defined, scientifically rigorous 
basis for the submission and evaluation of special need requests 
pursuant to the requirements of the PPA.
    APHIS considers the criteria to be fully sufficient for evaluation 
purposes. We reiterate that this final rule, in itself, would not 
affect small entities, but rather would influence future actions--
granting of special need requests--that may affect 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 7 CFR part 3015, subpart V.)

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 the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.), the information collection or recordkeeping requirements 
included in this rule have been approved by the Office of Management 
and Budget (OMB) under OMB control number 0579-0291.

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 rule, please contact Mrs. Celeste Sickles, 
APHIS' Information Collection Coordinator, at (301) 851-2908.

List of Subjects in 7 CFR Part 301

    Agricultural commodities, Plant diseases and pests, Quarantine, 
Reporting and recordkeeping requirements, Transportation.


0
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. Part 301 is amended by adding a new ``Subpart--Special Need 
Requests,'' Sec. Sec.  301.1 through 301.1-3, to read as follows:
Subpart--Special Need Requests
Sec.
301.1 Purpose and scope.
301.1-1 Definitions.
301.1-2 Criteria for special need requests.
301.1-3 Action on special need requests.

Subpart--Special Need Requests


Sec.  301.1   Purpose and scope.

    (a) Under section 436 of the Plant Protection Act (7 U.S.C. 7756), 
a State or political subdivision of a State may not impose prohibitions 
or restrictions upon the movement in interstate commerce of articles, 
means of conveyance, plants, plant products, biological control 
organisms, plant pests, or noxious weeds if the Secretary has issued a 
regulation or order to prevent the dissemination of the biological 
control organism, plant pest, or noxious weed within the United States. 
The only exceptions to this are:
    (1) If the prohibitions or restrictions issued by the State or 
political subdivision of a State are consistent with and do not exceed 
the regulations or orders issued by the Secretary, or
    (2) If the State or political subdivision of a State demonstrates 
to the Secretary and the Secretary finds that there is a special need 
for additional prohibitions or restrictions based on sound scientific 
data or a thorough risk assessment.
    (b) The regulations in this subpart provide for the submission and 
consideration of special need requests when a State or a political 
subdivision of a State seeks to impose prohibitions or restrictions on 
the movement in interstate commerce of articles, means of conveyance, 
plants, plant products, biological control organisms, plant pests, or 
noxious weeds that are in addition to the prohibitions or restrictions 
imposed by this part or by a Federal Order.


Sec.  301.1-1   Definitions.

    Administrator. The Administrator, Animal and Plant Health 
Inspection Service (APHIS), or any person authorized to act for the 
Administrator.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    Biological control organism. Any enemy, antagonist, or competitor 
used to control a plant pest or noxious weed.
    Interstate commerce. Trade, traffic, or other commerce
    (1) From one State into or through any other State or
    (2) Within the District of Columbia, Guam, the Virgin Islands of 
the United States, or any other territory or possession of the United 
States.

[[Page 63065]]

    Move (moved, movement). Shipped, offered to a common carrier for 
shipment, received for transportation or transported by a common 
carrier, or carried, transported, moved or allowed to be moved.
    Noxious weed. Any plant or plant product that can directly or 
indirectly injure or cause damage to crops (including nursery stock or 
plant products), livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health or the environment.
    Plant pest. Any living stage of any insects, mites, nematodes, 
slugs, snails, protozoa, or other invertebrate animals, bacteria, 
fungi, other parasitic plants or reproductive parts thereof, viruses, 
or any organisms similar to or allied with any of the foregoing, or any 
infectious substances which can directly or indirectly injure or cause 
disease or damage in any plants or parts thereof or any processed, 
manufactured, or other products of plants.
    State. The District of Columbia, Puerto Rico, the Northern Mariana 
Islands, or any State, territory, or possession of the United States.


Sec.  301.1-2   Criteria for special need requests.

    (a) A special need request, as described in Sec.  301.1, may be 
generated by a State or a political subdivision of a State. If the 
request is generated by a political subdivision of a State, the request 
must be submitted to APHIS through the State. States may also 
collaborate with other States to submit multi-State special need 
requests. However, if submitted, the multi-State special need request 
must include information in sufficient detail to allow APHIS to analyze 
the impacts on each State on an individual basis. All special need 
requests must be signed by the executive official or officials or by a 
plant protection official or officials of the State(s) making the 
request and must contain the following:
    (1) Data drawn from a scientifically sound detection survey, 
showing that the biological control organism, noxious weed, or plant 
pest of concern does not exist in the State or political subdivision 
or, if already present in the State or political subdivision, the 
distribution of the biological control organism, noxious weed, or plant 
pest of concern;
    (2) If the biological control organism, noxious weed, or plant pest 
is not present in the State or political subdivision, a risk analysis 
or other scientific data showing that the biological control organism, 
noxious weed, or plant pest could enter the State or political 
subdivision and become established;
    (3) Specific information showing that, if introduced into or 
allowed to spread within the State or political subdivision, the 
biological control organism, noxious weed, or plant pest would harm or 
injure the environment or agricultural resources in the State or 
political subdivision. The request should contain detailed information, 
including quantitative estimates, if available, about what harm or 
injury would result from the introduction or dissemination of the 
biological control organism, noxious weed, or plant pest in the State 
or political subdivision;
    (4) Specific information showing that the State or political 
subdivision has characteristics that make it particularly vulnerable to 
the biological control organism, noxious weed, or plant pest, such as 
unique plants, diversity of flora, historical concerns, or any other 
special basis for the request for additional restrictions or 
prohibitions; and
    (5) Information detailing the proposed additional prohibitions or 
restrictions and scientific data demonstrating that the proposed 
additional prohibitions or restrictions are necessary and adequate, and 
that there is no less drastic action that is feasible and that would be 
adequate, to prevent the introduction or spread of the biological 
control organism, noxious weed, or plant pest in the State or political 
subdivision.
    (b) All special need requests must be submitted to the Deputy 
Administrator for Plant Protection and Quarantine, APHIS, USDA, Jamie 
L. Whitten Federal Building, 14th Street and Independence Avenue, SW., 
Room 301-E, Washington, DC 20250.


Sec.  301.1-3   Action on special need requests.

    (a) Upon receipt of a complete special need request submitted in 
accordance with Sec.  301.1-2, APHIS will publish a notice in the 
Federal Register to inform the public of the special need request and 
to make the request and its supporting information available for review 
and comment for at least 60 days.
    (b) Following the close of the comment period, APHIS will publish 
another notice announcing the Administrator's decision to either grant 
or deny the special need request. The Administrator's determination 
will be based upon the evaluation of the information submitted by the 
State or political subdivision of a State in support of its request and 
would take into account any comments received.
    (1) If the Administrator grants the special need request, the State 
or political subdivision of a State will be authorized to impose only 
the specific prohibitions or restrictions identified in the request and 
approved by APHIS. APHIS will coordinate with the State, or with the 
State on behalf of the political subdivision of the State, to ensure 
that the additional prohibitions or restrictions are in accord with the 
special need exception granted by the Administrator.
    (2) If the Administrator denies the special need request, the State 
or political subdivision of a State will be notified in writing of the 
reason for the denial and may submit any additional information the 
State or political subdivision of a State may have in order to request 
a reconsideration.
    (c) If granted, a special need exception will be applicable for 2 
years, at the end of which the State or political subdivision of a 
State must submit a request for renewal of the exception. A special 
need renewal request must address the same criteria as the initial 
request submitted under Sec.  301.1-2 and must show that a special need 
still exists that warrants the continuation of the special need 
exception. The renewal must be submitted no sooner than 6 months and no 
later than 3 months prior to the end of the 2-year applicability period 
for the initial exception. Once a special need renewal request has been 
received, APHIS will follow the same notice and comment process 
outlined in paragraphs (a) and (b) of this section. If, by the end of 
the 2-year applicability period, the State or political subdivision of 
a State does not submit a special need renewal request, the State's or 
political subdivision's special need exception will lapse and the State 
or political subdivision of a State will have to reapply for the 
special need exception.
    (d) If the Administrator determines that there is a need for the 
withdrawal of a special need exception before the renewal date of the 
special need exception, the reasons for the withdrawal would be 
communicated to the State or to the political subdivision of the State 
and APHIS will publish a notice in the Federal Register to inform the 
public of the withdrawal of the special need exception and to make the 
information supporting the withdrawal available for review and comment 
for at least 60 days. Reasons for withdrawal of approval of a special 
need exception may include, but are not limited to, the availability of 
new scientific data or changes in APHIS regulations. Following the 
close of the comment period, APHIS will publish another notice 
announcing the Administrator's decision to either withdraw or uphold 
the special need exception. The Administrator's determination will be

[[Page 63066]]

based upon the evaluation of the information submitted in support of 
the withdrawal and would take into account any comments received.

(Approved by the Office of Management and Budget under control 
number 0579-0291)

    Done in Washington, DC, this 17th day of October 2008.
Bruce Knight,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. E8-25291 Filed 10-22-08; 8:45 am]
BILLING CODE 3410-34-P