Irradiation Treatment; Location of Facilities in the Southern United States, 42621-42625 [2012-17725]
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42621
Rules and Regulations
Federal Register
Vol. 77, No. 140
Friday, July 20, 2012
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. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
7 CFR Parts 305 and 319
[Docket No. APHIS–2009–0100]
RIN 0579–AD35
Irradiation Treatment; Location of
Facilities in the Southern United States
Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
AGENCY:
We are amending the
phytosanitary treatment regulations to
provide generic criteria for new
irradiation treatment facilities in the
Southern States of the United States.
This action will allow irradiation
facilities to be located anywhere in
these States, subject to approval, rather
than only in the currently approved
locations. We are also amending the
regulations to allow for the irradiation
treatment of certain imported fruit from
India and Thailand upon arrival in the
United States. This action will facilitate
the importation of fruit requiring
irradiation treatment while continuing
to provide protection against the
introduction of pests of concern into the
United States.
DATES: Effective Date: August 20, 2012.
FOR FURTHER INFORMATION CONTACT: Dr.
Inder P. S. Gadh, Senior Risk Manager—
Treatments, PPQ, APHIS, 4700 River
Road Unit 133, Riverdale, MD 20737–
1236; (301) 851–2018.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
Background
The phytosanitary treatment
regulations contained in 7 CFR part 305
(referred to below as the regulations) set
out the general requirements for
performing treatments and certifying or
approving treatment facilities for fruits,
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vegetables, and other articles to prevent
the introduction or dissemination of
plant pests or noxious weeds into or
through the United States. The Animal
and Plant Health Inspection Service
(APHIS) of the U.S. Department of
Agriculture (USDA) administers these
regulations.
The regulations in § 305.9 set out
irradiation treatment requirements for
imported regulated articles; regulated
articles moved interstate from Hawaii,
Puerto Rico, and the U.S. Virgin Islands;
and regulated articles moved interstate
from areas quarantined for certain pests
of concern. In § 305.9, paragraph (a)(1)
allows irradiation treatment facilities to
be located in any State of the United
States, except for the Southern States of
Alabama, Arizona, California, Florida,
Georgia, Kentucky, Louisiana,
Mississippi, Nevada, New Mexico,
North Carolina, South Carolina,
Tennessee, Texas, and Virginia. The
regulations do allow irradiation
facilities to be located at the maritime
ports of Gulfport, MS, and Wilmington,
NC, and the airport of Atlanta, GA.
The regulations in § 305.9 also allow
for irradiation treatment of articles
either prior to or after arrival in the
United States, provided an APHISapproved facility is available. The
regulations in parts 318 and 319 allow
the importation of certain fruits from
India (mangoes), Mexico (guavas),
Pakistan (mangoes), Thailand (litchis,
longans, mangoes, mangosteens,
pineapples, and rambutans), and
Vietnam (dragon fruits), and the
interstate movement of several fruits
and vegetables from Hawaii, after they
have received irradiation treatment.
While the regulations in parts 318 and
319 provide that fruits and vegetables
moving from Mexico, Pakistan,
Vietnam, and Hawaii may receive
irradiation at either the point of origin
or upon arrival in the mainland United
States, the regulations in part 319
require fruit from India and Thailand to
be treated prior to arrival in the United
States.
On September 29, 2011, we published
in the Federal Register a proposal 1 (76
FR 60390–60395, Docket No. APHIS–
2009–0100) to amend § 305.9 by
establishing generic phytosanitary
1 To view the proposed rule, supporting and
related documents, and the comments received, go
to https://www.regulations.gov/
#!docketDetail;D=APHIS-2009-0100.
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criteria to replace the current criteria for
irradiation facilities at the maritime
ports of Gulfport, MS, and Wilmington,
NC, and the airport of Atlanta, GA, and
to apply the proposed generic criteria to
any new irradiation treatment facilities
in the Southern States of the United
States. Under these criteria, in
conjunction with the current criteria for
irradiation facilities not located in the
Southern States, we proposed to allow
new irradiation facilities to be
established in all the Southern States for
the treatment of regulated articles that
are imported, moved interstate from
Hawaii or U.S. territories, or moved
interstate from areas quarantined for
certain pests of concern. We also
proposed to amend § 319.56–46 to allow
for irradiation treatment of mangoes
from India either prior to or after arrival
in the United States and § 319.56–47 to
allow for irradiation treatment of
tropical fruits from Thailand either prior
to or after arrival in the United States.
We solicited comments concerning
our proposal for 60 days ending
November 28, 2011. We received seven
comments by that date. One comment
consisted of 3,529 identical or nearly
identical letters. The comments were
from an advocacy group, a State
department of agriculture, and private
citizens. Two commenters expressed
support for the proposed rule. The
remaining comments are discussed
below by topic.
Some commenters stated that
irradiation is an inappropriate way to
deal with the risk of plant pests in
imported foods. One commenter
generally opposed the use of irradiation
as a phytosanitary measure. One
commenter opposed the rule as no
irradiation facilities have been built in
the currently approved locations in
Southern States.
Under the Plant Protection Act (7
U.S.C. 7701 et seq.), regulated articles
may be subject to remedial measures
necessary to prevent the spread of plant
pests. APHIS has determined that
irradiation is an effective form of
treatment against certain plant pests,
and the regulations in 7 CFR part 305
provide for irradiation as a
phytosanitary treatment for
commodities or articles that require
treatment prior to interstate movement
or importation. Before approving
irradiation as a treatment alternative for
a specific pest, APHIS performs an
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evaluation to determine its
effectiveness. As irradiation has been
determined to be effective, there is no
reason to deny importers the use of this
treatment option.
Several commenters expressed
concern about importing commodities
into the United States prior to
irradiation treatment, with one
commenter indicating that Florida is a
high-risk area for fruit flies and other
invasive exotic pests. Another
commenter stated that allowing
irradiation facilities in Southern States
would make it easier for pests to infest
key agricultural States and expressed
concern about the cost of containing and
eradicating exotic pests. One commenter
questioned why pest mitigation is not
occurring prior to export and did not
understand why the United States
would perform this task for exporters.
As we indicated in the proposed rule,
the regulations in § 305.9 allow for
irradiation treatment of articles either
prior to or after arrival in the United
States, provided that an APHISapproved facility is available. Articles
may be treated in the United States
instead of the exporting country for
several reasons, including when the
exporting country lacks the resources,
technical expertise, or infrastructure to
treat articles prior to export. The
regulations require safeguards that have
successfully prevented the introduction
or dissemination of plant pests into or
within the United States via the
importation or interstate movement of
irradiated articles since 1996, when
irradiation was first used as a
phytosanitary treatment. Based on our
experience, we are confident that
exporting countries have the ability to
comply with all APHIS requirements
and commodities from exporting
countries can be safely treated in the
United States.
APHIS recognizes that the Southern
States have conditions favorable for the
establishment of exotic fruit flies, and
that is why we proposed additional
safeguards for irradiation facilities in
these States that go beyond the current
requirements that apply to all
irradiation facilities. These safeguards
include the requirements that untreated
articles may not be removed from their
packaging prior to treatment under any
circumstances, that refrigerated or airconditioned conveyances must be used
to transport regulated articles to the
treatment facility, and that facilities
have contingency plans for safely
destroying or disposing of regulated
articles if the facility was unable to
properly treat a shipment. To help
prevent establishment of pests in the
unlikely event that they escape despite
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the required precautions, we will
require trapping and other pest
monitoring activities within 4 square
miles of the facility to help prevent
establishment of any escaped pests of
concern. Those activities will be paid
for by the facility. In addition, while
APHIS monitors the treatment, the costs
of treatment are the responsibility of the
exporter or the importer, not APHIS.
APHIS will only approve a proposed
facility if the Administrator determines
that regulated articles can be safely
transported to the facility from a port of
entry or points of origin in the United
States. We believe that the mitigations
included in this final rule have proven
effective in mitigating the risk
associated with the importation of
commodities into the United States, and
thus will provide protection against the
introduction or dissemination of pests
of concern into the United States. In the
environmental assessment (EA) that we
prepared for the proposed rule, we
evaluated the potential environmental
effects from allowing untreated
commodities to be transported into the
Southern United States. In the EA, we
determined that the mitigation measures
included in this final rule are adequate
to manage pest risks associated with
amending the irradiation regulations
and are expected to provide an effective
level of phytosanitary protection.
Several commenters were concerned
that the increased importation of
commodities into the United States
would have adverse economic effects on
domestic producers. One commenter
expressed concern that irradiation
facilities are expensive and would
increase the cost of food.
This rule does not authorize the
importation of any additional fruits or
vegetables, so it will not in and of itself
lead to the increased importation of
commodities. Any new imports would
have to be authorized through our
existing provisions in 7 CFR part 319.
While the availability of additional
treatment capacity in new areas might
spur businesses to explore new or
additional imports of articles, the PPA
authorizes APHIS to consider plant pest
risks when determining whether to
allow new articles to be imported, rather
than potential economic competition.
With respect to the costs of irradiation
increasing the costs of food, the final
rule does not add irradiation
requirements for any commodity and
therefore will not add any costs. We also
note that in most cases a variety of
phytosanitary treatments for a particular
article will be available, so importers
and marketers will choose the treatment
option that makes the most sense to
them from an economic and competitive
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standpoint. Products are unlikely to be
imported unless their importation is
economically feasible.
Many comments raised several issues
that concern matters under the
regulatory authority of other Federal
agencies, not APHIS. We do not intend
to reopen debate over matters that have
been resolved through rulemaking by
other agencies that have primary
authority in these areas.
For example, one commenter
suggested that irradiation facilities are
unsafe and that workers may be exposed
to dangerous levels of radiation. Many
other commenters stated that USDA
should not put consumers, U.S. farmers,
and communities at risk by expanding
the use of irradiation.
The Nuclear Regulatory Commission,
the Occupational Safety and Health
Administration, and the U.S.
Department of Transportation have the
primary regulatory responsibility for
issues including irradiation facility
construction, operation, employee and
public safety, and transportation of
radioisotopes. Their requirements in
these areas were established through
public rulemaking by the respective
agencies. In § 305.9(b) of the final rule,
we are requiring other agencies that
have regulatory oversight and
requirements regarding irradiation
facilities to concur in writing with the
establishment of the facility prior to
APHIS approval. In our EA, we
evaluated the potential environmental
effects from irradiation facilities and
found that, provided required safety
standards and control procedures are
adhered to, no impacts to the human
environment are expected.
Many commenters expressed concern
that irradiation will make foods unsafe
to eat. Commenters also stated that
irradiation would reduce the nutritional
value of fruits and vegetables,
particularly through vitamin depletion.
One commenter stated that ‘‘many of the
exporting countries will not have
regulatory frameworks comparable to
what U.S. producers are subjected to
and irradiation will be used as a
panacea to address those shortcomings.’’
One commenter stated that irradiation
can be a cover-up for poor food
handling practices and could also mask
the effects of spoilage.
The Food and Drug Administration
(FDA) has primary regulatory
responsibility for ensuring that
approved irradiation doses do not
render foods unsafe to eat. In our EA,
we discuss the safety of food that has
been irradiated, finding that irradiation
does not harm the nutritional value of
food, nor does it make the food unsafe
to eat or adversely affect the balance
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between microbial spoilage organisms
and pathogenic organisms. Regulation of
these matters, however, is outside the
scope of the current rulemaking and
outside the statutory authority of
APHIS. We do note for the record the
following information from the August
2000 report by the U.S. General
Accounting Office (now known as the
U.S. Government Accountability Office),
‘‘Food Irradiation: Available Research
Indicates That Benefits Outweigh Risks’’
(GAO/RCED–00–217):
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There is also some vitamin loss associated
with irradiation—with certain vitamins, such
as thiamin (B1), ascorbic acid (C), and alphatocopherol (E)—more affected by irradiation
than others. However, according to the
Institute of Food Technologists, it is highly
doubtful that there would ever be any
vitamin deficiency resulting from eating
irradiated food. For example, thiamin is the
most radiation-sensitive, water-soluble
vitamin. With regard to this vitamin, the
American Dietetic Association’s position
statement on food irradiation notes that FDA
evaluated an extreme case in which all meat,
poultry, and fish were irradiated at the
maximum permissible dose under conditions
resulting in the maximum destruction of
thiamin. Even in these circumstances, the
average thiamin intake was above the
Recommended Dietary Allowance, leading
FDA to conclude that there was no
deleterious effect on the total dietary intake
of thiamin as a result of irradiating foods. In
its 1980 evaluation of food irradiation, the
Joint Expert Committee convened by FAO,
WHO, and IAEA concluded that irradiation
caused no special nutritional problems in
food. Another meeting of experts in 1997—
organized by the same three international
organizations—concluded that even high
doses of irradiation (i.e., over 10 kGy) would
not result in nutrient losses that could
adversely affect a food’s nutritional value.
Irradiation cannot reverse the spoilage
process—the bad appearance, taste, and/or
smell will remain the same after irradiation.
In addition, current regulations do not allow
food processors to use doses of irradiation on
meat, poultry, fruits, and vegetables that
would be high enough to sterilize extremely
contaminated food. If a processor attempted
to use a sterilization dose on many of these
products, the odor, flavor, taste, and texture
would be seriously impaired and the
consumer would reject such products.
One commenter stated that the FDA
has not been able to keep up with the
volume of imports to ensure that they
are safe for human consumption.
This matter is outside the scope of the
current rulemaking and outside the
statutory authority of APHIS. However,
on this point we do note that the Food
Safety Modernization Act was enacted
on January 4, 2011, to enable FDA to
better protect public health by
strengthening the food safety system.
Therefore, for the reasons given in the
proposed rule and in this document, we
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are adopting the proposed rule as a final
rule, without change.
Executive Order 12866 and Regulatory
Flexibility Act
This final rule has been determined to
be not significant for the purposes of
Executive Order 12866 and, therefore,
has not been reviewed by the Office of
Management and Budget.
In accordance with the Regulatory
Flexibility Act, we have analyzed the
potential economic effects of this action
on small entities. The analysis is
summarized below. Copies of the full
analysis are available on the
Regulations.gov Web site (see footnote 1
in this document for a link to
Regulations.gov) or by contacting the
person listed under FOR FURTHER
INFORMATION CONTACT.
The final rule will benefit U.S.
entities by clearly and transparently
presenting the criteria that will govern
the approval of additional irradiation
facilities in the Southern United States,
thereby facilitating their establishment.
APHIS has not identified any costs
associated with establishing the generic
criteria for irradiation facility approval
described in the rule.
Beyond helping to make the approval
of future irradiation facilities in the
Southern United States an efficient
process, we do not anticipate that the
criteria set forth in this rule will result
in economic impacts on U.S. entities,
large or small.
Under these circumstances, the
Administrator of the Animal and Plant
Health Inspection Service has
determined that this action would not
have a significant economic impact on
a substantial number of small entities.
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.
National Environmental Policy Act
An environmental assessment and
finding of no significant impact have
been prepared for this final rule. The
environmental assessment provides a
basis for the conclusion that providing
generic criteria for new irradiation
treatment facilities in the Southern
States of the United States will not have
a significant impact on the quality of the
human environment. Based on the
finding of no significant impact, the
Administrator of the Animal and Plant
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42623
Health Inspection Service has
determined that an environmental
impact statement need not be prepared.
The environmental assessment and
finding of no significant impact were
prepared in accordance with: (1) The
National Environmental Policy Act of
1969 (NEPA), as amended (42 U.S.C.
4321 et seq.), (2) regulations of the
Council on Environmental Quality for
implementing the procedural provisions
of NEPA (40 CFR parts 1500–1508), (3)
USDA regulations implementing NEPA
(7 CFR part 1b), and (4) APHIS’ NEPA
Implementing Procedures (7 CFR part
372).
The environmental assessment and
finding of no significant impact may be
viewed on the Regulations.gov Web
site.2 Copies of the environmental
assessment and finding of no significant
impact are also available for public
inspection at USDA, Room 1141, South
Building, 14th Street and Independence
Avenue SW., Washington, DC, between
8 a.m. and 4:30 p.m., Monday through
Friday, except holidays. Persons
wishing to inspect copies are requested
to call ahead on (202) 690–2817 to
facilitate entry into the reading room. In
addition, copies may be obtained by
writing to the individual listed under
FOR FURTHER INFORMATION CONTACT.
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
0579–0383.
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
7 CFR Part 305
Irradiation, Phytosanitary treatment,
Plant diseases and pests, Quarantine,
2 Go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2009-0100. The
environmental assessment and finding of no
significant impact will appear in the resulting list
of documents.
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Reporting and recordkeeping
requirements.
7 CFR Part 319
Coffee, Cotton, Fruits, Imports, Logs,
Nursery stock, Plant diseases and pests,
Quarantine, Reporting and
recordkeeping requirements, Rice,
Vegetables.
Accordingly, we are amending 7 CFR
parts 305 and 319 as follows:
PART 305—PHYTOSANITARY
TREATMENTS
1. The authority citation for part 305
continues to read as follows:
■
Authority: 7 U.S.C. 7701–7772 and 7781–
7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22,
2.80, and 371.3.
2. Section 305.9 is amended as
follows:
■ a. By revising paragraph (a)(1) to read
as set forth below.
■ b. In paragraph (b), by adding a
sentence after the first sentence to read
as set forth below.
■ c. By adding a sentence after the
paragraph (c) introductory text heading
to read as set forth below.
■ d. In paragraph (e) introductory text,
by adding a sentence after the second
sentence to read as set forth below.
■ e. In paragraph (e)(1) introductory
text, by adding a new first sentence after
the paragraph heading to read as set
forth below.
■ f. By revising the OMB control
number at the end of the section to read
as set forth below.
■
§ 305.9
Irradiation treatment requirements.
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*
*
*
*
*
(a) * * *
(1) Where certified irradiation
facilities are available, an approved
irradiation treatment may be conducted
for any imported regulated article either
prior to shipment to the United States
or in the United States. For any
regulated article moved interstate from
Hawaii or U.S. territories, irradiation
treatment may be conducted either prior
to movement to the mainland United
States or in the mainland United States.
Irradiation facilities may be located in
any State on the mainland United
States. For irradiation facilities located
in the States of Alabama, Arizona,
California, Florida, Georgia, Kentucky,
Louisiana, Mississippi, Nevada, New
Mexico, North Carolina, South Carolina,
Tennessee, Texas, and Virginia, the
following additional conditions must be
met:
(i) Prospective facility operators must
submit a detailed layout of the facility
site and its location to APHIS. APHIS
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will evaluate plant health risks based on
the proposed location and layout of the
facility site. APHIS will only approve a
proposed facility if the Administrator
determines that regulated articles can be
safely transported to the facility from
port of entry or points of origin in the
United States.
(ii) The government of the State in
which the facility is to be located must
concur in writing with the
establishment of the facility or, if it does
not concur, must provide a written
explanation of concern based on pest
risks. In instances where the State
government does not concur with the
proposed facility location, APHIS and
the State will agree on a strategy to
resolve the pest risk concerns prior to
APHIS approval.
(iii) Untreated articles may not be
removed from their packaging prior to
treatment under any circumstances.
(iv) The facility must have
contingency plans, approved by APHIS,
for safely destroying or disposing of
regulated articles if the facility is unable
to properly treat a shipment.
(v) The facility may only treat articles
approved by APHIS for treatment at the
facility. Approved articles will be listed
in the compliance agreement required in
paragraph (c)(1)(i) of this section.
(vi) Arrangements for treatment must
be made before the departure of a
consignment from its port of entry or
points of origin in the United States.
APHIS and the facility must agree on all
parameters, such as time, routing, and
conveyance, by which the consignment
will move from the port of entry or
points of origin in the United States to
the treatment facility.
(vii) Regulated articles must be
conveyed to the facility in a refrigerated
(via motorized refrigeration equipment
or other methods including ice or
insulation) or air-conditioned
conveyance at a temperature that
minimizes the mobility of the pests of
concern for the article.
(viii) The facility must maintain and
provide APHIS with an updated map
identifying places where horticultural or
other crops are grown within 4 square
miles of the facility. Proximity of host
material to the facility will necessitate
trapping or other pest monitoring
activities to help prevent establishment
of any escaped pests of concern, as
approved by APHIS; these activities will
be listed in the compliance agreement
required in paragraph (c)(1)(i) of this
section. The treatment facility must
have a pest management plan within the
facility.
(ix) The facility must comply with
any additional requirements that APHIS
may require to prevent the escape of
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plant pests during transport to and from
the irradiation facility itself, for a
particular facility based on local
conditions, and for any other risk factors
of concern. These activities will be
listed in the compliance agreement
required in paragraph (c)(1)(i) of this
section.
*
*
*
*
*
(b) * * * Other agencies that have
regulatory oversight and requirements
must concur in writing with the
establishment of the facility prior to
APHIS approval. * * *
(c) * * * Compliance agreements for
facilities located in States listed in
paragraph (a)(1) of this section may also
contain additional provisions as
described in paragraphs (a)(1)(i) through
(a)(1)(ix) of this section. * * *
*
*
*
*
*
(e) * * * Facilities must be located
within the local commuting area for
APHIS employees for inspection
purposes.
(1) * * * Facilities shall be located
within an area over which the U.S.
Department of Homeland Security is
assigned authority to accept entries of
merchandise, to collect duties, and to
enforce the provisions of the customs
and navigation laws in force. * * *
*
*
*
*
*
(Approved by the Office of Management and
Budget under control numbers 0579–0155,
0579–0215, and 0579–0198, 0579– 0383)
PART 319—FOREIGN QUARANTINE
NOTICES
3. The authority citation for part 319
continues to read as follows:
■
Authority: 7 U.S.C. 450, 7701–7772, and
7781–7786; 21 U.S.C. 136 and 136a; 7 CFR
2.22, 2.80, and 371.3.
§ 319.56–46
[Amended]
4. Section § 319.56–46 is amended as
follows:
■ a. In paragraph (a), by removing the
words ‘‘in India’’.
■ b. In paragraph (e) introductory text,
by removing the words ‘‘certifying that
the fruit received the required
irradiation treatment. The phytosanitary
certificate must also bear’’ and adding
the word ‘‘with’’ in their place.
■
§ 319.56–47
[Amended]
5. Section 319.56–47 is amended as
follows:
■ a. In paragraph (b), by removing the
second sentence.
■ b. In paragraph (c)(1), by removing the
words ‘‘that the litchi were treated with
irradiation as described in paragraph (b)
of this section and’’.
■ c. In paragraph (c)(2), by removing the
words ‘‘with an additional declaration
■
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stating that the longan, mango,
mangosteen, pineapple, or rambutan
were treated with irradiation as
described in paragraph (b) of this
section’’.
Done in Washington, DC, this 16th day of
July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2012–17725 Filed 7–19–12; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 55 and 81
[Docket No. 00–108–9]
Chronic Wasting Disease Herd
Certification Program and Interstate
Movement of Farmed or Captive Deer,
Elk, and Moose
Animal and Plant Health
Inspection Service, USDA.
ACTION: Interim final rule; reopening of
comment period.
AGENCY:
We are reopening the
comment period for our interim final
rule that will establish a herd
certification program to control chronic
wasting disease (CWD) in farmed or
captive cervids in the United States. The
interim final rule requested comment on
our decision that our regulations will set
minimum requirements for the
interstate movement of farmed or
captive cervids but not preempt State or
local laws or regulations that are more
restrictive than our regulations, except
any such laws or regulations that
prohibit or further restrict the transit
through a State of deer, elk, and moose
that are otherwise eligible for interstate
movement. This action will allow
interested persons additional time to
prepare and submit comments on our
preemption policy with respect to CWD.
This document also indicates that we
will consider comments on issues other
than our preemption policy for future
rulemaking.
SUMMARY:
We will consider all comments
that we receive on or before August 13,
2012.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2006-01180199.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No. 00–
tkelley on DSK3SPTVN1PROD with RULES
DATES:
VerDate Mar<15>2010
16:50 Jul 19, 2012
Jkt 226001
108–8, Regulatory Analysis and
Development, PPD, APHIS, Station 3A–
03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at https://
www.regulations.gov/
#!docketDetail;D=APHIS-2006-0118 or
in our reading room, which is located in
room 1141 of the USDA South Building,
14th Street and Independence Avenue
SW., Washington, DC. Normal reading
room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 799–7039
before coming.
FOR FURTHER INFORMATION CONTACT: Dr.
Patrice Klein, Senior Staff Veterinarian,
National Center for Animal Health
Programs, Veterinary Services, APHIS,
4700 River Road Unit 43, Riverdale, MD
20737–1231; (301) 851–3435.
SUPPLEMENTARY INFORMATION: On June
13, 2012, we published in the Federal
Register (77 FR 35542–35571, Docket
No. 00–108–8) an interim final rule that
will establish a herd certification
program to control chronic wasting
disease (CWD) in farmed or captive
cervids in the United States. The
interim final rule will be effective on
August 13, 2012.
In the interim final rule, we requested
comments specifically on our decision
not to preempt State and local laws and
regulations that are more restrictive than
our regulations with respect to CWD,
except any such laws or regulations that
prohibit or further restrict the transit
through a State of deer, elk, and moose
that are otherwise eligible for interstate
movement. That decision was discussed
in section III of the Background section
of the interim final rule, under the
heading ‘‘APHIS’ Decision Not to
Preempt More Restrictive State
Requirements on Farmed or Captive
Cervids With Respect to CWD,’’
beginning on 77 FR 35545.
Comments on our decisions regarding
preemption of State and local laws and
regulations were required to be received
on or before July 13, 2012. We are
reopening the comment period on
Docket No. 00–108–8 until August 13,
2012. This action will allow interested
persons additional time to prepare and
submit comments. We will also consider
all comments received between July 14,
2012, and the date of this notice.
The interim final rule indicated that
we will publish another document in
the Federal Register after the comment
period closes that will include a
discussion of any comments we receive
on our preemption policy and any
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
42625
amendments we are making to the rule.
We still plan to do this. However, we
have received comments on aspects of
the interim final rule other than our
preemption policy. While we will not
address these comments in our
document discussing our preemption
policy, we will consider these
comments to determine whether future
rulemaking may be necessary, and we
encourage commenters to address any
aspect of the interim final rule that they
wish to.
Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22,
2.80, and 371.4.
Done in Washington, DC, this 16th day of
July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2012–17726 Filed 7–19–12; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2011–1412; Directorate
Identifier 2011–NM–158–AD; Amendment
39–17088; AD 2012–12–08]
RIN 2120–AA64
Airworthiness Directives; The Boeing
Company Airplanes
Correction
In rule document 2012–14544
appearing on pages 37781–37783 in the
issue of Monday, June 25, 2012 make
the following correction:
§ 39.13
[Corrected]
On page 37783, in the first column, in
the tenth full paragraph, under the
heading ‘‘(c) Applicability’’, the second
line should read ‘‘Model 777–200 and
–300 series airplanes;’’.
[FR Doc. C1–2012–14544 Filed 7–19–12; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2012–0055; Airspace
Docket No. 11–ACE–12]
RIN 2120–AA66
Modification of VOR Federal Airways
V–10, V–12, and V–508 in the Vicinity
of Olathe, KS
Federal Aviation
Administration (FAA), DOT.
AGENCY:
E:\FR\FM\20JYR1.SGM
20JYR1
Agencies
[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Rules and Regulations]
[Pages 42621-42625]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17725]
========================================================================
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.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Rules
and Regulations
[[Page 42621]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Parts 305 and 319
[Docket No. APHIS-2009-0100]
RIN 0579-AD35
Irradiation Treatment; Location of Facilities in the Southern
United States
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the phytosanitary treatment regulations to
provide generic criteria for new irradiation treatment facilities in
the Southern States of the United States. This action will allow
irradiation facilities to be located anywhere in these States, subject
to approval, rather than only in the currently approved locations. We
are also amending the regulations to allow for the irradiation
treatment of certain imported fruit from India and Thailand upon
arrival in the United States. This action will facilitate the
importation of fruit requiring irradiation treatment while continuing
to provide protection against the introduction of pests of concern into
the United States.
DATES: Effective Date: August 20, 2012.
FOR FURTHER INFORMATION CONTACT: Dr. Inder P. S. Gadh, Senior Risk
Manager--Treatments, PPQ, APHIS, 4700 River Road Unit 133, Riverdale,
MD 20737-1236; (301) 851-2018.
SUPPLEMENTARY INFORMATION:
Background
The phytosanitary treatment regulations contained in 7 CFR part 305
(referred to below as the regulations) set out the general requirements
for performing treatments and certifying or approving treatment
facilities for fruits, vegetables, and other articles to prevent the
introduction or dissemination of plant pests or noxious weeds into or
through the United States. The Animal and Plant Health Inspection
Service (APHIS) of the U.S. Department of Agriculture (USDA)
administers these regulations.
The regulations in Sec. 305.9 set out irradiation treatment
requirements for imported regulated articles; regulated articles moved
interstate from Hawaii, Puerto Rico, and the U.S. Virgin Islands; and
regulated articles moved interstate from areas quarantined for certain
pests of concern. In Sec. 305.9, paragraph (a)(1) allows irradiation
treatment facilities to be located in any State of the United States,
except for the Southern States of Alabama, Arizona, California,
Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico,
North Carolina, South Carolina, Tennessee, Texas, and Virginia. The
regulations do allow irradiation facilities to be located at the
maritime ports of Gulfport, MS, and Wilmington, NC, and the airport of
Atlanta, GA.
The regulations in Sec. 305.9 also allow for irradiation treatment
of articles either prior to or after arrival in the United States,
provided an APHIS-approved facility is available. The regulations in
parts 318 and 319 allow the importation of certain fruits from India
(mangoes), Mexico (guavas), Pakistan (mangoes), Thailand (litchis,
longans, mangoes, mangosteens, pineapples, and rambutans), and Vietnam
(dragon fruits), and the interstate movement of several fruits and
vegetables from Hawaii, after they have received irradiation treatment.
While the regulations in parts 318 and 319 provide that fruits and
vegetables moving from Mexico, Pakistan, Vietnam, and Hawaii may
receive irradiation at either the point of origin or upon arrival in
the mainland United States, the regulations in part 319 require fruit
from India and Thailand to be treated prior to arrival in the United
States.
On September 29, 2011, we published in the Federal Register a
proposal \1\ (76 FR 60390-60395, Docket No. APHIS-2009-0100) to amend
Sec. 305.9 by establishing generic phytosanitary criteria to replace
the current criteria for irradiation facilities at the maritime ports
of Gulfport, MS, and Wilmington, NC, and the airport of Atlanta, GA,
and to apply the proposed generic criteria to any new irradiation
treatment facilities in the Southern States of the United States. Under
these criteria, in conjunction with the current criteria for
irradiation facilities not located in the Southern States, we proposed
to allow new irradiation facilities to be established in all the
Southern States for the treatment of regulated articles that are
imported, moved interstate from Hawaii or U.S. territories, or moved
interstate from areas quarantined for certain pests of concern. We also
proposed to amend Sec. 319.56-46 to allow for irradiation treatment of
mangoes from India either prior to or after arrival in the United
States and Sec. 319.56-47 to allow for irradiation treatment of
tropical fruits from Thailand either prior to or after arrival in the
United States.
---------------------------------------------------------------------------
\1\ To view the proposed rule, supporting and related documents,
and the comments received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2009-0100.
---------------------------------------------------------------------------
We solicited comments concerning our proposal for 60 days ending
November 28, 2011. We received seven comments by that date. One comment
consisted of 3,529 identical or nearly identical letters. The comments
were from an advocacy group, a State department of agriculture, and
private citizens. Two commenters expressed support for the proposed
rule. The remaining comments are discussed below by topic.
Some commenters stated that irradiation is an inappropriate way to
deal with the risk of plant pests in imported foods. One commenter
generally opposed the use of irradiation as a phytosanitary measure.
One commenter opposed the rule as no irradiation facilities have been
built in the currently approved locations in Southern States.
Under the Plant Protection Act (7 U.S.C. 7701 et seq.), regulated
articles may be subject to remedial measures necessary to prevent the
spread of plant pests. APHIS has determined that irradiation is an
effective form of treatment against certain plant pests, and the
regulations in 7 CFR part 305 provide for irradiation as a
phytosanitary treatment for commodities or articles that require
treatment prior to interstate movement or importation. Before approving
irradiation as a treatment alternative for a specific pest, APHIS
performs an
[[Page 42622]]
evaluation to determine its effectiveness. As irradiation has been
determined to be effective, there is no reason to deny importers the
use of this treatment option.
Several commenters expressed concern about importing commodities
into the United States prior to irradiation treatment, with one
commenter indicating that Florida is a high-risk area for fruit flies
and other invasive exotic pests. Another commenter stated that allowing
irradiation facilities in Southern States would make it easier for
pests to infest key agricultural States and expressed concern about the
cost of containing and eradicating exotic pests. One commenter
questioned why pest mitigation is not occurring prior to export and did
not understand why the United States would perform this task for
exporters.
As we indicated in the proposed rule, the regulations in Sec.
305.9 allow for irradiation treatment of articles either prior to or
after arrival in the United States, provided that an APHIS-approved
facility is available. Articles may be treated in the United States
instead of the exporting country for several reasons, including when
the exporting country lacks the resources, technical expertise, or
infrastructure to treat articles prior to export. The regulations
require safeguards that have successfully prevented the introduction or
dissemination of plant pests into or within the United States via the
importation or interstate movement of irradiated articles since 1996,
when irradiation was first used as a phytosanitary treatment. Based on
our experience, we are confident that exporting countries have the
ability to comply with all APHIS requirements and commodities from
exporting countries can be safely treated in the United States.
APHIS recognizes that the Southern States have conditions favorable
for the establishment of exotic fruit flies, and that is why we
proposed additional safeguards for irradiation facilities in these
States that go beyond the current requirements that apply to all
irradiation facilities. These safeguards include the requirements that
untreated articles may not be removed from their packaging prior to
treatment under any circumstances, that refrigerated or air-conditioned
conveyances must be used to transport regulated articles to the
treatment facility, and that facilities have contingency plans for
safely destroying or disposing of regulated articles if the facility
was unable to properly treat a shipment. To help prevent establishment
of pests in the unlikely event that they escape despite the required
precautions, we will require trapping and other pest monitoring
activities within 4 square miles of the facility to help prevent
establishment of any escaped pests of concern. Those activities will be
paid for by the facility. In addition, while APHIS monitors the
treatment, the costs of treatment are the responsibility of the
exporter or the importer, not APHIS.
APHIS will only approve a proposed facility if the Administrator
determines that regulated articles can be safely transported to the
facility from a port of entry or points of origin in the United States.
We believe that the mitigations included in this final rule have proven
effective in mitigating the risk associated with the importation of
commodities into the United States, and thus will provide protection
against the introduction or dissemination of pests of concern into the
United States. In the environmental assessment (EA) that we prepared
for the proposed rule, we evaluated the potential environmental effects
from allowing untreated commodities to be transported into the Southern
United States. In the EA, we determined that the mitigation measures
included in this final rule are adequate to manage pest risks
associated with amending the irradiation regulations and are expected
to provide an effective level of phytosanitary protection.
Several commenters were concerned that the increased importation of
commodities into the United States would have adverse economic effects
on domestic producers. One commenter expressed concern that irradiation
facilities are expensive and would increase the cost of food.
This rule does not authorize the importation of any additional
fruits or vegetables, so it will not in and of itself lead to the
increased importation of commodities. Any new imports would have to be
authorized through our existing provisions in 7 CFR part 319. While the
availability of additional treatment capacity in new areas might spur
businesses to explore new or additional imports of articles, the PPA
authorizes APHIS to consider plant pest risks when determining whether
to allow new articles to be imported, rather than potential economic
competition.
With respect to the costs of irradiation increasing the costs of
food, the final rule does not add irradiation requirements for any
commodity and therefore will not add any costs. We also note that in
most cases a variety of phytosanitary treatments for a particular
article will be available, so importers and marketers will choose the
treatment option that makes the most sense to them from an economic and
competitive standpoint. Products are unlikely to be imported unless
their importation is economically feasible.
Many comments raised several issues that concern matters under the
regulatory authority of other Federal agencies, not APHIS. We do not
intend to reopen debate over matters that have been resolved through
rulemaking by other agencies that have primary authority in these
areas.
For example, one commenter suggested that irradiation facilities
are unsafe and that workers may be exposed to dangerous levels of
radiation. Many other commenters stated that USDA should not put
consumers, U.S. farmers, and communities at risk by expanding the use
of irradiation.
The Nuclear Regulatory Commission, the Occupational Safety and
Health Administration, and the U.S. Department of Transportation have
the primary regulatory responsibility for issues including irradiation
facility construction, operation, employee and public safety, and
transportation of radioisotopes. Their requirements in these areas were
established through public rulemaking by the respective agencies. In
Sec. 305.9(b) of the final rule, we are requiring other agencies that
have regulatory oversight and requirements regarding irradiation
facilities to concur in writing with the establishment of the facility
prior to APHIS approval. In our EA, we evaluated the potential
environmental effects from irradiation facilities and found that,
provided required safety standards and control procedures are adhered
to, no impacts to the human environment are expected.
Many commenters expressed concern that irradiation will make foods
unsafe to eat. Commenters also stated that irradiation would reduce the
nutritional value of fruits and vegetables, particularly through
vitamin depletion. One commenter stated that ``many of the exporting
countries will not have regulatory frameworks comparable to what U.S.
producers are subjected to and irradiation will be used as a panacea to
address those shortcomings.'' One commenter stated that irradiation can
be a cover-up for poor food handling practices and could also mask the
effects of spoilage.
The Food and Drug Administration (FDA) has primary regulatory
responsibility for ensuring that approved irradiation doses do not
render foods unsafe to eat. In our EA, we discuss the safety of food
that has been irradiated, finding that irradiation does not harm the
nutritional value of food, nor does it make the food unsafe to eat or
adversely affect the balance
[[Page 42623]]
between microbial spoilage organisms and pathogenic organisms.
Regulation of these matters, however, is outside the scope of the
current rulemaking and outside the statutory authority of APHIS. We do
note for the record the following information from the August 2000
report by the U.S. General Accounting Office (now known as the U.S.
Government Accountability Office), ``Food Irradiation: Available
Research Indicates That Benefits Outweigh Risks'' (GAO/RCED-00-217):
There is also some vitamin loss associated with irradiation--
with certain vitamins, such as thiamin (B1), ascorbic acid (C), and
alpha-tocopherol (E)--more affected by irradiation than others.
However, according to the Institute of Food Technologists, it is
highly doubtful that there would ever be any vitamin deficiency
resulting from eating irradiated food. For example, thiamin is the
most radiation-sensitive, water-soluble vitamin. With regard to this
vitamin, the American Dietetic Association's position statement on
food irradiation notes that FDA evaluated an extreme case in which
all meat, poultry, and fish were irradiated at the maximum
permissible dose under conditions resulting in the maximum
destruction of thiamin. Even in these circumstances, the average
thiamin intake was above the Recommended Dietary Allowance, leading
FDA to conclude that there was no deleterious effect on the total
dietary intake of thiamin as a result of irradiating foods. In its
1980 evaluation of food irradiation, the Joint Expert Committee
convened by FAO, WHO, and IAEA concluded that irradiation caused no
special nutritional problems in food. Another meeting of experts in
1997--organized by the same three international organizations--
concluded that even high doses of irradiation (i.e., over 10 kGy)
would not result in nutrient losses that could adversely affect a
food's nutritional value.
Irradiation cannot reverse the spoilage process--the bad
appearance, taste, and/or smell will remain the same after
irradiation. In addition, current regulations do not allow food
processors to use doses of irradiation on meat, poultry, fruits, and
vegetables that would be high enough to sterilize extremely
contaminated food. If a processor attempted to use a sterilization
dose on many of these products, the odor, flavor, taste, and texture
would be seriously impaired and the consumer would reject such
products.
One commenter stated that the FDA has not been able to keep up with
the volume of imports to ensure that they are safe for human
consumption.
This matter is outside the scope of the current rulemaking and
outside the statutory authority of APHIS. However, on this point we do
note that the Food Safety Modernization Act was enacted on January 4,
2011, to enable FDA to better protect public health by strengthening
the food safety system.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, without
change.
Executive Order 12866 and Regulatory Flexibility Act
This final rule has been determined to be not significant for the
purposes of Executive Order 12866 and, therefore, has not been reviewed
by the Office of Management and Budget.
In accordance with the Regulatory Flexibility Act, we have analyzed
the potential economic effects of this action on small entities. The
analysis is summarized below. Copies of the full analysis are available
on the Regulations.gov Web site (see footnote 1 in this document for a
link to Regulations.gov) or by contacting the person listed under FOR
FURTHER INFORMATION CONTACT.
The final rule will benefit U.S. entities by clearly and
transparently presenting the criteria that will govern the approval of
additional irradiation facilities in the Southern United States,
thereby facilitating their establishment. APHIS has not identified any
costs associated with establishing the generic criteria for irradiation
facility approval described in the rule.
Beyond helping to make the approval of future irradiation
facilities in the Southern United States an efficient process, we do
not anticipate that the criteria set forth in this rule will result in
economic impacts on U.S. entities, large or small.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
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.
National Environmental Policy Act
An environmental assessment and finding of no significant impact
have been prepared for this final rule. The environmental assessment
provides a basis for the conclusion that providing generic criteria for
new irradiation treatment facilities in the Southern States of the
United States will not have a significant impact on the quality of the
human environment. Based on the finding of no significant impact, the
Administrator of the Animal and Plant Health Inspection Service has
determined that an environmental impact statement need not be prepared.
The environmental assessment and finding of no significant impact
were prepared in accordance with: (1) The National Environmental Policy
Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2)
regulations of the Council on Environmental Quality for implementing
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA
Implementing Procedures (7 CFR part 372).
The environmental assessment and finding of no significant impact
may be viewed on the Regulations.gov Web site.\2\ Copies of the
environmental assessment and finding of no significant impact are also
available for public inspection at USDA, Room 1141, South Building,
14th Street and Independence Avenue SW., Washington, DC, between 8 a.m.
and 4:30 p.m., Monday through Friday, except holidays. Persons wishing
to inspect copies are requested to call ahead on (202) 690-2817 to
facilitate entry into the reading room. In addition, copies may be
obtained by writing to the individual listed under FOR FURTHER
INFORMATION CONTACT.
---------------------------------------------------------------------------
\2\ Go to https://www.regulations.gov/#!docketDetail;D=APHIS-
2009-0100. The environmental assessment and finding of no
significant impact will appear in the resulting list of documents.
---------------------------------------------------------------------------
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 0579-0383.
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
7 CFR Part 305
Irradiation, Phytosanitary treatment, Plant diseases and pests,
Quarantine,
[[Page 42624]]
Reporting and recordkeeping requirements.
7 CFR Part 319
Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant
diseases and pests, Quarantine, Reporting and recordkeeping
requirements, Rice, Vegetables.
Accordingly, we are amending 7 CFR parts 305 and 319 as follows:
PART 305--PHYTOSANITARY TREATMENTS
0
1. The authority citation for part 305 continues to read as follows:
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and
136a; 7 CFR 2.22, 2.80, and 371.3.
0
2. Section 305.9 is amended as follows:
0
a. By revising paragraph (a)(1) to read as set forth below.
0
b. In paragraph (b), by adding a sentence after the first sentence to
read as set forth below.
0
c. By adding a sentence after the paragraph (c) introductory text
heading to read as set forth below.
0
d. In paragraph (e) introductory text, by adding a sentence after the
second sentence to read as set forth below.
0
e. In paragraph (e)(1) introductory text, by adding a new first
sentence after the paragraph heading to read as set forth below.
0
f. By revising the OMB control number at the end of the section to read
as set forth below.
Sec. 305.9 Irradiation treatment requirements.
* * * * *
(a) * * *
(1) Where certified irradiation facilities are available, an
approved irradiation treatment may be conducted for any imported
regulated article either prior to shipment to the United States or in
the United States. For any regulated article moved interstate from
Hawaii or U.S. territories, irradiation treatment may be conducted
either prior to movement to the mainland United States or in the
mainland United States. Irradiation facilities may be located in any
State on the mainland United States. For irradiation facilities located
in the States of Alabama, Arizona, California, Florida, Georgia,
Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North Carolina,
South Carolina, Tennessee, Texas, and Virginia, the following
additional conditions must be met:
(i) Prospective facility operators must submit a detailed layout of
the facility site and its location to APHIS. APHIS will evaluate plant
health risks based on the proposed location and layout of the facility
site. APHIS will only approve a proposed facility if the Administrator
determines that regulated articles can be safely transported to the
facility from port of entry or points of origin in the United States.
(ii) The government of the State in which the facility is to be
located must concur in writing with the establishment of the facility
or, if it does not concur, must provide a written explanation of
concern based on pest risks. In instances where the State government
does not concur with the proposed facility location, APHIS and the
State will agree on a strategy to resolve the pest risk concerns prior
to APHIS approval.
(iii) Untreated articles may not be removed from their packaging
prior to treatment under any circumstances.
(iv) The facility must have contingency plans, approved by APHIS,
for safely destroying or disposing of regulated articles if the
facility is unable to properly treat a shipment.
(v) The facility may only treat articles approved by APHIS for
treatment at the facility. Approved articles will be listed in the
compliance agreement required in paragraph (c)(1)(i) of this section.
(vi) Arrangements for treatment must be made before the departure
of a consignment from its port of entry or points of origin in the
United States. APHIS and the facility must agree on all parameters,
such as time, routing, and conveyance, by which the consignment will
move from the port of entry or points of origin in the United States to
the treatment facility.
(vii) Regulated articles must be conveyed to the facility in a
refrigerated (via motorized refrigeration equipment or other methods
including ice or insulation) or air-conditioned conveyance at a
temperature that minimizes the mobility of the pests of concern for the
article.
(viii) The facility must maintain and provide APHIS with an updated
map identifying places where horticultural or other crops are grown
within 4 square miles of the facility. Proximity of host material to
the facility will necessitate trapping or other pest monitoring
activities to help prevent establishment of any escaped pests of
concern, as approved by APHIS; these activities will be listed in the
compliance agreement required in paragraph (c)(1)(i) of this section.
The treatment facility must have a pest management plan within the
facility.
(ix) The facility must comply with any additional requirements that
APHIS may require to prevent the escape of plant pests during transport
to and from the irradiation facility itself, for a particular facility
based on local conditions, and for any other risk factors of concern.
These activities will be listed in the compliance agreement required in
paragraph (c)(1)(i) of this section.
* * * * *
(b) * * * Other agencies that have regulatory oversight and
requirements must concur in writing with the establishment of the
facility prior to APHIS approval. * * *
(c) * * * Compliance agreements for facilities located in States
listed in paragraph (a)(1) of this section may also contain additional
provisions as described in paragraphs (a)(1)(i) through (a)(1)(ix) of
this section. * * *
* * * * *
(e) * * * Facilities must be located within the local commuting
area for APHIS employees for inspection purposes.
(1) * * * Facilities shall be located within an area over which the
U.S. Department of Homeland Security is assigned authority to accept
entries of merchandise, to collect duties, and to enforce the
provisions of the customs and navigation laws in force. * * *
* * * * *
(Approved by the Office of Management and Budget under control
numbers 0579-0155, 0579-0215, and 0579-0198, 0579- 0383)
PART 319--FOREIGN QUARANTINE NOTICES
0
3. The authority citation for part 319 continues to read as follows:
Authority: 7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136
and 136a; 7 CFR 2.22, 2.80, and 371.3.
Sec. 319.56-46 [Amended]
0
4. Section Sec. 319.56-46 is amended as follows:
0
a. In paragraph (a), by removing the words ``in India''.
0
b. In paragraph (e) introductory text, by removing the words
``certifying that the fruit received the required irradiation
treatment. The phytosanitary certificate must also bear'' and adding
the word ``with'' in their place.
Sec. 319.56-47 [Amended]
0
5. Section 319.56-47 is amended as follows:
0
a. In paragraph (b), by removing the second sentence.
0
b. In paragraph (c)(1), by removing the words ``that the litchi were
treated with irradiation as described in paragraph (b) of this section
and''.
0
c. In paragraph (c)(2), by removing the words ``with an additional
declaration
[[Page 42625]]
stating that the longan, mango, mangosteen, pineapple, or rambutan were
treated with irradiation as described in paragraph (b) of this
section''.
Done in Washington, DC, this 16th day of July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-17725 Filed 7-19-12; 8:45 am]
BILLING CODE 3410-34-P