[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]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
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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.
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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.
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\1\ To view the proposed rule, supporting and related documents,
and the comments received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0100.
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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.
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\2\ Go to http://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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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