Almonds Grown in California; Revision of Outgoing Quality Control Requirements, 28872-28874 [E9-14281]
Download as PDF
<![CDATA[
28872
Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Rules and Regulations
encouraged to participate in the
Committees’ deliberations on all issues.
Like all Committee meetings, the
February 19, 2009, meetings were public
meetings and entities of all sizes were
able to express views on this issue.
Finally, interested persons are invited to
submit information on the regulatory
and informational impacts of this action
on small businesses.
This action imposes no additional
reporting or recordkeeping requirements
on either small or large handlers. As
with all Federal marketing order
programs, reports and forms are
periodically reviewed to reduce
information requirements and
duplication by industry and public
sector agencies.
AMS is committed to complying 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.
USDA has not identified any relevant
Federal rules that duplicate, overlap, or
conflict with this rule.
A small business guide on complying
with fruit, vegetable, and specialty crop
marketing agreements and orders may
be viewed at: https://www.ams.usda.gov/
fv/moab.html. Any questions about the
compliance guide should be sent to Jay
Guerber at the previously mentioned
address in the FOR FURTHER INFORMATION
CONTACT section.
After consideration of all relevant
material presented, including the
information and recommendation
submitted by the Committee and other
available information, it is hereby found
that this rule, as hereinafter set forth,
will tend to effectuate the declared
policy of the Act.
Pursuant to 5 U.S.C. 553, it is also
found and determined upon good cause
that it is impracticable, unnecessary,
and contrary to the public interest to
give preliminary notice prior to putting
this rule into effect, and that good cause
exists for not postponing the effective
date of this rule until 30 days after
publication in the Federal Register
because: (1) The 2009–10 fiscal period
began March 1, 2009, and the marketing
orders require that the rates of
assessment for each fiscal period apply
to all assessable nectarines and peaches
handled during such fiscal period; (2)
the Committees need to have sufficient
funds to pay its expenses which are
incurred on a continuous basis; (3)
handlers are aware of this action which
was recommended by the Committees at
public meetings and is similar to other
assessment rate actions issued in past
years; and (4) this interim final rule
VerDate Nov<24>2008
16:53 Jun 17, 2009
Jkt 217001
provides a 60-day comment period, and
all comments timely received will be
considered prior to finalization of this
rule.
List of Subjects
7 CFR Part 916
Marketing agreements, Nectarines,
Reporting and recordkeeping
requirements.
7 CFR Part 917
Marketing agreements, Peaches, Pears,
Reporting and recordkeeping
requirements.
■ For the reasons set forth in the
preamble, 7 CFR parts 916 and 917 are
amended as follows:
■ 1. The authority citation for 7 CFR
parts 916 and 917 continues to read as
follows:
Authority: 7 U.S.C. 601–674.
PART 916—NECTARINES GROWN IN
CALIFORNIA
2. Section 916.234 is revised to read
as follows:
■
§ 916.234
Assessment rate.
On and after March 1, 2009, an
assessment rate of $0.0175 per 25-pound
container or container equivalent of
nectarines is established for California
nectarines.
PART 917—PEACHES GROWN IN
CALIFORNIA
3. Section 917.258 is revised to read
as follows:
■
§ 917.258
Assessment rate.
On and after March 1, 2009 an
assessment rate of $0.0025 per 25-pound
container or container equivalent of
peaches is established for California
peaches.
Dated: June 12, 2009.
Craig Morris,
Acting Associate Administrator.
[FR Doc. E9–14280 Filed 6–17–09; 8:45 am]
BILLING CODE P
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 981
[Doc. No. AMS–FV–08–0045; FV08–981–2
IFR]
Almonds Grown in California; Revision
of Outgoing Quality Control
Requirements
AGENCY:
Agricultural Marketing Service,
USDA.
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
ACTION: Interim final rule with request
for comments.
SUMMARY: This rule revises the outgoing
quality control regulations issued under
the California almond marketing order
(order). The order regulates the handling
of almonds grown in California and is
administered locally by the Almond
Board of California (Board). This rule
revises the term ‘‘validation’’ under the
Salmonella bacteria (Salmonella)
treatment program by specifying that
validation data must be both submitted
to and accepted by the Board’s
Technical Expert Review Panel (TERP)
for all treatment equipment prior to its
use under this program. This will help
ensure that all treatment equipment
meets a 4-log reduction of Salmonella in
almonds.
DATES: Effective June 19, 2009;
comments must be received by August
17, 2009.
ADDRESSES: Interested persons are
invited to submit written comments
concerning this rule. Comments must be
sent to the Docket Clerk, Marketing
Order Administration Branch, Fruit and
Vegetable Programs, AMS, USDA, 1400
Independence Avenue, SW., STOP
0237, Washington, DC 20250–0237; Fax:
(202) 720–8938, or Internet: https://
www.regulations.gov. Comments should
reference the document number and the
date and page number of this issue of
the Federal Register and will be
available for public inspection in the
Office of the Docket Clerk during regular
business hours, or can be viewed at:
https://www.regulations.gov. All
comments submitted in response to this
rule will be included in the record and
will be made available to the public.
Please be advised that the identity of the
individuals or entities submitting the
comments will be made public on the
Internet at the address provided above.
FOR FURTHER INFORMATION CONTACT:
Terry Vawter, Senior Marketing
Specialist, or Kurt J. Kimmel, Regional
Manager, California Marketing Field
Office, Marketing Order Administration
Branch, Fruit and Vegetable Programs,
AMS, USDA; Telephone: (559) 487–
5901, Fax: (559) 487–5906, or E-mail:
Terry.Vawter@ams.usda.gov, or
Kurt.Kimmel@ams.usda.gov.
Small businesses may request
information on complying with this
regulation by contacting Jay Guerber,
Marketing Order Administration
Branch, Fruit and Vegetable Programs,
AMS, USDA, 1400 Independence
Avenue, SW., STOP 0237, Washington,
DC 20250–0237; Telephone: (202) 720–
2491, Fax: (202) 720–8938, or E-mail:
Jay.Guerber@ams.usda.gov.
E:\FR\FM\18JNR1.SGM
18JNR1
Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Rules and Regulations
This
interim final rule is issued under
Marketing Order No. 981, as amended (7
CFR part 981), regulating the handling
of almonds grown in California,
hereinafter referred to as the ‘‘order.’’
The order is effective under the
Agricultural Marketing Agreement Act
of 1937, as amended (7 U.S.C. 601–674),
hereinafter referred to as the ‘‘Act.’’
The Department of Agriculture
(USDA) is issuing this rule in
conformance with Executive Order
12866.
This rule has been reviewed under
Executive Order 12988, Civil Justice
Reform. This rule is not intended to
have retroactive effect. This rule will
not preempt any State or local laws,
regulations, or policies, unless they
present an irreconcilable conflict with
this rule.
The Act provides that administrative
proceedings must be exhausted before
parties may file suit in court. Under
section 608c(15)(A) of the Act, any
handler subject to an order may file
with USDA a petition stating that the
order, any provision of the order, or any
obligation imposed in connection with
the order is not in accordance with law
and request a modification of the order
or to be exempted therefrom. Such
handler is afforded the opportunity for
a hearing on the petition. After the
hearing, USDA would rule on the
petition. The Act provides that the
district court of the United States in any
district in which the handler is an
inhabitant, or has his or her principal
place of business, has jurisdiction to
review USDA’s ruling on the petition,
provided an action is filed not later than
20 days after the date of the entry of the
ruling.
This interim final rule revises the
outgoing quality control requirements
under the Salmonella treatment
program. This rule revises the term
‘‘validation’’ by specifying that
validation data must be both submitted
to and accepted by the Board’s TERP for
all treatment equipment prior to its use
under the program. The TERP consists
of four scientists, with a representative
from the Food and Drug Administration
serving as an ex-officio member. This
will help ensure that all treatment
equipment meets a 4-log reduction of
Salmonella in almonds. This action was
unanimously recommended by the
Board at a meeting on May 20, 2008.
Section 981.42(b) of the order
provides authority for the Board to
establish, with approval of the
Secretary, such minimum quality and
inspection requirements applicable to
almonds to be handled or to be
processed into manufactured product,
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
16:53 Jun 17, 2009
Jkt 217001
as will contribute to orderly marketing
or be in the public interest. In such crop
year, no handler shall handle or process
almonds into manufactured items or
products unless they meet the
applicable requirements as evidenced
by certification acceptable to the Board.
The Board, with approval of the
Secretary, may establish rules and
regulations necessary and incidental to
the administration of this provision.
Section § 981.442(b) of the order’s
administrative rules and regulations
provides authority for a mandatory
treatment program to reduce the
potential for Salmonella in almonds. A
mandatory program went into effect in
September 2007. Specifically, handlers
must subject their almonds to a
treatment process that achieves a
minimum 4-log reduction in Salmonella
prior to shipment. ‘‘Log reduction’’
describes how much bacteria is reduced
by a treatment process. A 4-log
reduction decreases bacteria by a factor
of 10,000 (4 zeros). Handlers may treat
almonds themselves or transport the
almonds to off-site facilities for
treatment. Also, handlers may ship
untreated almonds to Board-approved
manufacturers within the U.S., Canada,
and Mexico who agree to treat the
almonds appropriately. Handlers may
also ship untreated almonds to locations
outside the U.S., Canada, and Mexico.
Containers of untreated almonds must
be labeled ‘‘unpasteurized.’’
Paragraph 3 of § 981.442(b) of the
regulations specifies that treatment
processes must be validated by a Boardapproved process authority. Paragraph
(i) of that section defines the term
‘‘validation’’ to mean that the treatment
technology and equipment have been
demonstrated to achieve a 4-log
reduction. Process authorities run tests
to ensure this parameter is met. A
process authority is a person who has
expert knowledge of appropriate
processes for the treatment of almonds
and meets criteria specified in
paragraph (ii) of that section.
Currently, the regulation does not
specify that process authorities submit
validation data to the Board’s TERP in
order to ensure that the treatment
equipment meets the program’s 4-log
requirement. Thus, the Board
recommended that the regulation be
revised accordingly. This will help
ensure that all treatment equipment
meets the program’s 4-log requirement.
Paragraph (3)(i) of § 981.442(b) of the
regulations issued under the order is
revised accordingly.
Initial Regulatory Flexibility Analysis
Pursuant to requirements set forth in
the Regulatory Flexibility Act (RFA), the
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
28873
Agricultural Marketing Service (AMS)
has considered the economic impact of
this rule on small entities. Accordingly,
AMS has prepared this initial regulatory
flexibility analysis.
The purpose of the RFA is to fit
regulatory actions to the scale of
business subject to such actions in order
that small businesses will not be unduly
or disproportionately burdened.
Marketing orders issued pursuant to the
Act, and the rules issued thereunder, are
unique in that they are brought about
through group action of essentially
small entities acting on their own
behalf. Thus, both statutes have small
entity orientation and compatibility.
There are approximately 6,200
producers of almonds in the production
area and approximately 100 handlers
subject to regulation under the
marketing order. Additionally, the
Board estimates there are about 15
process authorities and 30 almond
manufacturers under the Salmonella
treatment program. Small agricultural
producers are defined by the Small
Business Administration (13 CFR
121.201) as those having annual receipts
of less than $750,000, and small
agricultural service firms are defined as
those whose annual receipts are less
than $7,000,000.
Data for the most recently-completed
crop year indicate that about 50 percent
of the handlers shipped under
$7,000,000 worth of almonds. Dividing
average almond crop value for 2006–07
reported by the National Agricultural
Statistics Service of $2.258 billion by
the number of producers (6,200) yields
an average annual producer revenue
estimate of about $364,190. Based on
the foregoing, about half of the handlers
and a majority of almond producers may
be classified as small entities. While
data regarding the size of the process
authorities and almond manufacturers is
not available, it may be assumed that
some process authorities and
manufacturers may be classified as
small entities.
This rule revises § 981.442(b)(3)(i) of
the order’s administrative rules and
regulations. This rule revises the term
‘‘validation’’ under the Salmonella
treatment program to specify that
validation data must be both submitted
to and accepted by the TERP for each
piece of treatment equipment prior to its
use under the program. This revision
will help ensure that all treatment
equipment meets the program’s 4-log
requirement prior to its use. Authority
for this action is provided in § 981.42(b)
of the order.
Regarding the overall impact of this
action on affected entities, it is expected
to be minimal. Validation data is
E:\FR\FM\18JNR1.SGM
18JNR1
28874
Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Rules and Regulations
already submitted to the Board’s TERP
for review. This action simply specifies
that such data must be accepted by the
TERP for all treatment equipment prior
to its use under the program.
The Board’s Food Quality and Safety
Committee (committee) met on April 22,
2008, to consider this change. The
committee considered maintaining the
status quo whereby equipment could be
used under the program that had
completed validation testing, but had
not been accepted by the TERP. The
committee concluded that acceptance
by the TERP was important in order to
help ensure that all treatment
equipment consistently meets the 4-log
requirement of the program. The Board
agreed with the committee and
ultimately recommended that the term
‘‘validation’’ be revised accordingly.
This action does not impose any
additional reporting and recordkeeping
requirements on California almonds
handlers, process authorities, or almond
manufacturers. As with all Federal
marketing order programs, reports and
forms are periodically reviewed to
reduce information requirements and
duplication by industry and public
sector agencies.
AMS is committed to complying 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.
In addition, USDA has not identified
any relevant Federal rules that
duplicate, overlap, or conflict with this
rule.
Further, the committee and Board
meetings where this issue was discussed
were widely publicized throughout the
California almond industry and all
interested persons were invited to
attend the meetings and participate in
deliberations on all issues. The issue
was discussed at two committee
meetings in April 2008 and at two Board
meetings, one in April and one in May
2008. All of these meetings were public
meetings, and all entities, both large and
small, were able to express views on
this issue. Finally, interested persons
are invited to submit information on the
regulatory and informational impacts of
this action on small businesses.
A small business guide on complying
with fruit, vegetable, and specialty crop
marketing agreements and orders may
be viewed at: https://www.ams.usda.gov/
AMSv1.0/ams.fetchTemplateData.do?
template=TemplateN&page=Marketing
OrdersSmallBusinessGuide. Any
questions about the compliance guide
should be sent to Jay Guerber at the
previously mentioned address in the
VerDate Nov<24>2008
16:53 Jun 17, 2009
Jkt 217001
FOR FURTHER INFORMATION CONTACT
section.
This rule invites comments on a
revision to the outgoing quality control
requirements currently prescribed under
the almond marketing order. Any
comments received will be considered
prior to finalization of this rule.
After consideration of all relevant
material presented, including the
Board’s recommendation, and other
information, it is found that this interim
final rule, as hereinafter set forth, will
tend to effectuate the declared policy of
the Act.
Pursuant to 5 U.S.C. 553, it is also
found and determined upon good cause
that it is impracticable, unnecessary,
and contrary to the public interest to
give preliminary notice prior to putting
this rule into effect and that good cause
exists for not postponing the effective
date of this rule until 30 days after
publication in the Federal Register
because: (1) This rule makes a revision
to the requirements concerning
validation contained in the current
regulations to help ensure that all
treatment equipment meets a 4-log
reduction in Salmonella in almonds; (2)
handlers are aware of this action since
the Board unanimously recommended
this revision at a public meeting, and
interested parties had an opportunity to
provide input; and (3) this rule provides
a 60-day comment period and any
comments received will be considered
prior to finalization of this rule.
List of Subjects in 7 CFR Part 981
Almonds, Marketing agreements,
Nuts, Reporting and recordkeeping
requirements.
■ For the reasons set forth in the
preamble, 7 CFR part 981 is amended as
follows:
PART 981—ALMONDS GROWN IN
CALIFORNIA
1. The authority citation for 7 CFR
part 981 continues to read as follows:
■
Authority: 7 U.S.C. 601–674.
2. Paragraph (b)(3)(i) in § 981.442 is
revised to read as follows:
■
§ 981.442
Quality control.
*
*
*
*
*
(b) * * *
(3) * * *
(i) Validation means that the
treatment technology and equipment
have been demonstrated to achieve in
total a minimum 4-log reduction of
Salmonella bacteria in almonds.
Validation data prepared by a Boardapproved process authority must be
submitted to and accepted by the TERP
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
for each piece of equipment used to
treat almonds prior to its use under the
program.
*
*
*
*
*
Dated: June 12, 2009.
Craig Morris,
Acting Associate Administrator.
[FR Doc. E9–14281 Filed 6–17–09; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA–2009–N–0665]
Oral Dosage Form New Animal Drugs;
Toceranib
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
original approval of a new animal drug
application (NADA) filed by Pharmacia
& Upjohn Co., a Division of Pfizer, Inc.
The NADA provides for the veterinary
prescription use of toceranib phosphate
tablets in dogs for treatment of
recurrent, cutaneous mast cell tumors.
DATES: This rule is effective June 18,
2009.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337,
email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmacia
& Upjohn Co., a Division of Pfizer, Inc.,
235 East 42d St., New York, NY 10017,
filed NADA 141–295 that provides for
veterinary prescription use of
PALLADIA (toceranib phosphate)
Tablets in dogs for the treatment of
Patnaik grade II or III, recurrent,
cutaneous mast cell tumors with or
without regional lymph node
involvement. The NADA is approved as
of May 22, 2009, and the regulations are
amended in 21 CFR part 520 to reflect
the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
E:\FR\FM\18JNR1.SGM
18JNR1
]]>Agencies
[Federal Register Volume 74, Number 116 (Thursday, June 18, 2009)]
[Rules and Regulations]
[Pages 28872-28874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14281]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 981
[Doc. No. AMS-FV-08-0045; FV08-981-2 IFR]
Almonds Grown in California; Revision of Outgoing Quality Control
Requirements
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Interim final rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: This rule revises the outgoing quality control regulations
issued under the California almond marketing order (order). The order
regulates the handling of almonds grown in California and is
administered locally by the Almond Board of California (Board). This
rule revises the term ``validation'' under the Salmonella bacteria
(Salmonella) treatment program by specifying that validation data must
be both submitted to and accepted by the Board's Technical Expert
Review Panel (TERP) for all treatment equipment prior to its use under
this program. This will help ensure that all treatment equipment meets
a 4-log reduction of Salmonella in almonds.
DATES: Effective June 19, 2009; comments must be received by August 17,
2009.
ADDRESSES: Interested persons are invited to submit written comments
concerning this rule. Comments must be sent to the Docket Clerk,
Marketing Order Administration Branch, Fruit and Vegetable Programs,
AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC
20250-0237; Fax: (202) 720-8938, or Internet: https://www.regulations.gov. Comments should reference the document number and
the date and page number of this issue of the Federal Register and will
be available for public inspection in the Office of the Docket Clerk
during regular business hours, or can be viewed at: https://www.regulations.gov. All comments submitted in response to this rule
will be included in the record and will be made available to the
public. Please be advised that the identity of the individuals or
entities submitting the comments will be made public on the Internet at
the address provided above.
FOR FURTHER INFORMATION CONTACT: Terry Vawter, Senior Marketing
Specialist, or Kurt J. Kimmel, Regional Manager, California Marketing
Field Office, Marketing Order Administration Branch, Fruit and
Vegetable Programs, AMS, USDA; Telephone: (559) 487-5901, Fax: (559)
487-5906, or E-mail: Terry.Vawter@ams.usda.gov, or
Kurt.Kimmel@ams.usda.gov.
Small businesses may request information on complying with this
regulation by contacting Jay Guerber, Marketing Order Administration
Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence
Avenue, SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202)
720-2491, Fax: (202) 720-8938, or E-mail: Jay.Guerber@ams.usda.gov.
[[Page 28873]]
SUPPLEMENTARY INFORMATION: This interim final rule is issued under
Marketing Order No. 981, as amended (7 CFR part 981), regulating the
handling of almonds grown in California, hereinafter referred to as the
``order.'' The order is effective under the Agricultural Marketing
Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter
referred to as the ``Act.''
The Department of Agriculture (USDA) is issuing this rule in
conformance with Executive Order 12866.
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule is not intended to have retroactive effect.
This rule will not preempt any State or local laws, regulations, or
policies, unless they present an irreconcilable conflict with this
rule.
The Act provides that administrative proceedings must be exhausted
before parties may file suit in court. Under section 608c(15)(A) of the
Act, any handler subject to an order may file with USDA a petition
stating that the order, any provision of the order, or any obligation
imposed in connection with the order is not in accordance with law and
request a modification of the order or to be exempted therefrom. Such
handler is afforded the opportunity for a hearing on the petition.
After the hearing, USDA would rule on the petition. The Act provides
that the district court of the United States in any district in which
the handler is an inhabitant, or has his or her principal place of
business, has jurisdiction to review USDA's ruling on the petition,
provided an action is filed not later than 20 days after the date of
the entry of the ruling.
This interim final rule revises the outgoing quality control
requirements under the Salmonella treatment program. This rule revises
the term ``validation'' by specifying that validation data must be both
submitted to and accepted by the Board's TERP for all treatment
equipment prior to its use under the program. The TERP consists of four
scientists, with a representative from the Food and Drug Administration
serving as an ex-officio member. This will help ensure that all
treatment equipment meets a 4-log reduction of Salmonella in almonds.
This action was unanimously recommended by the Board at a meeting on
May 20, 2008.
Section 981.42(b) of the order provides authority for the Board to
establish, with approval of the Secretary, such minimum quality and
inspection requirements applicable to almonds to be handled or to be
processed into manufactured product, as will contribute to orderly
marketing or be in the public interest. In such crop year, no handler
shall handle or process almonds into manufactured items or products
unless they meet the applicable requirements as evidenced by
certification acceptable to the Board. The Board, with approval of the
Secretary, may establish rules and regulations necessary and incidental
to the administration of this provision.
Section Sec. 981.442(b) of the order's administrative rules and
regulations provides authority for a mandatory treatment program to
reduce the potential for Salmonella in almonds. A mandatory program
went into effect in September 2007. Specifically, handlers must subject
their almonds to a treatment process that achieves a minimum 4-log
reduction in Salmonella prior to shipment. ``Log reduction'' describes
how much bacteria is reduced by a treatment process. A 4-log reduction
decreases bacteria by a factor of 10,000 (4 zeros). Handlers may treat
almonds themselves or transport the almonds to off-site facilities for
treatment. Also, handlers may ship untreated almonds to Board-approved
manufacturers within the U.S., Canada, and Mexico who agree to treat
the almonds appropriately. Handlers may also ship untreated almonds to
locations outside the U.S., Canada, and Mexico. Containers of untreated
almonds must be labeled ``unpasteurized.''
Paragraph 3 of Sec. 981.442(b) of the regulations specifies that
treatment processes must be validated by a Board-approved process
authority. Paragraph (i) of that section defines the term
``validation'' to mean that the treatment technology and equipment have
been demonstrated to achieve a 4-log reduction. Process authorities run
tests to ensure this parameter is met. A process authority is a person
who has expert knowledge of appropriate processes for the treatment of
almonds and meets criteria specified in paragraph (ii) of that section.
Currently, the regulation does not specify that process authorities
submit validation data to the Board's TERP in order to ensure that the
treatment equipment meets the program's 4-log requirement. Thus, the
Board recommended that the regulation be revised accordingly. This will
help ensure that all treatment equipment meets the program's 4-log
requirement. Paragraph (3)(i) of Sec. 981.442(b) of the regulations
issued under the order is revised accordingly.
Initial Regulatory Flexibility Analysis
Pursuant to requirements set forth in the Regulatory Flexibility
Act (RFA), the Agricultural Marketing Service (AMS) has considered the
economic impact of this rule on small entities. Accordingly, AMS has
prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of
business subject to such actions in order that small businesses will
not be unduly or disproportionately burdened. Marketing orders issued
pursuant to the Act, and the rules issued thereunder, are unique in
that they are brought about through group action of essentially small
entities acting on their own behalf. Thus, both statutes have small
entity orientation and compatibility.
There are approximately 6,200 producers of almonds in the
production area and approximately 100 handlers subject to regulation
under the marketing order. Additionally, the Board estimates there are
about 15 process authorities and 30 almond manufacturers under the
Salmonella treatment program. Small agricultural producers are defined
by the Small Business Administration (13 CFR 121.201) as those having
annual receipts of less than $750,000, and small agricultural service
firms are defined as those whose annual receipts are less than
$7,000,000.
Data for the most recently-completed crop year indicate that about
50 percent of the handlers shipped under $7,000,000 worth of almonds.
Dividing average almond crop value for 2006-07 reported by the National
Agricultural Statistics Service of $2.258 billion by the number of
producers (6,200) yields an average annual producer revenue estimate of
about $364,190. Based on the foregoing, about half of the handlers and
a majority of almond producers may be classified as small entities.
While data regarding the size of the process authorities and almond
manufacturers is not available, it may be assumed that some process
authorities and manufacturers may be classified as small entities.
This rule revises Sec. 981.442(b)(3)(i) of the order's
administrative rules and regulations. This rule revises the term
``validation'' under the Salmonella treatment program to specify that
validation data must be both submitted to and accepted by the TERP for
each piece of treatment equipment prior to its use under the program.
This revision will help ensure that all treatment equipment meets the
program's 4-log requirement prior to its use. Authority for this action
is provided in Sec. 981.42(b) of the order.
Regarding the overall impact of this action on affected entities,
it is expected to be minimal. Validation data is
[[Page 28874]]
already submitted to the Board's TERP for review. This action simply
specifies that such data must be accepted by the TERP for all treatment
equipment prior to its use under the program.
The Board's Food Quality and Safety Committee (committee) met on
April 22, 2008, to consider this change. The committee considered
maintaining the status quo whereby equipment could be used under the
program that had completed validation testing, but had not been
accepted by the TERP. The committee concluded that acceptance by the
TERP was important in order to help ensure that all treatment equipment
consistently meets the 4-log requirement of the program. The Board
agreed with the committee and ultimately recommended that the term
``validation'' be revised accordingly.
This action does not impose any additional reporting and
recordkeeping requirements on California almonds handlers, process
authorities, or almond manufacturers. As with all Federal marketing
order programs, reports and forms are periodically reviewed to reduce
information requirements and duplication by industry and public sector
agencies.
AMS is committed to complying 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.
In addition, USDA has not identified any relevant Federal rules
that duplicate, overlap, or conflict with this rule.
Further, the committee and Board meetings where this issue was
discussed were widely publicized throughout the California almond
industry and all interested persons were invited to attend the meetings
and participate in deliberations on all issues. The issue was discussed
at two committee meetings in April 2008 and at two Board meetings, one
in April and one in May 2008. All of these meetings were public
meetings, and all entities, both large and small, were able to express
views on this issue. Finally, interested persons are invited to submit
information on the regulatory and informational impacts of this action
on small businesses.
A small business guide on complying with fruit, vegetable, and
specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateN&page=MarketingOrdersSmallBusinessGuide. Any questions about the compliance guide should be sent to
Jay Guerber at the previously mentioned address in the FOR FURTHER
INFORMATION CONTACT section.
This rule invites comments on a revision to the outgoing quality
control requirements currently prescribed under the almond marketing
order. Any comments received will be considered prior to finalization
of this rule.
After consideration of all relevant material presented, including
the Board's recommendation, and other information, it is found that
this interim final rule, as hereinafter set forth, will tend to
effectuate the declared policy of the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined upon good
cause that it is impracticable, unnecessary, and contrary to the public
interest to give preliminary notice prior to putting this rule into
effect and that good cause exists for not postponing the effective date
of this rule until 30 days after publication in the Federal Register
because: (1) This rule makes a revision to the requirements concerning
validation contained in the current regulations to help ensure that all
treatment equipment meets a 4-log reduction in Salmonella in almonds;
(2) handlers are aware of this action since the Board unanimously
recommended this revision at a public meeting, and interested parties
had an opportunity to provide input; and (3) this rule provides a 60-
day comment period and any comments received will be considered prior
to finalization of this rule.
List of Subjects in 7 CFR Part 981
Almonds, Marketing agreements, Nuts, Reporting and recordkeeping
requirements.
0
For the reasons set forth in the preamble, 7 CFR part 981 is amended as
follows:
PART 981--ALMONDS GROWN IN CALIFORNIA
0
1. The authority citation for 7 CFR part 981 continues to read as
follows:
Authority: 7 U.S.C. 601-674.
0
2. Paragraph (b)(3)(i) in Sec. 981.442 is revised to read as follows:
Sec. 981.442 Quality control.
* * * * *
(b) * * *
(3) * * *
(i) Validation means that the treatment technology and equipment
have been demonstrated to achieve in total a minimum 4-log reduction of
Salmonella bacteria in almonds. Validation data prepared by a Board-
approved process authority must be submitted to and accepted by the
TERP for each piece of equipment used to treat almonds prior to its use
under the program.
* * * * *
Dated: June 12, 2009.
Craig Morris,
Acting Associate Administrator.
[FR Doc. E9-14281 Filed 6-17-09; 8:45 am]
BILLING CODE P
