Pistachios Grown in California; Changes in Handling Requirements, 69139-69142 [07-5989]
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Federal Register / Vol. 72, No. 235 / Friday, December 7, 2007 / Rules and Regulations
then southeast, northeast, southeast,
southwest, southeast, northeast,
southeast, northeast, east, southeast,
southwest, northwest, southwest,
southeast, southwest, northwest,
southwest, southeast, southwest,
northwest, west, southeast, northwest,
west, and southwest on Alum Rock
Falls Road to State Highway 130; then
southeast on State Highway 130 to
Quimby Road; then southwest,
northwest, southwest, northwest,
southwest, and south on Quimby Road
to Buckeye Ranch; then southeast and
southwest on Buckeye Ranch to its
southwesternmost point; then southwest
from that point along an imaginary line
to the northeasternmost point of Fowler
Road; then southwest, southeast, east,
southeast, northwest, southwest,
southeast, south, west, northwest, and
west on Fowler Road to Yerba Buena
Road; then south and west on Yerba
Buena Road to San Felipe Road; then
southeast on San Felipe Road to
Farnsworth Drive; then southwest,
northwest, and southwest on
Farnsworth Drive to Silver Creek Valley
Road; then southwest, southeast,
southwest, and west on Silver Creek
Valley Road to Blossom Hill Road; then
west and southwest on Blossom Hill
Road to State Highway 82; then
northwest on State Highway 82 to
Southside Drive; then southeast from
the intersection of State Highway 82 and
Southside Drive along an imaginary line
to the northeasternmost point of
Hillsdale Drive; then southwest on
Hillsdale Drive to Hillsdale Avenue;
then west on Hillsdale Avenue to State
Highway 87; then northwest on State
Highway 87 to Interstate 880; then
northeast and north on Interstate 880 to
the point of beginning.
Solano County. That portion of
Solano County in the Dixon area
bounded by a line as follows: Beginning
at the intersection of Boyce Road and
Putah Creek Road; then northeast,
southeast, and northeast on Putah Creek
Road to Stevenson Bridge Road; then
northeast and northwest on Stevenson
Bridge Road to Putah Creek; then
southeast along Putah Creek to the south
fork of Putah Creek; then southeast
along the south fork of Putah Creek to
Old Davis Road; then south, west, and
south on Old Davis Road to Tremont
Road; then east on Tremont Road to
Bulkley Road; then south on Bulkley
Road to Midway Road; then west on
Midway Road to Sikes Road; then south
on Sikes Road to Swan Road; then west
on Swan Road to Bunker Station Road;
then south on Bunker Station Road to
Binghamton Road; then west on
Binghamton Road to State Highway 113;
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then north on State Highway 113 to
Hawkins Road; then west on Hawkins
Road to Lewis Road; then north on
Lewis Road to Weber Road; then west
and northwest on Weber Road to North
Meridian Road; then northwest and
north on North Meridian Road to
Sweeney Road; then west on Sweeney
Road to Halley Road; then north,
southwest, and northwest on Halley
Road to Wolfskill Road; then southwest
on Wolfskill Road to Boyce Road; then
northwest on Boyce Road to the point of
beginning.
Done in Washington, DC, this 30th day of
November 2007.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E7–23770 Filed 12–6–07; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 983
[Docket No. AMS–FV–07–0082; FV07–983–
1 IFR]
Pistachios Grown in California;
Changes in Handling Requirements
Agricultural Marketing Service,
USDA.
ACTION: Interim final rule with request
for comments.
AGENCY:
SUMMARY: This rule changes the
handling requirements currently
authorized under the California
pistachio marketing order (order). The
order regulates the handling of
pistachios grown in California and is
administered locally by the
Administrative Committee for
Pistachios (committee). This rule
suspends the minimum quality
requirements, including maximum
defects and minimum sizes, for
California pistachios. This will reduce
handler costs and provide handlers
more flexibility in meeting customer
needs.
Effective December 10, 2007;
comments received by February 5, 2008
will be considered prior to issuance of
a final rule.
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://
DATES:
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69139
www.regulations.gov. All comments
should reference the docket number and
the date and page number of this issue
of the Federal Register and will be
made available for public inspection in
the Office of the Docket Clerk during
regular business hours, or can be viewed
at: https://www.regulations.gov.
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 Email:
Terry.Vawter@usda.gov or
Kurt.Kimmel@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@usda.gov.
SUPPLEMENTARY INFORMATION: This rule
is issued under Marketing Order No.
983 (7 CFR part 983), regulating the
handling of pistachios 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. A 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
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the petition, provided an action is filed
not later than 20 days after the date of
the entry of the ruling.
This rule changes the handling
requirements for pistachios currently
authorized under the order. This rule
suspends the minimum quality
requirements, including maximum
defects and minimum sizes, for
California pistachios. This will reduce
handler costs and provide handlers
more flexibility in meeting customer
needs. This action was recommended by
the committee.
Section 983.39 establishes minimum
quality levels for pistachios, including
maximum defects and minimum sizes
permitted under the order. Under
§ 983.46, the Secretary may modify,
suspend, or make rules and regulations
to implement §§ 983.38 through 983.45
based upon a recommendation by seven
concurring committee members or other
available information.
The quality and size requirements
have been in effect for California
pistachios since the order’s inception in
2004. Evidence provided at the
promulgation hearing suggested that
there was a direct link between lowerquality pistachios and the incidence of
aflatoxin contamination (see 68 FR
45990). Aflatoxin is one of a group of
mycotoxins produced by the molds
Aspergillus flavus and Aspergillus
parasiticus. Aflatoxins are naturallyoccurring in the field and can be further
spread in improperly processed and
stored nuts, dried fruits, and grains. The
data presented at the hearing was based
on aflatoxin analyses of pistachios with
different defects. Although the data also
indicated that the levels of aflatoxin
associated with each defect varied
widely, researchers attributed this to
variability among the samples.
As further data was collected in 2005
and 2006, University of California
researchers concluded that variability in
aflatoxin levels seen in previous studies
may have been due to geographic
variability 1 2. Aflatoxin contamination
is more prevalent in pistachios
produced in the northern San Joaquin
Valley, while quality defects, largely
due to insect damage, are less prevalent.
The opposite is true for the southern
San Joaquin Valley. It is now believed
1 Doster, M.A., T.J. Michailides, L.D. Boeckler,
and D.P. Morgan, 2006. Development of expert
systems and predictive models for aflatoxin
contamination in pistachios. In California Pistachio
Industry Annual Report Crop Year 2005–2006, pg.
101–102.
2 Doster, M.A., T.J. Michailides, L.D. Boeckler,
and D.P. Morgan, 2007. Prediction of aflatoxin
contamination and a survey of fungi producing
Ochratoxin A in California pistachios. In California
Pistachio Industry Annual Report Crop Year 2006–
2007, pg. 109–110.
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that these differences in aflatoxin
contamination between the growing
areas are due to differences in climate.
The northern San Joaquin Valley has
more aflatoxin contamination because
its cooler temperatures and greater
moisture are more conducive to
Aspergillus and aflatoxin development,
but less conducive to insect population
and damage. However, in the southern
San Joaquin Valley, there is a higher
incidence of insect damage and a much
lower incidence of aflatoxin
contamination because of the drier
environment and higher temperatures.
Thus, recent research suggests that
aflatoxin occurrence in pistachios may
be attributable to climatic factors.
Additionally, growers and handlers
are reporting unexpected problems with
the size of pistachios this season, as
well as with staining of the nut shell
from the hull. Pistachios are smaller
than usual, and the large crop has
resulted in a large percentage of
pistachios which may not meet the
requirements of the order because the
sizes are smaller than currently
authorized, which is 30/64ths of an
inch. Staining is a problem this season
due to unseasonable humidity and
spotty rains on August 26th and 30th.
The moisture wet the outer hull, and the
hull then stained the pistachio shell.
Dark stains are an external defect, which
affects overall pistachio quality.
Thus, the committee recommended
suspending the minimum quality
requirements, which include maximum
defects and minimum sizes, under the
order. This will reduce handler costs
and provide handlers more flexibility in
meeting customer needs. Suspending
these requirements also necessitates
modifications to other sections of the
order and regulations that reference
minimum quality and size
requirements. Accordingly, this rule
partially suspends or amends language
in §§ 983.6, 983.7, 983.31, 983.38,
983.40, 983.41, 983.42, 983.45, 983.138,
983.143, and 983.147 of the order; and
suspends §§ 983.19, 983.20, 983.39, and
983.141 in their entirety.
Additionally, the third sentence in
§ 983.11(b), and all of § 983.71 are
removed because the committee’s State
counterpart, the California Pistachio
Commission, has been terminated and
there is currently no relationship
between the two organizations.
Initial Regulatory Flexibility Analysis
Pursuant to requirements set forth in
the Regulatory Flexibility Act (RFA),
Agricultural Marketing Service (AMS)
has considered the economic impact of
this action on small entities.
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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 would 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.
There are approximately 740
producers in the production area, and
50 handlers of California pistachios
subject to regulation. The Small
Business Administration (SBA) (13 CFR
121.201) defines small agricultural
producers as those having annual
receipts less than $750,000, and defines
small agricultural service firms those
whose annual receipts are less than
$6,500,000. Of the 740 producers,
approximately 722 have annual receipts
of less than $750,000. Forty-two of the
50 handlers subject to regulation have
annual pistachio receipts of less than
$6,500,000. Thus, the majority of
producers and handlers of California
pistachios may be classified as small
entities.
This rule changes the handling
requirements authorized under the
order. This rule suspends the minimum
quality requirements, including
maximum defects and minimum sizes,
for California pistachios. Authority for
this action is provided in § 983.46.
Regarding the impact on affected
entities, suspending the minimum
quality requirements will decrease
handler inspection costs. The committee
currently estimates that the direct costs
to obtain inspection average
approximately $50.00 per lot. The
average lot is approximately 44,000
pounds. With over 100,000,000 pounds
shipped domestically, the direct costs
for inspection for approximately 2,300
lots could total $115,000 for the
industry. The direct costs do not
include handler staff time in preparing
samples, and handler storage and
recordkeeping costs associated with
inspected pistachios.
The committee considered
alternatives to suspending the minimum
quality requirements. Some producers
were concerned that this could give
handlers too much latitude in their
operations. Other producers commented
that handlers’ customers would likely
dictate product quality and prevent
shipment of substandard pistachios into
the market. Ultimately, the majority of
committee members supported the
changes.
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Federal Register / Vol. 72, No. 235 / Friday, December 7, 2007 / Rules and Regulations
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), the form ACP–5, ‘‘Minimal
Testing’’ being suspended by this rule
was previously approved by the Office
of Management and Budget and
assigned OMB No. 0581–0215,
Pistachios Grown in California, for 1
burden hour. 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.
Further, the committee meetings
where this action was discussed were
widely publicized throughout the
pistachio industry and all interested
persons were encouraged to attend the
meetings and participate in the
committee’s deliberations. Like all
committee meetings, these were public
meetings, and entities of all sizes were
encouraged to express their views on
these issues. Finally, interested persons
are invited to submit comments on this
interim final rule, including 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/
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.
This rule invites comments on
changes to the handling requirements
currently prescribed under the order.
Any comments received will be
considered prior to finalization of this
rule.
The order provisions suspended by
this action no longer tend to effectuate
the declared policy of the Act.
Accordingly, after consideration of all
relevant material presented, including
the committee’s recommendation, and
other information, it is found that this
interim final rule, as hereinafter set
forth, will 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
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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) It relaxes quality
requirements currently in effect; (2)
handlers are already receiving 2007–08
crop pistachios, and this rule should
apply to as much of the 2007–08 crop
as possible; (3) handlers are aware of
these changes, which were discussed at
two public meetings; and (4) this rule
has 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 983
Pistachios, Marketing agreements and
orders, Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, 7 CFR part 983 is amended as
follows:
I
PART 983—PISTACHIOS GROWN IN
CALIFORNIA
1. The authority citation for 7 CFR
part 983 continues to read as follows:
I
Authority: 7 U.S.C. 601–674.
§ 983.40
[Amended]
9. Paragraph (a) of § 983.40 is
suspended indefinitely.
I 10. In § 983.40, paragraph (b), the
words ‘‘and/or the minimum quality’’
are suspended from the first sentence
indefinitely, the words ‘‘either’’ and ‘‘or
the minimum quality’’ are suspended
from the second sentence indefinitely,
and the words ‘‘, and the handler, under
the supervision of an inspector, shall
send the failed lot notification reports
for the lots that do not meet the
minimum quality requirements to the
committee’’ are suspended from the
third sentence indefinitely.
I 11. In § 983.40, paragraph (c), the fifth
sentence is suspended indefinitely.
I 12. Paragraph (e) of § 983.40 is
suspended indefinitely.
I
§ 983.41
[Amended]
13. Paragraph (b) of § 983.41 is
suspended indefinitely.
I
§ 983.42
[Amended]
14. In § 983.42, the words ‘‘and
minimum quality certificate’’ are
suspended indefinitely.
I
§ 983.45
§§ 983.19, 983.20, 983.39, 983.141
[Amended]
69141
[Amended]
2. In part 983, §§ 983.19, 983.20,
983.39, and 983.141 are suspended
indefinitely.
15. In § 983.45, the words ‘‘and
minimum quality requirements,’’ the
first ‘‘§ ,’’ and ‘‘and 983.39’’ are
suspended indefinitely.
§ 983.6
§ 983.71
I
I
[Amended]
[Removed]
16. Section 983.71 is removed.
17. Section 983.138 is revised to read
as follows:
I 3. In § 983.6, the words ‘‘free of
internal defects as defined in
§ 983.39(b)(4) and (5)’’ are suspended
indefinitely.
I
§ 983.7
Prior to testing, a sample shall be
drawn from each lot to be used to test
pistachios for aflatoxin. The lot sample
shall be of sufficient weight to comply
with Tables 1 and 2 of § 983.38.
[Amended]
I 4. In § 983.7, the words ‘‘and
minimum quality’’ are suspended
indefinitely.
§ 983.11
I
§ 983.138
[Amended]
§ 983.143
5. In § 983.11, paragraph (b), the third
sentence is removed.
I
§ 983.31
[Amended]
[Amended]
7. In § 983.38, paragraph (d)(1), the
words ‘‘and divided between those
pistachios for aflatoxin testing and those
for minimum quality testing’’ are
suspended indefinitely.
I
8. In § 983.38, paragraph (d)(4), the
word ‘‘, grade’’ is suspended from the
penultimate sentence indefinitely.
I
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[Amended]
18. Section 983.143 is amended by
revising paragraph (b) to read as follows:
I
§ 983.143
6. In § 983.31, the words ‘‘and/or
minimum quality’’ are suspended
indefinitely.
I
§ 983.38
Samples for testing.
Reinspection.
(a) * * *
(b) Each handler who handles
pistachios shall cause any lot or portion
of a lot initially certified for aflatoxin,
and subsequently materially changed, to
be reinspected for aflatoxin and certified
as a new lot or new lots: Provided, That,
handlers exempted from order
requirements under § 983.170 are
exempt from all reinspection
requirements.
I 19. In § 983.147, paragraph (a) is
revised to read as follows:
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Federal Register / Vol. 72, No. 235 / Friday, December 7, 2007 / Rules and Regulations
§ 983.147
Reports.
(a) ACP–2, Failed Lot Notification.
Each handler shall notify the
Administrative Committee for
Pistachios (committee) of all lots that
fail to meet the order’s maximum
aflatoxin requirements by completing
section A of this form. Handlers shall
furnish this report to the committee no
later than 10 days after completion of
the aflatoxin test. Each USDA-approved
aflatoxin testing laboratory shall
complete section C of this report, and
forward this report and the failing
aflatoxin test results to the committee
and to the handler within 10 days of the
test failure.
*
*
*
*
*
§ 983.147
[Amended]
20. Paragraph (d) of § 983.147 is
suspended indefinitely.
I
Dated: December 4, 2007.
Lloyd C. Day,
Administrator, Agricultural Marketing
Service.
[FR Doc. 07–5989 Filed 12–5–07; 10:02 am]
BILLING CODE 3410–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Erythromycin
AGENCY:
Food and Drug Administration,
HHS.
rfrederick on PROD1PC67 with RULES
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by Cross
Vetpharm Group Ltd. The supplemental
NADA provides for use of a 100
milligram per milliliter (mg/mL)
strength erythromycin injectable
solution in cattle for the treatment of
bovine respiratory disease.
DATES: This rule is effective December 7,
2007.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed a
supplement to NADA 12–123 for
GALLIMYCIN–100 (erythromycin)
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14:57 Dec 06, 2007
Jkt 214001
Injection. The supplemental NADA
provides for use of a 100 mg/mL
strength erythromycin injectable
solution in cattle for the treatment of
bovine respiratory disease. The
supplemental NADA is approved as of
November 15, 2007, and the regulations
in 21 CFR 522.820 are amended to
reflect the approval and a current
format.
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.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33(a)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subject in 21 CFR Part 522
Animal drugs.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 522 is amended as follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
I
2. Revise § 522.820 to read as follows:
§ 522.820
Erythromycin.
(a) Sponsor. See No. 061623 in
§ 510.600(c) of this chapter.
(b) Specifications—(1) Each milliliter
(mL) of solution contains 100
milligrams (mg) erythromycin base.
(2) Each mL of solution contains 200
mg erythromycin base.
(c) Related tolerances. See § 556.230
of this chapter.
(d) Conditions of use—(1) Dog.
Administer product described in
paragraph (b)(1) of this section as
follows:
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(i) Amount. 3 to 5 mg per pound (/lb)
body weight, intramuscularly, two to
three times daily, for up to 5 days.
(ii) Indications for use. For the
treatment of bacterial pneumonia, upper
respiratory infections (tonsillitis,
bronchitis, tracheitis, pharyngitis,
pleurisy), endometritis and metritis, and
bacterial wound infections caused by
Staphylococcus spp., Streptococcus
spp., and Corynebacterium spp.,
sensitive to erythromycin.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cats. Administer product
described in paragraph (b)(1) of this
section as follows:
(i) Amount. 3 to 5 mg/lb body weight,
intramuscularly, two to three times
daily, for up to 5 days.
(ii) Indications for use. For the
treatment of bacterial pneumonia, upper
respiratory infections (rhinitis,
bronchitis), secondary infections
associated with panleukopenia, and
bacterial wound infections caused by
Staphylococcus spp. and Streptococcus
spp., susceptible to erythromycin.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(3) Cattle. Administer products
described in paragraph (b) of this
section as follows:
(i) Amount. 4 mg/lb body weight by
deep intramuscular injection once daily
for up to 5 days.
(ii) Indications for use. For the
treatment of bovine respiratory disease
(shipping fever complex and bacterial
pneumonia) associated with Pasteurella
multocida susceptible to erythromycin.
(iii) Limitations. Do not use in female
dairy cattle over 20 months of age. Do
not slaughter treated animals within 6
days of last treatment. A withdrawal
period has not been established for this
product in pre-ruminating calves. Do
not use in calves to be processed for
veal. To avoid excess trim, do not
slaughter within 21 days of last
injection.
Dated: November 30, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–23763 Filed 12–6–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\07DER1.SGM
07DER1
Agencies
[Federal Register Volume 72, Number 235 (Friday, December 7, 2007)]
[Rules and Regulations]
[Pages 69139-69142]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5989]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 983
[Docket No. AMS-FV-07-0082; FV07-983-1 IFR]
Pistachios Grown in California; Changes in Handling Requirements
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Interim final rule with request for comments.
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SUMMARY: This rule changes the handling requirements currently
authorized under the California pistachio marketing order (order). The
order regulates the handling of pistachios grown in California and is
administered locally by the Administrative Committee for Pistachios
(committee). This rule suspends the minimum quality requirements,
including maximum defects and minimum sizes, for California pistachios.
This will reduce handler costs and provide handlers more flexibility in
meeting customer needs.
DATES: Effective December 10, 2007; comments received by February 5,
2008 will be considered prior to issuance of a final rule.
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. All comments should reference the docket number
and the date and page number of this issue of the Federal Register and
will be made available for public inspection in the Office of the
Docket Clerk during regular business hours, or can be viewed at: http:/
/www.regulations.gov.
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 Email: Terry.Vawter@usda.gov or Kurt.Kimmel@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@usda.gov.
SUPPLEMENTARY INFORMATION: This rule is issued under Marketing Order
No. 983 (7 CFR part 983), regulating the handling of pistachios 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. A
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
[[Page 69140]]
the petition, provided an action is filed not later than 20 days after
the date of the entry of the ruling.
This rule changes the handling requirements for pistachios
currently authorized under the order. This rule suspends the minimum
quality requirements, including maximum defects and minimum sizes, for
California pistachios. This will reduce handler costs and provide
handlers more flexibility in meeting customer needs. This action was
recommended by the committee.
Section 983.39 establishes minimum quality levels for pistachios,
including maximum defects and minimum sizes permitted under the order.
Under Sec. 983.46, the Secretary may modify, suspend, or make rules
and regulations to implement Sec. Sec. 983.38 through 983.45 based
upon a recommendation by seven concurring committee members or other
available information.
The quality and size requirements have been in effect for
California pistachios since the order's inception in 2004. Evidence
provided at the promulgation hearing suggested that there was a direct
link between lower-quality pistachios and the incidence of aflatoxin
contamination (see 68 FR 45990). Aflatoxin is one of a group of
mycotoxins produced by the molds Aspergillus flavus and Aspergillus
parasiticus. Aflatoxins are naturally-occurring in the field and can be
further spread in improperly processed and stored nuts, dried fruits,
and grains. The data presented at the hearing was based on aflatoxin
analyses of pistachios with different defects. Although the data also
indicated that the levels of aflatoxin associated with each defect
varied widely, researchers attributed this to variability among the
samples.
As further data was collected in 2005 and 2006, University of
California researchers concluded that variability in aflatoxin levels
seen in previous studies may have been due to geographic variability
1 2. Aflatoxin contamination is more prevalent in pistachios
produced in the northern San Joaquin Valley, while quality defects,
largely due to insect damage, are less prevalent. The opposite is true
for the southern San Joaquin Valley. It is now believed that these
differences in aflatoxin contamination between the growing areas are
due to differences in climate. The northern San Joaquin Valley has more
aflatoxin contamination because its cooler temperatures and greater
moisture are more conducive to Aspergillus and aflatoxin development,
but less conducive to insect population and damage. However, in the
southern San Joaquin Valley, there is a higher incidence of insect
damage and a much lower incidence of aflatoxin contamination because of
the drier environment and higher temperatures. Thus, recent research
suggests that aflatoxin occurrence in pistachios may be attributable to
climatic factors.
---------------------------------------------------------------------------
\1\ Doster, M.A., T.J. Michailides, L.D. Boeckler, and D.P.
Morgan, 2006. Development of expert systems and predictive models
for aflatoxin contamination in pistachios. In California Pistachio
Industry Annual Report Crop Year 2005-2006, pg. 101-102.
\2\ Doster, M.A., T.J. Michailides, L.D. Boeckler, and D.P.
Morgan, 2007. Prediction of aflatoxin contamination and a survey of
fungi producing Ochratoxin A in California pistachios. In California
Pistachio Industry Annual Report Crop Year 2006-2007, pg. 109-110.
---------------------------------------------------------------------------
Additionally, growers and handlers are reporting unexpected
problems with the size of pistachios this season, as well as with
staining of the nut shell from the hull. Pistachios are smaller than
usual, and the large crop has resulted in a large percentage of
pistachios which may not meet the requirements of the order because the
sizes are smaller than currently authorized, which is 30/64ths of an
inch. Staining is a problem this season due to unseasonable humidity
and spotty rains on August 26th and 30th. The moisture wet the outer
hull, and the hull then stained the pistachio shell. Dark stains are an
external defect, which affects overall pistachio quality.
Thus, the committee recommended suspending the minimum quality
requirements, which include maximum defects and minimum sizes, under
the order. This will reduce handler costs and provide handlers more
flexibility in meeting customer needs. Suspending these requirements
also necessitates modifications to other sections of the order and
regulations that reference minimum quality and size requirements.
Accordingly, this rule partially suspends or amends language in
Sec. Sec. 983.6, 983.7, 983.31, 983.38, 983.40, 983.41, 983.42,
983.45, 983.138, 983.143, and 983.147 of the order; and suspends
Sec. Sec. 983.19, 983.20, 983.39, and 983.141 in their entirety.
Additionally, the third sentence in Sec. 983.11(b), and all of
Sec. 983.71 are removed because the committee's State counterpart, the
California Pistachio Commission, has been terminated and there is
currently no relationship between the two organizations.
Initial Regulatory Flexibility Analysis
Pursuant to requirements set forth in the Regulatory Flexibility
Act (RFA), Agricultural Marketing Service (AMS) has considered the
economic impact of this action 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 would
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.
There are approximately 740 producers in the production area, and
50 handlers of California pistachios subject to regulation. The Small
Business Administration (SBA) (13 CFR 121.201) defines small
agricultural producers as those having annual receipts less than
$750,000, and defines small agricultural service firms those whose
annual receipts are less than $6,500,000. Of the 740 producers,
approximately 722 have annual receipts of less than $750,000. Forty-two
of the 50 handlers subject to regulation have annual pistachio receipts
of less than $6,500,000. Thus, the majority of producers and handlers
of California pistachios may be classified as small entities.
This rule changes the handling requirements authorized under the
order. This rule suspends the minimum quality requirements, including
maximum defects and minimum sizes, for California pistachios. Authority
for this action is provided in Sec. 983.46.
Regarding the impact on affected entities, suspending the minimum
quality requirements will decrease handler inspection costs. The
committee currently estimates that the direct costs to obtain
inspection average approximately $50.00 per lot. The average lot is
approximately 44,000 pounds. With over 100,000,000 pounds shipped
domestically, the direct costs for inspection for approximately 2,300
lots could total $115,000 for the industry. The direct costs do not
include handler staff time in preparing samples, and handler storage
and recordkeeping costs associated with inspected pistachios.
The committee considered alternatives to suspending the minimum
quality requirements. Some producers were concerned that this could
give handlers too much latitude in their operations. Other producers
commented that handlers' customers would likely dictate product quality
and prevent shipment of substandard pistachios into the market.
Ultimately, the majority of committee members supported the changes.
[[Page 69141]]
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
Chapter 35), the form ACP-5, ``Minimal Testing'' being suspended by
this rule was previously approved by the Office of Management and
Budget and assigned OMB No. 0581-0215, Pistachios Grown in California,
for 1 burden hour. 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.
Further, the committee meetings where this action was discussed
were widely publicized throughout the pistachio industry and all
interested persons were encouraged to attend the meetings and
participate in the committee's deliberations. Like all committee
meetings, these were public meetings, and entities of all sizes were
encouraged to express their views on these issues. Finally, interested
persons are invited to submit comments on this interim final rule,
including 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: http:/
/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.
This rule invites comments on changes to the handling requirements
currently prescribed under the order. Any comments received will be
considered prior to finalization of this rule.
The order provisions suspended by this action no longer tend to
effectuate the declared policy of the Act. Accordingly, after
consideration of all relevant material presented, including the
committee's recommendation, and other information, it is found that
this interim final rule, as hereinafter set forth, will 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) It relaxes quality requirements currently in effect; (2)
handlers are already receiving 2007-08 crop pistachios, and this rule
should apply to as much of the 2007-08 crop as possible; (3) handlers
are aware of these changes, which were discussed at two public
meetings; and (4) this rule has 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 983
Pistachios, Marketing agreements and orders, Reporting and
recordkeeping requirements.
0
For the reasons set forth in the preamble, 7 CFR part 983 is amended as
follows:
PART 983--PISTACHIOS GROWN IN CALIFORNIA
0
1. The authority citation for 7 CFR part 983 continues to read as
follows:
Authority: 7 U.S.C. 601-674.
Sec. Sec. 983.19, 983.20, 983.39, 983.141 [Amended]
0
2. In part 983, Sec. Sec. 983.19, 983.20, 983.39, and 983.141 are
suspended indefinitely.
Sec. 983.6 [Amended]
0
3. In Sec. 983.6, the words ``free of internal defects as defined in
Sec. 983.39(b)(4) and (5)'' are suspended indefinitely.
Sec. 983.7 [Amended]
0
4. In Sec. 983.7, the words ``and minimum quality'' are suspended
indefinitely.
Sec. 983.11 [Amended]
0
5. In Sec. 983.11, paragraph (b), the third sentence is removed.
Sec. 983.31 [Amended]
0
6. In Sec. 983.31, the words ``and/or minimum quality'' are suspended
indefinitely.
Sec. 983.38 [Amended]
0
7. In Sec. 983.38, paragraph (d)(1), the words ``and divided between
those pistachios for aflatoxin testing and those for minimum quality
testing'' are suspended indefinitely.
0
8. In Sec. 983.38, paragraph (d)(4), the word ``, grade'' is suspended
from the penultimate sentence indefinitely.
Sec. 983.40 [Amended]
0
9. Paragraph (a) of Sec. 983.40 is suspended indefinitely.
0
10. In Sec. 983.40, paragraph (b), the words ``and/or the minimum
quality'' are suspended from the first sentence indefinitely, the words
``either'' and ``or the minimum quality'' are suspended from the second
sentence indefinitely, and the words ``, and the handler, under the
supervision of an inspector, shall send the failed lot notification
reports for the lots that do not meet the minimum quality requirements
to the committee'' are suspended from the third sentence indefinitely.
0
11. In Sec. 983.40, paragraph (c), the fifth sentence is suspended
indefinitely.
0
12. Paragraph (e) of Sec. 983.40 is suspended indefinitely.
Sec. 983.41 [Amended]
0
13. Paragraph (b) of Sec. 983.41 is suspended indefinitely.
Sec. 983.42 [Amended]
0
14. In Sec. 983.42, the words ``and minimum quality certificate'' are
suspended indefinitely.
Sec. 983.45 [Amended]
0
15. In Sec. 983.45, the words ``and minimum quality requirements,''
the first ``Sec. ,'' and ``and 983.39'' are suspended indefinitely.
Sec. 983.71 [Removed]
0
16. Section 983.71 is removed.
0
17. Section 983.138 is revised to read as follows:
Sec. 983.138 Samples for testing.
Prior to testing, a sample shall be drawn from each lot to be used
to test pistachios for aflatoxin. The lot sample shall be of sufficient
weight to comply with Tables 1 and 2 of Sec. 983.38.
Sec. 983.143 [Amended]
0
18. Section 983.143 is amended by revising paragraph (b) to read as
follows:
Sec. 983.143 Reinspection.
(a) * * *
(b) Each handler who handles pistachios shall cause any lot or
portion of a lot initially certified for aflatoxin, and subsequently
materially changed, to be reinspected for aflatoxin and certified as a
new lot or new lots: Provided, That, handlers exempted from order
requirements under Sec. 983.170 are exempt from all reinspection
requirements.
0
19. In Sec. 983.147, paragraph (a) is revised to read as follows:
[[Page 69142]]
Sec. 983.147 Reports.
(a) ACP-2, Failed Lot Notification. Each handler shall notify the
Administrative Committee for Pistachios (committee) of all lots that
fail to meet the order's maximum aflatoxin requirements by completing
section A of this form. Handlers shall furnish this report to the
committee no later than 10 days after completion of the aflatoxin test.
Each USDA-approved aflatoxin testing laboratory shall complete section
C of this report, and forward this report and the failing aflatoxin
test results to the committee and to the handler within 10 days of the
test failure.
* * * * *
Sec. 983.147 [Amended]
0
20. Paragraph (d) of Sec. 983.147 is suspended indefinitely.
Dated: December 4, 2007.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. 07-5989 Filed 12-5-07; 10:02 am]
BILLING CODE 3410-02-P