Specialty Crops; Import Regulations; Proposed Pistachio Import Requirements, 65411-65419 [2011-27285]
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65411
Proposed Rules
Federal Register
Vol. 76, No. 204
Friday, October 21, 2011
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 999
[Doc. No. AMS–FV–09–0064; FV09–999–1
PR]
Specialty Crops; Import Regulations;
Proposed Pistachio Import
Requirements
Agricultural Marketing Service,
USDA.
ACTION: Proposed rule.
AGENCY:
This proposed rule invites
comments on the establishment of a
minimum quality regulation for lots of
pistachios imported into the United
States. The regulation would specify
maximum aflatoxin tolerance levels as
well as mandatory aflatoxin testing and
certification requirements. The
proposed import quality requirements
would be the same as or comparable to
those in effect for the domestically
produced commodity. Under this
proposal, aflatoxin levels in imported
pistachios could not exceed 15 parts per
billion (ppb), as certified by aflatoxin
inspection certificates issued by an
accredited laboratory. This action is
intended to assure consumers that all
pistachios offered for sale in the United
States meet the same aflatoxin
standards, thus promoting high quality
product in the market place and
fostering consumer satisfaction. This
rule also announces the Agricultural
Marketing Service’s (AMS) intention to
request approval by the Office of
Management and Budget (OMB) of a
new information collection requirement,
including two new forms that would be
completed by either laboratories or
pistachio importers.
DATES: Comments must be received by
December 20, 2011. Pursuant to the
Paperwork Reduction Act, comments on
the forms and information collection
burden must be received by December
20, 2011.
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SUMMARY:
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Interested persons are
invited to submit written comments
concerning this proposal. Comments
should be sent to the Docket Clerk,
Marketing Order and Agreement
Division, 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
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Laurel May or Kathleen Finn, Marketing
Order and Agreement Division, 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:
Laurel.May@ams.usda.gov or
Kathy.Finn@ams.usda.gov.
Small businesses may request
information on complying with this
regulation by contacting Laurel May at
the above mentioned address.
This
proposed rule is issued under section 8e
of the Agricultural Marketing
Agreement Act of 1937, as amended (7
U.S.C. 601–674), hereinafter referred to
as the ‘‘Act,’’ which provides that
whenever the grade, size, quality, or
maturity of certain specified
commodities, including pistachios, are
regulated under a Federal marketing
order, imports of these commodities
into the United States are prohibited
unless they meet the same or
comparable grade, size, quality, and
maturity requirements as those in effect
for the domestically produced
commodities. To ensure that these
requirements are met, the Act also
authorizes the Department of
Agriculture (USDA) to perform
inspections and related functions such
as commodity sampling, and to issue
SUPPLEMENTARY INFORMATION:
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inspection certificates for such imported
commodities.
USDA is issuing this rule in
conformance with Executive Order
12866.
There are no administrative
procedures that must be exhausted prior
to any judicial challenge to the
provisions of import regulations issued
under section 8e of the Act.
This proposed rule would add a new
§ 999.600 under 7 CFR part 999—
Specialty Crops; Import Regulations,
and would establish quality
requirements for maximum aflatoxin
tolerance levels and mandatory testing
and certification requirements for
pistachios offered for importation into
the United States. The proposed quality
requirements for imported pistachios
are the same as or comparable to those
established for pistachios grown in
California, Arizona, and New Mexico
under Marketing Agreement and Order
No. 983 (7 CFR part 983) (order), both
as amended.
This proposed rule would also revise
§ 999.500, which currently specifies
safeguard procedures for the
importation of walnuts and dates that
are exempt from § 8e regulations. This
section would be revised to include
safeguard procedures for the
importation of pistachios intended for
exempted purposes.
The order prohibits the shipping of
pistachios for domestic human
consumption that do not meet the
quality requirements for aflatoxin levels
in the nuts. Such quality requirements
specify that aflatoxin levels may not
exceed the maximum tolerance of 15
ppb. Pistachios that fail to meet these
requirements must be reworked and
retested, or disposed of as specified in
the order. These regulations were
designed to ensure that only high
quality pistachios containing low levels
of aflatoxin are shipped, thus promoting
high quality product in the market place
and fostering consumer satisfaction.
The order, which was established for
California pistachios in 2004, was
recently amended to include the states
of Arizona and New Mexico. Pistachios
grown in California, Arizona, and New
Mexico represent over 99 percent of the
U.S. domestic production, and 98
percent of the domestic consumption.
Thus, almost all domestically produced
pistachios are regulated under
Marketing Order No. 983. There is no
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Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules
other Federal marketing order in effect
for pistachios produced in the United
States.
According to USDA’s Foreign
Agricultural Service (FAS), Iran is
typically the world’s largest pistachio
producer, followed by the U.S. and
Turkey, although Syria’s production has
increased in recent years. During the
three most recent crop years (September
through August) for which complete
data is available, 2007–08 through
2009–10, the production averages in
millions of pounds (inshell basis) for
Iran, the U.S., Turkey, and Syria were
approximately 386, 350, 120, and 141,
respectively.
Historically, the bulk of U.S. pistachio
imports have come from Turkey and
Iran, although Iranian imports have
been prohibited since July 2010. The
remainder comes from other countries,
including Italy, China, Switzerland,
France, Australia, Hong Kong, and
Israel. Imported pistachios may be
inshell or shelled. According to FAS,
the U.S. imported an average of
approximately 1.7 million pounds of
pistachios (inshell basis) annually
during the three crop years from 2007–
08 through 2009–10. Average U.S.
consumption of pistachios during that
same period was approximately 100
million pounds (inshell basis) annually.
Imports, therefore, represent
approximately two percent of U.S.
pistachio consumption.
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Proposed Requirements
Definitions
The proposed regulations would
include definitions of terms used in the
import regulation. Such terms are the
same as or comparable to those defined
in the marketing order for domestic
pistachios as established at 69 FR 17844
(April 5, 2004) and amended at 74 FR
56532 (November 2, 2009).
Under the proposed regulations,
‘‘pistachio’’ would mean the nut of the
pistachio tree, Pistachia vera, whether
inshell or shelled. ‘‘Importer’’ would be
defined as a person who imports
pistachios into the United States.
‘‘Aflatoxin’’ would be defined as a
mycotoxin that can be found in nuts,
dried fruits, and grains. ‘‘Aflatoxin
inspection certificate’’ would mean a
certificate issued by a USDA or USDAaccredited laboratory. ‘‘USDA
laboratory’’ and ‘‘USDA-accredited
laboratory’’ would be defined as
laboratories authorized to test imported
pistachios for aflatoxin content.
‘‘Inspector’’ would mean any inspector
authorized by USDA to draw and
prepare pistachio samples for testing.
‘‘Lot’’ would mean any quantity of
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pistachios submitted for testing. Other
terms useful in the administration of the
import regulation would also be
defined.
Maximum Aflatoxin Tolerance
The presence or absence of aflatoxin
is considered a quality characteristic in
pistachios 1 because concerns about
aflatoxin contamination can impact
consumers’ perception of the quality of
pistachios, and therefore negatively
impact demand. According to research
provided by the industry, poor quality
pistachios impact demand and the
potential growth of demand for
pistachios.2 Moreover, any market
disturbances related to aflatoxin in
pistachios, regardless of the origin of
those pistachios, could have a
detrimental effect on the pistachio
industry.3
The proposed regulations would
establish a maximum aflatoxin tolerance
level of 15 ppb for lots of pistachios
imported into the U.S. for human
consumption. As required under section
8e of the Act, this is the same level
currently prescribed for domestic
pistachios regulated under the order.
Establishing a 15 ppb limit for aflatoxin
in all pistachios marketed for human
consumption in the United States is
expected to bolster overall consumer
confidence in pistachio quality and
strengthen the demand for pistachios.
Comparatively, the international Codex
Alimentarius Commission’s (Codex)
maximum aflatoxin tolerance for
pistachios is 10 ppb. The domestic
pistachio industry believes that 15 ppb
is appropriate to ensure the quality of
pistachios sold in U.S. markets,4
Research also supports the 15 ppb
tolerance.5 Additionally, a 15 ppb
tolerance for aflatoxin in domestic and
imported pistachios is consistent with
existing regulations for all domestic and
imported peanuts marketed in the
United States, for which USDA has
1 Gibbons, Jeff; 2002. Testimony in Pistachios
Grown in California; Hearing on Proposed
Marketing Agreement and Order No. 983. Pages
326–359.
2 Sumner, Daniel A; 2002. Testimony in
Pistachios Grown in California; Hearing on
Proposed Marketing Agreement and Order No. 983.
2002. Pages 698–735 and 747–820.
3 Reinecke, Karen; 2002. Testimony in Pistachios
Grown in California; Hearing on Proposed
Marketing Agreement and Order No. 983. Pages
152–183.
4 Gibbons, Jeff; 2002. Testimony in Pistachios
Grown in California; Hearing on Proposed
Marketing Agreement and Order No. 983. 2002.
Pages 326–359.
5 Eaton, David L.; Jennifer E. Hobden; and Bruce
J. Kelman. 2002. Aflatoxin in Pistachios:
Establishing a Regulatory Action Level in Support
of a Proposed Federal Marketing Order. 11 pages.
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established a 15 ppb aflatoxin
tolerance.6
Aflatoxin Sampling and Testing
Procedures
The proposed regulations provide for
aflatoxin sampling procedures based on
lot size. Such sampling procedures are
the same as or comparable to those
established for domestic shipments, and
mirror the sampling procedures
prescribed for pistachio shipments to
the European Union. At the discretion
of the importer, pistachio lots arriving at
a U.S. port of entry would be
warehoused near the port or shipped
inland to a pistachio handling facility to
await aflatoxin sampling and testing.
Importers would be responsible for any
transportation or storage fees incurred.
Depending on the size of the lot, a
specified number of incremental
samples would be pulled and combined
to form a lot sample. The lot sample
would then be divided into smaller test
samples, depending upon the size of the
lot to be tested. The required weight of
lot samples and test samples differs
between inshell pistachios and shelled
kernels because of the additional weight
of the shells for inshell pistachios. The
drawing and dividing of all samples
must be conducted by or under the
supervision of a Federal or Federal-State
inspector.
Following the drawing and dividing
of samples, each sample would be
properly identified and submitted to a
USDA or USDA-accredited laboratory
for analysis. Test samples would be
prepared and analyzed using High
Pressure Liquid Chromatography
(HPLC) or the Vicam Method (Aflatest).
The aflatoxin level would be calculated
on a kernel weight basis.
For lots of up to 4,400 lbs, one test
sample would be analyzed. If the
sample has an aflatoxin level at or
below 15 ppb, the lot could be certified
as negative for aflatoxin on the aflatoxin
inspection certificate, which would be
completed by the laboratory. If the
aflatoxin level is greater than 15 ppb,
the lot fails, and the laboratory would
fill out a failed lot notification report for
submission to the importer, the U.S.
Customs and Border Protection
(Customs), and USDA.
For lots of more than 4,400 lbs, two
test samples would be prepared. If the
first sample has an aflatoxin level at or
below 10 ppb, the lot could be certified
as negative for aflatoxin on the aflatoxin
inspection certificate. Analysis of the
other test sample would be unnecessary.
6 7 CFR part 996—Minimum Quality and
Handling Standards for Domestic and Imported
Peanuts Marketed in the United States.
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If the aflatoxin level of the first test
sample is above 20 ppb, the lot fails,
and the laboratory would fill out a failed
lot notification report for submission to
the importer, Customs, and USDA. If the
aflatoxin level of the first test sample is
higher than 10 ppb and at or below 20
ppb, the importer could elect to test the
second sample or rework the lot and
resubmit it for testing. If the importer
chooses to proceed with testing the
second sample, the results from testing
both samples would be averaged. If the
average results are at or below 15 ppb,
the lot may be certified negative for
aflatoxin. If the average results are
higher than 15 ppb, the lot fails and the
accredited lab would submit a failed lot
notification report to the importer,
Customs, and USDA. If the importer
chooses to rework the lot after the first
sample is analyzed, the lot would again
be subject to sampling and testing as if
it were a new lot.
If an aflatoxin inspection certificate is
issued certifying that a lot is negative for
aflatoxin at any stage of the sequential
testing (meaning that the lot’s aflatoxin
content is below the maximum
threshold), the certification would state
that the lot meets the § 8e import
aflatoxin requirements. The certification
would expire after 12 months.
Upon notification of any failed lot, the
importer would work with Customs to
determine the appropriate disposition of
the pistachios. Pistachios that fail to
meet the aflatoxin requirements would
be required to be sold for non-human
consumption, exported to another
destination with a higher aflatoxin
tolerance, or disposed of under the
supervision of Customs, and the Federal
or Federal-State Inspection Programs
could be called upon to verify disposals.
Any costs associated with certifying a
disposal would be paid by the importer.
Rework Procedures
Although reworking and retesting of a
failed lot would not be required,
importers could opt to take those steps,
which would provide them with an
opportunity to secure a return for their
imported product while maintaining the
integrity of the aflatoxin requirements.
The alternative would be to dispose of
the lot through proper channels as
described above. The rework procedures
described below are the same as or
comparable to those required for
domestic pistachios under the order.
Inshell pistachios. Rework procedures
for inshell pistachios failing to meet
aflatoxin requirements would require
importers to remove 100 percent of the
failing lot from its bulk or retail
packaging. These pistachios would be
required to pass through the sorting
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stages of the handling process in order
to remove those nuts having the
characteristics most susceptible to
harboring aflatoxin. After reworking the
lot, the importer would report the
weight of the total accepted and rejected
product to Customs and USDA on a
rework and failed lot disposition report,
and the acceptable portion of the
reworked lot would be resampled and
tested for aflatoxin. In the case of a
reworked lot, the lot sample size and the
test sample size would be doubled from
that specified in the initial testing. If,
after having been reworked, the lot fails
aflatoxin testing for a second time, the
lot could be shelled and the kernels
reworked, sampled, and tested in the
manner required for an original lot of
pistachio kernels. If the importer
decides not to pursue further reworking
of the failed lot, those pistachios would
be prohibited from entering the stream
of commerce for domestic human
consumption. The lot must be exported,
sold for domestic non-human
consumption purposes, or disposed of
as described above. The importer would
report the lot’s final disposition to
Customs and USDA on a rework and
failed lot disposition report.
Shelled pistachios. Rework
procedures proposed for pistachio
kernels failing to test negative for
aflatoxin would also require a
reprocessing of 100 percent of the
volume of the failing lot. As with inshell
pistachios, after reworking, the total
weight of the accepted product and the
total weight of the rejected product
would be reported by the importer to
Customs and USDA on the rework and
failed lot disposition report. The
reworked lot of kernels would be
resampled and retested for aflatoxin
content as previously described.
Comingling
Importers could comingle certified
lots with other certified lots of
pistachios. However, to maintain the
integrity of certified lots, the comingling
of certified and uncertified lots of
pistachios would cause the loss of
certification for the comingled lots.
Exemptions
Section 983.70 of the marketing order
provides that domestic handlers may
handle pistachios free of the regulatory
and assessment provisions of the order
if such pistachios are handled in
quantities not exceeding 5,000 dried
pounds during any production year. The
purpose of this provision is to provide
an exemption from the requirements of
the order for small quantities of
pistachios such as those that are grown
for home or personal use. Further, this
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exemption is applied on a production
year basis. Accordingly, under the
proposed import regulation, a
comparable 5,000-pound exemption
would apply to all shipments of
pistachios imported for human
consumption. Also, substandard
pistachios imported for use in nonhuman consumption outlets would not
be subject to the proposed aflatoxin
regulations.
Compliance
Any importer who violates any
provision of the proposed import
regulations would be subject to a
forfeiture in the amount prescribed in
section 608a(5) of the Act (7 U.S.C. 601–
674), or, upon conviction, penalties in
the amounts prescribed in section
608c(14) of the Act, or to both forfeiture
and penalty. False representation to any
agency of the United States on any
matter within its jurisdiction, knowing
it to be false, is a violation of 18 U.S.C.
1001, which provides for a fine or
imprisonment or both.
Safeguards
Safeguard procedures in the form of
importer and receiver reporting
requirements would be used to ensure
that substandard pistachios imported for
purposes other than human
consumption would be used only in
authorized outlets exempt from the
proposed aflatoxin regulations. The
safeguard procedures would be
comparable to those currently specified
for the importation of other exempted
commodities. Under the proposed
regulations, importers and receivers of
pistachios for other than human
consumption purposes would be
required to complete and submit to
USDA an Importer’s Exempt
Commodity Form (Form FV–6), the
generic form used by importers and
receivers of other exempted
commodities. The information provided
on Form FV–6 would be used by USDA
to track pistachios marketed for
exempted uses.
The provisions of this proposed rule
would establish maximum aflatoxin
tolerance levels and mandatory testing
and certification requirements for lots of
pistachios offered for importation into
the United States. The proposed import
quality requirements would be
implemented in accordance with
section 8e of the Act. These provisions
are intended to ensure that pistachios
imported into the United States for the
purposes of domestic human
consumption are of a quality
comparable to those pistachios
regulated under Marketing Order No.
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983 and contain no more than 15 ppb
of aflatoxin.
Initial Regulatory Flexibility Analysis
Pursuant to the requirements set forth
in the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601–612), the Agricultural
Marketing Service (AMS) has
considered the economic impact of this
proposed 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 rules issued thereunder, are
unique in that they are brought about
through group action of essentially
small entities acting on their own
behalf. Import regulations issued under
the Act are based on those established
under Federal marketing orders.
Small agricultural service firms,
which include importers and receivers,
have been defined by the Small
Business Administration (SBA) (13 CFR
121.201) as those having annual receipts
of less than $7,000,000.
AMS estimates that the there are
approximately 50 importers and
receivers who handled shipments of
pistachios into the United States
between 2007 and 2009. About 10 of the
50 firms are also substantially engaged
in the marketing of U.S. grown
pistachios, and are large firms according
to the SBA definition. Most of the
remaining 40 firms import a number of
different food products, and most are
also likely to be large firms under the
SBA definition, even though they
generally import only small quantities
of pistachios. There are also nine USDAaccredited laboratories in California that
perform aflatoxin testing for pistachios.
AMS estimates that four of the nine
laboratories would be considered small
firms according to the SBA definition.
Turkey and Iran have historically
been the source of most pistachios
imported into the U.S. Turkish
pistachios are imported predominantly
in the shell, while Iranian pistachios are
typically imported shelled. Imported
pistachios also come from Italy, China,
Switzerland, France, Australia, Hong
Kong, and Italy. Most pistachios
imported from other nations are also
shelled. The proposed import
regulations would establish protocols
for aflatoxin analysis for both inshell
and shelled pistachios.
Section 8e of the Act provides that
when certain domestically produced
commodities, including pistachios, are
regulated under a Federal marketing
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order, imports of that commodity must
meet the same or comparable grade,
quality, size, and maturity requirements.
This rule would establish a minimum
quality requirement for lots of imported
pistachios by specifying a maximum
aflatoxin tolerance level as well as
aflatoxin testing and certification
requirements. Importers would be
responsible for arranging for the
required transportation, storage,
sampling, testing, and certification of
such pistachios prior to importation.
Sampling would be conducted by the
Federal or Federal-State inspection
services, and aflatoxin testing and
certification would be performed by
USDA or USDA-accredited laboratories.
The proposed import aflatoxin testing
and certification requirements are the
same as or comparable to those
implemented under the order regulating
the handling of pistachios grown in
California, Arizona, and New Mexico.
Pistachios failing to meet the aflatoxin
requirements on initial analysis could
be reworked and retested, exported to
another destination with a higher
aflatoxin tolerance, or disposed of in
authorized outlets under the
supervision of Customs, with assistance
from the inspection service if necessary,
to verify proper disposal of substandard
nuts. Procedures for these activities also
are proposed. Lots of imported
pistachios that fail aflatoxin testing
could be diverted to certain non-human
consumption outlets and would be
subject to the safeguard provisions of
§ 999.500. Some reporting and
recordkeeping requirements also are
proposed in the pistachio import
regulation. These requirements also are
the same as or comparable to those
implemented under the order.
The cost of testing pistachios for
aflatoxin would vary, depending on
such factors as the location of the port
of entry and the size of the lot to be
tested. For purposes of estimating an
average per-pound testing expense for
imported pistachios, this analysis
assumes an average lot equal to one
container load weighing 16,000 pounds
of inshell pistachios arriving at the Port
of San Francisco and being tested for
aflatoxin by an accredited laboratory in
Fresno, California.
In the following example computation
of testing costs, there are four elements:
(1) A fee (at an hourly rate) charged by
the inspection fee to draw the sample,
(2) overnight shipping, (3) a fee charged
by the laboratory to determine the level
of aflatoxin, and (4) the ‘‘unit value’’ of
the quantity of pistachios drawn for the
sample. The unit value used in this
example computation is the average for
the last 3 complete marketing years for
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which import data are available, 2007/
08–2009/10. The unit value for the 3year period ($1.68 per pound) is
computed by dividing the average 3year import value ($2,900,000) by the
average import quantity (1,725,000
pounds). Data are from FAS.
The inspection service fee of $74 per
hour is multiplied by the estimated time
of 2 hours to draw a sample, for a cost
of $148. The overnight shipping cost
and laboratory fee are estimated at $200
and $100, respectively.
The next step in the example
computation is value of pistachios
drawn for the sample. Under the new
proposed section 996.600, in section (d)
Sampling, the weight of a lot sample is
16 kilograms (equivalent to 35.3
pounds) for a lot weighing between
11,001 and 22,000 pounds. Multiplying
35.3 pounds times the unit value of
imported pistachios ($1.68) yields a
value of the tested sample of
approximately $59. Assuming that
aflatoxin certification of the 16,000pound lot requires the testing of only
one sample, the sum of the four cost
elements would be $507, or
approximately 3.2 cents per pound
(approximately two percent of the unit
value of imported pistachios).
It is likely that a pistachio lot arriving
at the Port of San Francisco would be
transported to an inland handling
facility to await sampling and testing
and would incur no additional storage
costs. However, if the lot is stored at a
Customs warehouse near the port,
storage fees ranging between $100 and
$500 per day could be incurred while
the samples are analyzed. Analysis and
certification is estimated to require
between two to five days. Assuming a
three day turnaround for a lot incurring
$200 per day storage fees,
approximately $600, or 3.75 cents per
pound of pistachios could be added to
the testing expense described above.
Regarding the impact of this proposed
rule on affected entities, this proposal
would establish an import regulation for
pistachios as provided in section 8e of
the Act. The proposed import regulation
would require importers to arrange for
the testing and certification of all
imports of pistachios for human
consumption prior to importation.
There would be some increased costs to
importers associated with the testing
and certification of imported product.
However, it is expected that consumer
satisfaction, and therefore demand,
would be increased by regulating
imports and domestic product
uniformly. The additional costs are
expected to be offset by the benefits of
supplying the U.S. marketplace with
only high quality pistachios. As
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mentioned above, the proposed import
regulations are the same as or
comparable to those established for U.S.
domestic pistachio shipments. The
domestic industry recently adopted
aflatoxin sampling and testing
procedures that align with the Codex
Alimentarius Commission’s (Codex)
sampling plan (75 FR 43045; July 23,
2010). The Codex sampling plan is used
by the European Commission as its
regulation for the importation of tree
nuts into the European Union. Thus, the
proposed import regulations are
comparable to those widely recognized
by international pistachio markets.
Industry information suggests that
when aflatoxin levels in imported lots of
pistachios exceed the FDA maximum
tolerance of 20 ppb, the levels are
generally significantly higher than 20
ppb. Very few lots test between 15 ppb
and 20 ppb. It is anticipated that most
imported lots will test below the
proposed 15 ppb tolerance. Thus,
establishing a maximum aflatoxin
tolerance of 15 ppb for imported
pistachios is not expected to have a
significant impact on trade.
The alternative to this action is to
continue to allow pistachios to be
imported without having to meet
aflatoxin requirements the same as or
comparable to those established for
domestic pistachios. However, the
import regulations are necessary to
ensure that imported and domestic
pistachios for human consumption in
the United States are of uniformly high
quality. Further, the Act requires that
import regulations be issued whenever
marketing order regulations are
established for pistachios. Therefore,
this alternative is not appropriate.
The additional reporting and
recordkeeping requirements that would
be imposed under this proposed rule are
discussed in more detail below. Reports
and forms required under the pistachio
import regulation will be periodically
reviewed to reduce information
requirements and duplication by
industry and public sector agencies.
Additionally, except for the
applicable domestic regulations, USDA
has not identified any relevant Federal
rules that duplicate, overlap, or conflict
with this proposed 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/
MarketingOrdersSmallBusinessGuide.
Any questions about the compliance
guide should be sent to Laurel May at
the previously mentioned address in the
FOR FURTHER INFORMATION CONTACT
section.
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In accordance with section 8e of the
Act, the United States Trade
Representative has concurred with the
issuance of this proposed rule.
Interested persons are invited to
comment on this initial regulatory
flexibility analysis and submit
information on the regulatory and
informational impacts this proposed
action would likely have on small
businesses. A 60-day period for
comments is provided. All written
comments received within the comment
period will be considered before a final
determination is made on this matter.
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.
Paperwork Reduction Act
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
chapter 35), this notice announces that
AMS is requesting OMB approval of a
new information collection under OMB
No. 0581–NEW. Upon approval of this
new information collection by OMB, a
request will be made to merge this
collection with the forms currently
approved for use under OMB No. 0581–
0215, Pistachios Grown in California,
Arizona, and New Mexico.
Title: Pistachios Imported Into the
United States.
OMB Number: 0581–New.
Type of Request: New information
collection.
Abstract: The information collection
requirements contained in this request
are necessary in the administration of
proposed regulations for pistachios
imported into the United States. Such
regulations are authorized under
Section 8e of the Agricultural Marketing
Agreement Act of 1937 (Act), as
amended (7 U.S.C. 601–674), which
requires that whenever the Secretary of
Agriculture issues grade, size, quality,
or maturity regulations under domestic
marketing orders for certain
commodities, the same or comparable
regulations on imports of those
commodities must be issued.
The proposed rule would establish
mandatory aflatoxin testing and
certification requirements for pistachios
offered for importation into the United
States. These requirements would be the
same as or comparable to those
established under Marketing Order No.
983 regulating the handling of
pistachios grown in California, Arizona,
and New Mexico.
Under the proposed regulation,
laboratories that perform chemical
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analysis of aflatoxin content for
imported pistachios would be required
to report any lots that fail aflatoxin
testing. The Imported Pistachios—
Failed Lot Notification Report (FV–249)
would be completed by the laboratory
and submitted to the importer, Customs,
and USDA within 10 days of the failed
test. This report would contain
information about the failed lot,
including its identity and the aflatoxin
level determined during analysis of the
lot.
Under the proposed regulations,
importers would be required to report
the disposition of any failed lots,
including those that are reworked to
meet the aflatoxin requirements, on the
Imported Pistachios—Rework and
Failed Lot Disposition Report (FV–251).
This report would contain information
about the quantity of nuts that were
accepted and rejected during rework,
and would be used to report the
disposition of any pistachios failing
aflatoxin testing. Importers would be
required to complete and submit the
form to Customs and USDA within 10
days of reworking the lot.
USDA and Customs would use the
two reports described above to track
pistachio lots being offered for
importation into the United States and
follow up on the disposition of failing
lots to ensure that pistachios with
aflatoxin levels exceeding the maximum
tolerance of 15 ppb are not shipped to
domestic human consumption markets.
Safeguard procedures in the form of
importer and receiver reporting
requirements would be used to ensure
that shipments of pistachios exempt
from the import regulations are
disposed of only in authorized exempt
outlets. Under the proposed import
regulations, importers of exempt
imported pistachios would be required
to complete and submit, prior to
importation, an Importer’s Exempt
Commodity Form (FV–6). Form FV–6
would be used for tracking pistachios
marketed for exempted uses that do not
meet requirements for human
consumption. Form FV–6 is an
electronic form available through AMS,
is used by importers of other
commodities to report imports of
exempted products, and is already
approved by OMB through December
31, 2011 (OMB Control Number 0581–
0167—Specified Commodities Imported
into the United States Exempt From
Import Regulations). Importers and
receivers register as users of the
electronic form and then are granted
access to the reporting system. Receivers
use the same system to certify that the
commodity has been received and that
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Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules
it will be utilized for authorized exempt
purposes.
The two new forms require the
minimum amount of information
necessary to effectively carry out the
requirements of the Act, and their use
is necessary to fulfill the intent of the
Act and to administer section 8e
compliance activities. These reports and
the safeguard procedures outlined above
are the same as or comparable to the
reports and procedures currently
required by other domestic marketing
orders and import regulations.
The information collected on these
forms is used primarily by authorized
representatives of USDA, including
AMS, Fruit and Vegetable Programs’
regional and headquarters staff. AMS is
the primary user of the information.
The proposed request for a new
information collection under the
pistachio import regulations is as
follows:
through the use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of information
technology. Comments should reference
OMB No. 0581–NEW and the pistachio
import regulations, and be sent to USDA
in care of the Docket Clerk at the
previously mentioned address. All
comments received will be available for
public inspection during regular
business hours at the same address.
Imported Pistachios—Failed Lot
Notification—Form FV–New
Estimate of Burden: Public reporting
burden for this collection of information
is estimated to average 12 minutes per
response.
Respondents: USDA and USDAaccredited Laboratories.
Estimated Number of Respondents: 7.
Estimated Number of Responses per
Respondent: 4.
Estimated Total Annual Burden on
Respondents: 5.6 hours.
1. The authority citation for 7 CFR
Part 999 continues to read as follows:
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Imported Pistachios—Rework and
Failed Lot Disposition Report—Form
FV–New
Estimate of Burden: Public reporting
burden for this collection of information
is estimated to average 12 minutes per
response.
Respondents: Importers of pistachios
failing aflatoxin testing.
Estimated Number of Respondents:
10.
Estimated Number of Responses per
Respondent: 3.
Estimated Total Annual Burden on
Respondents: 6.0 hours.
Comments are invited on: (1) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on those who are to respond, including
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List of Subjects in 7 CFR Part 999
Dates, Filberts, Food grades and
standards, Imports, Nuts, Prunes,
Raisins, Reporting and recordkeeping
requirements, Walnuts.
For the reasons set forth above, 7 CFR
Part 999 is proposed to be amended as
follows:
PART 999—SPECIALTY CROPS;
IMPORT REGULATIONS
Authority: 7 U.S.C. 601–674.
2. Amend § 999.500 by revising the
section heading and paragraphs (a) and
(d) to read as follows:
§ 999.500 Safeguard procedures for
walnuts, certain dates, and pistachios
exempt from grade, size, quality, and
maturity requirements.
(a) Each person who imports or
receives any of the commodities listed
in paragraphs (a)(1) through (3) of this
section shall file an ‘‘Importer’s Exempt
Commodity Form’’ (FV–6) with the
Marketing Order and Agreement
Division, Fruit and Vegetable Programs,
AMS, USDA, and shall provide a
printed copy of the completed Form
FV–6 to the U.S. Customs and Border
Protection Regional Director or District
Director, as applicable, at the port at
which the customs entry is filed. A
printed copy shall accompany the lot to
the exempt outlet specified on the form.
Any lot of any commodity offered for
inspection or aflatoxin testing and, all or
a portion thereof, subsequently
imported as exempt under this
provision shall also be reported on an
‘‘Importer’s Exempt Commodity Form.’’
Such form, accompanied by a copy of
the applicable inspection certificate,
shall be provided to the Marketing
Order and Agreement Division. The
applicable commodities are:
(1) Dates which are donated to needy
persons, prisoners or Native Americans
on reservations;
(2) Walnuts which are: Green walnuts
(so immature that they cannot be used
for drying and sale as dried walnuts);
walnuts used in non-competitive outlets
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such as use by charitable institutions,
relief agencies, governmental agencies
for school lunch programs, and
diversion to animal feed or oil
manufacture; or
(3) Substandard pistachios which are
for non-human consumption purposes.
*
*
*
*
*
(d) All FV–6 forms and other
correspondence regarding entry of 8e
commodities must be submitted online,
mailed or faxed to the Marketing Order
and Agreement Division, Fruit and
Vegetable Programs, AMS, USDA, 1400
Independence Avenue SW., STOP 0237,
Washington, DC 20250–0237;
Telephone (202) 720–4607; or Fax (202)
720–5698. FV–6 forms submitted by
FAX must be followed by a mailed,
original copy of the FV–6.
3. Add § 999.600 to read as follows:
§ 999.600 Regulation governing the
importation of pistachios.
(a) Definitions. (1) Aflatoxin is one of
a group of mycotoxins produced by the
molds Aspergillus flavus and
Aspergillus parasiticus. Aflatoxins are
naturally occurring compounds
produced by molds, which can be
spread in improperly processed and
stored nuts, dried fruits, and grains.
(2) Aflatoxin inspection certificate
means a certificate issued by a USDA or
USDA-accredited laboratory.
(3) Certified lots of pistachios are
those for which aflatoxin inspection
certificates have been issued.
(4) Customs means the U.S. Customs
and Border Protection.
(5) Importation of pistachios means
the release of pistachios from the
custody of U.S. Customs and Border
Protection.
(6) Importer means a person who
engages in the importation of pistachios
into the United States.
(7) Inshell pistachios means
pistachios that have shells that have not
been removed.
(8) Inspection Service means the
Federal Inspection Service, Fruit and
Vegetable Programs, Agricultural
Marketing Service, USDA, or the
Federal-State Inspection Programs.
(9) Inspector means any inspector
authorized by USDA to draw and
prepare pistachio samples.
(10) Lot means any quantity of
pistachios that is submitted for testing
purposes under this part.
(11) Person means an individual,
partnership, limited-liability
corporation, corporation, trust,
association, or any other business unit.
(12) Pistachio means the nut of the
pistachio tree, Pistachia vera, whether
inshell or shelled.
(13) Secretary means the Secretary of
Agriculture of the United States or any
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officer or employee of the United States
Department of Agriculture who is, or
who may hereafter be, authorized to act
in his/her stead.
(14) Shelled pistachios means
pistachio kernels, or portions of kernels,
after the pistachio shells have been
removed.
(15) Substandard pistachios means
pistachios, inshell or shelled, that do
not comply with the aflatoxin
regulations of this section.
(16) USDA means the United States
Department of Agriculture, including
any officer, employee, service, program,
or branch of the Department of
Agriculture, or any other person acting
as the Secretary’s agent or representative
in connection with any provisions of
this section.
(17) USDA laboratory means
laboratories of the Science and
Technology Programs, Agricultural
Marketing Service, USDA, that perform
chemical analyses of pistachios for
aflatoxin content.
(18) USDA-accredited laboratory
means a laboratory that has been
approved or accredited by the U.S.
Department of Agriculture to perform
chemical analyses of pistachios for
aflatoxin content.
(b) Importation requirements. The
importation of any lot of pistachios for
human consumption is prohibited
unless it meets the requirements
contained in this section, which are
determined to be the same as or
comparable to those imposed upon
domestic pistachios handled pursuant
to Order No. 983, as amended (part 983
of this chapter).
(c) Maximum aflatoxin tolerance. No
importer shall ship for domestic human
consumption lots of pistachios that
exceed an aflatoxin level of 15 ppb.
Compliance with the aflatoxin
requirements of this section shall be
determined upon the basis of sampling
by a USDA-authorized inspector and
testing by a USDA or USDA-accredited
laboratory. All shipments must be
covered by an aflatoxin inspection
certificate issued by the laboratory.
Testing and certification must be
completed prior to the importation of
pistachios.
(d) Sampling. (1) Prior to, or upon,
arrival of a pistachio lot at a port of
entry, the importer shall provide a copy
of the Customs entry documentation for
the pistachio lot or lots to the Inspection
Service office that will draw and
prepare samples of the pistachio
shipment. More than one lot may be
listed on one entry document. The
documentation shall include: The
Customs entry number; the container
number(s) or other identification of the
lot(s); the weight of the pistachios in
each lot being imported, the location
where the lot will be made available for
sampling; and a contact name or
telephone number at the testing
location. The Inspection Service shall
sign, stamp, and return the entry
document to the importer. The importer
shall provide a copy of the relevant
entry documentation and such other
identifying information as may be
requested for each pistachio lot to the
inspector at the time samples are drawn
and prepared.
(2) All sampling for aflatoxin testing
shall be performed by USDA-authorized
inspectors in accordance with USDA
rules and regulations governing the
inspection and certification of fresh
fruits, vegetables, and other products (7
CFR part 51). The cost of each such
sampling and related certification shall
be borne by the applicant. Whenever
pistachios are offered for sampling and
testing, the applicant shall furnish any
labor and pay any costs incurred for
storing, moving, and opening containers
65417
as may be necessary for proper sampling
and testing. The applicant should make
advance arrangements with the
Inspection Service to avoid delay in
scheduling sampling. Importers may
make arrangements for required
sampling by contacting the Inspection
Service office closest to where the
pistachios will be made available for
sampling. For questions regarding
inspection services, a list of Federal or
Federal-State Inspection Program
offices, or for further assistance,
importers may contact: Fresh Products
Branch, Fruit and Vegetable Programs,
AMS, USDA, 1400 Independence
Avenue, SW., Room 1536–S,
Washington, DC, 20250; Telephone:
(202) 720–5870; Fax: (202) 720–0393.
(3) Lot samples shall be drawn from
each lot of pistachios designated for
aflatoxin testing, and individual test
samples shall be prepared by, or under
the supervision of, an inspector. Each
sample shall be drawn and prepared in
accordance with the sample size
requirements outlined in Tables 1 and 2
below. The gross weight of the inshell
lot and test samples for aflatoxin testing
and the minimum number of
incremental samples required are shown
in Table 1. The gross weight of the
kernel lot and test samples for aflatoxin
testing and the minimum number of
incremental samples required is shown
in Table 2. If more than one test sample
is necessary, the test samples shall be
designated by the inspector as Test
Sample #1 and Test Sample #2. Each
sample shall be placed in a suitable
container, with the lot number clearly
identified, and the importer shall
submit it, along with a copy of the
customs entry documentation, to a
USDA or USDA-accredited laboratory.
The importer shall assume all costs for
shipping samples to the laboratory.
TABLE 1—INSHELL PISTACHIO LOT SAMPLING INCREMENTS FOR AFLATOXIN CERTIFICATION
Minimum number
of incremental
samples for
the lot sample
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Lot weight (lbs.)
220 or less .......................................................................................................................
221–440 ...........................................................................................................................
441–1,100 ........................................................................................................................
1,101–2,200 .....................................................................................................................
2,201–4,400 .....................................................................................................................
4,401–11,000 ...................................................................................................................
11,001–22,000 .................................................................................................................
22,001–150,000 ...............................................................................................................
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Total weight
of lot sample
(kilograms)
10
15
20
30
40
60
80
100
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3.0
4.0
6.0
8.0
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16.0
20.0
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Weight of
test sample
(kilograms)
2.0
3.0
4.0
6.0
8.0
6.0
8.0
10.0
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TABLE 2—SHELLED PISTACHIO KERNEL LOT SAMPLING INCREMENTS FOR AFLATOXIN CERTIFICATION
Minimum number
of incremental
samples for the
lot sample
Lot weight (lbs.)
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220 or less .......................................................................................................................
221–440 ...........................................................................................................................
441–1,100 ........................................................................................................................
1,101–2,200 .....................................................................................................................
2,201–4,400 .....................................................................................................................
4,401–11,000 ...................................................................................................................
11,001–22,000 .................................................................................................................
22,001–150,000 ...............................................................................................................
(e) Aflatoxin testing. Importers may
make arrangements for required
chemical analysis for aflatoxin content
at the nearest USDA or USDAaccredited laboratory. For further
information concerning chemical
analysis and a list of laboratories
authorized to conduct such analysis
contact: Science and Technology
Programs, AMS, USDA, 1400
Independence Avenue, SW., STOP
0270, Washington, DC 20250–0270;
Telephone: (202) 720–5231; Fax: (202)
720–6496.
(1) Aflatoxin test samples shall be
received and logged by a USDA or
USDA-accredited laboratory, and each
test sample shall be prepared and
analyzed using High Pressure Liquid
Chromatography (HPLC) or the Vicam
Method (Aflatest). The aflatoxin level
shall be calculated on a kernel weight
basis.
(2) Lots that require a single test
sample will be certified as ‘‘negative’’
on the aflatoxin inspection certificate if
the sample has an aflatoxin level at or
below 15 ppb. If the aflatoxin level is
above 15 ppb, the lot fails and the
laboratory shall fill out an Imported
Pistachios—Failed Lot Notification
report (Form FV–249) as described in
paragraph (h)(1) of this section.
(3) Lots that require two test samples
will be certified as ‘‘negative’’ on the
aflatoxin inspection certificate if Test
Sample #1 has an aflatoxin level at or
below 10 ppb. If the aflatoxin level of
Test Sample #1 is above 20 ppb, the lot
fails and the laboratory shall fill out an
Imported Pistachios—Failed Lot
Notification report (Form FV–249). If
the aflatoxin level of Test Sample #1 is
above 10 ppb and at or below 20 ppb,
the laboratory may, at the importer’s
discretion, analyze Test Sample #2 and
average the test results of Test Samples
#1 and #2. Alternately, the importer
may elect to withdraw the lot from
testing, rework the lot, and resubmit it
for testing after reworking. If the
importer directs the laboratory to
proceed with the analysis of Test
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Sample #2, a lot will be certified as
negative to aflatoxin and the laboratory
shall issue an aflatoxin inspection
certificate if the averaged result of Test
Samples #1 and #2 is at or below 15
ppb. If the average aflatoxin level of Test
Samples #1 and #2 is above 15 ppb, the
lot fails and the laboratory shall fill out
an Imported Pistachios—Failed Lot
Notification report (Form FV–249).
(4) If an importer does not elect to use
Test Sample #2 for certification
purposes, the importer may request that
the laboratory return the sample to the
importer.
(f) Certification. Each lot of pistachios
sampled and tested in accordance with
paragraphs (d) and (e) of this section
shall be covered by an aflatoxin
inspection certificate completed by the
laboratory. The certification expires for
the lot or remainder of the lot after 12
months. Each such certificate shall set
forth the following:
(1) The date and place of sampling
and testing.
(2) The name of the applicant.
(3) The Customs entry number
pertaining to the lot or shipment
covered by the certificate.
(4) The quantity and identifying
marks of the lot tested.
(5) The aflatoxin level of the lot,
stated on a kernel weight basis.
(6) The statement, if applicable:
‘‘Meets U.S. import requirements under
section 8e of the AMA Act of 1937.’’
(7) If the lot fails to meet the import
requirements, a statement to that effect
and the reasons therefore.
(g) Failed lots/rework procedure. Any
lot or portion thereof that fails to meet
the import requirements prior to or after
reconditioning may be exported, sold
for non-human consumption, or
disposed of under the supervision of
Customs and, if necessary for
verification purposes, the Federal or
Federal-State Inspection Programs, with
the costs of certifying the disposal of
such lot paid by the importer.
(1) Inshell rework procedure for
aflatoxin. If inshell rework is selected as
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of lot sample
(kilograms)
10
15
20
30
40
60
80
100
1.0
1.5
2.0
3.0
4.0
6.0
8.0
10.0
Weight of
test sample
(kilograms)
1.0
1.5
2.0
3.0
4.0
3.0
4.0
5.0
a remedy to meet the aflatoxin
requirements of this part, then 100
percent of the product within that lot
shall be removed from the bulk and/or
retail packaging containers and
reworked to remove the portion of the
lot that caused the failure. Reworking
shall consist of mechanical, electronic,
or manual procedures normally used in
the handling of pistachios. After the
rework procedure has been completed,
the total weight of the accepted product
and the total weight of the rejected
product shall be reported by the
importer to Customs and USDA on an
Imported Pistachios—Rework and
Failed Lot Disposition report (Form FV–
251) as described in paragraph (h)(2) of
this section. The reworked lot shall be
sampled and tested for aflatoxin as
specified in paragraphs (d) and (e) of
this section, except that the lot sample
size and the test sample size shall be
doubled. If, after the lot has been
reworked and tested, it fails the
aflatoxin test for a second time, the lot
may be shelled and the kernels
reworked, sampled, and tested in the
manner specified for an original lot of
kernels, or the failed lot may be
exported, used for non-human
consumption, or otherwise disposed of.
(2) Kernel rework procedure for
aflatoxin. If pistachio kernel rework is
selected as a remedy to meet the
aflatoxin requirements of this part, then
100 percent of the product within that
lot shall be removed from the bulk and/
or retail packaging containers and
reworked to remove the portion of the
lot that caused the failure. Reworking
shall consist of mechanical, electronic,
or manual procedures normally used in
the handling of pistachios. After the
rework procedure has been completed
the total weight of the accepted product
and the total weight of the rejected
product shall be reported to Customs
and USDA on an Imported Pistachios—
Rework and Failed Lot Disposition
report (Form FV–251). The reworked lot
shall be sampled and tested for aflatoxin
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as specified in paragraphs (d) and (e) of
this section.
(3) Failed lot reporting. If a lot fails to
meet the aflatoxin requirements of this
part, the testing laboratory shall
complete an Imported Pistachios—
Failed Lot Notification report (Form FV–
249) as described in paragraph (h)(1) of
this section, and shall submit it to
Customs, the importer, and USDA
within 10 working days of the test
failure. This form must be completed
and submitted each time a lot fails
aflatoxin testing.
(h) Reports and recordkeeping. (1)
Form FV–249 Imported Pistachios—
Failed Lot Notification. Each USDA or
USDA-accredited laboratory shall notify
the importer; Customs; and the
Marketing Order and Agreement
Division, Fruit and Vegetable Programs,
AMS, USDA; of all lots that fail to meet
the maximum aflatoxin requirements by
completing this form and submitting it
within 10 days of failed aflatoxin
testing.
(2) Form FV–251 Imported
Pistachios—Rework and Failed Lot
Disposition. Each importer who reworks
a failing lot of pistachios shall complete
this report and shall forward it to
Customs and the Marketing Order and
Agreement Division, Fruit and
Vegetable Programs, AMS, USDA, no
later than 10 days after the rework is
completed. If rework is not selected as
a remedy, the importer shall complete
and submit this form within 10 days of
alternate disposition of the lot.
(i) Exemptions. Any importer may
import pistachios free of the
requirements of this section if such
importer imports a quantity not
exceeding a total of 5,000 dried pounds
between September 1 and August 31 of
each year. Substandard pistachios
imported for use in non-human
consumption outlets shall be subject to
the safeguard provisions contained in
§ 999.500.
(j) Reconditioning prior to
importation. Nothing contained in this
section shall be deemed to preclude
reconditioning pistachios prior to
importation, in order that such
pistachios may be made eligible to meet
the applicable aflatoxin regulations
prescribed in paragraphs (c) through (f)
of this section.
(k) Comingling. Certified lots of
pistachios may be comingled with other
certified lots, but the comingling of
certified lots and uncertified lots shall
cause the loss of certification for the
comingled lots.
(l) Retesting. Whenever USDA has
reason to believe that imported
pistachios may have been damaged or
deteriorated while in storage, USDA
VerDate Mar<15>2010
17:43 Oct 20, 2011
Jkt 226001
may reject the then effective inspection
certificate and may require the owner of
the pistachios to have them retested to
establish whether or not such pistachios
may be shipped for human
consumption.
(m) Compliance. Any person who
violates any provision of this section
shall be subject to a forfeiture in the
amount prescribed in section 8a(5) of
the Agricultural Marketing Agreement
Act of 1937, as amended; 7 U.S.C. 601–
674), or, upon conviction, a penalty in
the amount prescribed in section 8c(14)
of the said Act, or to both such forfeiture
and penalty. False representation to any
agency of the United States on any
matter within its jurisdiction, knowing
it to be false, is a violation of 18 U.S.C.
1001, which provides for a fine or
imprisonments or both.
(n) Other import requirements. The
provisions of this section do not
supersede any restrictions or
prohibitions on pistachios under the
Federal Plant Quarantine Act of 1912, or
any other applicable laws or regulations
of city, county, State, or Federal
Agencies including the Federal Food,
Drug and Cosmetic Act.
Dated: October 14, 2011.
David R. Shipman,
Acting Administrator, Agricultural Marketing
Service.
[FR Doc. 2011–27285 Filed 10–20–11; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2011–1139; Directorate
Identifier 2011–CE–021–AD]
RIN 2120–AA64
Airworthiness Directives; SOCATA
Airplanes
Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Notice of proposed rulemaking
(NPRM).
AGENCY:
We propose to adopt a new
airworthiness directive (AD) for
SOCATA Model TBM 700 airplanes.
This proposed AD results from
mandatory continuing airworthiness
information (MCAI) originated by an
aviation authority of another country to
identify and correct an unsafe condition
on an aviation product. The MCAI
describes the unsafe condition as:
SUMMARY:
A TBM 700 operator reported a case of
inverted installation of aileron control cables
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
65419
in the wing. The shortest cable was found
installed instead of the longest one on wing
tip side, with left hand (LH) threaded end in
upper section. This wrong installation could
have been caused by mistaken maintenance
data.
This condition, if not detected and
corrected, could lead to restricted movement
of the aileron, resulting in reduced control of
the aeroplane, particularly when operating
under adverse flight conditions on landing
and during avoidance manoeuvres.
The proposed AD would require
actions that are intended to address the
unsafe condition described in the MCAI.
DATES: We must receive comments on
this proposed AD by December 5, 2011.
ADDRESSES: You may send comments by
any of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: (202) 493–2251.
• Mail: U.S. Department of
Transportation, Docket Operations,
M–30, West Building Ground Floor,
Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590.
• Hand Delivery: U.S. Department of
Transportation, Docket Operations,
M–30, West Building Ground Floor,
Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
For service information identified in
this proposed AD, contact SOCATA—
Direction des Services—65921 Tarbes
Cedex 9—France; telephone +33 (0) 62
41 7300, fax +33 (0) 62 41 76 54, or for
North America: SOCATA NORTH
AMERICA, 7501 South Airport Road,
North Perry Airport (HWO), Pembroke
Pines, Florida 33023; telephone: (954)
893–1400; fax: (954) 964–4141; e-mail:
mysocata@socata.daher.com; Internet:
https://mysocata.com. You may review
copies of the referenced service
information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City,
Missouri 64106. For information on the
availability of this material at the FAA,
call (816) 329–4148.
Examining the AD Docket
You may examine the AD docket on
the Internet at https://
www.regulations.gov; or in person at the
Docket Management Facility between
9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD
docket contains this proposed AD, the
regulatory evaluation, any comments
received, and other information. The
street address for the Docket Office
(telephone (800) 647–5527) is in the
ADDRESSES section. Comments will be
available in the AD docket shortly after
receipt.
E:\FR\FM\21OCP1.SGM
21OCP1
Agencies
[Federal Register Volume 76, Number 204 (Friday, October 21, 2011)]
[Proposed Rules]
[Pages 65411-65419]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27285]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 76 , No. 204 / Friday, October 21, 2011 /
Proposed Rules
[[Page 65411]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 999
[Doc. No. AMS-FV-09-0064; FV09-999-1 PR]
Specialty Crops; Import Regulations; Proposed Pistachio Import
Requirements
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule invites comments on the establishment of a
minimum quality regulation for lots of pistachios imported into the
United States. The regulation would specify maximum aflatoxin tolerance
levels as well as mandatory aflatoxin testing and certification
requirements. The proposed import quality requirements would be the
same as or comparable to those in effect for the domestically produced
commodity. Under this proposal, aflatoxin levels in imported pistachios
could not exceed 15 parts per billion (ppb), as certified by aflatoxin
inspection certificates issued by an accredited laboratory. This action
is intended to assure consumers that all pistachios offered for sale in
the United States meet the same aflatoxin standards, thus promoting
high quality product in the market place and fostering consumer
satisfaction. This rule also announces the Agricultural Marketing
Service's (AMS) intention to request approval by the Office of
Management and Budget (OMB) of a new information collection
requirement, including two new forms that would be completed by either
laboratories or pistachio importers.
DATES: Comments must be received by December 20, 2011. Pursuant to the
Paperwork Reduction Act, comments on the forms and information
collection burden must be received by December 20, 2011.
ADDRESSES: Interested persons are invited to submit written comments
concerning this proposal. Comments should be sent to the Docket Clerk,
Marketing Order and Agreement Division, 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 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: Laurel May or Kathleen Finn, Marketing
Order and Agreement Division, 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:
Laurel.May@ams.usda.gov or Kathy.Finn@ams.usda.gov.
Small businesses may request information on complying with this
regulation by contacting Laurel May at the above mentioned address.
SUPPLEMENTARY INFORMATION: This proposed rule is issued under section
8e of the Agricultural Marketing Agreement Act of 1937, as amended (7
U.S.C. 601-674), hereinafter referred to as the ``Act,'' which provides
that whenever the grade, size, quality, or maturity of certain
specified commodities, including pistachios, are regulated under a
Federal marketing order, imports of these commodities into the United
States are prohibited unless they meet the same or comparable grade,
size, quality, and maturity requirements as those in effect for the
domestically produced commodities. To ensure that these requirements
are met, the Act also authorizes the Department of Agriculture (USDA)
to perform inspections and related functions such as commodity
sampling, and to issue inspection certificates for such imported
commodities.
USDA is issuing this rule in conformance with Executive Order
12866.
There are no administrative procedures that must be exhausted prior
to any judicial challenge to the provisions of import regulations
issued under section 8e of the Act.
This proposed rule would add a new Sec. 999.600 under 7 CFR part
999--Specialty Crops; Import Regulations, and would establish quality
requirements for maximum aflatoxin tolerance levels and mandatory
testing and certification requirements for pistachios offered for
importation into the United States. The proposed quality requirements
for imported pistachios are the same as or comparable to those
established for pistachios grown in California, Arizona, and New Mexico
under Marketing Agreement and Order No. 983 (7 CFR part 983) (order),
both as amended.
This proposed rule would also revise Sec. 999.500, which currently
specifies safeguard procedures for the importation of walnuts and dates
that are exempt from Sec. 8e regulations. This section would be
revised to include safeguard procedures for the importation of
pistachios intended for exempted purposes.
The order prohibits the shipping of pistachios for domestic human
consumption that do not meet the quality requirements for aflatoxin
levels in the nuts. Such quality requirements specify that aflatoxin
levels may not exceed the maximum tolerance of 15 ppb. Pistachios that
fail to meet these requirements must be reworked and retested, or
disposed of as specified in the order. These regulations were designed
to ensure that only high quality pistachios containing low levels of
aflatoxin are shipped, thus promoting high quality product in the
market place and fostering consumer satisfaction.
The order, which was established for California pistachios in 2004,
was recently amended to include the states of Arizona and New Mexico.
Pistachios grown in California, Arizona, and New Mexico represent over
99 percent of the U.S. domestic production, and 98 percent of the
domestic consumption. Thus, almost all domestically produced pistachios
are regulated under Marketing Order No. 983. There is no
[[Page 65412]]
other Federal marketing order in effect for pistachios produced in the
United States.
According to USDA's Foreign Agricultural Service (FAS), Iran is
typically the world's largest pistachio producer, followed by the U.S.
and Turkey, although Syria's production has increased in recent years.
During the three most recent crop years (September through August) for
which complete data is available, 2007-08 through 2009-10, the
production averages in millions of pounds (inshell basis) for Iran, the
U.S., Turkey, and Syria were approximately 386, 350, 120, and 141,
respectively.
Historically, the bulk of U.S. pistachio imports have come from
Turkey and Iran, although Iranian imports have been prohibited since
July 2010. The remainder comes from other countries, including Italy,
China, Switzerland, France, Australia, Hong Kong, and Israel. Imported
pistachios may be inshell or shelled. According to FAS, the U.S.
imported an average of approximately 1.7 million pounds of pistachios
(inshell basis) annually during the three crop years from 2007-08
through 2009-10. Average U.S. consumption of pistachios during that
same period was approximately 100 million pounds (inshell basis)
annually. Imports, therefore, represent approximately two percent of
U.S. pistachio consumption.
Proposed Requirements
Definitions
The proposed regulations would include definitions of terms used in
the import regulation. Such terms are the same as or comparable to
those defined in the marketing order for domestic pistachios as
established at 69 FR 17844 (April 5, 2004) and amended at 74 FR 56532
(November 2, 2009).
Under the proposed regulations, ``pistachio'' would mean the nut of
the pistachio tree, Pistachia vera, whether inshell or shelled.
``Importer'' would be defined as a person who imports pistachios into
the United States. ``Aflatoxin'' would be defined as a mycotoxin that
can be found in nuts, dried fruits, and grains. ``Aflatoxin inspection
certificate'' would mean a certificate issued by a USDA or USDA-
accredited laboratory. ``USDA laboratory'' and ``USDA-accredited
laboratory'' would be defined as laboratories authorized to test
imported pistachios for aflatoxin content. ``Inspector'' would mean any
inspector authorized by USDA to draw and prepare pistachio samples for
testing. ``Lot'' would mean any quantity of pistachios submitted for
testing. Other terms useful in the administration of the import
regulation would also be defined.
Maximum Aflatoxin Tolerance
The presence or absence of aflatoxin is considered a quality
characteristic in pistachios \1\ because concerns about aflatoxin
contamination can impact consumers' perception of the quality of
pistachios, and therefore negatively impact demand. According to
research provided by the industry, poor quality pistachios impact
demand and the potential growth of demand for pistachios.\2\ Moreover,
any market disturbances related to aflatoxin in pistachios, regardless
of the origin of those pistachios, could have a detrimental effect on
the pistachio industry.\3\
---------------------------------------------------------------------------
\1\ Gibbons, Jeff; 2002. Testimony in Pistachios Grown in
California; Hearing on Proposed Marketing Agreement and Order No.
983. Pages 326-359.
\2\ Sumner, Daniel A; 2002. Testimony in Pistachios Grown in
California; Hearing on Proposed Marketing Agreement and Order No.
983. 2002. Pages 698-735 and 747-820.
\3\ Reinecke, Karen; 2002. Testimony in Pistachios Grown in
California; Hearing on Proposed Marketing Agreement and Order No.
983. Pages 152-183.
---------------------------------------------------------------------------
The proposed regulations would establish a maximum aflatoxin
tolerance level of 15 ppb for lots of pistachios imported into the U.S.
for human consumption. As required under section 8e of the Act, this is
the same level currently prescribed for domestic pistachios regulated
under the order. Establishing a 15 ppb limit for aflatoxin in all
pistachios marketed for human consumption in the United States is
expected to bolster overall consumer confidence in pistachio quality
and strengthen the demand for pistachios. Comparatively, the
international Codex Alimentarius Commission's (Codex) maximum aflatoxin
tolerance for pistachios is 10 ppb. The domestic pistachio industry
believes that 15 ppb is appropriate to ensure the quality of pistachios
sold in U.S. markets,\4\ Research also supports the 15 ppb
tolerance.\5\ Additionally, a 15 ppb tolerance for aflatoxin in
domestic and imported pistachios is consistent with existing
regulations for all domestic and imported peanuts marketed in the
United States, for which USDA has established a 15 ppb aflatoxin
tolerance.\6\
---------------------------------------------------------------------------
\4\ Gibbons, Jeff; 2002. Testimony in Pistachios Grown in
California; Hearing on Proposed Marketing Agreement and Order No.
983. 2002. Pages 326-359.
\5\ Eaton, David L.; Jennifer E. Hobden; and Bruce J. Kelman.
2002. Aflatoxin in Pistachios: Establishing a Regulatory Action
Level in Support of a Proposed Federal Marketing Order. 11 pages.
\6\ 7 CFR part 996--Minimum Quality and Handling Standards for
Domestic and Imported Peanuts Marketed in the United States.
---------------------------------------------------------------------------
Aflatoxin Sampling and Testing Procedures
The proposed regulations provide for aflatoxin sampling procedures
based on lot size. Such sampling procedures are the same as or
comparable to those established for domestic shipments, and mirror the
sampling procedures prescribed for pistachio shipments to the European
Union. At the discretion of the importer, pistachio lots arriving at a
U.S. port of entry would be warehoused near the port or shipped inland
to a pistachio handling facility to await aflatoxin sampling and
testing. Importers would be responsible for any transportation or
storage fees incurred. Depending on the size of the lot, a specified
number of incremental samples would be pulled and combined to form a
lot sample. The lot sample would then be divided into smaller test
samples, depending upon the size of the lot to be tested. The required
weight of lot samples and test samples differs between inshell
pistachios and shelled kernels because of the additional weight of the
shells for inshell pistachios. The drawing and dividing of all samples
must be conducted by or under the supervision of a Federal or Federal-
State inspector.
Following the drawing and dividing of samples, each sample would be
properly identified and submitted to a USDA or USDA-accredited
laboratory for analysis. Test samples would be prepared and analyzed
using High Pressure Liquid Chromatography (HPLC) or the Vicam Method
(Aflatest). The aflatoxin level would be calculated on a kernel weight
basis.
For lots of up to 4,400 lbs, one test sample would be analyzed. If
the sample has an aflatoxin level at or below 15 ppb, the lot could be
certified as negative for aflatoxin on the aflatoxin inspection
certificate, which would be completed by the laboratory. If the
aflatoxin level is greater than 15 ppb, the lot fails, and the
laboratory would fill out a failed lot notification report for
submission to the importer, the U.S. Customs and Border Protection
(Customs), and USDA.
For lots of more than 4,400 lbs, two test samples would be
prepared. If the first sample has an aflatoxin level at or below 10
ppb, the lot could be certified as negative for aflatoxin on the
aflatoxin inspection certificate. Analysis of the other test sample
would be unnecessary.
[[Page 65413]]
If the aflatoxin level of the first test sample is above 20 ppb, the
lot fails, and the laboratory would fill out a failed lot notification
report for submission to the importer, Customs, and USDA. If the
aflatoxin level of the first test sample is higher than 10 ppb and at
or below 20 ppb, the importer could elect to test the second sample or
rework the lot and resubmit it for testing. If the importer chooses to
proceed with testing the second sample, the results from testing both
samples would be averaged. If the average results are at or below 15
ppb, the lot may be certified negative for aflatoxin. If the average
results are higher than 15 ppb, the lot fails and the accredited lab
would submit a failed lot notification report to the importer, Customs,
and USDA. If the importer chooses to rework the lot after the first
sample is analyzed, the lot would again be subject to sampling and
testing as if it were a new lot.
If an aflatoxin inspection certificate is issued certifying that a
lot is negative for aflatoxin at any stage of the sequential testing
(meaning that the lot's aflatoxin content is below the maximum
threshold), the certification would state that the lot meets the Sec.
8e import aflatoxin requirements. The certification would expire after
12 months.
Upon notification of any failed lot, the importer would work with
Customs to determine the appropriate disposition of the pistachios.
Pistachios that fail to meet the aflatoxin requirements would be
required to be sold for non-human consumption, exported to another
destination with a higher aflatoxin tolerance, or disposed of under the
supervision of Customs, and the Federal or Federal-State Inspection
Programs could be called upon to verify disposals. Any costs associated
with certifying a disposal would be paid by the importer.
Rework Procedures
Although reworking and retesting of a failed lot would not be
required, importers could opt to take those steps, which would provide
them with an opportunity to secure a return for their imported product
while maintaining the integrity of the aflatoxin requirements. The
alternative would be to dispose of the lot through proper channels as
described above. The rework procedures described below are the same as
or comparable to those required for domestic pistachios under the
order.
Inshell pistachios. Rework procedures for inshell pistachios
failing to meet aflatoxin requirements would require importers to
remove 100 percent of the failing lot from its bulk or retail
packaging. These pistachios would be required to pass through the
sorting stages of the handling process in order to remove those nuts
having the characteristics most susceptible to harboring aflatoxin.
After reworking the lot, the importer would report the weight of the
total accepted and rejected product to Customs and USDA on a rework and
failed lot disposition report, and the acceptable portion of the
reworked lot would be resampled and tested for aflatoxin. In the case
of a reworked lot, the lot sample size and the test sample size would
be doubled from that specified in the initial testing. If, after having
been reworked, the lot fails aflatoxin testing for a second time, the
lot could be shelled and the kernels reworked, sampled, and tested in
the manner required for an original lot of pistachio kernels. If the
importer decides not to pursue further reworking of the failed lot,
those pistachios would be prohibited from entering the stream of
commerce for domestic human consumption. The lot must be exported, sold
for domestic non-human consumption purposes, or disposed of as
described above. The importer would report the lot's final disposition
to Customs and USDA on a rework and failed lot disposition report.
Shelled pistachios. Rework procedures proposed for pistachio
kernels failing to test negative for aflatoxin would also require a
reprocessing of 100 percent of the volume of the failing lot. As with
inshell pistachios, after reworking, the total weight of the accepted
product and the total weight of the rejected product would be reported
by the importer to Customs and USDA on the rework and failed lot
disposition report. The reworked lot of kernels would be resampled and
retested for aflatoxin content as previously described.
Comingling
Importers could comingle certified lots with other certified lots
of pistachios. However, to maintain the integrity of certified lots,
the comingling of certified and uncertified lots of pistachios would
cause the loss of certification for the comingled lots.
Exemptions
Section 983.70 of the marketing order provides that domestic
handlers may handle pistachios free of the regulatory and assessment
provisions of the order if such pistachios are handled in quantities
not exceeding 5,000 dried pounds during any production year. The
purpose of this provision is to provide an exemption from the
requirements of the order for small quantities of pistachios such as
those that are grown for home or personal use. Further, this exemption
is applied on a production year basis. Accordingly, under the proposed
import regulation, a comparable 5,000-pound exemption would apply to
all shipments of pistachios imported for human consumption. Also,
substandard pistachios imported for use in non-human consumption
outlets would not be subject to the proposed aflatoxin regulations.
Compliance
Any importer who violates any provision of the proposed import
regulations would be subject to a forfeiture in the amount prescribed
in section 608a(5) of the Act (7 U.S.C. 601-674), or, upon conviction,
penalties in the amounts prescribed in section 608c(14) of the Act, or
to both forfeiture and penalty. False representation to any agency of
the United States on any matter within its jurisdiction, knowing it to
be false, is a violation of 18 U.S.C. 1001, which provides for a fine
or imprisonment or both.
Safeguards
Safeguard procedures in the form of importer and receiver reporting
requirements would be used to ensure that substandard pistachios
imported for purposes other than human consumption would be used only
in authorized outlets exempt from the proposed aflatoxin regulations.
The safeguard procedures would be comparable to those currently
specified for the importation of other exempted commodities. Under the
proposed regulations, importers and receivers of pistachios for other
than human consumption purposes would be required to complete and
submit to USDA an Importer's Exempt Commodity Form (Form FV-6), the
generic form used by importers and receivers of other exempted
commodities. The information provided on Form FV-6 would be used by
USDA to track pistachios marketed for exempted uses.
The provisions of this proposed rule would establish maximum
aflatoxin tolerance levels and mandatory testing and certification
requirements for lots of pistachios offered for importation into the
United States. The proposed import quality requirements would be
implemented in accordance with section 8e of the Act. These provisions
are intended to ensure that pistachios imported into the United States
for the purposes of domestic human consumption are of a quality
comparable to those pistachios regulated under Marketing Order No.
[[Page 65414]]
983 and contain no more than 15 ppb of aflatoxin.
Initial Regulatory Flexibility Analysis
Pursuant to the requirements set forth in the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing
Service (AMS) has considered the economic impact of this proposed 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 rules issued thereunder, are unique in that
they are brought about through group action of essentially small
entities acting on their own behalf. Import regulations issued under
the Act are based on those established under Federal marketing orders.
Small agricultural service firms, which include importers and
receivers, have been defined by the Small Business Administration (SBA)
(13 CFR 121.201) as those having annual receipts of less than
$7,000,000.
AMS estimates that the there are approximately 50 importers and
receivers who handled shipments of pistachios into the United States
between 2007 and 2009. About 10 of the 50 firms are also substantially
engaged in the marketing of U.S. grown pistachios, and are large firms
according to the SBA definition. Most of the remaining 40 firms import
a number of different food products, and most are also likely to be
large firms under the SBA definition, even though they generally import
only small quantities of pistachios. There are also nine USDA-
accredited laboratories in California that perform aflatoxin testing
for pistachios. AMS estimates that four of the nine laboratories would
be considered small firms according to the SBA definition.
Turkey and Iran have historically been the source of most
pistachios imported into the U.S. Turkish pistachios are imported
predominantly in the shell, while Iranian pistachios are typically
imported shelled. Imported pistachios also come from Italy, China,
Switzerland, France, Australia, Hong Kong, and Italy. Most pistachios
imported from other nations are also shelled. The proposed import
regulations would establish protocols for aflatoxin analysis for both
inshell and shelled pistachios.
Section 8e of the Act provides that when certain domestically
produced commodities, including pistachios, are regulated under a
Federal marketing order, imports of that commodity must meet the same
or comparable grade, quality, size, and maturity requirements.
This rule would establish a minimum quality requirement for lots of
imported pistachios by specifying a maximum aflatoxin tolerance level
as well as aflatoxin testing and certification requirements. Importers
would be responsible for arranging for the required transportation,
storage, sampling, testing, and certification of such pistachios prior
to importation. Sampling would be conducted by the Federal or Federal-
State inspection services, and aflatoxin testing and certification
would be performed by USDA or USDA-accredited laboratories.
The proposed import aflatoxin testing and certification
requirements are the same as or comparable to those implemented under
the order regulating the handling of pistachios grown in California,
Arizona, and New Mexico. Pistachios failing to meet the aflatoxin
requirements on initial analysis could be reworked and retested,
exported to another destination with a higher aflatoxin tolerance, or
disposed of in authorized outlets under the supervision of Customs,
with assistance from the inspection service if necessary, to verify
proper disposal of substandard nuts. Procedures for these activities
also are proposed. Lots of imported pistachios that fail aflatoxin
testing could be diverted to certain non-human consumption outlets and
would be subject to the safeguard provisions of Sec. 999.500. Some
reporting and recordkeeping requirements also are proposed in the
pistachio import regulation. These requirements also are the same as or
comparable to those implemented under the order.
The cost of testing pistachios for aflatoxin would vary, depending
on such factors as the location of the port of entry and the size of
the lot to be tested. For purposes of estimating an average per-pound
testing expense for imported pistachios, this analysis assumes an
average lot equal to one container load weighing 16,000 pounds of
inshell pistachios arriving at the Port of San Francisco and being
tested for aflatoxin by an accredited laboratory in Fresno, California.
In the following example computation of testing costs, there are
four elements: (1) A fee (at an hourly rate) charged by the inspection
fee to draw the sample, (2) overnight shipping, (3) a fee charged by
the laboratory to determine the level of aflatoxin, and (4) the ``unit
value'' of the quantity of pistachios drawn for the sample. The unit
value used in this example computation is the average for the last 3
complete marketing years for which import data are available, 2007/08-
2009/10. The unit value for the 3-year period ($1.68 per pound) is
computed by dividing the average 3-year import value ($2,900,000) by
the average import quantity (1,725,000 pounds). Data are from FAS.
The inspection service fee of $74 per hour is multiplied by the
estimated time of 2 hours to draw a sample, for a cost of $148. The
overnight shipping cost and laboratory fee are estimated at $200 and
$100, respectively.
The next step in the example computation is value of pistachios
drawn for the sample. Under the new proposed section 996.600, in
section (d) Sampling, the weight of a lot sample is 16 kilograms
(equivalent to 35.3 pounds) for a lot weighing between 11,001 and
22,000 pounds. Multiplying 35.3 pounds times the unit value of imported
pistachios ($1.68) yields a value of the tested sample of approximately
$59. Assuming that aflatoxin certification of the 16,000-pound lot
requires the testing of only one sample, the sum of the four cost
elements would be $507, or approximately 3.2 cents per pound
(approximately two percent of the unit value of imported pistachios).
It is likely that a pistachio lot arriving at the Port of San
Francisco would be transported to an inland handling facility to await
sampling and testing and would incur no additional storage costs.
However, if the lot is stored at a Customs warehouse near the port,
storage fees ranging between $100 and $500 per day could be incurred
while the samples are analyzed. Analysis and certification is estimated
to require between two to five days. Assuming a three day turnaround
for a lot incurring $200 per day storage fees, approximately $600, or
3.75 cents per pound of pistachios could be added to the testing
expense described above.
Regarding the impact of this proposed rule on affected entities,
this proposal would establish an import regulation for pistachios as
provided in section 8e of the Act. The proposed import regulation would
require importers to arrange for the testing and certification of all
imports of pistachios for human consumption prior to importation. There
would be some increased costs to importers associated with the testing
and certification of imported product. However, it is expected that
consumer satisfaction, and therefore demand, would be increased by
regulating imports and domestic product uniformly. The additional costs
are expected to be offset by the benefits of supplying the U.S.
marketplace with only high quality pistachios. As
[[Page 65415]]
mentioned above, the proposed import regulations are the same as or
comparable to those established for U.S. domestic pistachio shipments.
The domestic industry recently adopted aflatoxin sampling and testing
procedures that align with the Codex Alimentarius Commission's (Codex)
sampling plan (75 FR 43045; July 23, 2010). The Codex sampling plan is
used by the European Commission as its regulation for the importation
of tree nuts into the European Union. Thus, the proposed import
regulations are comparable to those widely recognized by international
pistachio markets.
Industry information suggests that when aflatoxin levels in
imported lots of pistachios exceed the FDA maximum tolerance of 20 ppb,
the levels are generally significantly higher than 20 ppb. Very few
lots test between 15 ppb and 20 ppb. It is anticipated that most
imported lots will test below the proposed 15 ppb tolerance. Thus,
establishing a maximum aflatoxin tolerance of 15 ppb for imported
pistachios is not expected to have a significant impact on trade.
The alternative to this action is to continue to allow pistachios
to be imported without having to meet aflatoxin requirements the same
as or comparable to those established for domestic pistachios. However,
the import regulations are necessary to ensure that imported and
domestic pistachios for human consumption in the United States are of
uniformly high quality. Further, the Act requires that import
regulations be issued whenever marketing order regulations are
established for pistachios. Therefore, this alternative is not
appropriate.
The additional reporting and recordkeeping requirements that would
be imposed under this proposed rule are discussed in more detail below.
Reports and forms required under the pistachio import regulation will
be periodically reviewed to reduce information requirements and
duplication by industry and public sector agencies.
Additionally, except for the applicable domestic regulations, USDA
has not identified any relevant Federal rules that duplicate, overlap,
or conflict with this proposed 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/MarketingOrdersSmallBusinessGuide. Any questions
about the compliance guide should be sent to Laurel May at the
previously mentioned address in the FOR FURTHER INFORMATION CONTACT
section.
In accordance with section 8e of the Act, the United States Trade
Representative has concurred with the issuance of this proposed rule.
Interested persons are invited to comment on this initial
regulatory flexibility analysis and submit information on the
regulatory and informational impacts this proposed action would likely
have on small businesses. A 60-day period for comments is provided. All
written comments received within the comment period will be considered
before a final determination is made on this matter.
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.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
chapter 35), this notice announces that AMS is requesting OMB approval
of a new information collection under OMB No. 0581-NEW. Upon approval
of this new information collection by OMB, a request will be made to
merge this collection with the forms currently approved for use under
OMB No. 0581-0215, Pistachios Grown in California, Arizona, and New
Mexico.
Title: Pistachios Imported Into the United States.
OMB Number: 0581-New.
Type of Request: New information collection.
Abstract: The information collection requirements contained in this
request are necessary in the administration of proposed regulations for
pistachios imported into the United States. Such regulations are
authorized under Section 8e of the Agricultural Marketing Agreement Act
of 1937 (Act), as amended (7 U.S.C. 601-674), which requires that
whenever the Secretary of Agriculture issues grade, size, quality, or
maturity regulations under domestic marketing orders for certain
commodities, the same or comparable regulations on imports of those
commodities must be issued.
The proposed rule would establish mandatory aflatoxin testing and
certification requirements for pistachios offered for importation into
the United States. These requirements would be the same as or
comparable to those established under Marketing Order No. 983
regulating the handling of pistachios grown in California, Arizona, and
New Mexico.
Under the proposed regulation, laboratories that perform chemical
analysis of aflatoxin content for imported pistachios would be required
to report any lots that fail aflatoxin testing. The Imported
Pistachios--Failed Lot Notification Report (FV-249) would be completed
by the laboratory and submitted to the importer, Customs, and USDA
within 10 days of the failed test. This report would contain
information about the failed lot, including its identity and the
aflatoxin level determined during analysis of the lot.
Under the proposed regulations, importers would be required to
report the disposition of any failed lots, including those that are
reworked to meet the aflatoxin requirements, on the Imported
Pistachios--Rework and Failed Lot Disposition Report (FV-251). This
report would contain information about the quantity of nuts that were
accepted and rejected during rework, and would be used to report the
disposition of any pistachios failing aflatoxin testing. Importers
would be required to complete and submit the form to Customs and USDA
within 10 days of reworking the lot.
USDA and Customs would use the two reports described above to track
pistachio lots being offered for importation into the United States and
follow up on the disposition of failing lots to ensure that pistachios
with aflatoxin levels exceeding the maximum tolerance of 15 ppb are not
shipped to domestic human consumption markets.
Safeguard procedures in the form of importer and receiver reporting
requirements would be used to ensure that shipments of pistachios
exempt from the import regulations are disposed of only in authorized
exempt outlets. Under the proposed import regulations, importers of
exempt imported pistachios would be required to complete and submit,
prior to importation, an Importer's Exempt Commodity Form (FV-6). Form
FV-6 would be used for tracking pistachios marketed for exempted uses
that do not meet requirements for human consumption. Form FV-6 is an
electronic form available through AMS, is used by importers of other
commodities to report imports of exempted products, and is already
approved by OMB through December 31, 2011 (OMB Control Number 0581-
0167--Specified Commodities Imported into the United States Exempt From
Import Regulations). Importers and receivers register as users of the
electronic form and then are granted access to the reporting system.
Receivers use the same system to certify that the commodity has been
received and that
[[Page 65416]]
it will be utilized for authorized exempt purposes.
The two new forms require the minimum amount of information
necessary to effectively carry out the requirements of the Act, and
their use is necessary to fulfill the intent of the Act and to
administer section 8e compliance activities. These reports and the
safeguard procedures outlined above are the same as or comparable to
the reports and procedures currently required by other domestic
marketing orders and import regulations.
The information collected on these forms is used primarily by
authorized representatives of USDA, including AMS, Fruit and Vegetable
Programs' regional and headquarters staff. AMS is the primary user of
the information.
The proposed request for a new information collection under the
pistachio import regulations is as follows:
Imported Pistachios--Failed Lot Notification--Form FV-New
Estimate of Burden: Public reporting burden for this collection of
information is estimated to average 12 minutes per response.
Respondents: USDA and USDA-accredited Laboratories.
Estimated Number of Respondents: 7.
Estimated Number of Responses per Respondent: 4.
Estimated Total Annual Burden on Respondents: 5.6 hours.
Imported Pistachios--Rework and Failed Lot Disposition Report--Form FV-
New
Estimate of Burden: Public reporting burden for this collection of
information is estimated to average 12 minutes per response.
Respondents: Importers of pistachios failing aflatoxin testing.
Estimated Number of Respondents: 10.
Estimated Number of Responses per Respondent: 3.
Estimated Total Annual Burden on Respondents: 6.0 hours.
Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden of the
proposed collection of information including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology. Comments should reference OMB
No. 0581-NEW and the pistachio import regulations, and be sent to USDA
in care of the Docket Clerk at the previously mentioned address. All
comments received will be available for public inspection during
regular business hours at the same address.
List of Subjects in 7 CFR Part 999
Dates, Filberts, Food grades and standards, Imports, Nuts, Prunes,
Raisins, Reporting and recordkeeping requirements, Walnuts.
For the reasons set forth above, 7 CFR Part 999 is proposed to be
amended as follows:
PART 999--SPECIALTY CROPS; IMPORT REGULATIONS
1. The authority citation for 7 CFR Part 999 continues to read as
follows:
Authority: 7 U.S.C. 601-674.
2. Amend Sec. 999.500 by revising the section heading and
paragraphs (a) and (d) to read as follows:
Sec. 999.500 Safeguard procedures for walnuts, certain dates, and
pistachios exempt from grade, size, quality, and maturity requirements.
(a) Each person who imports or receives any of the commodities
listed in paragraphs (a)(1) through (3) of this section shall file an
``Importer's Exempt Commodity Form'' (FV-6) with the Marketing Order
and Agreement Division, Fruit and Vegetable Programs, AMS, USDA, and
shall provide a printed copy of the completed Form FV-6 to the U.S.
Customs and Border Protection Regional Director or District Director,
as applicable, at the port at which the customs entry is filed. A
printed copy shall accompany the lot to the exempt outlet specified on
the form. Any lot of any commodity offered for inspection or aflatoxin
testing and, all or a portion thereof, subsequently imported as exempt
under this provision shall also be reported on an ``Importer's Exempt
Commodity Form.'' Such form, accompanied by a copy of the applicable
inspection certificate, shall be provided to the Marketing Order and
Agreement Division. The applicable commodities are:
(1) Dates which are donated to needy persons, prisoners or Native
Americans on reservations;
(2) Walnuts which are: Green walnuts (so immature that they cannot
be used for drying and sale as dried walnuts); walnuts used in non-
competitive outlets such as use by charitable institutions, relief
agencies, governmental agencies for school lunch programs, and
diversion to animal feed or oil manufacture; or
(3) Substandard pistachios which are for non-human consumption
purposes.
* * * * *
(d) All FV-6 forms and other correspondence regarding entry of 8e
commodities must be submitted online, mailed or faxed to the Marketing
Order and Agreement Division, Fruit and Vegetable Programs, AMS, USDA,
1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237;
Telephone (202) 720-4607; or Fax (202) 720-5698. FV-6 forms submitted
by FAX must be followed by a mailed, original copy of the FV-6.
3. Add Sec. 999.600 to read as follows:
Sec. 999.600 Regulation governing the importation of pistachios.
(a) Definitions. (1) Aflatoxin is one of a group of mycotoxins
produced by the molds Aspergillus flavus and Aspergillus parasiticus.
Aflatoxins are naturally occurring compounds produced by molds, which
can be spread in improperly processed and stored nuts, dried fruits,
and grains.
(2) Aflatoxin inspection certificate means a certificate issued by
a USDA or USDA-accredited laboratory.
(3) Certified lots of pistachios are those for which aflatoxin
inspection certificates have been issued.
(4) Customs means the U.S. Customs and Border Protection.
(5) Importation of pistachios means the release of pistachios from
the custody of U.S. Customs and Border Protection.
(6) Importer means a person who engages in the importation of
pistachios into the United States.
(7) Inshell pistachios means pistachios that have shells that have
not been removed.
(8) Inspection Service means the Federal Inspection Service, Fruit
and Vegetable Programs, Agricultural Marketing Service, USDA, or the
Federal-State Inspection Programs.
(9) Inspector means any inspector authorized by USDA to draw and
prepare pistachio samples.
(10) Lot means any quantity of pistachios that is submitted for
testing purposes under this part.
(11) Person means an individual, partnership, limited-liability
corporation, corporation, trust, association, or any other business
unit.
(12) Pistachio means the nut of the pistachio tree, Pistachia vera,
whether inshell or shelled.
(13) Secretary means the Secretary of Agriculture of the United
States or any
[[Page 65417]]
officer or employee of the United States Department of Agriculture who
is, or who may hereafter be, authorized to act in his/her stead.
(14) Shelled pistachios means pistachio kernels, or portions of
kernels, after the pistachio shells have been removed.
(15) Substandard pistachios means pistachios, inshell or shelled,
that do not comply with the aflatoxin regulations of this section.
(16) USDA means the United States Department of Agriculture,
including any officer, employee, service, program, or branch of the
Department of Agriculture, or any other person acting as the
Secretary's agent or representative in connection with any provisions
of this section.
(17) USDA laboratory means laboratories of the Science and
Technology Programs, Agricultural Marketing Service, USDA, that perform
chemical analyses of pistachios for aflatoxin content.
(18) USDA-accredited laboratory means a laboratory that has been
approved or accredited by the U.S. Department of Agriculture to perform
chemical analyses of pistachios for aflatoxin content.
(b) Importation requirements. The importation of any lot of
pistachios for human consumption is prohibited unless it meets the
requirements contained in this section, which are determined to be the
same as or comparable to those imposed upon domestic pistachios handled
pursuant to Order No. 983, as amended (part 983 of this chapter).
(c) Maximum aflatoxin tolerance. No importer shall ship for
domestic human consumption lots of pistachios that exceed an aflatoxin
level of 15 ppb. Compliance with the aflatoxin requirements of this
section shall be determined upon the basis of sampling by a USDA-
authorized inspector and testing by a USDA or USDA-accredited
laboratory. All shipments must be covered by an aflatoxin inspection
certificate issued by the laboratory. Testing and certification must be
completed prior to the importation of pistachios.
(d) Sampling. (1) Prior to, or upon, arrival of a pistachio lot at
a port of entry, the importer shall provide a copy of the Customs entry
documentation for the pistachio lot or lots to the Inspection Service
office that will draw and prepare samples of the pistachio shipment.
More than one lot may be listed on one entry document. The
documentation shall include: The Customs entry number; the container
number(s) or other identification of the lot(s); the weight of the
pistachios in each lot being imported, the location where the lot will
be made available for sampling; and a contact name or telephone number
at the testing location. The Inspection Service shall sign, stamp, and
return the entry document to the importer. The importer shall provide a
copy of the relevant entry documentation and such other identifying
information as may be requested for each pistachio lot to the inspector
at the time samples are drawn and prepared.
(2) All sampling for aflatoxin testing shall be performed by USDA-
authorized inspectors in accordance with USDA rules and regulations
governing the inspection and certification of fresh fruits, vegetables,
and other products (7 CFR part 51). The cost of each such sampling and
related certification shall be borne by the applicant. Whenever
pistachios are offered for sampling and testing, the applicant shall
furnish any labor and pay any costs incurred for storing, moving, and
opening containers as may be necessary for proper sampling and testing.
The applicant should make advance arrangements with the Inspection
Service to avoid delay in scheduling sampling. Importers may make
arrangements for required sampling by contacting the Inspection Service
office closest to where the pistachios will be made available for
sampling. For questions regarding inspection services, a list of
Federal or Federal-State Inspection Program offices, or for further
assistance, importers may contact: Fresh Products Branch, Fruit and
Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., Room
1536-S, Washington, DC, 20250; Telephone: (202) 720-5870; Fax: (202)
720-0393.
(3) Lot samples shall be drawn from each lot of pistachios
designated for aflatoxin testing, and individual test samples shall be
prepared by, or under the supervision of, an inspector. Each sample
shall be drawn and prepared in accordance with the sample size
requirements outlined in Tables 1 and 2 below. The gross weight of the
inshell lot and test samples for aflatoxin testing and the minimum
number of incremental samples required are shown in Table 1. The gross
weight of the kernel lot and test samples for aflatoxin testing and the
minimum number of incremental samples required is shown in Table 2. If
more than one test sample is necessary, the test samples shall be
designated by the inspector as Test Sample 1 and Test Sample
2. Each sample shall be placed in a suitable container, with
the lot number clearly identified, and the importer shall submit it,
along with a copy of the customs entry documentation, to a USDA or
USDA-accredited laboratory. The importer shall assume all costs for
shipping samples to the laboratory.
Table 1--Inshell Pistachio Lot Sampling Increments for Aflatoxin Certification
----------------------------------------------------------------------------------------------------------------
Minimum number
of incremental Total weight of Weight of test
Lot weight (lbs.) samples for the lot sample sample
lot sample (kilograms) (kilograms)
----------------------------------------------------------------------------------------------------------------
220 or less............................................... 10 2.0 2.0
221-440................................................... 15 3.0 3.0
441-1,100................................................. 20 4.0 4.0
1,101-2,200............................................... 30 6.0 6.0
2,201-4,400............................................... 40 8.0 8.0
4,401-11,000.............................................. 60 12.0 6.0
11,001-22,000............................................. 80 16.0 8.0
22,001-150,000............................................ 100 20.0 10.0
----------------------------------------------------------------------------------------------------------------
[[Page 65418]]
Table 2--Shelled Pistachio Kernel Lot Sampling Increments for Aflatoxin Certification
----------------------------------------------------------------------------------------------------------------
Minimum number
of incremental Total weight of Weight of test
Lot weight (lbs.) samples for the lot sample sample
lot sample (kilograms) (kilograms)
----------------------------------------------------------------------------------------------------------------
220 or less............................................... 10 1.0 1.0
221-440................................................... 15 1.5 1.5
441-1,100................................................. 20 2.0 2.0
1,101-2,200............................................... 30 3.0 3.0
2,201-4,400............................................... 40 4.0 4.0
4,401-11,000.............................................. 60 6.0 3.0
11,001-22,000............................................. 80 8.0 4.0
22,001-150,000............................................ 100 10.0 5.0
----------------------------------------------------------------------------------------------------------------
(e) Aflatoxin testing. Importers may make arrangements for required
chemical analysis for aflatoxin content at the nearest USDA or USDA-
accredited laboratory. For further information concerning chemical
analysis and a list of laboratories authorized to conduct such analysis
contact: Science and Technology Programs, AMS, USDA, 1400 Independence
Avenue, SW., STOP 0270, Washington, DC 20250-0270; Telephone: (202)
720-5231; Fax: (202) 720-6496.
(1) Aflatoxin test samples shall be received and logged by a USDA
or USDA-accredited laboratory, and each test sample shall be prepared
and analyzed using High Pressure Liquid Chromatography (HPLC) or the
Vicam Method (Aflatest). The aflatoxin level shall be calculated on a
kernel weight basis.
(2) Lots that require a single test sample will be certified as
``negative'' on the aflatoxin inspection certificate if the sample has
an aflatoxin level at or below 15 ppb. If the aflatoxin level is above
15 ppb, the lot fails and the laboratory shall fill out an Imported
Pistachios--Failed Lot Notification report (Form FV-249) as described
in paragraph (h)(1) of this section.
(3) Lots that require two test samples will be certified as
``negative'' on the aflatoxin inspection certificate if Test Sample
1 has an aflatoxin level at or below 10 ppb. If the aflatoxin
level of Test Sample 1 is above 20 ppb, the lot fails and the
laboratory shall fill out an Imported Pistachios--Failed Lot
Notification report (Form FV-249). If the aflatoxin level of Test
Sample 1 is above 10 ppb and at or below 20 ppb, the
laboratory may, at the importer's discretion, analyze Test Sample
2 and average the test results of Test Samples 1 and
2. Alternately, the importer may elect to withdraw the lot
from testing, rework the lot, and resubmit it for testing after
reworking. If the importer directs the laboratory to proceed with the
analysis of Test Sample 2, a lot will be certified as negative
to aflatoxin and the laboratory shall issue an aflatoxin inspection
certificate if the averaged result of Test Samples 1 and
2 is at or below 15 ppb. If the average aflatoxin level of
Test Samples 1 and 2 is above 15 ppb, the lot fails
and the laboratory shall fill out an Imported Pistachios--Failed Lot
Notification report (Form FV-249).
(4) If an importer does not elect to use Test Sample 2 for
certification purposes, the importer may request that the laboratory
return the sample to the importer.
(f) Certification. Each lot of pistachios sampled and tested in
accordance with paragraphs (d) and (e) of this section shall be covered
by an aflatoxin inspection certificate completed by the laboratory. The
certification expires for the lot or remainder of the lot after 12
months. Each such certificate shall set forth the following:
(1) The date and place of sampling and testing.
(2) The name of the applicant.
(3) The Customs entry number pertaining to the lot or shipment
covered by the certificate.
(4) The quantity and identifying marks of the lot tested.
(5) The aflatoxin level of the lot, stated on a kernel weight
basis.
(6) The statement, if applicable: ``Meets U.S. import requirements
under section 8e of the AMA Act of 1937.''
(7) If the lot fails to meet the import requirements, a statement
to that effect and the reasons therefore.
(g) Failed lots/rework procedure. Any lot or portion thereof that
fails to meet the import requirements prior to or after reconditioning
may be exported, sold for non-human consumption, or disposed of under
the supervision of Customs and, if necessary for verification purposes,
the Federal or Federal-State Inspection Programs, with the costs of
certifying the disposal of such lot paid by the importer.
(1) Inshell rework procedure for aflatoxin. If inshell rework is
selected as a remedy to meet the aflatoxin requirements of this part,
then 100 percent of the product within that lot shall be removed from
the bulk and/or retail packaging containers and reworked to remove the
portion of the lot that caused the failure. Reworking shall consist of
mechanical, electronic, or manual procedures normally used in the
handling of pistachios. After the rework procedure has been completed,
the total weight of the accepted product and the total weight of the
rejected product shall be reported by the importer to Customs and USDA
on an Imported Pistachios--Rework and Failed Lot Disposition report
(Form FV-251) as described in paragraph (h)(2) of this section. The
reworked lot shall be sampled and tested for aflatoxin as specified in
paragraphs (d) and (e) of this section, except that the lot sample size
and the test sample size shall be doubled. If, after the lot has been
reworked and tested, it fails the aflatoxin test for a second time, the
lot may be shelled and the kernels reworked, sampled, and tested in the
manner specified for an original lot of kernels, or the failed lot may
be exported, used for non-human consumption, or otherwise disposed of.
(2) Kernel rework procedure for aflatoxin. If pistachio kernel
rework is selected as a remedy to meet the aflatoxin requirements of
this part, then 100 percent of the product within that lot shall be
removed from the bulk and/or retail packaging containers and reworked
to remove the portion of the lot that caused the failure. Reworking
shall consist of mechanical, electronic, or manual procedures normally
used in the handling of pistachios. After the rework procedure has been
completed the total weight of the accepted product and the total weight
of the rejected product shall be reported to Customs and USDA on an
Imported Pistachios--Rework and Failed Lot Disposition report (Form FV-
251). The reworked lot shall be sampled and tested for aflatoxin
[[Page 65419]]
as specified in paragraphs (d) and (e) of this section.
(3) Failed lot reporting. If a lot fails to meet the aflatoxin
requirements of this part, the testing laboratory shall complete an
Imported Pistachios--Failed Lot Notification report (Form FV-249) as
described in paragraph (h)(1) of this section, and shall submit it to
Customs, the importer, and USDA within 10 working days of the test
failure. This form must be completed and submitted each time a lot
fails aflatoxin testing.
(h) Reports and recordkeeping. (1) Form FV-249 Imported
Pistachios--Failed Lot Notification. Each USDA or USDA-accredited
laboratory shall notify the importer; Customs; and the Marketing Order
and Agreement Division, Fruit and Vegetable Programs, AMS, USDA; of all
lots that fail to meet the maximum aflatoxin requirements by completing
this form and submitting it within 10 days of failed aflatoxin testing.
(2) Form FV-251 Imported Pistachios--Rework and Failed Lot
Disposition. Each importer who reworks a failing lot of pistachios
shall complete this report and shall forward it to Customs and the
Marketing Order and Agreement Division, Fruit and Vegetable Programs,
AMS, USDA, no later than 10 days after the rework is completed. If
rework is not selected as a remedy, the importer shall complete and
submit this form within 10 days of alternate disposition of the lot.
(i) Exemptions. Any importer may import pistachios free of the
requirements of this section if such importer imports a quantity not
exceeding a total of 5,000 dried pounds between September 1 and August
31 of each year. Substandard pistachios imported for use in non-human
consumption outlets shall be subject to the safeguard provisions
contained in Sec. 999.500.
(j) Reconditioning prior to importation. Nothing contained in this
section shall be deemed to preclude reconditioning pistachios prior to
importation, in order that such pistachios may be made eligible to meet
the applicable aflatoxin regulations prescribed in paragraphs (c)
through (f) of this section.
(k) Comingling. Certified lots of pistachios may be comingled with
other certified lots, but the comingling of certified lots and
uncertified lots shall cause the loss of certification for the
comingled lots.
(l) Retesting. Whenever USDA has reason to believe that imported
pistachios may have been damaged or deteriorated while in storage, USDA
may reject the then effective inspection certificate and may require
the owner of the pistachios to have them retested to establish whether
or not such pistachios may be shipped for human consumption.
(m) Compliance. Any person who violates any provision of this
section shall be subject to a forfeiture in the amount prescribed in
section 8a(5) of the Agricultural Marketing Agreement Act of 1937, as
amended; 7 U.S.C. 601-674), or, upon conviction, a penalty in the
amount prescribed in section 8c(14) of the said Act, or to both such
forfeiture and penalty. False representation to any agency of the
United States on any matter within its jurisdiction, knowing it to be
false, is a violation of 18 U.S.C. 1001, which provides for a fine or
imprisonments or both.
(n) Other import requirements. The provisions of this section do
not supersede any restrictions or prohibitions on pistachios under the
Federal Plant Quarantine Act of 1912, or any other applicable laws or
regulations of city, county, State, or Federal Agencies including the
Federal Food, Drug and Cosmetic Act.
Dated: October 14, 2011.
David R. Shipman,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2011-27285 Filed 10-20-11; 8:45 am]
BILLING CODE 3410-02-P