Specialty Crops; Import Regulations; New Pistachio Import Requirements, 51686-51693 [2012-20974]
Download as PDF
<![CDATA[
51686
Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Rules and Regulations
for not postponing the effective date of
this rule until 30 days after publication
in the Federal Register because
handlers have already received the 2012
fiscal year olive crop from growers, the
fiscal year began January 1, 2012, and
the assessment rate applies to all
California olives handled during the
2012 fiscal year and subsequent fiscal
years. Further, handlers are aware of
this rule which was recommended at a
public meeting. Also, a 30-day comment
period was provided for in the proposed
rule.
List of Subjects in 7 CFR Part 932
Olives, Marketing agreements,
Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, 7 CFR part 932 is amended as
follows:
PART 932—OLIVES GROWN IN
CALIFORNIA
1. The authority citation for 7 CFR
part 932 continues to read as follows:
■
Authority: 7 U.S.C. 601–674.
2. Section 932.230 is revised to read
as follows:
■
§ 932.230
Assessment rate.
On and after January 1, 2012, an
assessment rate of $31.32 per ton is
established for California olives.
Dated: August 21, 2012.
Ruihong Guo,
Acting Administrator, Agricultural Marketing
Service.
[FR Doc. 2012–21036 Filed 8–24–12; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 999
[Doc. No. AMS–FV–09–0064; FV09–999–1
FR]
Specialty Crops; Import Regulations;
New Pistachio Import Requirements
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:
This rule establishes a
minimum quality regulation for lots of
pistachios imported into the United
States. The regulation specifies
maximum aflatoxin tolerance levels as
well as mandatory aflatoxin testing and
certification requirements. These import
quality requirements are the same as or
comparable to those in effect for the
pmangrum on DSK3VPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
14:47 Aug 24, 2012
Jkt 226001
domestically produced commodity.
Under this regulation, aflatoxin levels in
imported pistachios may 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.
DATES: Effective Date: September 26,
2012.
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 Email: 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 final
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 final rule adds a new § 999.600
under 7 CFR part 999—Specialty Crops;
Import Regulations, and establishes
quality requirements for maximum
aflatoxin tolerance levels and
mandatory testing and certification
requirements for pistachios offered for
importation into the United States.
These quality requirements for imported
pistachios are the same as or
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
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 final rule also revises § 999.500,
which specifies safeguard procedures
for the importation of walnuts and dates
that are exempt from § 8e regulations.
This section is 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. This regulation was 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
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
E:\FR\FM\27AUR1.SGM
27AUR1
Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Rules and Regulations
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.
Requirements
Definitions
The new regulation includes
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 new regulation, ‘‘pistachio’’
means the nut of the pistachio tree,
Pistachia vera, whether inshell or
shelled. ‘‘Importer’’ is defined as a
person who imports pistachios into the
United States. ‘‘Aflatoxin’’ is defined as
a mycotoxin that can be found in nuts,
dried fruits, and grains. ‘‘Aflatoxin
inspection certificate’’ means a
certificate issued by a USDA or USDAaccredited laboratory. ‘‘USDA
laboratory’’ and ‘‘USDA-accredited
laboratory’’ are defined as laboratories
authorized to test imported pistachios
for aflatoxin content. ‘‘Inspector’’ means
any inspector authorized by USDA to
draw and prepare pistachio samples for
testing. ‘‘Lot’’ means any quantity of
pistachios submitted for testing. Other
terms useful in the administration of the
import regulation are also defined.
pmangrum on DSK3VPTVN1PROD with RULES
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.
VerDate Mar<15>2010
14:47 Aug 24, 2012
Jkt 226001
The new regulation establishes 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
Aflatoxin Sampling and Testing
Procedures
The new regulation provides 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 will be warehoused
near the port or shipped inland to a
pistachio handling facility to await
aflatoxin sampling and testing.
Importers will be responsible for any
transportation or storage fees incurred.
Depending on the size of the lot, a
specified number of incremental
samples will be pulled and combined to
form a lot sample. The lot sample will
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
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.
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
51687
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 must be
properly identified and submitted to a
USDA or USDA-accredited laboratory
for analysis. Test samples will be
prepared and analyzed using High
Pressure Liquid Chromatography
(HPLC) or the immunoaffinity column
with direct flourometry method as
approved by the Association of Official
Analytical Chemists (AOAC). The
aflatoxin level will be calculated on a
kernel weight basis.
For lots of up to 4,400 lbs, one test
sample will be analyzed. If the sample
has an aflatoxin level at or below 15
ppb, the lot may be certified as negative
for aflatoxin on the aflatoxin inspection
certificate, which will be completed by
the laboratory. If the aflatoxin level is
greater than 15 ppb, the lot fails, and the
laboratory will 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 will be prepared. If the first
sample has an aflatoxin level at or
below 10 ppb, the lot may be certified
as negative for aflatoxin on the aflatoxin
inspection certificate. Analysis of the
other test sample would be unnecessary.
If the aflatoxin level of the first test
sample is above 20 ppb, the lot fails,
and the laboratory will 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 may 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 will 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 will 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 will 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 will state that the lot meets
the § 8e import aflatoxin requirements.
The certification will expire after 12
months.
E:\FR\FM\27AUR1.SGM
27AUR1
51688
Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Rules and Regulations
pmangrum on DSK3VPTVN1PROD with RULES
Upon notification of any failed lot, the
importer will work with Customs to
determine the appropriate disposition of
the pistachios. Pistachios that fail to
meet the aflatoxin requirements will 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 will be paid by the importer.
Rework Procedures
Although reworking and retesting of a
failed lot is not required, importers may
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 require importers
to remove 100 percent of the failing lot
from its bulk or retail packaging. These
pistachios are 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 will
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 will be
resampled and tested for aflatoxin. In
the case of a reworked lot, the lot
sample size and the test sample size will
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 may 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 are 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 must
report the lot’s final disposition to
Customs and USDA on a rework and
failed lot disposition report.
Shelled pistachios. Rework
procedures for pistachio kernels failing
to test negative for aflatoxin will also
VerDate Mar<15>2010
14:47 Aug 24, 2012
Jkt 226001
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
will be reported by the importer to
Customs and USDA on the rework and
failed lot disposition report. The
reworked lot of kernels must be
resampled and retested for aflatoxin
content as previously described.
Comingling
Importers may 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 will
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
import regulation, a comparable 5,000pound annual exemption applies to
importers of pistachios for human
consumption. Also, substandard
pistachios imported for use in nonhuman consumption outlets are not
subject to the proposed aflatoxin
regulations.
Compliance
Any importer who violates any
provision of the import regulation may
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 will be used to ensure that
substandard pistachios imported for
purposes other than human
consumption are used only in
authorized outlets exempt from the
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
aflatoxin regulations. The safeguard
procedures are comparable to those
currently specified for the importation
of other exempted commodities. Under
the new regulation, importers and
receivers of pistachios for other than
human consumption purposes are
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 will be used by USDA to
track pistachios marketed for exempted
uses.
This rule establishes maximum
aflatoxin tolerance levels and
mandatory testing and certification
requirements for lots of pistachios
offered for importation into the United
States. The import quality requirements
will 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.
983 and contain no more than 15 ppb
of aflatoxin.
Final 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
final rule on small entities. Accordingly,
AMS has prepared this final 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 there are
approximately 64 importers and
receivers who handled shipments of
pistachios into the United States
between 2007 and 2009. About 10 of the
64 firms are also substantially engaged
in the marketing of U.S. grown
pistachios, and are large firms according
E:\FR\FM\27AUR1.SGM
27AUR1
pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Rules and Regulations
to the SBA definition. Most of the
remaining 54 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 seven
USDA-accredited laboratories in
California that perform aflatoxin testing
for pistachios. AMS estimates that four
of the seven 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. This import regulation
establishes 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 establishes minimum
quality requirements for lots of
imported pistachios by specifying a
maximum aflatoxin tolerance level as
well as aflatoxin testing and
certification requirements. Importers are
responsible for arranging for the
required transportation, storage,
sampling, testing, and certification of
such pistachios prior to importation.
Sampling is conducted by the Federal or
Federal-State inspection services, and
aflatoxin testing and certification is
performed by USDA or USDAaccredited laboratories.
These 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 may 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 are
also described. Lots of imported
pistachios that fail aflatoxin testing may
be diverted to certain non-human
consumption outlets and are subject to
VerDate Mar<15>2010
14:47 Aug 24, 2012
Jkt 226001
the safeguard provisions of § 999.500.
Some reporting and recordkeeping
requirements also are included 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 varies, 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 service to draw and
prepare 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 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
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
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
51689
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 rule on
affected entities, this final rule
establishes an import regulation for
pistachios as provided in section 8e of
the Act. The import regulation requires
importers to arrange for the testing and
certification of all imports of pistachios
for human consumption prior to
importation. There are some increased
costs to importers associated with the
testing and certification of imported
product. However, it is expected that
consumer satisfaction, and therefore
demand, will 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
mentioned above, these import
requirements 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,
these import requirements 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.
This import regulation requires
importers to report any pistachio lots
that fail aflatoxin testing and any lots
that are reworked or disposed on two
new forms. It is estimated that the total
reporting burden associated with these
two forms is 11.6 hours for the industry
as a whole. The new reporting forms
require the minimum amount of
information necessary to effectively
E:\FR\FM\27AUR1.SGM
27AUR1
pmangrum on DSK3VPTVN1PROD with RULES
51690
Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Rules and Regulations
carry out the requirements and intent of
the Act and to administer section 8e
compliance activities. These reports are
the same as or comparable to the reports
and procedures currently required by
other domestic marketing orders and
import regulations.
The alternative to this action is to
continue to allow pistachios to be
imported without having to meet
aflatoxin requirements that are the same
as or comparable to those established for
domestic pistachios. However, the
import regulation is 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.
In compliance with OMB regulations
(5 CFR part 1320) which implement the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35), forms FV–249
Imported Pistachios—Failed Lot
Notification Report and FV–251
Imported Pistachios—Rework and
Failed Lot Disposition Report, were
approved by OMB and assigned OMB
Number 0581–0278 on November 23,
2011. Following the publication of this
final rule, AMS will submit a request to
OMB to merge these two forms with the
forms currently approved under OMB
No. 0581–0215, Pistachios Grown in
California, Arizona, and New Mexico.
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.
Additionally, except for the
applicable domestic regulations, USDA
has not identified any relevant Federal
rules that duplicate, overlap, or conflict
with this rule. Reports and forms
required under the pistachio import
regulation will be reviewed periodically
to reduce information requirements and
duplication by industry and public
sector agencies.
A proposed rule regarding this action
was published in the Federal Register
on October 21, 2011 (76 FR 65411).
Copies of the rule were mailed or sent
via facsimile to all known pistachio
importers and to the embassies of
countries from whom pistachios are
currently imported in significant
volumes. The rule was made available
through the Internet by USDA and the
Office of the Federal Register. A 60-day
comment period ending December 20,
2011, was provided to allow interested
persons to respond to the proposal.
VerDate Mar<15>2010
14:47 Aug 24, 2012
Jkt 226001
Four comments were received during
the comment period in response to the
proposal. All four commenters were
supportive of the proposed regulation.
One commenter, representing the
domestic pistachio industry, noted that
the proposed provisions for reworking
and retesting imported lots that test
positive for aflatoxin provided a
safeguard against testing anomalies so
that shipments are not unfairly rejected
while ensuring a flow of high quality
pistachios into the stream of commerce.
Two private citizen commenters urged
USDA to facilitate the timely and
uniform sampling and testing of
imported lots upon entry to optimize
product freshness and marketability.
Import regulations are applied
uniformly at all U.S. ports of entry, and
Federal and Federal-state inspection
protocols are consistent throughout the
U.S. Similarly, all laboratories
authorized to participate in aflatoxin
testing for imported pistachios have
been approved by USDA and conform to
uniform analytical standards and
practices. The sampling and testing of
imported lots will be handled with the
same timeliness and integrity applied to
domestic lots.
The proposed regulation named a
commercially available testing kit as one
option for aflatoxin analysis in imported
pistachios. One commenter suggested
that any AOAC-approved method,
rather than a particular product, be
specified in the regulation to encourage
the ongoing development of improved
technology and ensure its availability to
the industry. USDA does not intend to
endorse the use of specific commercial
products. However, as mentioned above,
to ensure analytical testing uniformity
and integrity, USDA has currently
approved only two methods for
aflatoxin testing in domestic and
imported pistachios. Both are included
in the import regulation. Accordingly,
§ 999.600(e)(1) of the import regulation
has been modified by replacing the
name of the specific testing kit with a
generic description of the approved
method. USDA would consider further
modifications to the regulation as new
analytical methods are tested and
approved.
A small business guide on complying
with fruit, vegetable, and specialty crop
marketing agreements and orders may
be viewed at: 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
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
Representative has concurred with the
issuance of this final rule.
After consideration of all relevant
matter presented, including the
information provided by the industry
and other available information, it is
hereby found that this rule, as
hereinafter set forth, will tend to
effectuate the declared policy of the Act.
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 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 § 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 (a)(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
E:\FR\FM\27AUR1.SGM
27AUR1
Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Rules and Regulations
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 a new § 999.600 to read as
follows:
pmangrum on DSK3VPTVN1PROD with RULES
§ 999.600 Regulation governing the
importation of pistachios.
(a) Definitions. As used in this part:
(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
VerDate Mar<15>2010
14:47 Aug 24, 2012
Jkt 226001
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
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
51691
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
E:\FR\FM\27AUR1.SGM
27AUR1
51692
Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Rules and Regulations
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
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 ...............................................................................................................
Total weight of
lot sample
(kilograms)
10
15
20
30
40
60
80
100
Weight of test
sample
(kilograms)
2.0
3.0
4.0
6.0
8.0
12.0
16.0
20.0
2.0
3.0
4.0
6.0
8.0
6.0
8.0
10.0
TABLE 2—SHELLED PISTACHIO KERNEL LOT SAMPLING INCREMENTS FOR AFLATOXIN CERTIFICATION
Minimum number
of incremental
samples for the
lot sample
Lot weight
(lbs.)
pmangrum on DSK3VPTVN1PROD with RULES
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 AOACapproved immunoaffinity column with
direct fluorometry method. 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.
VerDate Mar<15>2010
14:47 Aug 24, 2012
Jkt 226001
(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.
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
Total weight 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
(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
E:\FR\FM\27AUR1.SGM
27AUR1
pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Rules and Regulations
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
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
VerDate Mar<15>2010
14:47 Aug 24, 2012
Jkt 226001
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
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–
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
51693
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: August 21, 2012.
David R. Shipman,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2012–20974 Filed 8–24–12; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 1033
[Doc. No. AO–11–0333; AMS–DA–11–0067;
DA–11–04]
Milk in the Mideast Marketing Area;
Order Amending the Order
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:
This final rule amends the
Pool Plant provisions of the Mideast
Federal milk marketing order regulating
distributing plants physically located
within the marketing area, with a Class
I utilization of at least 30 percent and
with combined route disposition and
transfers of at least 50 percent
distributed into Federal milk marketing
areas, as Pool Distributing Plants under
the terms of the order. More than the
required number of producers for the
Mideast marketing area approved the
issuance of the final order as amended.
FOR FURTHER INFORMATION CONTACT: Erin
C. Taylor, Order Formulation and
Enforcement Division, USDA/AMS/
Dairy Programs, STOP 0231–Room
2963, 1400 Independence Ave. SW.,
Washington, DC 20250–0231, (202) 720–
7183, email address: erin.taylor@ams.
usda.gov.
DATES: Effective Date: October 1, 2012.
SUPPLEMENTARY INFORMATION: This final
rule more adequately defines the plants,
and the producer milk associated with
those plants, that serve the fluid needs
SUMMARY:
E:\FR\FM\27AUR1.SGM
27AUR1
]]>Agencies
[Federal Register Volume 77, Number 166 (Monday, August 27, 2012)]
[Rules and Regulations]
[Pages 51686-51693]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20974]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 999
[Doc. No. AMS-FV-09-0064; FV09-999-1 FR]
Specialty Crops; Import Regulations; New Pistachio Import
Requirements
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule establishes a minimum quality regulation for lots of
pistachios imported into the United States. The regulation specifies
maximum aflatoxin tolerance levels as well as mandatory aflatoxin
testing and certification requirements. These import quality
requirements are the same as or comparable to those in effect for the
domestically produced commodity. Under this regulation, aflatoxin
levels in imported pistachios may 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.
DATES: Effective Date: September 26, 2012.
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 Email:
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 final 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 final rule adds a new Sec. 999.600 under 7 CFR part 999--
Specialty Crops; Import Regulations, and establishes quality
requirements for maximum aflatoxin tolerance levels and mandatory
testing and certification requirements for pistachios offered for
importation into the United States. These 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 final rule also revises Sec. 999.500, which specifies
safeguard procedures for the importation of walnuts and dates that are
exempt from Sec. 8e regulations. This section is 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. This regulation was 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 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
[[Page 51687]]
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.
Requirements
Definitions
The new regulation includes 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 new regulation, ``pistachio'' means the nut of the
pistachio tree, Pistachia vera, whether inshell or shelled.
``Importer'' is defined as a person who imports pistachios into the
United States. ``Aflatoxin'' is defined as a mycotoxin that can be
found in nuts, dried fruits, and grains. ``Aflatoxin inspection
certificate'' means a certificate issued by a USDA or USDA-accredited
laboratory. ``USDA laboratory'' and ``USDA-accredited laboratory'' are
defined as laboratories authorized to test imported pistachios for
aflatoxin content. ``Inspector'' means any inspector authorized by USDA
to draw and prepare pistachio samples for testing. ``Lot'' means any
quantity of pistachios submitted for testing. Other terms useful in the
administration of the import regulation are also 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 new regulation establishes 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 new regulation provides 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 will be warehoused near the port or shipped inland to a
pistachio handling facility to await aflatoxin sampling and testing.
Importers will be responsible for any transportation or storage fees
incurred. Depending on the size of the lot, a specified number of
incremental samples will be pulled and combined to form a lot sample.
The lot sample will 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 must be
properly identified and submitted to a USDA or USDA-accredited
laboratory for analysis. Test samples will be prepared and analyzed
using High Pressure Liquid Chromatography (HPLC) or the immunoaffinity
column with direct flourometry method as approved by the Association of
Official Analytical Chemists (AOAC). The aflatoxin level will be
calculated on a kernel weight basis.
For lots of up to 4,400 lbs, one test sample will be analyzed. If
the sample has an aflatoxin level at or below 15 ppb, the lot may be
certified as negative for aflatoxin on the aflatoxin inspection
certificate, which will be completed by the laboratory. If the
aflatoxin level is greater than 15 ppb, the lot fails, and the
laboratory will 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 will be prepared.
If the first sample has an aflatoxin level at or below 10 ppb, the lot
may be certified as negative for aflatoxin on the aflatoxin inspection
certificate. Analysis of the other test sample would be unnecessary. If
the aflatoxin level of the first test sample is above 20 ppb, the lot
fails, and the laboratory will 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 may 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 will 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
will 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 will 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 will state that the lot
meets the Sec. 8e import aflatoxin requirements. The certification
will expire after 12 months.
[[Page 51688]]
Upon notification of any failed lot, the importer will work with
Customs to determine the appropriate disposition of the pistachios.
Pistachios that fail to meet the aflatoxin requirements will 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 will be paid by the importer.
Rework Procedures
Although reworking and retesting of a failed lot is not required,
importers may 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 require importers to remove 100
percent of the failing lot from its bulk or retail packaging. These
pistachios are 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 will 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 will be resampled and tested for aflatoxin. In the case of
a reworked lot, the lot sample size and the test sample size will 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 may 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 are 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 must report the lot's final disposition to Customs
and USDA on a rework and failed lot disposition report.
Shelled pistachios. Rework procedures for pistachio kernels failing
to test negative for aflatoxin will 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 will be reported by the importer to
Customs and USDA on the rework and failed lot disposition report. The
reworked lot of kernels must be resampled and retested for aflatoxin
content as previously described.
Comingling
Importers may 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 will 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 import
regulation, a comparable 5,000-pound annual exemption applies to
importers of pistachios for human consumption. Also, substandard
pistachios imported for use in non-human consumption outlets are not
subject to the proposed aflatoxin regulations.
Compliance
Any importer who violates any provision of the import regulation
may 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 will be used to ensure that substandard pistachios
imported for purposes other than human consumption are used only in
authorized outlets exempt from the aflatoxin regulations. The safeguard
procedures are comparable to those currently specified for the
importation of other exempted commodities. Under the new regulation,
importers and receivers of pistachios for other than human consumption
purposes are 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 will be used by USDA to track pistachios marketed for
exempted uses.
This rule establishes maximum aflatoxin tolerance levels and
mandatory testing and certification requirements for lots of pistachios
offered for importation into the United States. The import quality
requirements will 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. 983 and contain no more than 15 ppb of aflatoxin.
Final 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 final rule on
small entities. Accordingly, AMS has prepared this final 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 there are approximately 64 importers and
receivers who handled shipments of pistachios into the United States
between 2007 and 2009. About 10 of the 64 firms are also substantially
engaged in the marketing of U.S. grown pistachios, and are large firms
according
[[Page 51689]]
to the SBA definition. Most of the remaining 54 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 seven USDA-accredited
laboratories in California that perform aflatoxin testing for
pistachios. AMS estimates that four of the seven 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. This import regulation
establishes 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 establishes minimum quality requirements for lots of
imported pistachios by specifying a maximum aflatoxin tolerance level
as well as aflatoxin testing and certification requirements. Importers
are responsible for arranging for the required transportation, storage,
sampling, testing, and certification of such pistachios prior to
importation. Sampling is conducted by the Federal or Federal-State
inspection services, and aflatoxin testing and certification is
performed by USDA or USDA-accredited laboratories.
These 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 may 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 are also described.
Lots of imported pistachios that fail aflatoxin testing may be diverted
to certain non-human consumption outlets and are subject to the
safeguard provisions of Sec. 999.500. Some reporting and recordkeeping
requirements also are included 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 varies, 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
service to draw and prepare 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 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 rule on affected entities, this final
rule establishes an import regulation for pistachios as provided in
section 8e of the Act. The import regulation requires importers to
arrange for the testing and certification of all imports of pistachios
for human consumption prior to importation. There are some increased
costs to importers associated with the testing and certification of
imported product. However, it is expected that consumer satisfaction,
and therefore demand, will 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 mentioned above, these import requirements 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, these import requirements 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.
This import regulation requires importers to report any pistachio
lots that fail aflatoxin testing and any lots that are reworked or
disposed on two new forms. It is estimated that the total reporting
burden associated with these two forms is 11.6 hours for the industry
as a whole. The new reporting forms require the minimum amount of
information necessary to effectively
[[Page 51690]]
carry out the requirements and intent of the Act and to administer
section 8e compliance activities. These reports are the same as or
comparable to the reports and procedures currently required by other
domestic marketing orders and import regulations.
The alternative to this action is to continue to allow pistachios
to be imported without having to meet aflatoxin requirements that are
the same as or comparable to those established for domestic pistachios.
However, the import regulation is 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.
In compliance with OMB regulations (5 CFR part 1320) which
implement the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35),
forms FV-249 Imported Pistachios--Failed Lot Notification Report and
FV-251 Imported Pistachios--Rework and Failed Lot Disposition Report,
were approved by OMB and assigned OMB Number 0581-0278 on November 23,
2011. Following the publication of this final rule, AMS will submit a
request to OMB to merge these two forms with the forms currently
approved under OMB No. 0581-0215, Pistachios Grown in California,
Arizona, and New Mexico.
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.
Additionally, except for the applicable domestic regulations, USDA
has not identified any relevant Federal rules that duplicate, overlap,
or conflict with this rule. Reports and forms required under the
pistachio import regulation will be reviewed periodically to reduce
information requirements and duplication by industry and public sector
agencies.
A proposed rule regarding this action was published in the Federal
Register on October 21, 2011 (76 FR 65411). Copies of the rule were
mailed or sent via facsimile to all known pistachio importers and to
the embassies of countries from whom pistachios are currently imported
in significant volumes. The rule was made available through the
Internet by USDA and the Office of the Federal Register. A 60-day
comment period ending December 20, 2011, was provided to allow
interested persons to respond to the proposal.
Four comments were received during the comment period in response
to the proposal. All four commenters were supportive of the proposed
regulation. One commenter, representing the domestic pistachio
industry, noted that the proposed provisions for reworking and
retesting imported lots that test positive for aflatoxin provided a
safeguard against testing anomalies so that shipments are not unfairly
rejected while ensuring a flow of high quality pistachios into the
stream of commerce. Two private citizen commenters urged USDA to
facilitate the timely and uniform sampling and testing of imported lots
upon entry to optimize product freshness and marketability. Import
regulations are applied uniformly at all U.S. ports of entry, and
Federal and Federal-state inspection protocols are consistent
throughout the U.S. Similarly, all laboratories authorized to
participate in aflatoxin testing for imported pistachios have been
approved by USDA and conform to uniform analytical standards and
practices. The sampling and testing of imported lots will be handled
with the same timeliness and integrity applied to domestic lots.
The proposed regulation named a commercially available testing kit
as one option for aflatoxin analysis in imported pistachios. One
commenter suggested that any AOAC-approved method, rather than a
particular product, be specified in the regulation to encourage the
ongoing development of improved technology and ensure its availability
to the industry. USDA does not intend to endorse the use of specific
commercial products. However, as mentioned above, to ensure analytical
testing uniformity and integrity, USDA has currently approved only two
methods for aflatoxin testing in domestic and imported pistachios. Both
are included in the import regulation. Accordingly, Sec. 999.600(e)(1)
of the import regulation has been modified by replacing the name of the
specific testing kit with a generic description of the approved method.
USDA would consider further modifications to the regulation as new
analytical methods are tested and approved.
A small business guide on complying with fruit, vegetable, and
specialty crop marketing agreements and orders may be viewed at:
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 final rule.
After consideration of all relevant matter presented, including the
information provided by the industry and other available information,
it is hereby found that this rule, as hereinafter set forth, will tend
to effectuate the declared policy of the Act.
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 amended as
follows:
PART 999--SPECIALTY CROPS; IMPORT REGULATIONS
0
1. The authority citation for 7 CFR Part 999 continues to read as
follows:
Authority: 7 U.S.C. 601-674.
0
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 (a)(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
[[Page 51691]]
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.
0
3. Add a new Sec. 999.600 to read as follows:
Sec. 999.600 Regulation governing the importation of pistachios.
(a) Definitions. As used in this part:
(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 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
[[Page 51692]]
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
----------------------------------------------------------------------------------------------------------------
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
AOAC-approved immunoaffinity column with direct fluorometry method. 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
[[Page 51693]]
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 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: August 21, 2012.
David R. Shipman,
Administrator, Agricultural Marketing Service.
[FR Doc. 2012-20974 Filed 8-24-12; 8:45 am]
BILLING CODE 3410-02-P
