Specialty Crops; Import Regulations; Proposed Pistachio Import Requirements
This proposed rule invites comments on the establishment of a minimum quality regulation for lots of pistachios imported into the United States. The regulation would specify maximum aflatoxin tolerance levels as well as mandatory aflatoxin testing and certification requirements. The proposed import quality requirements would be the same as or comparable to those in effect for the domestically produced commodity. Under this proposal, aflatoxin levels in imported pistachios could not exceed 15 parts per billion (ppb), as certified by aflatoxin inspection certificates issued by an accredited laboratory. This action is intended to assure consumers that all pistachios offered for sale in the United States meet the same aflatoxin standards, thus promoting high quality product in the market place and fostering consumer satisfaction. This rule also announces the Agricultural Marketing Service's (AMS) intention to request approval by the Office of Management and Budget (OMB) of a new information collection requirement, including two new forms that would be completed by either laboratories or pistachio importers.
Table of Contents Back to Top
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- Proposed Requirements
- Maximum Aflatoxin Tolerance
- Aflatoxin Sampling and Testing Procedures
- Rework Procedures
- Initial Regulatory Flexibility Analysis
- Paperwork Reduction Act
- Imported Pistachios—Failed Lot Notification—Form FV-New
- Imported Pistachios—Rework and Failed Lot Disposition Report—Form FV-New
- List of Subjects in 7 CFR Part 999
- PART 999—SPECIALTY CROPS; IMPORT REGULATIONS
Tables Back to Top
- Table 1—Inshell Pistachio Lot Sampling Increments for Aflatoxin Certification
- Table 2—Shelled Pistachio Kernel Lot Sampling Increments for Aflatoxin Certification
DATES: Back to Top
Comments must be received by December 20, 2011. Pursuant to the Paperwork Reduction Act, comments on the forms and information collection burden must be received by December 20, 2011.
ADDRESSES: Back to Top
Interested persons are invited to submit written comments concerning this proposal. Comments should be sent to the Docket Clerk, Marketing Order and Agreement Division, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet: http://www.regulations.gov. All comments should reference the document number and the date and page number of this issue of the Federal Register and will be available for public inspection in the office of the Docket Clerk during regular business hours, or can be viewed at http://www.regulations.gov. All comments submitted in response to this rule will be included in the record and will be made available to the public. Please be advised that the identity of the individuals or entities submitting the comments will be made public on the Internet at the address provided above.
FOR FURTHER INFORMATION CONTACT: Back to Top
Laurel May or Kathleen Finn, Marketing Order and Agreement Division, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or E-mail: Laurel.May@ams.usda.gov or Kathy.Finn@ams.usda.gov.
Small businesses may request information on complying with this regulation by contacting Laurel May at the above mentioned address.
SUPPLEMENTARY INFORMATION: Back to Top
This proposed rule is issued under section 8e of the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act,” which provides that whenever the grade, size, quality, or maturity of certain specified commodities, including pistachios, are regulated under a Federal marketing order, imports of these commodities into the United States are prohibited unless they meet the same or comparable grade, size, quality, and maturity requirements as those in effect for the domestically produced commodities. To ensure that these requirements are met, the Act also authorizes the Department of Agriculture (USDA) to perform inspections and related functions such as commodity sampling, and to issue inspection certificates for such imported commodities.
USDA is issuing this rule in conformance with Executive Order 12866.
There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of import regulations issued under section 8e of the Act.
This proposed rule would add a new § 999.600 under 7 CFR part 999—Specialty Crops; Import Regulations, and would establish quality requirements for maximum aflatoxin tolerance levels and mandatory testing and certification requirements for pistachios offered for importation into the United States. The proposed quality requirements for imported pistachios are the same as or comparable to those established for pistachios grown in California, Arizona, and New Mexico under Marketing Agreement and Order No. 983 (7 CFR part 983) (order), both as amended.
This proposed rule would also revise § 999.500, which currently specifies safeguard procedures for the importation of walnuts and dates that are exempt from § 8e regulations. This section would be revised to include safeguard procedures for the importation of pistachios intended for exempted purposes.
The order prohibits the shipping of pistachios for domestic human consumption that do not meet the quality requirements for aflatoxin levels in the nuts. Such quality requirements specify that aflatoxin levels may not exceed the maximum tolerance of 15 ppb. Pistachios that fail to meet these requirements must be reworked and retested, or disposed of as specified in the order. These regulations were designed to ensure that only high quality pistachios containing low levels of aflatoxin are shipped, thus promoting high quality product in the market place and fostering consumer satisfaction.
The order, which was established for California pistachios in 2004, was recently amended to include the states of Arizona and New Mexico. Pistachios grown in California, Arizona, and New Mexico represent over 99 percent of the U.S. domestic production, and 98 percent of the domestic consumption. Thus, almost all domestically produced pistachios are regulated under Marketing Order No. 983. There is no other Federal marketing order in effect for pistachios produced in the United States.
According to USDA's Foreign Agricultural Service (FAS), Iran is typically the world's largest pistachio producer, followed by the U.S. and Turkey, although Syria's production has increased in recent years. During the three most recent crop years (September through August) for which complete data is available, 2007-08 through 2009-10, the production averages in millions of pounds (inshell basis) for Iran, the U.S., Turkey, and Syria were approximately 386, 350, 120, and 141, respectively.
Historically, the bulk of U.S. pistachio imports have come from Turkey and Iran, although Iranian imports have been prohibited since July 2010. The remainder comes from other countries, including Italy, China, Switzerland, France, Australia, Hong Kong, and Israel. Imported pistachios may be inshell or shelled. According to FAS, the U.S. imported an average of approximately 1.7 million pounds of pistachios (inshell basis) annually during the three crop years from 2007-08 through 2009-10. Average U.S. consumption of pistachios during that same period was approximately 100 million pounds (inshell basis) annually. Imports, therefore, represent approximately two percent of U.S. pistachio consumption.
Proposed Requirements Back to Top
The proposed regulations would include definitions of terms used in the import regulation. Such terms are the same as or comparable to those defined in the marketing order for domestic pistachios as established at 69 FR 17844 (April 5, 2004) and amended at 74 FR 56532 (November 2, 2009).
Under the proposed regulations, “pistachio” would mean the nut of the pistachio tree, Pistachia vera, whether inshell or shelled. “Importer” would be defined as a person who imports pistachios into the United States. “Aflatoxin” would be defined as a mycotoxin that can be found in nuts, dried fruits, and grains. “Aflatoxin inspection certificate” would mean a certificate issued by a USDA or USDA-accredited laboratory. “USDA laboratory” and “USDA-accredited laboratory” would be defined as laboratories authorized to test imported pistachios for aflatoxin content. “Inspector” would mean any inspector authorized by USDA to draw and prepare pistachio samples for testing. “Lot” would mean any quantity of pistachios submitted for testing. Other terms useful in the administration of the import regulation would also be defined.
Maximum Aflatoxin Tolerance
The presence or absence of aflatoxin is considered a quality characteristic in pistachios  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.  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. 
The proposed regulations would establish a maximum aflatoxin tolerance level of 15 ppb for lots of pistachios imported into the U.S. for human consumption. As required under section 8e of the Act, this is the same level currently prescribed for domestic pistachios regulated under the order. Establishing a 15 ppb limit for aflatoxin in all pistachios marketed for human consumption in the United States is expected to bolster overall consumer confidence in pistachio quality and strengthen the demand for pistachios. Comparatively, the international Codex Alimentarius Commission's (Codex) maximum aflatoxin tolerance for pistachios is 10 ppb. The domestic pistachio industry believes that 15 ppb is appropriate to ensure the quality of pistachios sold in U.S. markets,  Research also supports the 15 ppb tolerance.  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. 
Aflatoxin Sampling and Testing Procedures
The proposed regulations provide for aflatoxin sampling procedures based on lot size. Such sampling procedures are the same as or comparable to those established for domestic shipments, and mirror the sampling procedures prescribed for pistachio shipments to the European Union. At the discretion of the importer, pistachio lots arriving at a U.S. port of entry would be warehoused near the port or shipped inland to a pistachio handling facility to await aflatoxin sampling and testing. Importers would be responsible for any transportation or storage fees incurred. Depending on the size of the lot, a specified number of incremental samples would be pulled and combined to form a lot sample. The lot sample would then be divided into smaller test samples, depending upon the size of the lot to be tested. The required weight of lot samples and test samples differs between inshell pistachios and shelled kernels because of the additional weight of the shells for inshell pistachios. The drawing and dividing of all samples must be conducted by or under the supervision of a Federal or Federal-State inspector.
Following the drawing and dividing of samples, each sample would be properly identified and submitted to a USDA or USDA-accredited laboratory for analysis. Test samples would be prepared and analyzed using High Pressure Liquid Chromatography (HPLC) or the Vicam Method (Aflatest). The aflatoxin level would be calculated on a kernel weight basis.
For lots of up to 4,400 lbs, one test sample would be analyzed. If the sample has an aflatoxin level at or below 15 ppb, the lot could be certified as negative for aflatoxin on the aflatoxin inspection certificate, which would be completed by the laboratory. If the aflatoxin level is greater than 15 ppb, the lot fails, and the laboratory would fill out a failed lot notification report for submission to the importer, the U.S. Customs and Border Protection (Customs), and USDA.
For lots of more than 4,400 lbs, two test samples would be prepared. If the first sample has an aflatoxin level at or below 10 ppb, the lot could be certified as negative for aflatoxin on the aflatoxin inspection certificate. Analysis of the other test sample would be unnecessary. If the aflatoxin level of the first test sample is above 20 ppb, the lot fails, and the laboratory would fill out a failed lot notification report for submission to the importer, Customs, and USDA. If the aflatoxin level of the first test sample is higher than 10 ppb and at or below 20 ppb, the importer could elect to test the second sample or rework the lot and resubmit it for testing. If the importer chooses to proceed with testing the second sample, the results from testing both samples would be averaged. If the average results are at or below 15 ppb, the lot may be certified negative for aflatoxin. If the average results are higher than 15 ppb, the lot fails and the accredited lab would submit a failed lot notification report to the importer, Customs, and USDA. If the importer chooses to rework the lot after the first sample is analyzed, the lot would again be subject to sampling and testing as if it were a new lot.
If an aflatoxin inspection certificate is issued certifying that a lot is negative for aflatoxin at any stage of the sequential testing (meaning that the lot's aflatoxin content is below the maximum threshold), the certification would state that the lot meets the § 8e import aflatoxin requirements. The certification would expire after 12 months.
Upon notification of any failed lot, the importer would work with Customs to determine the appropriate disposition of the pistachios. Pistachios that fail to meet the aflatoxin requirements would be required to be sold for non-human consumption, exported to another destination with a higher aflatoxin tolerance, or disposed of under the supervision of Customs, and the Federal or Federal-State Inspection Programs could be called upon to verify disposals. Any costs associated with certifying a disposal would be paid by the importer.
Although reworking and retesting of a failed lot would not be required, importers could opt to take those steps, which would provide them with an opportunity to secure a return for their imported product while maintaining the integrity of the aflatoxin requirements. The alternative would be to dispose of the lot through proper channels as described above. The rework procedures described below are the same as or comparable to those required for domestic pistachios under the order.
Inshell pistachios. Rework procedures for inshell pistachios failing to meet aflatoxin requirements would require importers to remove 100 percent of the failing lot from its bulk or retail packaging. These pistachios would be required to pass through the sorting stages of the handling process in order to remove those nuts having the characteristics most susceptible to harboring aflatoxin. After reworking the lot, the importer would report the weight of the total accepted and rejected product to Customs and USDA on a rework and failed lot disposition report, and the acceptable portion of the reworked lot would be resampled and tested for aflatoxin. In the case of a reworked lot, the lot sample size and the test sample size would be doubled from that specified in the initial testing. If, after having been reworked, the lot fails aflatoxin testing for a second time, the lot could be shelled and the kernels reworked, sampled, and tested in the manner required for an original lot of pistachio kernels. If the importer decides not to pursue further reworking of the failed lot, those pistachios would be prohibited from entering the stream of commerce for domestic human consumption. The lot must be exported, sold for domestic non-human consumption purposes, or disposed of as described above. The importer would report the lot's final disposition to Customs and USDA on a rework and failed lot disposition report.
Shelled pistachios. Rework procedures proposed for pistachio kernels failing to test negative for aflatoxin would also require a reprocessing of 100 percent of the volume of the failing lot. As with inshell pistachios, after reworking, the total weight of the accepted product and the total weight of the rejected product would be reported by the importer to Customs and USDA on the rework and failed lot disposition report. The reworked lot of kernels would be resampled and retested for aflatoxin content as previously described.
Importers could comingle certified lots with other certified lots of pistachios. However, to maintain the integrity of certified lots, the comingling of certified and uncertified lots of pistachios would cause the loss of certification for the comingled lots.
Section 983.70 of the marketing order provides that domestic handlers may handle pistachios free of the regulatory and assessment provisions of the order if such pistachios are handled in quantities not exceeding 5,000 dried pounds during any production year. The purpose of this provision is to provide an exemption from the requirements of the order for small quantities of pistachios such as those that are grown for home or personal use. Further, this exemption is applied on a production year basis. Accordingly, under the proposed import regulation, a comparable 5,000-pound exemption would apply to all shipments of pistachios imported for human consumption. Also, substandard pistachios imported for use in non-human consumption outlets would not be subject to the proposed aflatoxin regulations.
Any importer who violates any provision of the proposed import regulations would be subject to a forfeiture in the amount prescribed in section 608a(5) of the Act (7 U.S.C. 601-674), or, upon conviction, penalties in the amounts prescribed in section 608c(14) of the Act, or to both forfeiture and penalty. False representation to any agency of the United States on any matter within its jurisdiction, knowing it to be false, is a violation of 18 U.S.C. 1001, which provides for a fine or imprisonment or both.
Safeguard procedures in the form of importer and receiver reporting requirements would be used to ensure that substandard pistachios imported for purposes other than human consumption would be used only in authorized outlets exempt from the proposed aflatoxin regulations. The safeguard procedures would be comparable to those currently specified for the importation of other exempted commodities. Under the proposed regulations, importers and receivers of pistachios for other than human consumption purposes would be required to complete and submit to USDA an Importer's Exempt Commodity Form (Form FV-6), the generic form used by importers and receivers of other exempted commodities. The information provided on Form FV-6 would be used by USDA to track pistachios marketed for exempted uses.
The provisions of this proposed rule would establish maximum aflatoxin tolerance levels and mandatory testing and certification requirements for lots of pistachios offered for importation into the United States. The proposed import quality requirements would be implemented in accordance with section 8e of the Act. These provisions are intended to ensure that pistachios imported into the United States for the purposes of domestic human consumption are of a quality comparable to those pistachios regulated under Marketing Order No. 983 and contain no more than 15 ppb of aflatoxin.
Initial Regulatory Flexibility Analysis Back to Top
Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Import regulations issued under the Act are based on those established under Federal marketing orders.
Small agricultural service firms, which include importers and receivers, have been defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $7,000,000.
AMS estimates that the there are approximately 50 importers and receivers who handled shipments of pistachios into the United States between 2007 and 2009. About 10 of the 50 firms are also substantially engaged in the marketing of U.S. grown pistachios, and are large firms according to the SBA definition. Most of the remaining 40 firms import a number of different food products, and most are also likely to be large firms under the SBA definition, even though they generally import only small quantities of pistachios. There are also nine USDA-accredited laboratories in California that perform aflatoxin testing for pistachios. AMS estimates that four of the nine laboratories would be considered small firms according to the SBA definition.
Turkey and Iran have historically been the source of most pistachios imported into the U.S. Turkish pistachios are imported predominantly in the shell, while Iranian pistachios are typically imported shelled. Imported pistachios also come from Italy, China, Switzerland, France, Australia, Hong Kong, and Italy. Most pistachios imported from other nations are also shelled. The proposed import regulations would establish protocols for aflatoxin analysis for both inshell and shelled pistachios.
Section 8e of the Act provides that when certain domestically produced commodities, including pistachios, are regulated under a Federal marketing order, imports of that commodity must meet the same or comparable grade, quality, size, and maturity requirements.
This rule would establish a minimum quality requirement for lots of imported pistachios by specifying a maximum aflatoxin tolerance level as well as aflatoxin testing and certification requirements. Importers would be responsible for arranging for the required transportation, storage, sampling, testing, and certification of such pistachios prior to importation. Sampling would be conducted by the Federal or Federal-State inspection services, and aflatoxin testing and certification would be performed by USDA or USDA-accredited laboratories.
The proposed import aflatoxin testing and certification requirements are the same as or comparable to those implemented under the order regulating the handling of pistachios grown in California, Arizona, and New Mexico. Pistachios failing to meet the aflatoxin requirements on initial analysis could be reworked and retested, exported to another destination with a higher aflatoxin tolerance, or disposed of in authorized outlets under the supervision of Customs, with assistance from the inspection service if necessary, to verify proper disposal of substandard nuts. Procedures for these activities also are proposed. Lots of imported pistachios that fail aflatoxin testing could be diverted to certain non-human consumption outlets and would be subject to the safeguard provisions of § 999.500. Some reporting and recordkeeping requirements also are proposed in the pistachio import regulation. These requirements also are the same as or comparable to those implemented under the order.
The cost of testing pistachios for aflatoxin would vary, depending on such factors as the location of the port of entry and the size of the lot to be tested. For purposes of estimating an average per-pound testing expense for imported pistachios, this analysis assumes an average lot equal to one container load weighing 16,000 pounds of inshell pistachios arriving at the Port of San Francisco and being tested for aflatoxin by an accredited laboratory in Fresno, California.
In the following example computation of testing costs, there are four elements: (1) A fee (at an hourly rate) charged by the inspection fee to draw the sample, (2) overnight shipping, (3) a fee charged by the laboratory to determine the level of aflatoxin, and (4) the “unit value” of the quantity of pistachios drawn for the sample. The unit value used in this example computation is the average for the last 3 complete marketing years for which import data are available, 2007/08-2009/10. The unit value for the 3-year period ($1.68 per pound) is computed by dividing the average 3-year import value ($2,900,000) by the average import quantity (1,725,000 pounds). Data are from FAS.
The inspection service fee of $74 per hour is multiplied by the estimated time of 2 hours to draw a sample, for a cost of $148. The overnight shipping cost and laboratory fee are estimated at $200 and $100, respectively.
The next step in the example computation is value of pistachios drawn for the sample. Under the new proposed section 996.600, in section (d) Sampling, the weight of a lot sample is 16 kilograms (equivalent to 35.3 pounds) for a lot weighing between 11,001 and 22,000 pounds. Multiplying 35.3 pounds times the unit value of imported pistachios ($1.68) yields a value of the tested sample of approximately $59. Assuming that aflatoxin certification of the 16,000-pound lot requires the testing of only one sample, the sum of the four cost elements would be $507, or approximately 3.2 cents per pound (approximately two percent of the unit value of imported pistachios).
It is likely that a pistachio lot arriving at the Port of San Francisco would be transported to an inland handling facility to await sampling and testing and would incur no additional storage costs. However, if the lot is stored at a Customs warehouse near the port, storage fees ranging between $100 and $500 per day could be incurred while the samples are analyzed. Analysis and certification is estimated to require between two to five days. Assuming a three day turnaround for a lot incurring $200 per day storage fees, approximately $600, or 3.75 cents per pound of pistachios could be added to the testing expense described above.
Regarding the impact of this proposed rule on affected entities, this proposal would establish an import regulation for pistachios as provided in section 8e of the Act. The proposed import regulation would require importers to arrange for the testing and certification of all imports of pistachios for human consumption prior to importation. There would be some increased costs to importers associated with the testing and certification of imported product. However, it is expected that consumer satisfaction, and therefore demand, would be increased by regulating imports and domestic product uniformly. The additional costs are expected to be offset by the benefits of supplying the U.S. marketplace with only high quality pistachios. As mentioned above, the proposed import regulations are the same as or comparable to those established for U.S. domestic pistachio shipments. The domestic industry recently adopted aflatoxin sampling and testing procedures that align with the Codex Alimentarius Commission's (Codex) sampling plan (75 FR 43045; July 23, 2010). The Codex sampling plan is used by the European Commission as its regulation for the importation of tree nuts into the European Union. Thus, the proposed import regulations are comparable to those widely recognized by international pistachio markets.
Industry information suggests that when aflatoxin levels in imported lots of pistachios exceed the FDA maximum tolerance of 20 ppb, the levels are generally significantly higher than 20 ppb. Very few lots test between 15 ppb and 20 ppb. It is anticipated that most imported lots will test below the proposed 15 ppb tolerance. Thus, establishing a maximum aflatoxin tolerance of 15 ppb for imported pistachios is not expected to have a significant impact on trade.
The alternative to this action is to continue to allow pistachios to be imported without having to meet aflatoxin requirements the same as or comparable to those established for domestic pistachios. However, the import regulations are necessary to ensure that imported and domestic pistachios for human consumption in the United States are of uniformly high quality. Further, the Act requires that import regulations be issued whenever marketing order regulations are established for pistachios. Therefore, this alternative is not appropriate.
The additional reporting and recordkeeping requirements that would be imposed under this proposed rule are discussed in more detail below. Reports and forms required under the pistachio import regulation will be periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
Additionally, except for the applicable domestic regulations, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/MarketingOrdersSmallBusinessGuide. Any questions about the compliance guide should be sent to Laurel May at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.
In accordance with section 8e of the Act, the United States Trade Representative has concurred with the issuance of this proposed rule.
Interested persons are invited to comment on this initial regulatory flexibility analysis and submit information on the regulatory and informational impacts this proposed action would likely have on small businesses. A 60-day period for comments is provided. All written comments received within the comment period will be considered before a final determination is made on this matter.
AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
Paperwork Reduction Act Back to Top
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), this notice announces that AMS is requesting OMB approval of a new information collection under OMB No. 0581-NEW. Upon approval of this new information collection by OMB, a request will be made to merge this collection with the forms currently approved for use under OMB No. 0581-0215, Pistachios Grown in California, Arizona, and New Mexico.
Title: Pistachios Imported Into the United States.
OMB Number: 0581-New.
Type of Request: New information collection.
Abstract: The information collection requirements contained in this request are necessary in the administration of proposed regulations for pistachios imported into the United States. Such regulations are authorized under Section 8e of the Agricultural Marketing Agreement Act of 1937 (Act), as amended (7 U.S.C. 601-674), which requires that whenever the Secretary of Agriculture issues grade, size, quality, or maturity regulations under domestic marketing orders for certain commodities, the same or comparable regulations on imports of those commodities must be issued.
The proposed rule would establish mandatory aflatoxin testing and certification requirements for pistachios offered for importation into the United States. These requirements would be the same as or comparable to those established under Marketing Order No. 983 regulating the handling of pistachios grown in California, Arizona, and New Mexico.
Under the proposed regulation, laboratories that perform chemical analysis of aflatoxin content for imported pistachios would be required to report any lots that fail aflatoxin testing. The Imported Pistachios—Failed Lot Notification Report (FV-249) would be completed by the laboratory and submitted to the importer, Customs, and USDA within 10 days of the failed test. This report would contain information about the failed lot, including its identity and the aflatoxin level determined during analysis of the lot.
Under the proposed regulations, importers would be required to report the disposition of any failed lots, including those that are reworked to meet the aflatoxin requirements, on the Imported Pistachios—Rework and Failed Lot Disposition Report (FV-251). This report would contain information about the quantity of nuts that were accepted and rejected during rework, and would be used to report the disposition of any pistachios failing aflatoxin testing. Importers would be required to complete and submit the form to Customs and USDA within 10 days of reworking the lot.
USDA and Customs would use the two reports described above to track pistachio lots being offered for importation into the United States and follow up on the disposition of failing lots to ensure that pistachios with aflatoxin levels exceeding the maximum tolerance of 15 ppb are not shipped to domestic human consumption markets.
Safeguard procedures in the form of importer and receiver reporting requirements would be used to ensure that shipments of pistachios exempt from the import regulations are disposed of only in authorized exempt outlets. Under the proposed import regulations, importers of exempt imported pistachios would be required to complete and submit, prior to importation, an Importer's Exempt Commodity Form (FV-6). Form FV-6 would be used for tracking pistachios marketed for exempted uses that do not meet requirements for human consumption. Form FV-6 is an electronic form available through AMS, is used by importers of other commodities to report imports of exempted products, and is already approved by OMB through December 31, 2011 (OMB Control Number 0581-0167—Specified Commodities Imported into the United States Exempt From Import Regulations). Importers and receivers register as users of the electronic form and then are granted access to the reporting system. Receivers use the same system to certify that the commodity has been received and that it will be utilized for authorized exempt purposes.
The two new forms require the minimum amount of information necessary to effectively carry out the requirements of the Act, and their use is necessary to fulfill the intent of the Act and to administer section 8e compliance activities. These reports and the safeguard procedures outlined above are the same as or comparable to the reports and procedures currently required by other domestic marketing orders and import regulations.
The information collected on these forms is used primarily by authorized representatives of USDA, including AMS, Fruit and Vegetable Programs' regional and headquarters staff. AMS is the primary user of the information.
The proposed request for a new information collection under the pistachio import regulations is as follows:
Imported Pistachios—Failed Lot Notification—Form FV-New Back to Top
Estimate of Burden: Public reporting burden for this collection of information is estimated to average 12 minutes per response.
Respondents: USDA and USDA-accredited Laboratories.
Estimated Number of Respondents: 7.
Estimated Number of Responses per Respondent: 4.
Estimated Total Annual Burden on Respondents: 5.6 hours.
Imported Pistachios—Rework and Failed Lot Disposition Report—Form FV-New Back to Top
Estimate of Burden: Public reporting burden for this collection of information is estimated to average 12 minutes per response.
Respondents: Importers of pistachios failing aflatoxin testing.
Estimated Number of Respondents: 10.
Estimated Number of Responses per Respondent: 3.
Estimated Total Annual Burden on Respondents: 6.0 hours.
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments should reference OMB No. 0581-NEW and the pistachio import regulations, and be sent to USDA in care of the Docket Clerk at the previously mentioned address. All comments received will be available for public inspection during regular business hours at the same address.
For the reasons set forth above, 7 CFR Part 999 is proposed to be amended as follows:
PART 999—SPECIALTY CROPS; IMPORT REGULATIONS Back to Top
1. The authority citation for 7 CFR Part 999 continues to read as follows:
2. Amend § 999.500 by revising the section heading and paragraphs (a) and (d) to read as follows:
§ 999.500 Safeguard procedures for walnuts, certain dates, and pistachios exempt from grade, size, quality, and maturity requirements.
(a) Each person who imports or receives any of the commodities listed in paragraphs (a)(1) through (3) of this section shall file an “Importer's Exempt Commodity Form” (FV-6) with the Marketing Order and Agreement Division, Fruit and Vegetable Programs, AMS, USDA, and shall provide a printed copy of the completed Form FV-6 to the U.S. Customs and Border Protection Regional Director or District Director, as applicable, at the port at which the customs entry is filed. A printed copy shall accompany the lot to the exempt outlet specified on the form. Any lot of any commodity offered for inspection or aflatoxin testing and, all or a portion thereof, subsequently imported as exempt under this provision shall also be reported on an “Importer's Exempt Commodity Form.” Such form, accompanied by a copy of the applicable inspection certificate, shall be provided to the Marketing Order and Agreement Division. The applicable commodities are:
(1) Dates which are donated to needy persons, prisoners or Native Americans on reservations;
(2) Walnuts which are: Green walnuts (so immature that they cannot be used for drying and sale as dried walnuts); walnuts used in non-competitive outlets such as use by charitable institutions, relief agencies, governmental agencies for school lunch programs, and diversion to animal feed or oil manufacture; or
(3) Substandard pistachios which are for non-human consumption purposes.
* * * * *
(d) All FV-6 forms and other correspondence regarding entry of 8e commodities must be submitted online, mailed or faxed to the Marketing Order and Agreement Division, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone (202) 720-4607; or Fax (202) 720-5698. FV-6 forms submitted by FAX must be followed by a mailed, original copy of the FV-6.
3. Add § 999.600 to read as follows:
§ 999.600 Regulation governing the importation of pistachios.
(a) Definitions. (1) Aflatoxin is one of a group of mycotoxins produced by the molds Aspergillus flavus and Aspergillus parasiticus. Aflatoxins are naturally occurring compounds produced by molds, which can be spread in improperly processed and stored nuts, dried fruits, and grains.
(2) Aflatoxin inspection certificate means a certificate issued by a USDA or USDA-accredited laboratory.
(3) Certified lots of pistachios are those for which aflatoxin inspection certificates have been issued.
(4) Customs means the U.S. Customs and Border Protection.
(5) Importation of pistachios means the release of pistachios from the custody of U.S. Customs and Border Protection.
(6) Importer means a person who engages in the importation of pistachios into the United States.
(7) Inshell pistachios means pistachios that have shells that have not been removed.
(8) Inspection Service means the Federal Inspection Service, Fruit and Vegetable Programs, Agricultural Marketing Service, USDA, or the Federal-State Inspection Programs.
(9) Inspector means any inspector authorized by USDA to draw and prepare pistachio samples.
(10) Lot means any quantity of pistachios that is submitted for testing purposes under this part.
(11) Person means an individual, partnership, limited-liability corporation, corporation, trust, association, or any other business unit.
(12) Pistachio means the nut of the pistachio tree, Pistachia vera, whether inshell or shelled.
(13) Secretary means the Secretary of Agriculture of the United States or any officer or employee of the United States Department of Agriculture who is, or who may hereafter be, authorized to act in his/her stead.
(14) Shelled pistachios means pistachio kernels, or portions of kernels, after the pistachio shells have been removed.
(15) Substandard pistachios means pistachios, inshell or shelled, that do not comply with the aflatoxin regulations of this section.
(16) USDA means the United States Department of Agriculture, including any officer, employee, service, program, or branch of the Department of Agriculture, or any other person acting as the Secretary's agent or representative in connection with any provisions of this section.
(17) USDA laboratory means laboratories of the Science and Technology Programs, Agricultural Marketing Service, USDA, that perform chemical analyses of pistachios for aflatoxin content.
(18) USDA-accredited laboratory means a laboratory that has been approved or accredited by the U.S. Department of Agriculture to perform chemical analyses of pistachios for aflatoxin content.
(b) Importation requirements. The importation of any lot of pistachios for human consumption is prohibited unless it meets the requirements contained in this section, which are determined to be the same as or comparable to those imposed upon domestic pistachios handled pursuant to Order No. 983, as amended (part 983 of this chapter).
(c) Maximum aflatoxin tolerance. No importer shall ship for domestic human consumption lots of pistachios that exceed an aflatoxin level of 15 ppb. Compliance with the aflatoxin requirements of this section shall be determined upon the basis of sampling by a USDA-authorized inspector and testing by a USDA or USDA-accredited laboratory. All shipments must be covered by an aflatoxin inspection certificate issued by the laboratory. Testing and certification must be completed prior to the importation of pistachios.
(d) Sampling. (1) Prior to, or upon, arrival of a pistachio lot at a port of entry, the importer shall provide a copy of the Customs entry documentation for the pistachio lot or lots to the Inspection Service office that will draw and prepare samples of the pistachio shipment. More than one lot may be listed on one entry document. The documentation shall include: The Customs entry number; the container number(s) or other identification of the lot(s); the weight of the pistachios in each lot being imported, the location where the lot will be made available for sampling; and a contact name or telephone number at the testing location. The Inspection Service shall sign, stamp, and return the entry document to the importer. The importer shall provide a copy of the relevant entry documentation and such other identifying information as may be requested for each pistachio lot to the inspector at the time samples are drawn and prepared.
(2) All sampling for aflatoxin testing shall be performed by USDA-authorized inspectors in accordance with USDA rules and regulations governing the inspection and certification of fresh fruits, vegetables, and other products (7 CFR part 51). The cost of each such sampling and related certification shall be borne by the applicant. Whenever pistachios are offered for sampling and testing, the applicant shall furnish any labor and pay any costs incurred for storing, moving, and opening containers as may be necessary for proper sampling and testing. The applicant should make advance arrangements with the Inspection Service to avoid delay in scheduling sampling. Importers may make arrangements for required sampling by contacting the Inspection Service office closest to where the pistachios will be made available for sampling. For questions regarding inspection services, a list of Federal or Federal-State Inspection Program offices, or for further assistance, importers may contact: Fresh Products Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., Room 1536-S, Washington, DC, 20250; Telephone: (202) 720-5870; Fax: (202) 720-0393.
(3) Lot samples shall be drawn from each lot of pistachios designated for aflatoxin testing, and individual test samples shall be prepared by, or under the supervision of, an inspector. Each sample shall be drawn and prepared in accordance with the sample size requirements outlined in Tables 1 and 2 below. The gross weight of the inshell lot and test samples for aflatoxin testing and the minimum number of incremental samples required are shown in Table 1. The gross weight of the kernel lot and test samples for aflatoxin testing and the minimum number of incremental samples required is shown in Table 2. If more than one test sample is necessary, the test samples shall be designated by the inspector as Test Sample #1 and Test Sample #2. Each sample shall be placed in a suitable container, with the lot number clearly identified, and the importer shall submit it, along with a copy of the customs entry documentation, to a USDA or USDA-accredited laboratory. The importer shall assume all costs for shipping samples to the laboratory.
|Lot weight (lbs.)||Minimum number of incremental samples for the lot sample||Total weight of lot sample (kilograms)||Weight of test sample (kilograms)|
|220 or less||10||2.0||2.0|
|Lot weight (lbs.)||Minimum number of incremental samples for the lot sample||Total weight of lot sample (kilograms)||Weight of test sample (kilograms)|
|220 or less||10||1.0||1.0|
(e) Aflatoxin testing. Importers may make arrangements for required chemical analysis for aflatoxin content at the nearest USDA or USDA-accredited laboratory. For further information concerning chemical analysis and a list of laboratories authorized to conduct such analysis contact: Science and Technology Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0270, Washington, DC 20250-0270; Telephone: (202) 720-5231; Fax: (202) 720-6496.
(1) Aflatoxin test samples shall be received and logged by a USDA or USDA-accredited laboratory, and each test sample shall be prepared and analyzed using High Pressure Liquid Chromatography (HPLC) or the Vicam Method (Aflatest). The aflatoxin level shall be calculated on a kernel weight basis.
(2) Lots that require a single test sample will be certified as “negative” on the aflatoxin inspection certificate if the sample has an aflatoxin level at or below 15 ppb. If the aflatoxin level is above 15 ppb, the lot fails and the laboratory shall fill out an Imported Pistachios—Failed Lot Notification report (Form FV-249) as described in paragraph (h)(1) of this section.
(3) Lots that require two test samples will be certified as “negative” on the aflatoxin inspection certificate if Test Sample #1 has an aflatoxin level at or below 10 ppb. If the aflatoxin level of Test Sample #1 is above 20 ppb, the lot fails and the laboratory shall fill out an Imported Pistachios—Failed Lot Notification report (Form FV-249). If the aflatoxin level of Test Sample #1 is above 10 ppb and at or below 20 ppb, the laboratory may, at the importer's discretion, analyze Test Sample #2 and average the test results of Test Samples #1 and #2. Alternately, the importer may elect to withdraw the lot from testing, rework the lot, and resubmit it for testing after reworking. If the importer directs the laboratory to proceed with the analysis of Test Sample #2, a lot will be certified as negative to aflatoxin and the laboratory shall issue an aflatoxin inspection certificate if the averaged result of Test Samples #1 and #2 is at or below 15 ppb. If the average aflatoxin level of Test Samples #1 and #2 is above 15 ppb, the lot fails and the laboratory shall fill out an Imported Pistachios—Failed Lot Notification report (Form FV-249).
(4) If an importer does not elect to use Test Sample #2 for certification purposes, the importer may request that the laboratory return the sample to the importer.
(f) Certification. Each lot of pistachios sampled and tested in accordance with paragraphs (d) and (e) of this section shall be covered by an aflatoxin inspection certificate completed by the laboratory. The certification expires for the lot or remainder of the lot after 12 months. Each such certificate shall set forth the following:
(1) The date and place of sampling and testing.
(2) The name of the applicant.
(3) The Customs entry number pertaining to the lot or shipment covered by the certificate.
(4) The quantity and identifying marks of the lot tested.
(5) The aflatoxin level of the lot, stated on a kernel weight basis.
(6) The statement, if applicable: “Meets U.S. import requirements under section 8e of the AMA Act of 1937.”
(7) If the lot fails to meet the import requirements, a statement to that effect and the reasons therefore.
(g) Failed lots/rework procedure. Any lot or portion thereof that fails to meet the import requirements prior to or after reconditioning may be exported, sold for non-human consumption, or disposed of under the supervision of Customs and, if necessary for verification purposes, the Federal or Federal-State Inspection Programs, with the costs of certifying the disposal of such lot paid by the importer.
(1) Inshell rework procedure for aflatoxin. If inshell rework is selected as a remedy to meet the aflatoxin requirements of this part, then 100 percent of the product within that lot shall be removed from the bulk and/or retail packaging containers and reworked to remove the portion of the lot that caused the failure. Reworking shall consist of mechanical, electronic, or manual procedures normally used in the handling of pistachios. After the rework procedure has been completed, the total weight of the accepted product and the total weight of the rejected product shall be reported by the importer to Customs and USDA on an Imported Pistachios—Rework and Failed Lot Disposition report (Form FV-251) as described in paragraph (h)(2) of this section. The reworked lot shall be sampled and tested for aflatoxin as specified in paragraphs (d) and (e) of this section, except that the lot sample size and the test sample size shall be doubled. If, after the lot has been reworked and tested, it fails the aflatoxin test for a second time, the lot may be shelled and the kernels reworked, sampled, and tested in the manner specified for an original lot of kernels, or the failed lot may be exported, used for non-human consumption, or otherwise disposed of.
(2) Kernel rework procedure for aflatoxin. If pistachio kernel rework is selected as a remedy to meet the aflatoxin requirements of this part, then 100 percent of the product within that lot shall be removed from the bulk and/or retail packaging containers and reworked to remove the portion of the lot that caused the failure. Reworking shall consist of mechanical, electronic, or manual procedures normally used in the handling of pistachios. After the rework procedure has been completed the total weight of the accepted product and the total weight of the rejected product shall be reported to Customs and USDA on an Imported Pistachios—Rework and Failed Lot Disposition report (Form FV-251). The reworked lot shall be sampled and tested for aflatoxin as specified in paragraphs (d) and (e) of this section.
(3) Failed lot reporting. If a lot fails to meet the aflatoxin requirements of this part, the testing laboratory shall complete an Imported Pistachios—Failed Lot Notification report (Form FV-249) as described in paragraph (h)(1) of this section, and shall submit it to Customs, the importer, and USDA within 10 working days of the test failure. This form must be completed and submitted each time a lot fails aflatoxin testing.
(h) Reports and recordkeeping. (1) Form FV-249 Imported Pistachios—Failed Lot Notification. Each USDA or USDA-accredited laboratory shall notify the importer; Customs; and the Marketing Order and Agreement Division, Fruit and Vegetable Programs, AMS, USDA; of all lots that fail to meet the maximum aflatoxin requirements by completing this form and submitting it within 10 days of failed aflatoxin testing.
(2) Form FV-251 Imported Pistachios—Rework and Failed Lot Disposition. Each importer who reworks a failing lot of pistachios shall complete this report and shall forward it to Customs and the Marketing Order and Agreement Division, Fruit and Vegetable Programs, AMS, USDA, no later than 10 days after the rework is completed. If rework is not selected as a remedy, the importer shall complete and submit this form within 10 days of alternate disposition of the lot.
(i) Exemptions. Any importer may import pistachios free of the requirements of this section if such importer imports a quantity not exceeding a total of 5,000 dried pounds between September 1 and August 31 of each year. Substandard pistachios imported for use in non-human consumption outlets shall be subject to the safeguard provisions contained in § 999.500.
(j) Reconditioning prior to importation. Nothing contained in this section shall be deemed to preclude reconditioning pistachios prior to importation, in order that such pistachios may be made eligible to meet the applicable aflatoxin regulations prescribed in paragraphs (c) through (f) of this section.
(k) Comingling. Certified lots of pistachios may be comingled with other certified lots, but the comingling of certified lots and uncertified lots shall cause the loss of certification for the comingled lots.
(l) Retesting. Whenever USDA has reason to believe that imported pistachios may have been damaged or deteriorated while in storage, USDA may reject the then effective inspection certificate and may require the owner of the pistachios to have them retested to establish whether or not such pistachios may be shipped for human consumption.
(m) Compliance. Any person who violates any provision of this section shall be subject to a forfeiture in the amount prescribed in section 8a(5) of the Agricultural Marketing Agreement Act of 1937, as amended; 7 U.S.C. 601-674), or, upon conviction, a penalty in the amount prescribed in section 8c(14) of the said Act, or to both such forfeiture and penalty. False representation to any agency of the United States on any matter within its jurisdiction, knowing it to be false, is a violation of 18 U.S.C. 1001, which provides for a fine or imprisonments or both.
(n) Other import requirements. The provisions of this section do not supersede any restrictions or prohibitions on pistachios under the Federal Plant Quarantine Act of 1912,or any other applicable laws or regulations of city, county, State, or Federal Agencies including the Federal Food, Drug and Cosmetic Act.
Dated: October 14, 2011.
David R. Shipman,
Acting Administrator,Agricultural Marketing Service.
[FR Doc. 2011-27285 Filed 10-20-11; 8:45 am]
BILLING CODE 3410-02-P
Footnotes Back to Top
1. Gibbons, Jeff; 2002. Testimony in Pistachios Grown in California; Hearing on Proposed Marketing Agreement and Order No. 983. Pages 326-359.Back to Context
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.Back to Context
3. Reinecke, Karen; 2002. Testimony in Pistachios Grown in California; Hearing on Proposed Marketing Agreement and Order No. 983. Pages 152-183.Back to Context
4. Gibbons, Jeff; 2002. Testimony in Pistachios Grown in California; Hearing on Proposed Marketing Agreement and Order No. 983. 2002. Pages 326-359.Back to Context
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.Back to Context