Source: http://thefederalregister.com/2012/08/27/2012-20974.html
Timestamp: 2018-02-24 06:03:21
Document Index: 265516687

Matched Legal Cases: ['§ 999', 'art 999', 'art 983', '§ 999', '§ 8', 'art 996', '§ 8', '§ 999', '§ 999', 'ART 999', 'art 999', '§ 999', '§ 999', '§ 999', '§ 999', 'art 983', '§ 999']

Federal Register | Specialty Crops; Import Regulations; New Pistachio Import Req
[Doc. No. AMS-FV-09-0064; FV09-999-1 FR]
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.
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.govorKathy.Finn@ams.usda.gov.
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 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.
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) annuallyduring 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.
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.
The presence or absence of aflatoxin is considered a quality characteristic in pistachios1 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
1Gibbons, Jeff; 2002. Testimony inPistachios Grown in California; Hearing on Proposed Marketing Agreement and Order No. 983.Pages 326-359.
2Sumner, Daniel A; 2002. Testimony inPistachios Grown in California; Hearing on Proposed Marketing Agreement and Order No. 983.2002. Pages 698-735 and 747-820.
3Reinecke, Karen; 2002. Testimony inPistachios 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
4Gibbons, Jeff; 2002. Testimony inPistachios Grown in California; Hearing on Proposed Marketing Agreement and Order No. 983.2002. Pages 326-359.
5Eaton, 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.
67 CFR part 996—Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the United States.
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.
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.
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 accordingto 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.
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 § 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.
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 effectivelycarry 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.
A proposed rule regarding this action was published in theFederal Registeron 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.
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.
PART 999—SPECIALTY CROPS; IMPORT REGULATIONS 1. The authority citation for 7 CFR Part 999 continues to read as follows: Authority:
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.
(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, anddiversion to animal feed or oil manufacture; or
3. Add a new § 999.600 to read as follows:
§ 999.600 Regulation governing the importation of pistachios.
(a)Definitions.As used in this part:
(1)Aflatoxinis one of a group of mycotoxins produced by the moldsAspergillus flavusandAspergillus 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 certificatemeans a certificate issued by a USDA or USDA-accredited laboratory.
(3)Certified lots of pistachiosare those for which aflatoxin inspection certificates have been issued.
(4)Customsmeans the U.S. Customs and Border Protection.
(5)Importation of pistachiosmeans the release of pistachios from the custody of U.S. Customs and Border Protection.
(6)Importermeans a person who engages in the importation of pistachios into the United States.
(7)Inshell pistachiosmeans pistachios that have shells that have not been removed.
(8)Inspection Servicemeans the Federal Inspection Service, Fruit and Vegetable Programs, Agricultural Marketing Service, USDA, or the Federal-State Inspection Programs.
(9)Inspectormeans any inspector authorized by USDA to draw and prepare pistachio samples.
(10)Lotmeans any quantity of pistachios that is submitted for testing purposes under this part.
(11)Personmeans an individual, partnership, limited-liability corporation, corporation, trust, association, or any other business unit.
(12)Pistachiomeans the nut of the pistachio tree,Pistachia vera,whether inshell or shelled.
(13)Secretarymeans 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 pistachiosmeans pistachio kernels, or portions of kernels, after the pistachio shells have been removed.
(15)Substandard pistachiosmeans pistachios, inshell or shelled, that do not comply with the aflatoxin regulations of this section.
(16)USDAmeans 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 laboratorymeans laboratories of the Science and Technology Programs, Agricultural Marketing Service, USDA, that perform chemical analyses of pistachios for aflatoxin content.
(18)USDA-accredited laboratorymeans 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.
(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 clearlyidentified, 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 Lot weight
Minimum number of incremental samples for the lot sample Total weight of lot sample
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 Lot weight
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.
(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 anImported Pistachios—Failed Lot Notificationreport (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 anImported Pistachios—Failed Lot Notificationreport (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 anImported Pistachios—Failed Lot Notificationreport (Form FV-249).
(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:
(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, withthe 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 anImported Pistachios—Rework and Failed Lot Dispositionreport (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 anImported Pistachios—Rework and Failed Lot Dispositionreport (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 anImported Pistachios—Failed Lot Notificationreport (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.