Notifications for United States of America (932 notifications)

This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals cloquintocet-mexyl, pyroxsulam, isopyrazam, fluxapyroxad, prothioconazole, spirotetramat, tetraconazole, fenpyroximate, Bacillus amyloliquefaciens strain F727, 1-Triacontanol, and isoamyl acetate in or on various commodities.

The Food and Drug Administration has filed a petition, submitted by Wm. Wrigley Jr. Company, proposing that the color additive regulations be amended to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum.

The Food and Drug Administration is announcing the effective date for the definition of qualified auditor in the two final rules that appeared in the Federal Register of 17 September 2015. In the Federal Register of 17 September 2015 (80 FR 55908), FDA published a final rule for "Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food" (preventive controls for human food rule). In Section 117.3, FDA included the definition of a qualified auditor. In the definition, FDA provided examples of qualified auditors. Paragraph 2 of the definition reads "An audit agent of a certification body that is accredited in accordance with regulations in part 1, subpart M of this chapter". At the time the final rule published, paragraph 2 referred to a provision in a future final rule: "Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits to Issue Certifications" (third-party certification rule). The preamble to the preventive controls for human food rule stated that FDA would publish a document in the Federal Register announcing the effective date of paragraph (2) once FDA finalized the third-party certification rule (80 FR 55908 at 55954). The final third-party certification rule (80 FR 74569) published in the Federal Register on 27 November 2015, with an effective date of 26 January 2016. This document announces that the effective date for paragraph 2 in the definition of qualified auditor in Section 117.3 (80 FR 55098 at 56147) is 19 September 2016. http://members.wto.org/crnattachments/2016/SPS/USA/16_4032_00_e.pdf

The Food Safety and Inspection Service (FSIS) is amending its recordkeeping regulations to require that all official establishments and retail stores that grind raw beef products for sale in commerce maintain the following records: The establishment numbers of establishments supplying material used to prepare each lot of raw ground beef product; all supplier lot numbers and production dates; the names of the supplied materials, including beef components and any materials carried over from one production lot to the next; the date and time each lot of raw ground beef product is produced; and the date and time when grinding equipment and other related food-contact surfaces are cleaned and sanitized. These requirements also apply to raw beef products that are ground at an individual customer's request when new source materials are used. Effective date: 20 June 2016. A related measure was previously notified on 16 May 2012 as G/SPS/N/USA/2373.

The Animal and Plant Health Inspection Service (APHIS) is advising the public that we have determined that it is warranted to amend cold treatment schedule T107-d-3 in the Plant Protection and Quarantine Treatment Manual to extend the applicability of the treatment to grapefruit from Australia. We have prepared a treatment evaluation document that describes the amended treatment schedule and explains why we have determined that it is effective at neutralizing certain target pests. We are making this treatment evaluation document available to the public for review and comment. Federal Register/Vol. 81, No. 180/Friday, 16 September 2016/pgs. 63735-63736

The Food and Drug Administration has filed a petition, submitted by McCormick & Company, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract to color shell eggs at levels consistent with good manufacturing practice.

The Animal and Plant Health Inspection Service (APHIS) is proposing to amend the regulations concerning the importation of fruits and vegetables to allow the importation of fresh persimmon with calyxes from Japan into the United States. As a condition of entry, the persimmons would have to be produced in accordance with a systems approach that would include requirements for orchard certification, orchard pest control, post-harvest safeguards, fruit culling, traceback, and sampling. The persimmons would also have to be accompanied by a phytosanitary certificate with an additional declaration stating that they were produced under, and meet all the components of, the agreed upon systems approach and were inspected and found to be free of quarantine pests in accordance with the proposed requirements. This action would allow the importation of fresh persimmons with calyxes from Japan while continuing to protect against the introduction of plant pests into the United States. Federal Register/Vol. 81, No. 168/Tuesday, 30 August 2016/Pgs. 59522-59526.

The Animal and Plant Health Inspection Service (APHIS) is proposing to amend the regulations concerning the importation of fruits and vegetables to allow the importation of fresh raspberry fruit from Morocco into the continental United States. As a condition of entry, the raspberries would have to be produced under a systems approach to mitigate for the fungus Monilinia fructigena and would have to be inspected prior to exportation from Morocco and found free of this pest. The raspberries would have to be imported in commercial consignments only, produced at registered places of production, and field inspected for signs of M. fructigena infection no more than 30 days prior to harvest in registered packinghouses. The raspberries would also have to be accompanied by a phytosanitary certificate with an additional declaration stating that the conditions for importation have been met. Raspberry consignments would be subject to further inspection at the port of entry into the continental United States. This action would allow the importation of raspberries from Morocco while continuing to protect against the introduction of plant pests into the United States. Federal Register/Vol. 81, No. 166/Friday, 26 August 2016/Pgs. 58867-58869.

The Animal and Plant Health Inspection Service (APHIS) is proposing to amend the regulations concerning the importation of fruits and vegetables to allow the importation of fresh persimmons from New Zealand into the United States. As a condition of entry, the persimmons would have to be produced in accordance with a systems approach that would include requirements for orchard certification, orchard pest control, post harvest safeguards, fruit culling, traceback, sampling, and treatment with either hot water or modified atmosphere treatment. The persimmons would also have to be accompanied by a phytosanitary certificate with an additional declaration stating that they were produced under, and meet all the components of, the systems approach and were inspected and found to be free of quarantine pests in accordance with the proposed requirements. This action would allow the importation of fresh persimmons from New Zealand while continuing to protect against the introduction of plant pests into the United States. Federal Register/Vol. 81, No. 166/Friday, 26 August 2016/Pgs. 58870-58873.

The Food and Drug Administration (FDA) is extending the dates for compliance with certain provisions in four final rules. FDA is extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, FDA is clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule. The notice published in the Federal Register on 24 August 2016, 81 FR 57784 and can be found at: https://www.gpo.gov/fdsys/pkg/FR-2016-08-24/pdf/2016-20176.pdf.

The Food Safety and Inspection Service (FSIS) is amending its regulations on ante-mortem inspection to remove a provision that permits establishments to set apart and hold for treatment veal calves that are unable to rise from a recumbent position and walk because they are tired or cold. FSIS is also amending its regulations to require all non-ambulatory disabled cattle to be promptly disposed of after they have been condemned. In addition, after review and consideration of comments to the proposed rule, FSIS is amending the regulations by removing a provision that requires ante-mortem inspection to be conducted in pens. This final rule makes clear that FSIS inspectors have the authority to conduct ante-mortem inspection and condemn non-ambulatory disabled veal calves the moment they arrive on the premises of the establishment. These amendments will improve compliance with the Humane Methods of Slaughter Act of 1978 (HMSA) and the humane slaughter implementing regulations. The amendments will also improve the Agency's inspection efficiency by eliminating the time that FSIS inspectors spend re-inspecting nonambulatory disabled veal calves. The effective date of this final rule is 16 September 2016. http://members.wto.org/crnattachments/2016/SPS/USA/16_3421_00_e.pdf

This regulation establishes tolerances for residues of flumioxazin in or on soybean forage and hay.

The Food and Drug Administration (FDA) is issuing a final rule that amends and clarifies the criteria in FDA regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. FDA is amending its regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify FDA of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether FDA has questioned the basis of a conclusion of GRAS status. The notice was published in the Federal Register on 17 August 2016, 81 FR 54959 and can be found at: https://www.gpo.gov/fdsys/pkg/FR-2016-08-17/pdf/2016-19164.pdf.

This regulation establishes tolerances for residues of halauxifen-methyl and its metabolite, XDE-729 acid, in or on barley and wheat.

This regulation establishes tolerances for residues of aminocyclopyrachlor in or on milk and livestock commodities imported into the United States.

This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

The Animal and Plant Health Inspection Service (APHIS) is proposing to amend the regulations governing the importation of plants for planting to add orchid plants of the genera Phalaenopsis and Cymbidium from the Republic of Korea to the list of plants that may be imported into the continental United States in an approved growing medium, subject to specified growing, inspection, and certification requirements. We are taking this action in response to a request from the Republic of Korea and after determining that the plants could be imported under certain conditions, without resulting in the introduction into, or the dissemination within, the United States of a plant pest or noxious weed. Federal Register/Vol. 81, No. 156/Friday, 12 August 2016/pgs. 53334-53336

The Animal and Plant Health Inspection Service (APHIS) is amending the National Poultry Improvement Plan (NPIP), its auxiliary provisions, and the indemnity regulations for the control of H5 and H7 low pathogenic avian influenza. Specifically, we are clarifying who may participate in the NPIP, amending participation requirements, amending definitions for poultry and breeding stock, amending the approval process for new diagnostic tests, and amending slaughter plant inspection and laboratory inspection and testing requirements. These changes will align the regulations with international standards and make them more transparent to Animal and Plant Health Inspection Service stakeholders and the general public. The changes in this final rule were voted on and approved by the voting delegates at the Plan's 2014 National Plan Conference. The Notice is available in English at: https://www.regulations.gov/document?D=APHIS-2014-0101-0004. Federal Register/Vol. 81, No. 156/Friday, 12 August 2016/pg. 53247-53252 On 24 March 2016, we published in the Federal Register (81 FR 15652-15660, Docket No. APHIS-2014-0101) a proposal to amend the regulations by clarifying who may participate in the NPIP and amending participation requirements. We solicited comments concerning our proposal for 60 days ending 23 May 2016. We received one comment by that date.

The Animal and Plant Health Inspection Service is advising the public of our decision to authorize the importation of fresh pomegranates from Peru into the continental United States. Based on the findings of a pest risk analysis, which we made available for the public to review and comment through a previous notice, we have concluded that the application of designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests via the importation of fresh pomegranates from Peru. The notice is available in English at: https://www.regulations.gov/document?D=APHIS-2016-0012-0012. Federal Register/Vol. 81, No. 154/Wednesday, 10 August 2016/pgs. 52810- 52811 In accordance with that process, we published a notice in the Federal Register on 14 March 2016 (81 FR 13310, Docket No. APHIS-2016-0012), in which we announced the availability, for review and comment, of a pest risk assessment (PRA) that identifies pests of quarantine significance that could follow the pathway of importation of pomegranates from Peru into the continental United States. We solicited comments on the PRA and risk management document (RMD) for 60 days, ending on 13 May 2016. We received eight comments by that date.

The Animal and Plant Health Inspection Service (APHIS) is advising the public of our decision to authorize the importation of fresh figs (Ficus carica) from Peru into the continental United States. Based on the findings of a pest risk analysis, which we made available for the public to review and comment through a previous notice, we have concluded that the application of designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests via the importation of fresh figs from Peru. The notice is available in English at: https://www.regulations.gov/document?D=APHIS-2016-0011-0008. Federal Register/Vol. 81, No. 154/Wednesday, 10 August 2016/pgs.52812-52813 In accordance with that process, we published a notice  (1) in the Federal Register on 14 March 2016 (81 FR 13310-13311, Docket No. APHIS-2016-0011), in which we announced the availability, for review and comment, of a pest risk assessment (PRA) that identifies pests of quarantine significance that could follow the pathway of importation of figs from Peru into the continental United States. We solicited comments on the PRA and risk management document (RMD) for 60 days, ending on 13 May 2016. We received four comments by that date.