The U.S. Food and Drug Administration has issued draft guidance for industry (GFI #233) entitled, “Veterinary Feed Directive Common Format Questions and Answers” to provide animal drug sponsors who are seeking approval for use of their drug in or on animal feed as a veterinary feed directive (VFD) drug with a recommended common format for a fillable form -- called a VFD -- that can later be used by veterinarians to authorize the use of the sponsor’s drug in feed. The draft guidance describes the requirements for sponsor submission of a VFD to FDA as part of the application process for approval of a new animal drug for use in or on animal feed as a VFD drug, as well as the required and optional information to be included on the VFD. The draft guidance also provides examples that illustrate how a common VFD format might appear and how some of the information on the VFD may be pre-populated by a sponsor. By recommending a common format, the draft guidance is expected to help veterinarians, distributors (including feed mills), and animal producers quickly identify relevant information on a VFD order. A common format is also expected to reduce the risk of a veterinarian making an error or leaving out required information when filling in the form. Guidance documents represent the FDA’s current thinking on particular topics, policies, and regulatory issues. While “guidance for industry” documents are prepared primarily for industry, they also are used by FDA staff and other stakeholders to understand the agency’s interpretation of laws and policies.
Bayer AG Chief Executive Werner Baumann defended the company’s planned $66 billion acquisition of U.S. seed maker Monsanto Co. to a gathering of investors and analysts, while laying out increased midterm sales and earnings targets for the crop and pharmaceuticals businesses. “There was a perception that this was something that came out of the blue and was completely off strategy,” Mr. Baumann said of the Monsanto deal.“Just to set the record straight, we were crystal clear, in Sept 2014, that our objective is to build our life-sciences portfolio,” based on health care and agriculture, he added. Mr. Baumann’s comments came less than a week after Bayer announced an agreement to acquire Monsanto for $128 a share, following months of haggling between the two companies.
Sens. Thad Cochran (R., Miss.) and Jon Tester (D., Mont.) introduced legislation to amend a 95-year-old law to address technological advances now being used in livestock sales. The senators’ bill (S. 3350) would amend the Packers & Stockyards Act of 1921 to ensure that the law’s protections are extended to online or video livestock auctions and to ensure modern electronic banking options. “The Packers & Stockyards Act was written to protect the integrity of livestock sales and to promote competition. This legislation is intended to make certain that this law remains an effective tool for livestock producers by recognizing the benefits of modern technology,” Cochran said. “Plain and simple, the old laws on the books are all hat and no cattle. Every year when I buy my steer and hog to feed my family, I think about the folks who are buying and selling 1,000 head. These hardworking producers deserve a sensible process that keeps up with their changing industry,” Tester said. “This is a commonsense bill that will strengthen Montana’s livestock industry and ensure that it continues trucking into the future.” The Senate legislation would clarify that Packers & Stockyards Act provisions apply to online or video auctions. This change would ensure that producer protections provided at fixed-facility livestock markets are extended to those who buy or sell through online or video auctions.
The Trans Pacific Partnership (TPP) sets forth each nation’s tariff commitments. It is argued by many in agriculture that TPP is a good deal and needs all of our support. Others are more critical. The annex sections dealing with Japan appear to be fodder for those who have concern about the fairness of TPP regarding the United States. The section on rice, for example, does not appear to be great. While Canada has four chapters regarding tariff eliminations and tariff rate quotas and Chile has two, there are eight such chapters related to Japan. Among the eight chapters is Japan’s listing of its tariff schedule that numbers 1,133 pages. (HUGE!) The level of detail is mind boggling. It can be read from the Japanese schedule there are certain areas where it imposes substantial tariffs on the product. Certain meats presently have a 50% base rate tariff and in year 1 of the agreement, if ratified, the tariff on Cheek meat and head meat would drop from 50% to 39% and tariffs on such products would last not for 20 years. Even after 20 years a 9% tariff would apply to the product.
The Agricultural Development Bank of China [AGDBC.UL], one of the country's main policy lenders, agreed to loan at least 3 trillion yuan ($450 billion) by 2020 for the modernization of China's agriculture industry, state media said on Sunday. The Ministry of Agriculture and the bank, which lends in line with government policy, signed an agreement to protect national food security, support the sector doing business overseas and develop China's seed industry, according to the official Xinhua news agency. It was not immediately clear whether this commitment is separate from the bank's plan announced in May to lend 3 trillion yuan for poverty reduction via agricultural investments.The move reported on Sunday also aims to increase the agriculture industry's efficiency and foster rural income growth.
U.S. Department of Agriculture (USDA) Under Secretary for Natural Resources and Environment Robert Bonnie today announced a new three-year, $328 million restoration strategy to improve water quality and help coastal ecosystems heal following the Deepwater Horizon oil spill. The strategy will guide how USDA will steer conservation efforts on private lands in priority areas of the Gulf of Mexico region. As Gulf Coast Ecosystem Restoration Council, or RESTORE Council, USDA will work in partnership with the five Gulf States, other federal agencies, and landowners to explore opportunities for how the funding announced today can complement RESTORE Council and other funding from the settlement of the Deepwater Horizon oil spill. Bonnie announced the strategy today from a working forest near Carriere, Mississippi where the landowner has worked with USDA's Natural Resources Conservation Service (NRCS) to adopt a variety of conservation practices to improve water quality downstream.
The Senate has approved a bill to boost efforts to combat illegal wildlife poaching and trafficking, a growing problem worldwide with an estimated cost of up to $10 billion a year. The measure is aimed at protecting a variety of animals, from lions, elephants and rhinos to exotic birds and sharks. It supports ongoing work of a presidential task force on wildlife trafficking and directs U.S. agencies to work with countries affected by wildlife crime, such as the 2015 killing of Cecil the lion by an American during an illegal hunt in Zimbabwe. It also gives prosecutors more tools to go after individuals involved in trophy hunting and other crimes.
Half of private sector employees don’t have access to a workplace retirement savings plan, but by next year several states expect to have new plans up and running. Washington state is anticipating an early 2017 start date for its Small Business Retirement Marketplace, where financial services firms will offer low-cost plans to businesses with less than 100 employees, including solo business owners. The Marketplace will be voluntary for employers—and employees. By contrast, programs in Oregon and Illinois, with expected June 1, 2017 start dates, will be mandatory for employers, while employees will always be able to opt out. In Oregon, employees will be automatically enrolled into a plan that is pooled and professionally managed. In Illinois’ Secure Choice program, employees will be automatically enrolled in a Roth IRA-like savings account.
The National List of Reportable Animal Diseases (NLRAD) was created through a deliberative process led by the United States Animal Health Association/American Association of Veterinary Laboratory Diagnosticians’ Committee on Animal Health Surveillance and Information Systems and the National Animal Health Reporting System Steering Committee. The paper proposes a single, standardized list of reportable animal diseases, and outlines who will be responsible for reporting, and describes how diseases are to be reported. Based on the comments we receive on the proposed NLRAD, we will likely begin rulemaking to publish a proposed rule establishing a new part in title 9, Code of Federal Regulations for the NLRAD and associated reporting requirements. We are seeking stakeholder feedback on the draft plan for responding to emerging animal diseases.Please send your comments by November 1, 2016,
In a notice published in the Federal Register, the agency requests information from the public about how to establish appropriately targeted durations of use for the approximately 32% of therapeutic products affected by GFI #213 with no defined duration of use in order to foster stewardship of medically important antimicrobial drugs in food-producing animals and help preserve the effectiveness of these antimicrobials in animal and human medicine. Specifically, for certain species and disease indications as listed in the FR notice, the FDA wants to obtain additional information on: The underlying diseases requiring these drugs for therapeutic purposes, and periods when livestock or poultry are at risk of developing these diseases; More targeted antimicrobial use regimens for these diseases and husbandry practices that may help avoid the need for these antimicrobials, or that may help make more targeted antimicrobial use regimens more effective; and Strategies for updating affected labeling of drug products that do not currently include a defined duration of use.