Joi Jackson

A Tale of Two Maps: Why Crop Insurance Is Different.

People often ask why Washington has to involve itself at all in providing crop insurance to American farmers. After all, homeowners across the country buy fire insurance, individuals buy life insurance, business owners buy casualty and liability insurance, all without taxpayers having to kick in subsidies.  So why are farmers any different?  Why the special […]

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“Dietary Supplement” is a Proper Statement of Identity

FDA has revised a guidance document to acknowledge that “Dietary Supplement” alone properly may be used as the statement of identity in labeling a dietary supplement.  Announcement of this revision was published in a Federal Register notice on March 7th. The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended section 403 of the

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RMA’s 2.2 Percent “Improper Payment” Rate: Why this Matters.

At the recent crop insurance industry conference in Indian Wells, California, Brandon Willis, administrator of USDA’s Risk Management Agency or RMA, surprised many and made some trade-press headlines by announcing a seemingly-obscure statistic: that RMA’s “improper payment” rate — a closely-watched standardized measure of waste and abuse required of all major Federal spending programs –

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SNAP, Crackle, Pot! Kentucky Federal Court Holds FNS Cannot Deny a Retailer’s Food Stamp Authorization for Misdemeanor Marijuana Conviction

USDA’s Food & Nutrition Service (FNS) is authorized to administer the Supplemental Nutrition Assistance Program (“SNAP”).  This $80 billion program, formerly known as the food stamp program, provides monthly supplemental nutrition benefits to more than 45 million Americans.  SNAP beneficiaries may redeem their monthly benefits at over 250,000 SNAP-authorized retailers across the country.   To participate

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Medical Privacy Update: HHS Guidance on Permitted Uses and Disclosures of PHI for Treatment and Health Care Operations

Late last week, HHS’s Office for Civil Rights (OCR) and Office of the National Coordinator for Health IT (ONC) issued two Fact Sheets (or guidance documents) intended to assist regulated industry in Understanding Some of HIPAA’s Permitted Uses and Disclosures of protected health information (PHI): Permitted Uses and Disclosures: Exchange for Health Care Operations, 45

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Interstate Structure to Oversee and Regulate Medical Marijuana

There is a need for an interstate structure to provide coordination and regulatory oversight of medical marijuana (cannabis) use in the 23 states that have approved its use by either referendum or legislation.  Five jurisdictions — Colorado, Washington, Oregon, Alaska and the District of Columbia — have now also authorized the recreational use of cannabis.

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OFW Law Trial Team Wins Five Hog Nuisance Cases in Indiana

Beginning in late 2009 and early 2010, attorneys Richard Hailey of Indianapolis, Charles Speer and Britt Bieri of Kansas City, and Richard Middleton brought five lawsuits based on negligence and nuisance in Randolph County, Indiana, on behalf of neighbors against Maxwell Farms of Indiana and several individual farmers.  The complaints stated that the basis for

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For Crop Insurance AIPs, a New Financial Environment

USDA’s Federal crop insurance program has benefited from a unique public-private partnership that is one of the most successful in government.  USDA’s Risk Management Agency (RMA) and Federal Crop Insurance Corporation (FCIC) set the insurance policies, subsidize them and regulate them, but they rely on private agents and insurance companies (called Approved Insurance Providers or

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It’s Not What You Call It – It’s How You Manage It

By OFW Law and HACCP Consulting Group Under the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) made the decision that registered facilities would be required to implement food safety plans based on preventive controls rather than the principles of HACCP.  Since HACCP is already mandatory for identified hazards in seafood, juice and foods

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Arbitration in Federal Crop Insurance AIP-Farmer Disputes

This past year, USDA’s Risk Management Agency (RMA), which administers the Federal crop insurance program on behalf of USDA’s Federal Crop Insurance Corporation (FCIC), quietly issued three new regulatory interpretations with deep implications for the conduct of arbitration between FCIC farmer-customers and companies the sell them crop insurance (Approved Insurance Providers or AIPs).   The impact,

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Bernie on Agriculture

By Marshall Matz, as published in Agri-Pulse Earlier this month, I summarized the agriculture positions of the candidates for President on both sides of the aisle. You can read that column here. Since that time, Senator Bernie Sanders (I-VT) who is running for the Democratic nomination, (“Bernie” as he prefers) has released a position paper on agriculture entitled

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Doom and Gloom Suggest “Keeping Watch on Listeria”

Dr. Doom and Ms. Gloom have been addressing the fact that both FSIS and FDA are paying more attention to Listeria control in ready-to-eat facilities.  In previous blogs, they have discussed facility maintenance and repair as well as employee practices.  Doom and Gloom also recommend that facilities that manufacture RTE foods maintain a Listeria Control

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Senate Agriculture Committee Approves the Improving Child Nutrition Integrity and Access Act of 2016

They did it.  Senate Agriculture, Nutrition and Forestry Committee Chairman Pat Roberts (R-KS) and Ranking Member Debbie Stabenow (D-MI) have completed their personal work on the Improving Child Nutrition Integrity and Access Act of 2016, and got it approved today with a unanimous vote of their Committee members. They did it.  They crafted a bill

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“The Guidance Is Coming” . . . For Real! OCR Issues Guidance On Individuals’ Right to Access

In our last blog on medical privacy, we noted that HHS’s Office for Civil Rights (OCR) promised that a number of HIPAA guidances were forthcoming in the next several months.  It appears that (at least so far) OCR is keeping its promise, issuing its long-awaited guidance addressing Individuals’ Right under HIPAA to Access their Health

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2015 Dietary Guidelines for Americans Released… And Some Thought Already Being Given to the 2020 Guidelines!

The Secretaries of Agriculture and Health and Human Services have released the 2015-2020 Dietary Guidelines for Americans (DGA) following what had been a captivating review of the Scientific Report of the Dietary Guidelines Advisory Committee, a process that began in 2013.  In the end, the Guidelines continue many of the recommendations made by the 2010

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Medical Privacy Update and 2015 Retrospective

MEDICAL PRIVACY UPDATE: New PHI Disclosures Permitted for Firearm Background Checks Earlier today, HHS published a Final Rule modifying the HIPAA Privacy Rule (45 C.F.R. § 164.512) to allow certain Covered Entities to disclose limited PHI to the FBI’s National Instant Criminal Background Check System (NICS) to help identify individuals subject to the “Federal mental

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Database for Dietary Ingredient Content of Dietary Supplements

Scientists from the Agricultural Research Service’s (ARS) Nutrient Data Laboratory, part of the Beltsville Human Nutrition Research Center, and the National Institutes of Health’s (NIH) Office of Dietary Supplements, in collaboration with other federal agencies, earlier this year updated and released a database that validates the content of popular dietary supplements — the Dietary Supplement

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New Law Phases in Federal Ban of Microbeads in Personal Care Products – Preempts State Laws

President Obama signed into law this week the Microbead-Free Waters Act of 2015 (H.R. 1321), which amends the Federal Food, Drug and Cosmetics Act to prohibit the manufacture and introduction into interstate commerce of rinse-off cosmetics containing intentionally-added plastic microbeads.  The small plastic particles, often found in face washes, soaps and toothpaste, have become a

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CFSAN Office Restructuring

FDA has created within CFSAN the Office of Dietary Supplement Programs (ODSP), elevating the program from its previous status as a division under the Office of Nutrition, Labeling and Dietary Supplements (ONLDS).  Elevating the program’s position will raise the profile of dietary supplements within the agency, and will enhance the effectiveness of dietary supplement regulation

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Beef and Pork are Now Un-COOL, and That’s a Good Thing

America’s meat industry and our trading partners engaged in a collective sigh of relief on Friday. Prior to embarking on his annual Christmas retreat to Hawaii, President Obama signed the 2016 Consolidated Appropriations Act into law. Tucked into the 2,009-page bill was a measure that repeals USDA’s special country-of-origin labeling (COOL) requirements for fresh and

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FDA Final Rule: CGMPs and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

On September 17, 2015, the federal Food and Drug Administration (“FDA”) released a major final rule to implement the Food Safety Modernization Act (“FSMA”): Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (the “Final Rule”), 80 Fed. Reg. 56170 (Sept. 17, 2015). Additional information on the FSMA and the

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Doom and Gloom Certified as Lead Instructors for FSCPA Preventive Controls for Human Food

Happy Holidays from OFW Law’s Dr. Barbara Masters, D.V.M., and Jolyda Swaim, A.K.A Dr. Doom and Ms. Gloom.  As 2016 approaches, it is time for many of you to start considering the need to comply with the mandatory training requirements for Qualified Individuals as part of the FDA Hazard Analysis, Risk-Based Preventive Controls regulation.  Dr. Doom and Ms. Gloom

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