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FDA Issues Guidance on Hops and Wine Grapes

The FDA recently issued Guidance announcing its decision to exercise enforcement discretion with regard to the Produce Safety Rule for entities growing, harvesting, packing or holding hops and wine grapes, as well as almonds and pulse crops (dry, edible seeds in the legume family harvested solely in dried form).

More specifically, while the FDA considers rulemaking to address the unique circumstances of these four crops, the FDA does not expect entities growing, harvesting, packing or holding these commodities to meet any of the Produce Safety Regulation requirements with respect to these commodities.

  1. Hops: The FDA’s rationale for exercising enforcement discretion for hops is that hops used in the making of beer receive adequate pathogen reduction through means other than a cook step (e.g., pH, alcohol content and fermentation) and hops are not used outside of the brewing process.
  2. Wine Grapes: For wine grapes exclusively grown for use in winemaking, the FDA believes similarly, i.e., that wine grapes receive adequate pathogen reduction through means other than a cook step citing again pH, alcohol content and fermentation. In addition, the FDA believes that wine grapes grown, harvested and used solely for wine are a sufficiently distinct commodity from table grapes so they can be regulated differently (table grapes remain subject to the Produce Safety Rule). Furthermore, in the law that ended the government shutdown earlier this year, Congress said that no funds may be used to enforce the Produce Safety Rule with respect to grape varietals that are used solely for wine and receive commercial processing that adequately reduces the presence of microorganisms of public health significance. Undoubtedly, this helped move the FDA towards its decision to not enforce the Produce Safety Rule with regard to wine grapes.

The FDA’s guidance is effective immediately.




TTB to Allow Proprietors to Request Alternating Premise Variances for Storage of Tax- and Non-Tax-Determined Commodities

On May 16, 2018, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued Industry Circular 2018-3, allowing proprietors of distilled spirits plants (DSPs), bonded wine cellars (BWCs) and breweries to submit a request for a variance to the typical method for storing tax-determined and non-tax-determined products. Under TTB regulations, a proprietor designates areas of the premises as bonded and non-bonded. With few exceptions, tax-determined products can only be stored on non-bonded areas of the premises and non-tax-determined products can only be stored in bonded areas.

Under Industry Circular 2018-3, proprietors may request a variance to the bonded/non-bonded designations established in existing regulations. This variance would allow an “alternation” of a specific area or multiple areas between a bonded and non-bonded designation. An “alternation” allows two practices (e.g., brewing and winemaking) statutorily prohibited from occurring at the same premise to occur through the creation of a legal fiction. The premise “alternates” between one type of premise to accomplish one task and reverts to another type of premise to accomplish another task. (more…)




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