SECTION I REGULATORY Updated March 2014

Transcription

1 SECTION I REGULATORY This section provides a brief description of federal regulations and guidelines that pertain to the vinegar industry. Although federal regulations are established by the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA) and other agencies, some states may have different requirements. Updated March 2014

2 TABLE OF CONTENTS Page Federal Regulations and Guidelines I-3 General Labeling Requirements I-3 Current Good Manufacturing Practice I-3 Compliance Policy Guides (CPG) for the Vinegar Industry I-3 Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act) I-4 Reportable Food Registry I-6 National Organic Program I-6 Environmental Protection Agency I-6 Relevant Compliance Policy Guides (CPG) for the Vinegar Industry I-7 Acetic Acid Is Not Vinegar FDA Restates Policy I-8 Vinegar is GRAS I-12 Diluted with Water to Uniform 40 Grain Strength I-13 Commercial Strength Vinegar I-14 Table Strength and Pickling Strength Vinegar I-16 Nutrients in Vinegar I-17 Nutritional Labeling of Vinegar I-18 Definition of Natural United States Department of Agriculture and Food and Drug Administration I-19 Use of Vinegar in USDA-Regulated Products with a Natural Claim I-20 The Vinegar Institute s Material Safety Data Sheets (MSDSs) I-21 Vinegar Identified in Standards and Guidelines of Certain Foods I-22 United States Department of Agriculture Definition of Vinegar I-26 Acidulants in Meat and Poultry Products I-27 Residual Alcohol Content I-28 General Alcohol FAQs (Excerpt related to vinegar) I-29 Pesticides and Pesticide Residues I-32 Food and Drug Administration Letter of Guaranty I-33 Vinegar Exclusion from California Hazardous Substances List I-34 Occupational Safety and Health Administration (OSHA) Hazard Communication Standard I-35 I-2

3 FEDERAL REGULATIONS AND GUIDELINES The vinegar industry must comply with certain regulations specified by the Food & Drug Administration (FDA) in the Code of Federal Regulations, i.e., general labeling requirements, current good manufacturing practices and guidelines set forth by the FDA as Compliance Policy Guides (CPGs). Applicable regulations from the National Organic Program (NOP) and the Environmental Protection Agency (EPA) are also noted. A brief description of these regulations follows. GENERAL LABELING REQUIREMENTS All vinegar manufacturers must comply with general federal regulations for declaration of product identity, net quantity, nutritional labeling, ingredient designation and product information as described in the Code of Federal Regulations, Title 21, Part 101. These regulations are contained in Kellen Company s A Labeling Manual for the Food Industry. Specific information related to nutritional labeling can be found on page I-18 of this document. Additional information is also available in the Food and Drug Administration s (FDA), Guidance for Industry: A Food Labeling Guide available at: CURRENT GOOD MANUFACTURING PRACTICE A manufacturer is subject to the Code of Federal Regulations, Title 21, Part Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food. This regulation describes the methods, equipment, facilities and controls for producing processed food. As the minimum sanitary and processing requirements for producing safe and wholesome food, they are an important part of regulatory control over the safety of the nation's food supply. The CGMPs consist of the following subparts: General Provisions, Buildings and Facilities, Equipment, Production and Process Controls and Defect Action Levels. Additional information regarding the CGMPs may be accessed via the FDA website: COMPLIANCE POLICY GUIDES (CPG) FOR THE VINEGAR INDUSTRY Compliance Policy Guides (CPG) explain the Food and Drug Administration s (FDA) policy on regulatory issues related to FDA laws or regulations. CPGs relevant to the vinegar industry can be found on page I- 7. I-3

4 PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 (THE BIOTERRORISM ACT) Food Facility Registration (21 CFR, Subpart H, ) Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in the regulation for human or animal consumption in the U.S. must register with FDA. Examples of "food" include: Dietary supplements and dietary ingredients Infant formula Beverages (including alcoholic beverages and bottled water) Fruits and vegetables Fish and seafood Dairy products and shell eggs Raw agricultural commodities for use as food or components of food Canned and frozen foods Bakery goods, snack food, and candy (including chewing gum) Live food animals Animal feeds and pet food Food contact substances and pesticides are not "food" and as such, a facility that manufactures/ processes, packs, or holds a food contact substance or a pesticide is not required to register with FDA. The Food Facility Registration requirements may be accessed via the FDA website: Prior Notice of Imported Food Shipments (21 CFR Subpart I, ) The FDA must be notified in advance of any shipments of food for humans and animals that are imported into the U.S., unless the food is excluded from Prior Notice. Food contact substances or pesticides are not included in the definition of food. Prior notice can be submitted by using the U.S. Customs and Border Protection s (CBP) Automated Broker Interface of the Automated Commercial System (ABI/ACS) or FDA's Prior Notice System Interface (PNSI). Most of the prior notice information required by the final rule is data usually provided at entry by importers or brokers to CBP after the food arrives in the United States. The Bioterrorism Act requires that this information also be provided to FDA in advance of an imported food's arrival to the U.S. FDA uses this information in advance of the arrival to review, evaluate, and assess the information, and determine whether to inspect the imported food. Requirements related to the Prior Notice of Imported Food Shipment regulation may be accessed via the FDA website: I-4

5 Establishment and Maintenance of Records (21 CFR, Subpart J, ) Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food are required to establish and maintain records that identify the immediate previous source of all foods received, and that identify the subsequent recipient of the food product. Farms and restaurants are excluded from the regulation. When FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, the regulation requires that firms make records available to FDA inspectors as soon as possible, but in no case more than 24 hours after receiving the request. Certain records must be maintained by nontransporters of food (i.e., persons who own food or who hold, manufacture, process, pack, import, receive, or distribute food for purposes other than transportation) and transporters of food. The term transporter refers to persons who have possession, custody, or control of an article of food in the U.S. for the sole purpose of transporting the food, whether by road, rail, water, or air. The term also includes foreign persons that transport food in the U.S., regardless of whether the foreign persons have possession, custody, or control of food for the sole purpose of transporting it. Requirements related to the Establishment and Maintenance of Records regulation may be accessed via the FDA website: Administrative Detention (21 CFR, Subpart K, ) The FDA may detain an article of food on the strength of credible evidence or information resulting from an inspection, examination, or investigation. The regulation requires a detention order to be approved by the FDA District Director of the district where the detained article of food is located, or by a higher official. A copy of the detention order will be given to the owner, operator, and/or agent in charge of the place where the article of food is located and to the owner of the food provided the owner's identity can be determined readily. If FDA issues a detention order for an article of food located in a vehicle or other carrier, the agency also must provide a copy of the detention order to the shipper of record and the owner and operator of the vehicle or other carrier provided the owner's identity can be determined readily. The regulation requires detained articles of food to be held in secure locations, as determined by FDA. The food may not be transferred from the place where it has been ordered detained, or from the place where the detained article has been removed without FDA approval, until FDA terminates the detention order, or the detention period expires. A detention may not exceed 30 days, and violation of a detention order is a prohibited act. A detention order may be appealed by submitting the appeal in writing to the FDA District Director, in whose district the detained article of food is located. The appeal must be submitted within the applicable timeframes established in 21 CFR Requirements related to the Administrative Detention regulation may be accessed via the FDA website: I-5

6 REPORTABLE FOOD REGISTRY The Reportable Food Registry (the Registry) is an electronic portal for the food industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The Registry helps the FDA better protect public health by tracking patterns and targeting inspections. The Registry applies to all FDA-regulated categories of food and feed, except dietary supplements and infant formula. Registered food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Federal, state, and local government officials may voluntarily use the Registry portal to report information about reportable foods. Additional information regarding the Reportable Food Registry may be accessed via the FDA website: NATIONAL ORGANIC PROGRAM The National Organic Program (NOP) is a marketing program housed within the United States Department of Agriculture s (USDA) Agricultural Marketing Service (AMS). The NOP regulations are codified in 7 CFR Part 205. Congress passed the Organic Foods Production Act (OFPA) of The OFPA required the USDA to develop national standards for organically produced agricultural products to assure consumers that agricultural products marketed as organic meet consistent, uniform standards. The NOP establishes national standards for the production and handling of organically produced products, including a National List of substances approved for and prohibited from use in organic production and handling. The OFPA and the NOP regulations require that agricultural products labeled as organic originate from farms or handling operations certified by a State or private entity that has been accredited by USDA. Requirements for labeling products as organic and containing organic ingredients are also established by the NOP. Additional information regarding the NOP is available via the USDA website: ENVIRONMENTAL PROTECTION AGENCY There is a myriad of regulations related to air and water quality. The Environmental Protection Agency (EPA) regulates air and water quality at the Federal level. Additional information on EPA is available via EPA s website: Additional information on the Clean Air Act can be located here: Information on the Clean Water Act can be located here: It is important to note that air and water quality are also often regulated at the state level. Additionally, water may be regulated at the local level. As such, it is important to understand the regulations at the state and local level with respect to air and water standards. I-6

7 RELEVANT COMPLIANCE POLICY GUIDES (CPG) FOR THE VINEGAR INDUSTRY Compliance Policy Guides (CPG) explain the Food and Drug Administration s (FDA) policy on regulatory issues related to FDA laws or regulations. These include Current Good Manufacturing Practice (CGMP) regulations and application commitments. They advise the field inspection and compliance staffs as to the Agency's standards and procedures to be applied when determining industry compliance. Compliance Policy Guides may derive from a request for an advisory opinion, from a petition from outside the Agency, or from a perceived need for a policy clarification by FDA personnel. The following are CPGs relevant to the vinegar industry: CPG Sec Vinegar, Definitions - Adulteration with Vinegar Eels ( CPG Sec Acetic Acid - Use in Foods - Labeling of Foods in Which Used ( ) CPG Sec Alcohol; Use of Synthetic Alcohol in Foods ( Reference: U.S. Food and Drug Administration, Inspections, Compliance, Enforcement, and Criminal Investigations, I-7

8 ACETIC ACID IS NOT VINEGAR FDA RESTATES POLICY The Food and Drug Administration reinforced the position taken by The Vinegar Institute in the final order affirming the GRAS status of acetic acid, published in the June 25, 1982, Federal Register. On June 4, 1979, The Institute filed strong objections to a statement in the proposal which read, Acetic acid is the most widely known form of vinegar, a dilute aqueous solution. It was our contention this statement would be interpreted to indicate that dilute acetic acid and vinegar are identical, and would change FDA s past policy against substitution of acetic acid for vinegar. The final order reads: FDA agrees with the comment and agrees that the above quoted statement... could not be interpreted erroneously. Diluted acetic acid is not vinegar. (Emphasis added) After indicating how acetic acid should be labeled, the preamble to the final order continues: Furthermore, the agency considers it misleading if the labeling of a food in which acetic acid is used implies or suggests that the food contains or was prepared with vinegar. Acetic acid should not be substituted for vinegar in pickled foods, which consumers customarily expect to be prepared with vinegar. A copy of the Federal Register notice follows on the next page. Also, see CPG Sec Acetic Acid - Use in Foods - Labeling of Foods in Which Used ( ) I-8

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12 VINEGAR IS GRAS Title 21, Part 582 details Substances Generally Recognized as Safe (GRAS). Section notes the following with respect to vinegar: It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, sugar, vinegar, baking powder, and monosodium glutamate as safe for their intended use Reference: Code of Federal Regulations, Title 21 Part 582: ( I-12

13 DILUTED WITH WATER TO UNIFORM 40 GRAIN STRENGTH The Food and Drug Administration requires that when water is added to vinegar to reduce the acetic acid strength, the label must indicate: diluted with water to percent acid strength (the blank being filled out with the actual percent of acetic acid). In no case should the acetic acid strength be less than 4%. Section 403 has been tested in the past. The following is the resulting option. VINEGAR Administration assumed that statement Diluted (Reduced) to Legal Strength meant reduced to four per cent acidity, the minimum strength recognized in advisory definition and standard for vinegar under Food and Drugs Act. Statement held to be misleading, and presence of water should be made known under Section 403(i)(2). Statement might read Reduced with water to 40 grain strength, etc. There is no product which could be properly labeled as compound distilled vinegar unless it were a mixture of two different lots of distilled vinegar. TC-53 February 12, 1940 Three of the labels you submit bear the statement Diluted (Reduced) to Legal Strength, by which we assume you mean that they are reduced to four per cent acidity, the minimum strength recognized in the advisory definition and standard for vinegar under the * * * Food and Drugs Act. The label statement is, therefore, misleading in our opinion. Since in diluting the vinegar water is, of course, added, its presence should be made known on the label in the light of the requirements of Section 403(i)(2). The statement might read Reduced with water to 40 grain strength or Diluted with water to 4 per cent acetic acid strength or some equivalent expression which clearly shows the addition of water. It should not be referred to as legal strength since there is no legal standard for vinegar under the * * * new Act. There is not product which could be properly labeled as compound distilled vinegar unless it were a mixture of two different lots of distilled vinegar. If, on the other hand, your vinegar is a mixture of distilled vinegar and some other kind of vinegar, the name of both vinegars should be set forth on the label. If the vinegar has been reduced to a lower grainage or percentage of acid than the original, that fact should be set forth on the label. * * * Reference: The Compliance Policy Guide (CPG), Vinegar, Definitions Adulteration with Vinegar Eels confirms the above interpretation. Links to this CPG as well as other relevant CPGs are noted on page I-7. I-13

14 COMMERCIAL STRENGTH VINEGAR The term commercial strength vinegar has been defined by the Department of the Treasury, Bureau of Alcohol, Tobacco and Firearms as follows: We (Bureau of Alcohol, Tobacco and Firearms) consider commercial strength vinegar to be at least a 40 grain product containing not less than four percent of acetic acid. Also, we reconsidered our position with regard to the amount of residual alcohol which may remain in commercial strength vinegar produced from denatured alcohol and have determined that 0.6 percent of proof spirits (0.3% alcohol by volume) is an unreasonably restrictive limit. Therefore, we are establishing the limit of residual alcohol which may remain in such vinegar at not more than 0.5 percent of alcohol by volume. Thus, your 40 grain product would be a commercial strength vinegar, and a maximum residual alcohol content of 0.5 percent of alcohol by volume in the finished product would be within the limitation established in this letter. References: Letter, January 24, 1975, from O.J. Pierce, Regulatory Enforcement, Bureau of Alcohol, Tobacco and Firearms Code of Federal Regulations (CFR): 27 CFR Approval Policies notes the following: Commercial strength (40 grain) vinegar made from specially denatured alcohol may contain trace amounts of residual alcohol, not to exceed 0.5 percent of alcohol by volume, in the finished product. ( I-14

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16 TABLE STRENGTH AND PICKLING STRENGTH VINEGAR It is the position of The Vinegar Institute that 4.0% vinegar is adequate and appropriate for purposes of food preservation. However, throughout the country when one refers to table strength or pickling strength vinegar (the terms are used synonymously), it is traditionally meant to be 5.0% vinegar. It is recognized that 5.0% vinegar provides added assurance of safe canning and pickling procedures although tests have shown that vinegar at 4.0% destroys those organisms commonly associated with foodborne illness. I-16

17 NUTRIENTS IN VINEGAR Nutritional Value The U.S. Department of Agriculture has done extensive research into the nutritional value of hundreds of foods. The results of their work are included in the USDA National Nutrient Database for Standard Reference, Release 26. Relevant information related to vinegar is provided below: Vinegar, Cider ( Vinegar, Distilled ( Vinegar, Red Wine Vinegar, Balsamic ( Reference: U.S. Department of Agriculture, Agricultural Research Service USDA National Nutrient Database for Standard Reference, Release 26. Nutrient Data Laboratory Home Page, I-17

18 NUTRITIONAL LABELING OF VINEGAR Nutritional Labeling Most vinegars contain insignificant amounts of some or all of the mandatory nutrients required in nutrition labeling. Nutrition analysis of specific vinegar products will provide the information necessary to correctly label each product. Nutrition labeling is not required for vinegar if it meets the requirements for insignificant amounts of ALL of the following components: calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron, as outlined in 21 CFR 101.9(j)(4). The language in 101.9(j)(4) is below: (j) The following foods are exempt from this section or are subject to special labeling requirements: (4) Foods that contain insignificant amounts of all of the nutrients and food components required to be included in the declaration of nutrition information under paragraph (c) of this section, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. (Emphasis added.) Claims or other nutrition information subject the food to the provisions of this section. An insignificant amount of a nutrient or food component shall be that amount that allows a declaration of zero in nutrition labeling, except that for total carbohydrate, dietary fiber, and protein, it shall be an amount that allows a declaration of ``less than 1 gram.'' Foods that are exempt under this paragraph include coffee beans (whole or ground), tea leaves, plain unsweetened instant coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors. *Note: There are other provisions in 21 CFR 101.9(j), only (4) has been included above. The inclusion of nutrition claims or other nutrition information on the label or advertising subjects the product to full nutrition labeling. If the vinegar product contains insignificant amounts of EIGHT or more of the nutrients listed above (including trans fat), nutrition information may be presented in a simplified format. (See 21 CFR 101.9(f)(1) for more information.) Reference: Code of Federal Regulations (CFR: 21 CFR Nutrition Labeling of Food ( Note: In 2014, the U.S. Food and Drug Administration proposed new labeling rules, but no final rule has been issued. I-18

19 DEFINITIONS OF NATURAL - UNITED STATES DEPARTMENT OF AGRICULTURE AND FOOD AND DRUG ADMINISTRATION United States Department of Agriculture (USDA) A product containing no artificial ingredient or added color and is only minimally processed. Minimal processing means that the product was processed in a manner that does not fundamentally alter the product. The label must include a statement explaining the meaning of the term natural (such as "no artificial ingredients; minimally processed"). Reference: U.S. Food and Drug Administration (FDA) In a January 6, 1993 Federal Register notice, it was noted, "FDA is not undertaking a rulemaking to define the term "natural." Because of resource limitations and other agency priorities, FDA is not undertaking a rulemaking to establish a definition for "natural" at this time. The agency will maintain its current policy not to restrict the use of the term "natural" except for added color, synthetic substances and flavors as provided in Additionally, the agency will maintain its policy regarding the use of "natural" as a meaning nothing artificial or synthetic (including all color additives regardless of source) has been included in or has been added to, a food that would not normally be expected to be in the food. Further, at this time, the agency will continue to distinguish between natural and artificial flavors as outlined in " References: 58 Federal Register 2407, January 6, CFR ; ( I-19

20 USE OF VINEGAR IN USDA-REGULATED PRODUCTS WITH A NATURAL CLAIM Products regulated by the United States Department of Agriculture (USDA), as noted on the previous page, are required to meet a definition of natural different than those regulated under the Food and Drug Administration (FDA). Most vinegars are considered natural by the USDA, with the exception of white distilled vinegar. However, there is also a concern with products that are considered multi-functional those ingredients that might also have a preservative effect. Below is a link to USDA s Labeling Policy Book. Pages details information related to natural and the concerns with products that are considered multi-functional ingredients, like vinegar. The following, in part, was shared with The Vinegar Institute, As you may know, since 1982, when the policy on the claim natural was instituted, FSIS [Food Safety Inspection Service] has evaluated labeling bearing the voluntary claim on a case-by-case basis. In terms of using ingredients that were to be more than minimally processed and/or serving a function that is not consistent with the policy (e.g., as a preservative, FSIS has required data to support ingredient use. Since 1982, vinegar derived from fermenting fruits and grains, e.g., rice vinegar and apple cider vinegar, has been considered acceptable. If The Vinegar Institute wishes to submit information (including a detailed process flow description) to show that the production of any vinegar these days is consistent with the description of not more than minimal processing in the FSIS 1982 policy on natural, I believe that this would be a positive way forward to alleviate the concerns that you [The Vinegar Institute] expressed. To date, USDA has not issued a final rule on natural. References: USDA s Food Standards and Labeling Policy Book, August ( from Dr. Robert Post, June 13, 2007 USDA Policy Memoranda ( I-20

21 THE VINEGAR INSTITUTE S MATERIAL SAFETY DATA SHEETS (MSDSs) The Vinegar Institute (VI) commissioned a third party to develop material safety data sheets (MSDSs) for vinegar and concentrated vinegar, which are reviewed on a periodic basis. This information is only available to VI members and is housed on the members-only section of the VI website at Directions to access these documents are provided on the website. I-21

22 VINEGAR IDENTIFIED IN STANDARDS AND GUIDELINES OF CERTAIN FOODS Catsup Standard of Identity Vinegars are identified as an optional ingredient for the catsup standard of identity. Of note, in a final rule of the Food and Drug Administration on April 17, 1984, concerning tomato concentrates, catsup and tomato juice, the FDA confirmed a position that acetic acid cannot be used to replace vinegar in catsup products. The Federal Register states: FDA does not consider diluted acetic acid to be vinegar and, therefore, acetic acid may not be substituted for vinegar in products that consumers customarily expect to be prepared with vinegar. A copy of the Federal Register notice is provided on page I-24. Also, see CPG Sec Acetic Acid - Use in Foods - Labeling of Foods in Which Used ( ) French Dressing Standard of Identity The standard of identity for French dressing (21 Code of Federal Regulations ) specifies vinegar as one of the acidifying ingredient options as follows: Description. French dressing is the separable liquid food or the emulsified viscous fluid food prepared from vegetable oil(s) and one or both of the acidifying ingredients specified in paragraph (b) of this section. Acidifying ingredients. (1) Any vinegar or any vinegar diluted with water, or any such vinegar or diluted vinegar mixed with an optional acidifying ingredient as specified in paragraph (c)(9) of this section. For the purpose of this paragraph, any blend of two or more vinegars is considered to be a vinegar. Reference: Code of Federal Regulations, Title 21, ( Mayonnaise Standard of Identity The standard of identity for mayonnaise (21 Code of Federal Regulations ) specifies vinegar as one of the acidifying ingredient options as follows: Description. Mayonnaise is the emulsified semisolid food prepared from vegetable oil(s), one or both of the acidifying ingredients specified in paragraph (b) of this section (b) Acidifying ingredients. (1) Any vinegar or any vinegar diluted with water to an acidity, calculated as acetic acid, of not less than 21 2 percent by weight, or any such vinegar or diluted vinegar mixed with an optional acidifying ingredient as specified in paragraph (d)(6) of this section. For the purpose of this paragraph, any blend of two or more vinegars is considered to be a vinegar. I-22

23 Reference: Code of Federal Regulations, Title 21, 169,140 ( Salad Dressing Standard of Identity The standard of identity for mayonnaise (21 Code of Federal Regulations ) specifies vinegar as one of the acidifying ingredient options as follows: Description. Salad dressing is the emulsified semisolid food prepared from vegetable oil(s), one or both of the acidifying ingredients specified in paragraph (b) of this section (b) Acidifying ingredients. (1) Any vinegar or any vinegar diluted with water, or any such vinegar or diluted vinegar mixed with an optional acidifying ingredient as specified in paragraph (e)(6) of this section. For the purpose of this paragraph, any blend of two or more vinegars is considered to be a vinegar. Reference: Code of Federal Regulations, Title 21, ( Compliance Policy Guide for Mustard In the absence of a standard of identity for prepared mustard, FDA has established a compliancy policy guide for prepared mustard. Vinegar is listed as one of the ingredients for prepared mustard. Reference: Compliance Policy Guide for Mustard ( United States Standards for Grades of Pickles The United States standards for grades of pickles denotes vinegar as an ingredient in several pickle varieties. Reference: The United States Standards for Grades of Pickles ( I-23

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26 UNITED STATES DEPARTMENT OF AGRICULTURE DEFINITION OF VINEGAR Vinegar is defined as follows in the United States Department of Agriculture s (USDA) Food Standards and Labeling Policy Book: VINEGAR: Product must contain at least 4 grams of acetic acid per 100 cubic centimeters (approximately 4 percent acetic acid). This strength is referred to as 40 grain vinegar. Cider vinegar, which during the course of manufacture has developed an excess of acetic acid over 4 percent, may be reduced to a strength not less 4 percent. Cider vinegar so reduced is not regarded as adulterated but must be labeled as to its nature as diluted or water added cider vinegar. However, when vinegar of any concentration (not less than 4 percent acetic acid) is used in a food product, the only labeling requirement is vinegar. Statements like diluted or water added are not required. Reference: USDA s Food Standards and Labeling Policy Book, August ( I-26

27 ACIDULANTS IN MEAT AND POULTRY PRODUCTS USDA Vinegar Policy A confirmation of the use of vinegar in the preparation of certain meat and poultry products has been received from the USDA Food Safety and Inspection Service. The agency has agreed to protect the integrity of the term pickled by continuing to require the use of vinegar in pickled meat products. A letter to The Vinegar Institute from Donald L. Houston, Administrator of the USDA Food Safety and Inspection Service has stated: The Food Safety and Inspection Service (FSIS) shares your views regarding the use of acetic acid in place of vinegar. Our policy has been and still is identical to the policy of the Food and Drug Administration (FDA). We have consistently declined to allow diluted acetic acid to replace vinegar. The purpose of the acidifier rule published in the Federal Register on September 12 [1984] was to allow the use of various food grade acids as ph control agents in meat and poultry products. It was not intended to allow the use of these acids to prepare pickling solutions. We will continue to require the use of vinegar in vinegar pickles. References: November 14, 1984 from D.L. Houston, United States Department of Agriculture Pickled products are mentioned throughout USDA s Food Standards and Labeling Policy Book, August ( USDA Policy Memoranda ( I-27

28 RESIDUAL ALCOHOL CONTENT The Department of the Treasury, Bureau of Alcohol, Tobacco and Firearms, has stated that they consider that the amount of residual alcohol which may remain in commercial strength vinegar produced from specially denatured alcohol shall be not more than 0.5 percent of alcohol by volume. Thus, the Bureau has determined that a 40 grain product would be a commercial strength vinegar, and a maximum residual alcohol content of 0.5% alcohol by volume in the finished product is within the limit established. References: 1/24/75 Letter to R.H. Kellen from Ora J. Pierce, Bureau of Alcohol, Tobacco and Firearms Code of Federal Regulations (CFR): 27 CFR Approval Policies notes the following: Commercial strength (40 grain) vinegar made from specially denatured alcohol may contain trace amounts of residual alcohol, not to exceed 0.5 percent of alcohol by volume, in the finished product. Note: The residual alcohol amount of not more than 0.5 percent alcohol by volume is also confirmed on the Alcohol and Tobacco Tax and Trade Bureau s website ( on the page, General Alcohol FAQs under the section, Vinegar production using specially denatured alcohol (SDA). Additionally, the citation in the Code of Federal Regulations (CFR), 21 CFR notes the following: Commercial strength (40 grain) vinegar made from specially denatured alcohol may contain trace amounts of residual alcohol, not to exceed 0.5 percent of alcohol by volume, in the finished product. I-28

29 General Alcohol FAQs (Excerpt related to vinegar) Alcohol and Tobacco Tax and Trade Bureau U. S. Department of the Treasury G7: Are commercial vinegar producers regulated by TTB? Yes. Many vinegar production methods include a stage where alcohol has developed but vinegar, with its distinctive sour taste, has not. TTB regulates commercial vinegar production when there is a potential Federal excise tax liability as beverage alcohol under 26 U.S.C. 5001, 5041, or 5051 at any stage of production, including on raw materials used to make the vinegar. Finished vinegar is not subject to alcohol beverage excise tax for any one of the following reasons: the manufacturing process makes it unsuitable for beverage use; the manufacturing process does not involve the production of alcohol; or none of the ingredients used to make the vinegar are subject to excise tax. TTB does not regulate the following types of commercial vinegar production: vinegar made by diluting acetic acid; wine vinegar made from purchased wine that was made unfit for beverage use by the producing winery; or rice or malt vinegar made from purchased rice wine or beer that was made unfit for beverage use by the producing brewery. Generally, all other vinegar production methods are regulated by TTB. The TTB requirements to produce various types of finished vinegar are discussed below. Our website contains links to the TTB regulations cited on this page. Wine Vinegar The regulations covering wine and wine vinegar production are in 27 CFR part 24 Wine. If you make vinegar from fresh fruit or juice, (this type of vinegar is classified as nonbeverage wine) you must: Qualify as a bonded wine cellar by filing an application and bond with TTB using Permits Online. See Getting started in the Wine Industry for more information. If you make only vinegar, you will not need the Federal Alcohol Administration Act wine producer s permit that is required for producers of beverage wine. Obtain approval for your formula indicating how you plan to make nonbeverage wine /vinegar. Keep records and file reports in accordance with 27 CFR part 24, subpart O. You will not be subject to excise tax if you make only finished vinegar according to your approved formula. I-29

30 If you make vinegar from purchased beverage wine on which no tax has been paid, you must: File a bond (TTB Form ) with TTB to cover the tax on wine on hand, in transit, and unaccounted for until it is made into vinegar. Purchase the wine in bond from a bonded wine cellar or winery. In accordance with 27 CFR , keep records of wine received, wine used in the manufacture of vinegar, vinegar produced, and vinegar removed, and allow examination of your premises by TTB officers. If you make vinegar from beverage wine on which the excise taxes are paid, TTB cannot refund the tax to you. Your operations will not be regulated by TTB. If you make vinegar from wine that was made unfit for beverage use by the producing wine cellar or winery (therefore has no tax liability), then your operations are not regulated by TTB. Malt or Rice Vinegar The regulations covering production of beer or rice wine (saké) are in 27 CFR part 25 Beer. Nonbeverage products made from beer or rice wine at breweries under approved formulas will not be subject to the Federal excise tax on beer when they are removed for sale. If you produce your own beer or rice wine in the making of vinegar, you must: o Qualify with TTB as a brewer by filing a Brewer s Notice and bond with TTB. In addition, you must obtain approval of the manufacturing of vinegar as an other authorized use of the brewery under 27 CFR 25.23(b) prior to production. o Obtain approval of your formula indicating how you plan to make nonbeverage beer or rice wine. o Keep records and file reports in accordance with 27 CFR part 25, subpart U. o File tax returns, even when no tax is due (see 27 CFR ). If you purchase beer or rice wine that was made unfit for beverage use by the producing brewery, you may make that beer or rice wine into vinegar and your operations will not be regulated by TTB. By law, beer or rice wine that is fit for beverage use cannot be transferred from the brewery to a manufacturer without payment of tax. If you make vinegar from beverage beer or rice wine on which the excise taxes are paid, TTB cannot refund the tax to you. Your operations will not be regulated by TTB. I-30

31 Vinegar produced by distilling or the vaporizing process If you want to produce vinegar by the vaporizing process (a process that involves the distillation of alcohol), see our information on qualifying as a distilled spirits plant under 27 CFR Part 19. See 27 CFR part 19 subpart W for rules on production of vinegar by the vaporizing process. Manufacturer of nonbeverage products (MNBP) If you buy taxpaid distilled spirits for vinegar production, TTB has a system for allowing drawback of most of the distilled spirits tax. See 27 CFR part 17 and our frequently asked questions to learn about the formula approval and claim process. Vinegar production using specially denatured alcohol (SDA) "Specially denatured" alcohol is a distilled spirits product with certain materials added that make it unfit for beverage use, but suitable for industrial uses. These denatured alcohol products may be shipped free of tax to persons who hold TTB permits as industrial alcohol users. See 27 CFR part 20 and "Information for Specially Denatured Spirits Applicants" for the permit, formula approval, and recordkeeping requirements for SDA users. Use Permits Online to apply. Three formulas of SDA are authorized as a raw material for vinegar production. In two of them (SDA formulas 29 and 35-A), the denaturant is ethyl acetate, and in the other (SDA formula 18), the denaturant is vinegar. See 27 CFR 21.43, 21.56, and for the specific formulas. Commercial strength vinegar made from SDA may contain trace amounts of residual alcohol, not to exceed 0.5 percent alcohol by volume, in the finished product (27 CFR ). Labeling of vinegar Check with the Food and Drug Administration for vinegar labeling rules. Other requirements Check with your State alcohol regulatory agency to see if they regulate vinegar production. If you have further questions, you may contact: For more information Regulations and Rulings Division for general information; National Revenue Center for information on the qualification process; Advertising, Labeling and Formulation Division for information about formulas for nonbeverage products made at a winery or brewery; or Nonbeverage Products Laboratory for nonbeverage products made by an MNBP or SDA user, and for advice concerning imported nonbeverage alcohol products. Reference: Alcohol and Tobacco Tax and Trade Bureau - I-31

32 PESTICIDES AND PESTICIDE RESIDUES Additional details regarding pesticides used on crops and pesticide residue tolerances are available in 40 Code of Federal Regulations (CFR) Part 180. Reference: I-32

33 Letter of Guaranty Food and Drug Administration Section 303 of the Federal Food, Drug, and Cosmetic Act (the Act) provides penalties for persons who violate certain provisions of the Act. Section 303, paragraph (c) of the Act states that no person shall be subject to the penalties of subsection (a)(1) for having received, or proffered delivery of, adulterated or misbranded food additives if he has established a good faith guarantee from whom he received the articles. This paragraph was included in the 1958 amendments to the Federal Food, Drug and Cosmetic Act and remains the legal basis for the "letter of guaranty" supplied by many manufacturers to their clients. Title 21 CFR Guaranty and Title 21 CFR Suggested forms of guaranty, provide example language for such a letter of guarantee. References: Food and Drug Administration website ( ) 21 CFR Part 7 ( ) I-33

34 VINEGAR EXCLUSION FROM CALIFORNIA HAZARDOUS SUBSTANCES LIST The California Department of Industrial Relations conducted a hearing on February 3, 1982, to hear public testimony on a proposed Hazardous Substances List which was issued by the Director on November 20, The Director of the Department was required to issue the list in compliance with Chapter 2.5 of Division 5 of the California Labor Code known as The Hazardous Substances Information Training Act (also referred to as California s Right to Know Law ). Under the law, the Director s recommended list must be approved by the California Occupational Safety and Health Standards (OSHA) Board before manufacturers are required to comply. The proposed Hazardous Substances List contained some 794 chemicals of widely varying origin. Among these was acetic acid at 10% concentrations. Because of the need for clarification of the Department s intent with respect to vinegar, testimony was submitted at the hearing on behalf of the vinegar industry by The Vinegar Institute. As a result, the completed review of the proposed Hazardous Substances List, as forwarded to the Occupational Safety and Health Standards Board for approval, contained the following footnote (Number 1) regarding acetic acid, which reads as follows: Refers to solutions greater than or equal to 10%. Exempt when present in food or beverages, such as vinegar, apple cider, and wine, regardless of concentration. The Vinegar Institute was also represented in a final public hearing held on May 27, 1982, in Los Angeles, California, to answer any possible opposition to the exclusion of vinegar. No further comments were presented and the Department of Industrial Relations recommended in final that vinegar be specifically excluded from the OSHA Hazardous Substances List. Reference: Chapter 3.2. California Occupational Safety and Health Regulations (CAL/OSHA) Subchapter 1. Regulations of the Director of Industrial Relations, Article 5. Hazardous Substances Information and Training. I-34

35 OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA) HAZARD COMMUNICATION STANDARD OSHA s The Hazard Communication Standard (HCS) is now aligned with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Some key elements and related dates are noted below. Effective Completion Date Requirement(s) Who December 1, 2013 June 1, 2015* December 1, 2015 Train employees on the new label elements and safety data sheet (SDS) format. Compliance with all modified provisions of this final rule, except: The Distributor shall not ship containers labeled by the chemical manufacturer or importer unless it is a GHS label Employers Chemical manufacturers, importers, distributors and employers June 1, 2016 Transition Period to the effective completion dates noted above Update alternative workplace labeling and hazard communication program as necessary, and provide additional employee training for newly identified physical or health hazards. May comply with either 29 CFR (the final standard), or the current standard, or both Employers Chemical manufacturers, importers, distributors, and employers The final rule can be found here: Additional information (including a question and answer document) can also be found on the Department of Labor s website here: I-35