House File 338 - Introduced HOUSE FILE 338 BY HOLT A BILL FOR An Act relating to raw milk, by providing for the production 1 of raw milk at certain dairies, the manufacture of products 2 using raw milk, and the labeling and distribution of raw 3 milk and manufactured products, and making penalties 4 applicable. 5 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 6 TLSB 1809YH (1) 90 da/ns
H.F. 338 Section 1. NEW SECTION . 135.16B Raw milk —— associated 1 products. 2 The department of health and human services may demand that 3 a raw milk producer provide the department with all records of 4 tests to determine the coliform count and standard plate count 5 of dairy animals maintained at the raw milk dairy as required 6 in section 195.6. 7 Sec. 2. Section 137.104, subsection 2, Code 2023, is amended 8 by adding the following new paragraph: 9 NEW PARAGRAPH . e. Demand that a raw milk producer provide 10 the board with all records of tests to determine the coliform 11 count and standard plate count of dairy animals maintained at 12 the raw milk dairy as required in section 195.6. 13 Sec. 3. NEW SECTION . 137D.2A Raw milk —— associated 14 products. 15 A home food processing establishment shall not advertise 16 for sale, offer for sale, sell or otherwise distribute, or use 17 raw milk, or a manufactured raw milk product or raw milk dairy 18 product, as provided in chapter 195. 19 Sec. 4. Section 137F.1, subsection 9, Code 2023, is amended 20 by adding the following new paragraph: 21 NEW PARAGRAPH . o. (1) The premises of a raw milk dairy 22 where raw milk is produced, processed, labeled, marketed, or 23 distributed by a raw milk producer in compliance with chapter 24 195. 25 (2) The premises of a raw milk dairy where a raw milk 26 product or a raw milk dairy product is manufactured, labeled, 27 marketed, or distributed by a raw milk producer in compliance 28 with chapter 195. 29 Sec. 5. Section 137F.1, subsection 10, Code 2023, is amended 30 by adding the following new paragraph: 31 NEW PARAGRAPH . d. (1) The premises of a raw milk dairy 32 where raw milk is produced, processed, labeled, marketed, or 33 distributed by a raw milk producer in compliance with chapter 34 195. 35 -1- LSB 1809YH (1) 90 da/ns 1/ 13
H.F. 338 (2) A premises of a raw milk dairy where a raw milk product 1 or raw milk dairy product is manufactured, labeled, marketed, 2 or distributed by a raw milk producer in compliance with 3 chapter 195. 4 Sec. 6. NEW SECTION . 137F.8B Raw milk —— associated 5 products. 6 A food establishment or farmers market shall not advertise 7 for sale, offer for sale, sell or otherwise distribute, or use 8 raw milk, or a manufactured raw milk product or a raw milk 9 dairy product, regardless of whether the food establishment 10 or farmers market is regulated by the department under 11 this chapter or another chapter, another state agency, or a 12 municipality. 13 Sec. 7. Section 159.6, subsection 6, Code 2023, is amended 14 to read as follows: 15 6. Regulation and inspection of foods, drugs, and other 16 articles, as provided in Title V, subtitle 4 , but . However, 17 chapter 205 of that subtitle shall be enforced as provided in 18 that chapter. Except as expressly authorized in subtitle 4, 19 the department shall not regulate any of the following: 20 a. The production, processing, labeling, marketing, or 21 distribution of raw milk by a raw milk producer in compliance 22 with chapter 195. 23 b. The manufacture, labeling, marketing, or distribution 24 of a raw milk product or raw milk dairy product by a raw milk 25 producer in compliance with chapter 195. 26 Sec. 8. Section 190.2, Code 2023, is amended by adding the 27 following new subsection: 28 NEW SUBSECTION . 3. This section does not apply to any of 29 the following: 30 a. The manufacture, labeling, marketing, or distribution of 31 raw milk by a raw milk producer in compliance with chapter 195. 32 b. The manufacture, labeling, marketing, or distribution 33 of a raw milk product or raw milk dairy product by a raw milk 34 producer in compliance with chapter 195. 35 -2- LSB 1809YH (1) 90 da/ns 2/ 13
H.F. 338 Sec. 9. Section 191.2, subsection 5, unnumbered paragraph 1 1, Code 2023, is amended to read as follows: 2 All bottles, containers, and packages Bottles, containers, 3 and packages. Except as provided in subsection 5A, a container 4 or package enclosing milk or a milk products product shall be 5 conspicuously labeled or marked with all of the following : 6 Sec. 10. Section 191.2, Code 2023, is amended by adding the 7 following new subsection: 8 NEW SUBSECTION . 5A. Raw milk and associated products. A 9 container holding raw milk, or a manufactured raw milk product 10 or a raw milk dairy product, distributed by a raw milk producer 11 shall be labeled as required in section 195.8. 12 Sec. 11. Section 192.103, subsections 1 and 2, Code 2023, 13 are amended to read as follows: 14 1. Only grade “A” pasteurized milk and milk products 15 shall be sold to the final consumer, or to restaurants, soda 16 fountains, grocery stores, or similar establishments . However, 17 in except as follows: 18 a. In an emergency, the sale of pasteurized milk and milk 19 products which that have not been graded, or the grade of which 20 is unknown, may be authorized by the secretary, in which case, 21 such products shall be labeled “ungraded”. 22 b. A raw milk producer may distribute raw milk, or a 23 manufactured raw milk product or raw milk dairy product, in 24 compliance with chapter 195. 25 2. No A person shall not within the state produce, provide, 26 sell, offer, or expose for sale, or have in possession with 27 intent to sell, any milk or milk product which is adulterated 28 or misbranded. However, in an emergency, the sale of 29 pasteurized milk and milk products which have not been graded, 30 or the grade of which is unknown, may be authorized by the 31 secretary, in which case such products shall be labeled 32 “ungraded”. 33 Sec. 12. NEW SECTION . 194.22 Raw milk dairies —— exception. 34 This chapter does not apply to any of the following: 35 -3- LSB 1809YH (1) 90 da/ns 3/ 13
H.F. 338 1. The production, processing, marketing, and distribution 1 of raw milk, if the raw milk is produced by a raw milk producer 2 at a raw milk dairy as provided in chapter 195. 3 2. The manufacture, marketing, and distribution of a 4 raw milk product or raw milk dairy product, if the raw milk 5 product or raw milk dairy product is manufactured by a raw milk 6 producer at a raw milk dairy as provided in chapter 195. 7 Sec. 13. NEW SECTION . 195.1 Definitions. 8 As used in this chapter, unless the context otherwise 9 requires: 10 1. “Dairy animal” means a cow, goat, or sheep that is 11 actively producing milk. 12 2. “Department” means the department of agriculture and land 13 stewardship. 14 3. “Distribute” means to transfer an item or offer to 15 transfer an item to another person, either free of charge or by 16 sale or exchange. 17 4. “Milk” means the lacteal secretion of a dairy animal. 18 5. “Raw milk” means milk that is not pasteurized or graded 19 as otherwise required in chapters 190, 192, and 194. 20 6. “Raw milk dairy” means an operation where not more than 21 ten dairy animals are maintained to actively produce milk at 22 any one time. 23 7. “Raw milk dairy product” means a product, other than a 24 milk product, manufactured using milk or a milk product as the 25 primary ingredient, and that includes any quantity of raw milk. 26 8. “Raw milk producer” means a milk producer who owns or 27 operates a raw milk dairy. 28 9. “Raw milk product” means a product manufactured using 29 milk as its exclusive ingredient as described in 21 C.F.R. 30 §1240.3 and that includes any quantity of raw milk. 31 Sec. 14. NEW SECTION . 195.2 Conflicts with other law. 32 This chapter shall be construed to supplement applicable 33 provisions in chapters 190, 191, 192, and 194. If there is a 34 conflict between a provision in this chapter and one of those 35 -4- LSB 1809YH (1) 90 da/ns 4/ 13
H.F. 338 other chapters, the provision in this chapter shall prevail 1 but only to the extent of interpreting the provision in this 2 chapter. 3 Sec. 15. NEW SECTION . 195.3 Exclusions. 4 This chapter does not apply to a bulk milk tanker, milk 5 grader, milk hauler, milk plant, milk processing plant, dairy 6 plant, transfer station, or receiving station. 7 Sec. 16. NEW SECTION . 195.4 Rulemaking prohibited. 8 The department shall not adopt rules to administer or 9 enforce this chapter. 10 Sec. 17. NEW SECTION . 195.5 General —— election by raw milk 11 producer. 12 A raw milk producer may elect to process, market, or 13 distribute raw milk produced at the raw milk producer’s 14 raw milk dairy in compliance with this chapter. A raw milk 15 producer may also elect to use the raw milk to manufacture, 16 market, or distribute a raw milk product or raw milk dairy 17 product at the raw milk producer’s raw milk dairy in compliance 18 with this chapter. 19 Sec. 18. NEW SECTION . 195.6 Production and processing of 20 raw milk. 21 If a raw milk producer makes an election described in section 22 195.5 to produce and process raw milk, all of the following 23 apply: 24 1. The raw milk must be produced exclusively from dairy 25 animals maintained at the raw milk dairy. 26 2. The raw milk must not be pasteurized or graded. 27 3. The raw milk must be processed in a manner that ensures 28 the health and safety of persons consuming the raw milk 29 produced at the raw milk dairy, or consuming raw milk products 30 or raw dairy products manufactured at the raw milk dairy. The 31 raw milk producer must do all of the following: 32 a. Each month, test each dairy animal maintained at the raw 33 milk producer’s raw milk dairy to determine the dairy animal’s 34 coliform count and standard plate count. The raw milk producer 35 -5- LSB 1809YH (1) 90 da/ns 5/ 13
H.F. 338 shall retain a record of each test at the raw milk dairy for at 1 least three years. 2 b. Each twelve-month period, employ a licensed veterinarian 3 to examine each dairy animal maintained at the raw milk 4 producer’s raw milk dairy to determine the dairy animal’s 5 health status. The examination must at least include a blood 6 test for common diseases afflicting the type of dairy animal 7 being examined. 8 Sec. 19. NEW SECTION . 195.7 Distribution of raw milk or 9 associated products. 10 1. A raw milk producer shall only take an order for the 11 distribution of raw milk at the raw milk producer’s raw milk 12 dairy where the raw milk is produced. The raw milk producer 13 shall only distribute the raw milk to an individual placing the 14 order. 15 a. The raw milk producer shall post the summary of the test 16 to determine the coliform count and standard plate count of 17 the dairy animals retained at the raw milk dairy as provided 18 in section 195.6. The summary shall be posted at the raw milk 19 dairy’s distribution point for the raw milk. The individual 20 being distributed the raw milk may examine the records for the 21 three-year period that the records are required to be retained 22 by the raw milk producer under section 195.6. 23 b. If the raw milk producer distributes raw milk in a 24 container, the container shall be labeled as provided in 25 section 195.8. 26 c. The raw milk producer shall distribute the raw milk 27 directly to the individual at the raw milk dairy or to a 28 location specified by the individual. However, a person shall 29 not deliver the raw milk to a place of business where food or 30 food items are distributed on a retail basis, including but 31 not limited to a home food processing establishment regulated 32 under chapter 137D or a food establishment or farmers market 33 regulated under chapter 137F. The raw milk shall only be used 34 for consumption by the individual, members of the individual’s 35 -6- LSB 1809YH (1) 90 da/ns 6/ 13
H.F. 338 household, and the individual’s nonpaying guests or nonpaying 1 employees. 2 d. A person shall not resell raw milk. 3 2. A raw milk producer shall only take an order for the 4 distribution of a raw milk product or raw milk dairy product 5 at the raw milk producer’s raw milk dairy where the raw milk 6 product or raw milk dairy product is manufactured. The raw 7 milk producer shall only distribute the raw milk product or raw 8 milk dairy product to an individual placing the order. The raw 9 milk producer may distribute the raw milk product or raw milk 10 dairy product to the individual without charge or on a retail 11 basis. 12 a. The raw milk producer shall post the summary of the most 13 recent test to determine the coliform count and standard plate 14 count of dairy animals as retained at the raw milk dairy as 15 provided in section 195.6. The summary shall be posted at the 16 raw milk dairy’s distribution point for the raw milk products 17 or raw milk dairy products. The individual being distributed 18 the raw milk product or raw milk dairy product may examine the 19 records for the three-year period that the records are required 20 to be retained by the raw milk producer under section 195.6. 21 b. If the raw milk producer distributes a raw milk product 22 or raw milk dairy product in a container, the container shall 23 be labeled as provided in section 195.8. 24 c. The raw milk producer shall distribute the raw milk 25 product or raw milk dairy product directly to the individual 26 at the raw milk dairy or to a location specified by the 27 individual. However, a person shall not deliver the raw milk 28 product or raw milk dairy product to a place of business where 29 food or a food item is distributed on a retail basis, including 30 but not limited to a home food processing establishment 31 regulated under chapter 137D or a food establishment or farmers 32 market regulated under chapter 137F. The raw milk product or 33 raw milk dairy product shall only be used for consumption by 34 the individual, members of the individual’s household, or the 35 -7- LSB 1809YH (1) 90 da/ns 7/ 13
H.F. 338 individual’s nonpaying guests or nonpaying employees. 1 d. A person shall not resell the raw milk product or raw 2 milk dairy product. 3 Sec. 20. NEW SECTION . 195.8 Labeling containers holding 4 raw milk or associated products. 5 1. A raw milk producer who distributes raw milk, or a 6 manufactured raw milk product or raw milk dairy product, shall 7 label the container holding the raw milk, or the manufactured 8 raw milk product or raw milk dairy product. The label shall 9 be permanently affixed to the container. The words on the 10 label shall be printed using upper case letters in at least 11 twelve point boldface type. If the container includes a main 12 informational or advertising panel, the label shall be part of 13 the panel. 14 2. a. For a container holding raw milk, the label shall 15 state the following: 16 Notice to Consumers 17 This container holds raw milk that is not subject to state 18 inspection or other public health regulations that require 19 pasteurization and grading. 20 b. For a container holding a raw milk product or raw milk 21 dairy product, the label shall state the following: 22 Notice to Consumers 23 This container holds a raw milk product or raw milk dairy 24 product that is not subject to state inspection or other public 25 health regulations that require pasteurization and grading. 26 Sec. 21. NEW SECTION . 195.9 Enforcement actions. 27 The department of health and human services acting under 28 chapter 135 or a local board of health acting under chapter 29 137 may demand that the raw milk producer provide it with all 30 records of tests to determine the coliform count and standard 31 plate count of dairy animals maintained at the raw milk dairy 32 as required in section 195.6. The demand shall be based on an 33 affidavit signed by a licensed physician certifying that in 34 the physician’s opinion an individual contracted an illness as 35 -8- LSB 1809YH (1) 90 da/ns 8/ 13
H.F. 338 a direct result of consuming raw milk produced at a raw milk 1 dairy, or consuming a raw milk product or a raw milk dairy 2 product manufactured at a raw milk dairy. 3 EXPLANATION 4 The inclusion of this explanation does not constitute agreement with 5 the explanation’s substance by the members of the general assembly. 6 BACKGROUND. This bill amends provisions regulating dairies 7 where raw milk is produced and processed for human consumption 8 (fluid milk), or produced and processed to be manufactured as 9 a food item (a milk product or dairy product) at a processing 10 or manufacturing facility (milk plant or dairy plant). 11 Generally, the department of inspections and appeals (DIA), or 12 a local authority under contract with DIA, provides for the 13 licensing and inspection of both food processing plants and 14 food establishments such as grocery stores and restaurants. 15 The production and processing of milk, and the processing 16 and manufacture of milk products and dairy products, are 17 administered and enforced by the department of agriculture and 18 land stewardship (DALS). 19 FEDERAL LAW. Generally, states are provided responsibility 20 for enacting health and sanitation standards for their dairy 21 industry subject to oversight by the federal government. 22 DALS’ regulations are based on voluntary standards published 23 by the United States food and drug administration (FDA), 24 and specifically the “Grade ‘A’ Pasteurized Milk Ordinance” 25 commonly referred to as the PMO (Code section 192.102). 26 The PMO provides standards for the production, processing, 27 distribution, transportation, handling, sampling, examination, 28 grading, labeling, and sale of grade “A” pasteurized milk 29 and grade “A” milk products. In administering the PMO, DALS 30 conducts inspections of dairy herds, dairy farms, milk plants, 31 milk receiving stations, and milk transfer stations. DALS 32 issues licenses or permits to milk producers, milk haulers, 33 and milk transfer stations subject to suspension or revocation 34 (21 IAC 68.12). FDA also regulates the labeling of milk and 35 -9- LSB 1809YH (1) 90 da/ns 9/ 13
H.F. 338 dairy products (21 C.F.R. pt. 131). The United States, acting 1 through FDA, prohibits the delivery of unpasteurized milk, 2 or milk products manufactured using unpasteurized milk, into 3 interstate commerce (21 C.F.R. pt. 1240). Voluntary standards 4 governing the grading of milk are established by the United 5 States department of agriculture (USDA) (7 C.F.R. pt. 58, 6 adopted by DALS pursuant to Code section 190.2; 21 IAC 71.1). 7 Grade “A” milk is the standard used for fluid milk production. 8 Grade “B” milk is subject to less restrictive standards 9 allowing it to be used in manufacturing (Code chapter 194). 10 DALS GENERAL AUTHORITY. Under Code chapter 189, DALS 11 regulates adulterated articles and the labeling of those 12 articles and may report violations to the appropriate county 13 attorney (Code section 189.25). This includes inspections of 14 locations (Code section 189.4). A person is prohibited from 15 manufacturing, selling, or delivering an adulterated article 16 (Code section 189.15). DALS may act to enjoin a person from 17 violating provisions prohibiting the marketing of adulterated 18 food (Code section 190.15), including adulterated milk, and 19 adulterated milk products and dairy products (Code sections 20 190.4 and 190.5). DALS may confiscate an adulterated or 21 improperly labeled article (Code section 189.17). DALS is 22 granted authority to petition a district court to restrain 23 a person who violates a statute or rule regulating milk 24 production, processing, manufacture, labeling, and sales (Code 25 sections 190.15, 191.10, and 192.146). 26 BILL’S PROVISIONS —— TERMINOLOGY. The bill uses a number 27 of key terms, including “raw milk” meaning milk that is not 28 graded or pasteurized, “raw milk dairy” which includes a dairy 29 farm where dairy animals (milk-producing cows, goats, or 30 sheep) are maintained and where a “raw milk producer” owning 31 or operating the dairy farm may store and process the raw milk 32 for distribution as fluid milk, or may manufacture the raw 33 milk into “raw milk products” or “raw milk dairy products” for 34 distribution (new Code section 195.1). Code chapters refer to 35 -10- LSB 1809YH (1) 90 da/ns 10/ 13
H.F. 338 both terms “milk product” and “dairy product” as does federal 1 law. Generally, FDA defines “milk product” to include cheese, 2 butter, ice cream, and yogurt (21 C.F.R. §1240.3) and USDA 3 defines a “dairy product” similarly (7 C.F.R. §58.101). The 4 bill defines a “raw milk product” as a product using milk as 5 an exclusive ingredient, if any quantity of the milk is raw 6 milk, and a “raw dairy product” as a product using milk as the 7 primary ingredient, if any quantity of the milk is raw milk 8 (new Code section 195.1). The term “distribute” refers to both 9 the transfer of raw milk or a manufactured raw milk product 10 or raw milk dairy product to final consumers with or without 11 charge (new Code section 195.7). 12 BILL’S PROVISIONS —— EXCLUSION FROM DIA REGULATIONS. The 13 bill prohibits a home food processing establishment regulated 14 by DIA from advertising for sale, offering for sale, selling, 15 or otherwise distributing raw milk, or a manufactured raw milk 16 product or raw milk dairy product (new Code section 137D.2A). 17 The premises of a raw milk dairy is not a food establishment or 18 a food processing plant regulated by DIA (Code section 137F.1). 19 Similarly, the bill prohibits a food establishment or farmers 20 market from advertising for sale, offering for sale, selling, 21 or otherwise distributing raw milk, or a manufactured raw milk 22 product or a raw milk dairy product (new Code section 137F.8B). 23 BILL’S PROVISIONS —— ADMINISTRATION AND ENFORCEMENT. The 24 bill’s provisions are codified as new Code chapter 195. The 25 new chapter is construed to supplement applicable provisions of 26 the other Code chapters regulating the state’s dairy industry 27 (Code chapters 190, 191, 192, and 194). DALS is prohibited 28 from adopting rules to administer or enforce provisions in the 29 new Code chapter. 30 BILL’S PROVISIONS —— REQUIREMENTS FOR PROCESSING, MARKETING, 31 AND DISTRIBUTING RAW MILK OR MANUFACTURING, MARKETING, AND 32 DISTRIBUTING A RAW MILK PRODUCT OR RAW MILK DAIRY PRODUCT. A 33 raw milk producer must not own or operate a raw milk dairy 34 having more than 10 dairy animals actively producing milk (new 35 -11- LSB 1809YH (1) 90 da/ns 11/ 13
H.F. 338 Code section 195.1). The milk cannot be pasteurized or graded. 1 On a monthly basis, the raw milk producer must test each dairy 2 animal to determine its coliform and standard plate counts. On 3 a yearly basis, the raw milk producer must employ a licensed 4 veterinarian to examine the health status of each dairy animal, 5 including by administering a blood test (new Code section 6 195.6). 7 In distributing raw milk, or a manufactured raw milk product 8 or raw dairy product, a raw milk producer can only take an 9 order by an individual (new Code section 195.7). The order 10 must be made at the raw milk dairy. The individual may examine 11 the health records of the raw milk dairy’s dairy animals and 12 the records must be retained for three years. The raw milk 13 producer may deliver the raw milk or the manufactured raw milk 14 product or raw milk dairy product to the individual at the 15 raw milk dairy or at a location specified by the individual. 16 However, the raw milk producer cannot deliver the raw milk or 17 the manufactured raw milk product or raw milk dairy product 18 to a location where food or food items are sold on a retail 19 basis (e.g., a location regulated by DIA). The raw milk or 20 the manufactured raw milk product or raw milk dairy product 21 can only be used for consumption by the individual making 22 the order, a member of the individual’s household, or the 23 individual’s nonpaying guests or nonpaying employee. A 24 person cannot resell the raw milk or the manufactured raw milk 25 product or raw milk dairy product. If the raw milk, or the 26 manufactured raw milk product or raw milk dairy product is 27 distributed in a container, the container must be labeled with 28 a notice to consumers stating it contains raw milk or that raw 29 milk has been used as an ingredient in manufacturing the raw 30 milk product or raw dairy product, and the raw milk, or the 31 raw milk product or raw dairy product, has not been subject to 32 public health regulations (new Code section 195.8). 33 BILL’S PROVISIONS —— RECORDS. The Iowa department of health 34 and human services or a local board of health may demand that 35 -12- LSB 1809YH (1) 90 da/ns 12/ 13
H.F. 338 a raw milk producer provide it with all records of tests to 1 determine the coliform count and standard plate count of dairy 2 animals maintained at a raw milk dairy. 3 APPLICABLE PENALTIES. A person who violates the bill’s 4 provisions is guilty of a simple misdemeanor (Code section 5 189.21). A person who violates a provision regulated by the 6 Iowa department of health and human services is guilty of 7 a simple misdemeanor (Code section 135.38). A person who 8 violates a provision regulated by a local board of health is 9 also guilty of a simple misdemeanor and subject to a civil 10 penalty not to exceed $750. A simple misdemeanor is punishable 11 by confinement for no more than 30 days and a fine of at least 12 $105 but not more than $855. 13 -13- LSB 1809YH (1) 90 da/ns 13/ 13