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Federal Register / Vol. 75, No. 83 / Friday, April 30, 20 - page 5 / 11

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wwoods2 on DSK1DXX6B1PROD with PROPOSALS PART 1

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Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Proposed Rules

22717

The regulations DOT proposed in the 2004 SNPRM would have included a recommendation that each person who

of Juice Concentrates and Certain Shelf Stable Juices; FDA Guidance on Food Security Preventive Measures for Dairy

offers for transportation or transports

Farms, Bulk Milk Transporters, Bulk

food or food products by motor vehicle or rail car use guidance documents and materials issued by FDA and USDA, and specifically identified three of FDA’s guidance documents that were then in effect: FDA Guidance on Bulk Transport

Milk Transfer Stations, and Fluid Milk Processors; and FDA Guidance on Food Security Preventive Measures for Food Producers, Processors, and Transporters (i.e., the guidances in Refs. 16, 17, and 18).

E. Our Current Regulations and Guidance Documents Addressing Transportation of Food

We have addressed the transportation

of food in several regulations (in Title 21 of the Code of Federal Regulations (21 CFR)) and guidance documents that are limited in scope. We describe the most relevant regulations and guidance documents in table 1 of this document.

TABLE 1.—FDA REGULATIONS AND GUIDANCES ADDRESSING THE TRANSPORTATION OF FOOD

FR 52612 at 52618, Novem-

Practice for Medicated Feeds; Equipment Cleanout Proce-

ber 30, 1976)

dures

Type

Regulation

Regulation

Year & Reference*

Title

1976 (§ 225.65; 41

Current Good Manufacturing

1986; (§ 110.93 51 FR 22458, June 19, 1986)

Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food; Warehousing and Dis- tribution

Description

Requires adequate cleanout

procedures for all equipment used in the manufacture or

distribution of medicated feeds that are essential to avoiding unsafe contamina- tion of feeds with drugs

Requires that storage and trans- portation of finished food be under conditions that will pro- tect food against physical, chemical, and microbial con- tamination as well as against deterioration of the food and the container

Circumstances

Implemented requirements in

section 501(a)(2)(B) of the act (21 U.S.C. 351(a)(2)(B))

Issued as part of a broad revi- sion to our current good man- ufacturing practice (CGMP) regulations for food

1997 (§§ 589.2000(c) through (e); 62 FR 30936, June 5, 1997), up- dated in 2008 (§§ 589.2000(c) through (e); 73 FR 22720, April 25, 2008) [Related Small En- tity Compliance Guide (SECG) published in 1998 (Ref. 19)]

Listing of Specific Substances Prohibited From Use in Ani- mal Food or Feed; Require- ments for renderers; Require- ments for protein blenders, feed manufacturers, and dis- tributors; and Requirements for persons that intend to sep- arate mammalian and non- mammalian materials

Regulation

1998; (Ref. 20)

Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables**

Guidance

2001; (§ 120.24(c)); 66 FR 6138 at 6172, January 19, 2001) [Related SECG published in 2003 (Ref. 22)]

Hazard Analysis And Critical Control Point (HACCP) Sys- tems; Process Controls

Regulation

Includes recommendations re- garding microbial food safety hazards and good agricultural and management practices common to the growing, packing, and transporting of most fresh fruits and vegeta- bles

Issued as part of the 1997 Pres- idential ‘‘Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegeta- bles’’ (Ref. 21)

Requires that juice processors complete a 5-log pathogen re- duction treatment and final product packaging within a single processing facility oper- ating under CGMPs*** (‘‘single facility requirement’’)

Added to the final rule to ad- dress comments expressing concern about the potential for recontamination or re- growth of surviving pathogens if individual treatments de- signed to achieve a 5-log re- duction are separated by time or space

Requires distributors of mam- malian and nonmammalian materials for animal food to provide for measures to avoid commingling or cross-con- tamination of the materials

To provide animal feed protec- tions by prohibiting the feed- ing of mammalian protein to ruminant animals

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