wwoods2 on DSK1DXX6B1PROD with PROPOSALS PART 1
Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Proposed Rules
C. The 1996 Joint ANPRM
In 1996, FDA and FSIS jointly issued an advance notice of proposed rulemaking (61 FR 59372, November 22, 1996) (the 1996 joint ANPRM). FDA and FSIS issued the 1996 joint ANPRM in part to address FDA’s safety concerns regarding the transportation of food raised by a 1994 outbreak of salmonellosis involving ice cream mix that became contaminated during transport in tanker trucks that had previously hauled raw liquid eggs (Ref. 9). In the 1996 joint ANPRM, FDA and FSIS requested comments and information about approaches FDA and FSIS might take, under existing legal authorities, to foster food safety improvements that may be needed in the transportation and storage of potentially hazardous foods.4
FDA took no subsequent action on the 1996 joint ANPRM. Data and information received in response to the 1996 joint ANPRM are now more than 10 years old.
D. The 2005 SFTA
In 2005, Congress passed the 2005 SFTA, Public Law 109–59, 119 Stat. 1911, which:
Requires the Secretary of HHS to
issue regulations setting forth sanitary transportation practices to be followed by shippers, carriers by motor vehicle or rail vehicle, receivers, and others engaged in food transport; and
Requires the Secretary of DOT, in
consultation with the Secretaries of HHS and USDA, to establish procedures for transportation safety inspections for the purpose of identifying suspected incidents of contamination or adulteration of a food.5
1. Our Responsibilities Under Section 416 of the Act
The statutory authority in section 416 of the act extends to broader aspects of the sanitary transportation of food than the statutory authority in the 1990
4 As discussed in the 1996 joint ANPRM (61 FR 59372), potentially hazardous foods, including meat, poultry, eggs and egg products, fish, seafood, and dairy products, are those that are capable of supporting the rapid multiplication of microorganisms that cause foodborne illness. Currently, we generally use the term ‘‘Time/ Temperature Control for Safety (TCS) Food’’ rather than ‘‘potentially hazardous food’’ and define a TCS food as a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation (Ref. 14). Examples of TCS foods include the foods identified as potentially hazardous foods in the 1996 joint ANPRM, and plant foods such as raw seed sprouts and cut melons (Ref. 14).
The procedures DOT would establish are outside the scope of this document. We intend to assist DOT as appropriate in developing DOT’s procedures for these inspections. 5
SFTA, which was primarily directed toward preventing the contamination of food products by previously hauled nonfood products. The authority in section 416 of the act places a statutory obligation upon HHS (and, by delegation, to FDA) to issue regulations establishing requirements for the food transportation industry to use sanitary transportation practices to ensure that food is not transported under conditions that may render food adulterated. We describe key provisions of section 416 of the act in the following bulleted paragraphs.
Section 416(b) (21 U.S.C. 350e(b))
requires us to establish regulations requiring shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation6 of food to use sanitary transportation practices prescribed by us to ensure that food is not transported under conditions that may render the food adulterated.
Section 416(c) (21 U.S.C. 350e(c))
addresses the content of the regulations to be established under section 416(b). Æ Section 416(c)(1) (21 U.S.C. 350e(c)(1)) requires these regulations to prescribe such practices as we determine to be appropriate relating to: (A) sanitation; (B) packaging, isolation, and other protective measures; (C) limitations on the use of vehicles; (D) information to be disclosed (to a carrier by a person arranging for the transportation of food, and to a manufacturer or other person that arranges for the transportation of food by a carrier; or furnishes a tank vehicle or bulk vehicle7 for the transportation of food); and (E) recordkeeping. Æ Section 416(c)(2) (21 U.S.C. 350e(c)(2)) requires these regulations to include: (A) a list of nonfood products that we determine may, if shipped in a bulk vehicle, render adulterated food that is subsequently transported in the same vehicle; and (B) a list of nonfood products that we determine may, if shipped in a motor vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), render adulterated food that is simultaneously or subsequently transported in the same vehicle.
6 ‘‘Transportation’’ is defined by section 416(a)) of the act (21 U.S.C. 350e(a)) as ‘‘any movement in commerce by a motor vehicle or rail vehicle.’’
7 ‘‘Bulk vehicle‘‘ is defined by section 416(a) of the act as ‘‘a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, and any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.’’
Section 416(d) (21 U.S.C. 350e(d))
provides that we may waive any requirement under section 416, with respect to any class of persons, vehicles, food, or nonfood products, if we determine that the waiver (A) will not result in the transportation of food under conditions that would be unsafe for human or animal health; and (B) will not be contrary to the public interest. We must publish in the Federal Register any waiver and the reasons for the waiver.
Section 416(e) (21 U.S.C. 350e(e))
provides that State or local requirements concerning transportation of food are preempted if: (A) complying with both the State or local requirement and section 416, or a regulation prescribed under section 416, is not possible; or (B) the State or local requirement as applied or enforced is an obstacle to accomplishing and carrying out section 416 or a regulation prescribed under section 416.
2. Amendments to Sections 301, 402, and 703 of the Act
The 2005 SFTA also amended the act to add or revise provisions as follows:
Sections 402(i) and 301(hh) (21
S.C. 342(i) and 331(hh)): Section
402(i) provides that a food shall be deemed adulterated if it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations issued under section 416 of the act. Under section 301(hh), the failure (or the causing thereof) by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food to comply with the sanitary transportation practices prescribed by us under section 416 is a prohibited act subject to the sanctions and penalties provided in Chapter III of the act.
Sections 703(b) and 301(e) (21
S.C. 373(b) and 331(e)): Section 703(b)
requires any person subject to section 416 to permit a designated officer or employee who requests required records (i.e., records required to be kept in accordance with section 416(c)(1)(E)) to have access to all such records at reasonable times and to copy all such records. Under section 301(e), the refusal to permit access to or copying of any record as required by section 416, or the failure to establish or maintain any record required under section 416, or the refusal to permit access to or verification or copying of any such required record is a prohibited act subject to the sanctions and penalties provided in Chapter III of the act.
13:40 Apr 29, 2010