FDA & USDA Related Articles

How Now Mad Cow?

The most famous (but unidentified) cow since Mrs. O’Leary’s has caused significant policy changes at the USDA and created a public, or at least a media, frenzy of pandemic proportions, although no human deaths or illnesses in the United States or Canada have been traced to bovine spongiform encephalopathy (BSE), the scientific name for “mad cow.”

On December 30, 2003, a busy day for federal food regulators (see article on ephedra in this issue), Secretary of Agriculture Ann Veneman announced some immediate changes in the federal meat inspection program that affect only cattle. According to Veneman these changes had been “under consideration” for several years:

  1. “Downer” cattle are banned from human consumption.
  2. USDA inspectors will conduct pre-slaughter (“ante-mortem” in USDA speak) inspections for indications of BSE in addition to post slaughter BSE inspections.
  3. BSE tested cattle will not be marked “passed” until negative test results are in fact received. (Duh!!!)
  4. Prohibit the use in the human food supply of (a) certain nervous system cattle parts and related organs (known as Specified Risk Materials or "SRM's") from cattle over 30 months of age and (b) the small intestine of all cattle. The regulations will also prohibit the use of some of these parts in advanced meat recovery (AMR).
  5. Prohibit the use of air-injection stunning to prevent brain material from infecting any other parts of a carcass
  6. Prohibit the use of mechanically separated meat in human food.

With the exception of Item 3, the above changes were published in the Federal Register on January 12, 2004 as “interim rules” that will become effective 90 days after publication. Item 3 is an “interpretative rule” that became effective upon publication, also on January 12.

Meanwhile, other groups with meat related agendas have jumped into the BSE fray. Not surprisingly, PETA is using BSE to promote veganism. (One should recall that veganism is not some sort of foolproof protection to food borne illness. Last November, a Hepatitis A outbreak linked to green onions resulted in at least three deaths.) Meat producers who sell organic and free-range cattle are pointing out that their livestock are not given feed that contains animal tissue. Perhaps the biggest marketing opportunity is for the proponents of country of origin labeling (“COOL”) who now face a two year legislative moratorium on COOL’s originally scheduled implementation date of September 1, 2004.

Finally, as we go to press, the FDA has announced its own set of rules which will prohibit the use of material from downer cattle and the use of SRM's in the food products it regulates. The FDA will also prohibit the use of certain animal materials in animal feed.

Comment: In the article in this issue on ephedra we discussed the possibly of FDA using its new police power under the Bioterrorism Act to detain product. No such discussion will occur here because meat and other products subject to the exclusive jurisdiction of the USDA are not subject to the FDA’s Bioterrorism Rules which include facility registration, import pre-notification, tracking record keeping as well as administrative detention. Although COOL was originally conceived for commercial (i.e. “Buy American”) purposes and not as a food safety law, perhaps its proponents will recast it as a public health measure that would, at least in part, fill this gap in the Bioterrorism Rules.


FDA Publishes Second & Final Set of Proposed Bioterrorism Rules

The FDA has published for comment its second and final set of proposed rules to implement the mandates of the 2002 Bioterrorism Act. As reported in the Winter 2003 issue of Food & Marketing Law Update, the agency previously published rules pertaining to facility registration and prior notice to the FDA of the importation of food products into the United States. The new proposed rules cover record keeping requirements for the receipt and shipment of food from processor to retailer and the circumstances and procedures under which the FDA can administratively detain inventories of food products.

The record keeping rules apply to “non-transporters” such as processors and distributors and “transporters” such as independent trucking companies and public warehouses. Subject to certain exemptions, including exemptions for farms, restaurants and USDA inspected firms, the rules apply to both foreign facilities and domestic companies (whether or not they operate a facility) who are engaged in the food business. Non-transporters must keep records pertaining to (i) the immediate previous source (“IPS”) of a food or a food ingredient and (ii) the immediate subsequent recipient (“ISR”) of its products. Transporters must keep records pertaining to the identification of the shippers and the recipients of food products. The rule requires detailed records to tie specific food products with the firms that made, handled or received them. During normal business hours, FDA inspectors must be given access to these records within four hours of their request. FDA inspectors may request these records if they have a reason to believe that a non-transporter or a transporter handled an adulterated food that presents a serious threat to human or animal health. The FDA has not specified any particular format for collecting, storing or retrieving the required information and has generally assumed that most firms’ current record keeping practices will be adequate.

The administrative detention rule gives the FDA the power for the first time in its history to administratively detain (i.e. without a court order) for up to 30 days any food product that presents a serious threat to human or animal health. Subject to the approval of a district director, FDA inspectors may order an administrative detention. The rule also provides for administrative review of a detention order. Note that FDA authority under both this rule and the record-keeping rule is not limited to acts of bioterrorism.

As is the case with the facility registration and import notification rules, the record keeping and administrative detention rules will go into affect no later than December 12, 2003. Depending on the size of the business, firms must be in compliance with the record-keeping rule within six to 18 months after the December 12 effective date.

Proposed Importation Notification Rule Modified to Be More User Friendly

The import notification rule as originally proposed by the FDA called for a completely separate FDA only system. After significant negative reaction from industry, the FDA has announced that its system will be integrated with the Bureau of Customs and Border Protection’s existing Automated Commercial System (“ACS”).

Comment: Combining facilities registration and record keeping requirements creates a traceable trail of custody of food products. Combined with detention authority, this could allow the FDA to target those businesses that have or may have food products that are or are suspected of being a threat of serious adverse health consequences or death to humans or animals. Inspectors could merely contact those businesses in the chain of distribution and order administrative detention.


FDA Adopts New Trans Fat Labeling

In the most significant change in the nutritional labeling rules since the NLEA rules became effective in 1993, the FDA has mandated that “Nutrition Facts” and “Supplement Facts” panels will have to disclose the amount of trans fatty acids in the product. This declaration is to appear immediately below the declaration for saturated fat. For products having less than 5 grams of trans fat per serving, the amount of trans fat should be rounded off to the nearest 0.5 gram and for products with 5 grams or more of trans fat, the rounding should be to the nearest whole gram. Products that contain less than 0.5 grams of trans fat will not be required to declare trans fat if there are no label claims about fat, fatty acid or cholesterol content. However, the products must state in a footnote that they are not “a significant source” of trans fat. Because trans fat is assumed to have no nutritional value, there will no DRV or DV for it. The new rule will become effective on January 1, 2006.

The new rule also contains a series of conforming amendments that integrate the trans fat declaration into the currently permitted variations of the general nutrient labeling requirements such as the qualifications permitting the use of the simplified labeling format. Also, in order to correct an inadvertent omission in the original FDA regulations, saturated fat will have to be declared whenever any nutrient content claim is made about fatty acids.

Pending further review, the FDA has not approved any on-label nutrient content claims about trans fat such as “trans fat free” nor has the FDA specified any benchmark limits that might be imposed on trans fat containing foods making health claims.