Now Mad Cow?
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
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:
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
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
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.
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.
Publishes Second & Final Set of Proposed Bioterrorism Rules
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.
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.
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.
Importation Notification Rule Modified to Be More User Friendly
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”).
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.
Adopts New Trans Fat Labeling
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,
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.
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.