Ceramicware, Bisphenol A, & Infant Formula Provisions of House-Passed Food Safety Bill
On July 30, 2009, the House of Representatives passed the Food Safety Enhancement Act of 2009 (H.R. 2749), a bill to require registration of importers and brokers; generate resources to support FDA oversight of food safety; increase inspections; and require food imports to demonstrate safety; among other things.
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(Although the House has passed H.R. 2749, it is not yet in effect. Generally, in order for a bill to be implemented, identical versions of that bill must be passed by both the House and Senate, and then the bill must be approved (enacted) by the President.)
The following are highlights of the ceramicware, Bisphenol A (BPA1), and infant formula requirements of House-passed H.R. 2749.
Labeling for Ceramic Tableware, Cookware with Lead-Based Glaze/Decorations
H.R. 2749 would consider ceramic tableware or cookware that includes a glaze or decorations containing lead for an intended functional purpose to be misbranded2 under 21 USC 343, unless:
the product and its packaging bear the statement "This product is made with lead-based glaze consistent with Food and Drug Administration (FDA) guidelines for such lead"; or
the product is in compliance with the requirements applicable to ornamental and decorative ceramicware in 21 CFR 109.16 (or any successor regulation).
This provision would apply only to ceramic tableware or cookware that is manufactured on or after the date that is one year after H.R. 2749's enactment.
(The Health and Human Services (HHS) Secretary would also be required to educate consumers on the safety of ceramicware for food use by posting information on the FDA Web site regarding the content of lead in ceramicware and its glaze, H.R. 2749's labeling requirements, the use of ceramicware in microwave ovens, etc.)
BPA in Food/Drink Containers Would be Evaluated, Approved Uses May Change
No later than December 31, 2009, the HHS Secretary would be required to notify Congress whether the available scientific data support a determination that there is a reasonable certainty of no harm, for infants, young children, pregnant women, and adults, for approved uses of polycarbonate plastic and epoxy resin made with BPA in food and beverage containers, including reusable food and beverage containers, under the conditions of use prescribed in current FDA regulations.
Possible revocation, modification of approved uses. If the HHS Secretary concludes that such a determination cannot be made for any approved use, Congress should be informed of the actions the HHS Secretary intends to take to regulate food additives to protect the public health, which may include:
revoking or modifying any of the approved uses of BPA in food and beverage containers, including reusable food and beverage containers; and
ensuring that the public is sufficiently informed of such determination and the steps the public may take in response to such determination.
(See ITT's Online Archives or 06/04/09 news, 09060420, for BP summary of House Energy and Commerce Committee's request for an FDA review of its decision on the safety of BPA.)
Information Would be Required on New Infant Formula Ingredients, Etc.
H.R. 2749 would amend the information submission and registration requirements of Section 412 of the Food, Drug, and Cosmetic (FD&C) Act (21 USC 350a) that must be met in order to introduce or deliver for introduction a new infant formula into interstate commerce. The amendments would require the submission of information on any new ingredient in a new infant formula including:
a citation to a prior approval by the HHS Secretary of the new ingredient for use in infant formula under section 409 of the FD&C Act;
a citation to or information showing a prior consideration of the new ingredient for use in infant formula under any program established by the Secretary for the review of ingredients used in food; or
for a new ingredient that is not a food additive or a color additive, information equivalent to that provided under any program established by the Secretary for the review of ingredients used in food.
For submissions regarding a new ingredient that is not a food additive or a color additive, the 90 day period provided under 21 USC 350a(c)(1)(B) after which the person may market the new infant formula would not begin until the HHS Secretary had reviewed the information submitted and provided notice of the results of the review.
Misbranding. H.R. 2749 would also consider a new infant formula that is not the subject of the required registration and information submission requirements of 21 USC 350a(c)(1) to be misbranded2. In addition, new infant formula would be considered misbranded if it were introduced into interstate commerce before the 90 day period provided under 21 USC 350a(c)(1)(B).
(For purposes of 21 USC 350a(c)(1), the term ''new infant formula'' continues to include:
an infant formula manufactured by a person which has not previously manufactured an infant formula, and
an infant formula manufactured by a person which has previously manufactured infant formula and in which there is a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer.)
(See ITT's Online Archives or 03/06/09 and 10/10/08 news, 09030615 and 08101025, for BP summaries of melamine-related detentions and testing of milk products and infant formula from China.)
1Bisphenol A, commonly known as BPA, is used in a wide variety of consumer products, including food containers, water bottles, and baby bottles.
2Introducing misbranded food into interstate commerce is a prohibited act under 21 USC 331.
(See ITT's Online Archives or 08/25/09, 08/12/09, 08/10/09 and 08/04/09 news, 09082510, 09081205, 09081015 and 09080415, for BP summaries of the facility and export, food tracing, broker and importer-specific requirements of H.R. 2749.
See ITT's Online Archives or 07/31/09 and 07/30/09 news, 09073110 and 09073005, for BP summaries of the House passing H.R. 2749 and the House failing to pass H.R. 2749 under expedited procedures, respectively.
See ITT's Online Archives or 07/08/09, 07/02/09, 06/30/09, 06/26/09, and 06/25/09 news, 09070820, 09070210, 09063015, 09062625 and 09062515, for BP summaries of various aspects of the House Energy and Commerce Committee version of H.R. 2749.)
H.R. 2749 as passed by the House available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h2749rfs.txt.pdf
House Committee on Energy and Commerce short bill summary (dated July 2009) available at http://energycommerce.house.gov/Press_111/20090729/hr2749_floorsummary.pdf
House Committee on Energy and Commerce section-by-section bill summary (dated July 2009) available at
http://energycommerce.house.gov/Press_111/20090729/hr2749_sectionsummary.pdf