[Congressional Record Volume 144, Number 151 (Wednesday, October 21, 1998)]
[Extensions of Remarks]
[Pages E2280-E2281]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 H.R. 4679: THE ANTIMICROBIAL REGULATION TECHNICAL CORRECTIONS ACT OF 
                                  1998

                                 ______
                                 

                            HON. TOM BLILEY

                              of virginia

                    in the house of representatives

                       Tuesday, October 20, 1998

  Mr. BLILEY. Mr. Speaker, I would like to provide additional 
background information on Congress' intent and understanding regarding 
H.R. 4679, the ``Antimicrobial Regulation Technical Corrections Act of 
1998.''
  With the enactment of the Food Quality Protection Act (FQPA) of 1996, 
changes were made in the definition of ``pesticide chemical'' and 
``food additive'' under the Federal Food, Drug, and Cosmetic Act 
(FFDCA). In addition, FQPA added a definition of ``pesticide chemical 
residue.'' These new definitions had a significant and unintended 
impact on the regulatory responsibility for approving the use of

[[Page E2281]]

certain antimicrobial substances in food contact applications. 
Historically, such substances were regulated by the Food and Drug 
Administration (FDA) as food additives and were approved by that agency 
under Section 409 of the (FFDCA). With the FQPA definitional changes, 
such substances now fall within the term ``pesticide chemical'' and are 
subject to regulation by the Environmental Protection Agency (EPA) 
under Section 408 of the FFDCA.
  Since the passage of the FQPA in August 1996, these shifts in 
regulatory jurisdiction have led to delays in the processing of 
petitions for clearance of certain antimicrobials under the FFDCA. In 
the interim, in addition to the losses to the companies with pending 
petitions, the American public is losing the economic and environmental 
advantages that these products may offer. An amendment similar to the 
proposed technical correction was considered in October 1997, late in 
the conference on the FDA Modernization Act (FDAMA) but was deferred 
for later consideration. In the FDAMA Conference Report, however, the 
conferees urged the interested parties to pursue a new vehicle to 
achieve resolution of this jurisdictional issue.
  The technical correction made by H.R. 4679 does not remove any use of 
a substance from regulation as a pesticide under the Federal 
Insecticide, Fungicide and Rodenticide Act (FIFRA). Thus, any use of an 
antimicrobial in the manufacture of packaging for both food and non-
food applications that is a pesticidal use under FIFRA would, in 
addition to FDA review as a food additive, continue to be subject to 
pesticide registration under FIFRA. Moreover, the proposed legislative 
language does not affect FDA's existing jurisdiction over antimicrobial 
substances (with the exception of ethylene oxide and propylene oxide) 
used in or on processed food, which are not ``pesticide chemicals'' 
under the FFDCA.
  H.R. 4679 would achieve the following:
  1. Consistent with its traditional broad regulatory authority over 
food products and processing, FDA would have authority under FFDCA 
Section 409 to regulate as food additives--
  Those antimicrobial substances used in or on food, or water that 
comes into contact with food, if such substances are used where food is 
prepared, packed or held for commercial purposes.
  Most antimicrobials used as food contact substances, such as those 
used in the manufacture of food contact packaging.
  2. Consistent with EPA's traditional role in reviewing uses of 
antimicrobials in agricultural applications, EPA would retain authority 
under FFDCA Section 408 to regulate--
  Antimicrobials used on raw agricultural commodities, or on water used 
on such commodities in the field; in a facility where raw agricultural 
commodities are the only food treated, and the treatment is in a manner 
that does not change the status of the food as a raw agricultural 
commodity (e.g., washing, waxing, fumigating, and packing such 
commodities in such a manner); or during transportation of raw 
agricultural commodities between the field and such a treatment 
facility.
  Under this legislation, Congress intends that EPA will continue to 
regulate fumigants applied to stored raw agricultural commodities in 
the above locations.
  3. EPA would have regulatory authority under FFDCA, over residues of 
the fumigants ethylene oxide and propylene oxide on both raw 
agricultural commodities and processed food, including ground spices. 
Additionally, use of ethylene oxide and propylene oxide on foods, 
including processed foods, will be a pesticidal use under FIFRA.
  4. EPA would have regulatory authority over residues of 
antimicrobials used on semi-permanent or permanent food contact 
surfaces other than food packaging. Similarly, EPA would have 
regulatory authority over antimicrobial substances impregnated in semi-
permanent or permanent food contact surfaces other than food packaging 
if the substance is intended to serve the same purpose as application 
of an antimicrobial to the exterior of such surface.
  5. A ``grandfather/transitional'' provision would ensure that any 
regulation authorizing the use of an antimicrobial substance that, 
under this legislation is not a pesticide chemical use and thus is 
subject to FDA's regulatory authority under section 409, would be 
considered a regulation issued under Section 409. Thus, after the 
passage of the amendment, all antimicrobial products under FDA's food 
additive authority would be regulated under the same statutory 
authority.
  Except as noted for ethylene oxide and propylene oxide, this 
amendment would affect the regulation of antimicrobial pesticides only 
under the FFDCA. EPA would continue to regulate antimicrobial 
pesticides under FIFRA, and EPA's authorities under that statute would 
not be changed. Companies selling or distributing antimicrobial 
pesticides must apply to EPA for registration of their products. EPA 
will review the applications under FIFRA sec. 3, which requires among 
other things that the products not cause ``unreasonable adverse effects 
on the environment.'' That term is defined in FIFRA sec. 2(bb) to mean: 
``(1) any unreasonable adverse effects on the environment taking into 
account the economic, social, and environmental costs and benefits of 
the use of any pesticide, and (2) a human dietary risk from residues 
that result from a use of a pesticide in or on any food inconsistent 
with the standard under section 408 of the Federal Food, Drug, and 
Cosmetic Act .  . .''
  Thus, it is Congress' intent that EPA, in deciding under FIFRA 
whether to grant, amend, or cancel a registration for an antimicrobial 
pesticide that poses a human dietary risk, shall take such action only 
if EPA determines that the risks from such residues are not 
inconsistent with the safety standard in FFDCA sec. 408. Additionally, 
Congress intends that in granting, modifying, or canceling a tolerance 
for a pesticide chemical residue under section 408, EPA consider 
exposures to substances regulated under section 409 where applicable.
  Overall, the technical correction made by H.R. 4679 presents an 
opportunity to reverse a change that Congress did not intend to make 
and allow companies to bring these beneficial antimicrobial products to 
market without further unnecessary delay. Importantly, shifting 
regulatory jurisdiction over certain antimicrobial uses of FDA will 
continue to ensure public health protection provided by the FFDCA.

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