[Federal Register: October 9, 1998 (Volume 63, Number 196)]
[Notices]
[Page 54531-54544]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09oc98-210]
[[Page 54531]]
_______________________________________________________________________
Part III
Department of Health and Human Services
Food and Drug Administration
Environmental Protection Agency
_______________________________________________________________________
Legal and Policy Interpretation of the Jurisdiction Under the Federal
Food, Drug, and Cosmetic Act of the Food and Drug Administration and
the Environmental Protection Agency Over the Use of Certain
Antimicrobial Substances; Notice
[[Page 54532]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[98N-0867]
ENVIRONMENTAL PROTECTION AGENCY
[OPP-300624; FRL-5773-8]
Legal and Policy Interpretation of the Jurisdiction Under the
Federal Food, Drug, and Cosmetic Act of the Food and Drug
Administration and the Environmental Protection Agency Over the Use of
Certain Antimicrobial Substances
AGENCIES: Environmental Protection Agency (EPA) and Food and Drug
Administration (FDA).
ACTION: Notice of policy interpretation.
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SUMMARY: The Food Quality Protection Act of 1996 became law on August
3, 1996. FQPA amended both the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and the Federal Food, Drug, and Cosmetic Act
(FFDCA). Among other things, FQPA changed the regulatory authority of
both EPA and FDA with respect to the FFDCA's regulation of pesticide
residues in or on food. This notice: (1) Sets forth legal and policy
interpretations of the FFDCA as they relate to the jurisdiction of EPA
and FDA over antimicrobial substances used in or on food, including
food-contact articles; (2) discusses interpretations of certain terms
in FIFRA and the implementing regulations relevant to the authority of
the two agencies; (3) provides a description of how EPA and FDA propose
to clarify the post-FQPA regulatory authority over certain
antimicrobial substances; and (4) discusses how EPA and FDA plan to
handle the review of petitions for antimicrobial substances that will
remain under EPA's jurisdiction and for those that EPA proposes to
return to FDA's regulatory authority through EPA rulemaking.
DATES: The policy set out in this notice is effective immediately. Both
FDA and EPA will accept comments on this notice for 90 days from
October 9, 1998.
ADDRESSES: Comments should be sent to both FDA and EPA dockets at the
addresses listed below. Submit written comments identified by the
appropriate docket number (for FDA 98N-0867 and for EPA OPP-300624) to:
FDA at: Dockets Management Branch (HFA-305), Food and Drug
Administration, Rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
EPA at: Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, deliver comments to: Rm. 119, CM #2,
1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically to EPA: opp-
docket@epamail.epa.gov. Follow the instructions under Unit VII. of this
document. No Confidential Business Information (CBI) should be
submitted through e-mail.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. A copy of the comment that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential will be included in the
public docket by EPA without prior notice. The public docket is
available for public inspection in Rm. 119 at the Virginia address
given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays.
FOR FURTHER INFORMATION CONTACT: Regarding EPA issues: William L.
Jordan, Antimicrobials Division (7510W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460,
Telephone: (703) 308-6411.
Regarding FDA issues: Mark A. Hepp, Office of Pre-Market Approval
Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug
Administration, 200 C St., SW., Washington, DC 20204-0002, Telephone:
(202) 418-3098.
SUPPLEMENTARY INFORMATION:
Electronic Availability:
Internet
Electronic copies of this document and PR Notice 97P-1 are
available from the EPA home page at the Federal Register-Environmental
Documents entry for this document under ``Laws and Regulations''
(http://www.epa.gov/fedrgstr/).
Fax on Demand
Using a faxphone call 202-401-0527 and select item 6108 for a copy
of the PR Notice and select item 6113 for a copy of this Federal
Register notice.
EPA and FDA are issuing this joint notice to clarify, subsequent to
the enactment of the Food Quality Protection Act of 1996 (FQPA), the
jurisdiction over antimicrobials that are used in or on food, including
those used in or on edible food, and those used in the manufacture of,
or in or on, food-contact articles. In addition, the agencies are
setting forth a proposed allocation of jurisdiction for these
antimicrobials. Implementation of some of these decisions would require
EPA rulemaking. Such rulemaking, if finalized as proposed, would
reestablish FDA's regulatory authority over certain antimicrobial
substances. Therefore, the agencies are presenting an interim plan to
coordinate the review of petitions for the antimicrobial substances
that would be affected by any proposed EPA rulemaking.
This joint notice is subject to FDA's good guidance practices
(GGPs) Level 1 guidance (62 FR 8961, February 27, 1997). FDA will not
solicit public input prior to implementation because the guidance
presents a less burdensome policy that is consistent with the public
health. This guidance does not create or confer any rights for or on
any person and does not operate to bind FDA, EPA, or the public.
I. Legal Background
As described more fully below, EPA regulates the sale,
distribution, and use of ``pesticides'' under FIFRA, 7 U.S.C. 136 et
seq. Historically, EPA and FDA have shared regulatory authority under
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 321 et seq.
over the residues of such ``pesticides'' in or on food. The FQPA of
1996 amended FFDCA in ways that alter EPA's and FDA's jurisdiction over
certain pesticides with antimicrobial uses.
A. EPA Jurisdiction and Authorities Under FIFRA
In general, FIFRA gives EPA authority to regulate the sale,
distribution, and use of a ``pesticide.'' A ``pesticide'' is defined as
any substance or mixture of substances intended for preventing,
destroying, repelling, or mitigating any pest, . . .'' (FIFRA section
2(u)). The term ``pest'' includes ``(1) any insect, rodent, nematode,
fungus, weed, or (2) any . . . virus, bacteria, or other microorganism
which the Administrator declares to be a pest'' (FIFRA section 2(t)).
As a result of these broad definitions, EPA regulates, as FIFRA
pesticides, a wide variety of chemical substances marketed for a
diverse array of uses. For example, EPA regulates, as pesticides,
substances used to control weeds and fungi on crops, and microorganisms
that may be present on permanent or semi-permanent surfaces, such as
counter tops and food processing equipment that may come in contact
with food.
[[Page 54533]]
It should be noted that FIFRA defines ``fungus'' as ``any non-
chlorophyll-bearing thallophyte . . . as for example . . . mildew,
mold, yeast, and bacteria . . .,'' but the definition specifically
excludes those organisms when ``on or in processed food, beverages, or
pharmaceuticals'' (FIFRA section 2(k)). Further, EPA has broadened this
statutory exclusion in its FIFRA regulations at 40 CFR 152.5(d).
Specifically, under this rule, an organism is not considered a ``pest''
if it is a ``fungus, bacterium, virus, or other microorganisms [sic] .
. . on or in processed food or processed animal feed, beverages, drugs,
. . . or cosmetics . . . .'' In applying this exclusion, EPA has
historically interpreted the words ``processed food'' and ``processed
animal feed'' as they are commonly understood--food that has undergone
processing and is intended to be consumed immediately or after some
further processing or preparation. Because the commonly understood
meaning of these terms applies to edible food articles, EPA has not
considered food-contact items (such as paperboard and ceramic ware) to
be ``processed food'' within the meaning of that term in FIFRA and
EPA's implementing regulations.1 Thus, EPA has regarded any
antimicrobial substance used in or on paper, paperboard, or other food-
contact items as a ``pesticide'' under FIFRA.
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1The discussion in the paragraph above, however, does not
purport to interpret the FFDCA definition, but rather to address the
meaning of the terms ``processed food'' and ``processed animal
feed'' used in FIFRA and EPA's implementing regulations.
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With minor exceptions, no pesticide product may be sold or
distributed unless EPA has licensed or ``registered'' the product
(FIFRA section 12(a)(1)(A)). EPA registers products on the basis of
data showing that the pesticide, when used in accordance with the terms
and conditions of registration and in accordance with widespread and
commonly recognized practice, will perform its intended function
without causing ``unreasonable adverse effects on the environment''
(FIFRA section 3(c)(5)). Through registration, EPA regulates the
composition, packaging, and labeling of pesticides. The labeling of a
pesticide product includes information prescribing how a product may be
used and generally contains directions specifying the sites on which
the product may be used, the amount that may be applied, the frequency
of application, and appropriate precautions necessary to reduce risks.
It is unlawful to use a registered pesticide in a manner inconsistent
with its labeling (FIFRA section 12(a)(2)(G)).
B. EPA and FDA Jurisdiction and Authorities Under FFDCA Prior to FQPA
The FFDCA prohibits the introduction or delivery for introduction
into interstate commerce of any food that is ``adulterated'' (FFDCA
section 301(a)). Food is deemed adulterated, among other reasons, ``if
it is a raw agricultural commodity and it bears or contains a pesticide
chemical which is unsafe within the meaning of section 408(a); or if it
is, or it bears or contains, any food additive which is unsafe within
the meaning of section 409'' (FFDCA section 402(a)(2)(B), (C) (emphasis
added)). As discussed more fully below, prior to the enactment of FQPA,
some FIFRA ``pesticides''--primarily agricultural chemicals--were
``pesticide chemicals'' under FFDCA; other FIFRA ``pesticides''--
including antimicrobials--were ``food additives'' under FFDCA. Thus,
pre-FQPA, both EPA and FDA had responsibilities under FFDCA for the
regulation of residues in food resulting from use of substances
considered ``pesticides'' under FIFRA. Each agency's pre-FQPA authority
is described directly below. Section C in this unit explains the
changes in each agency's authority brought about by FQPA.
1. EPA jurisdiction and authorities. Under Reorganization Plan 3 of
1970, which created the Environmental Protection Agency, EPA assumed
the authority in FFDCA to set tolerances, and exemptions from the
requirement of a tolerance, for ``pesticide chemicals'' (5 U.S.C. App.
I, 84 Stat. 2086). At that time, the FFDCA defined a ``pesticide
chemical,'' as ``any substance which . . . is a `pesticide' within the
meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 136(u)) as now in force or as hereafter amended, and which is
used in the production, storage, or transportation of raw agricultural
commodities'' (FFDCA section 201(q), 21 U.S.C. 321(q) (1994) (amended
1996)). Thus, in addition to registering pesticides under FIFRA, EPA
regulated the presence of the residues in food of FIFRA ``pesticides''
resulting from their use in or on raw agricultural commodities.
It is important to note that the definition of ``pesticide
chemical'' in FFDCA was narrower than FIFRA's definition of
``pesticide,'' and therefore EPA had jurisdiction over residues in or
on food for only some FIFRA pesticides. As a practical matter, EPA's
authority under FFDCA extended only to pesticides used in agricultural
production--e.g., weed killers, fungicides, growth regulators, and
insecticides applied to growing crops and stored raw agricultural
commodities.
In general, a ``pesticide chemical'' in or on a raw agricultural
commodity was considered ``unsafe'' unless there was a tolerance or an
exemption from the requirement of a tolerance for the pesticide
chemical and the residue of the pesticide chemical conformed to the
terms of the tolerance or exemption. See FFDCA section 408(a)(1), 21
U.S.C. 346a(a)(1) (1994) (amended 1996). A tolerance sets out the
maximum amount of a residue that may legally remain on a particular
food. For example, EPA established a tolerance of 0.05 parts per
million (ppm) of the weed killer alachlor in peanuts. See 40 CFR
180.249. Any residue of alachlor over that amount would cause the
peanuts to be adulterated. An exemption from the requirement of a
tolerance represents a determination by EPA that any amount of residue
of a specific pesticide chemical expected to be present in or on a raw
agricultural commodity as a result of its use would be safe. For
pesticides subject to a tolerance exemption, there is no numerical
limit on the amount of permitted residue.
In its administration of FIFRA and FFDCA, EPA has adopted policies
to ensure the coordinated application of both statutes. Specifically,
EPA will not register a pesticide under FIFRA if its use is expected to
result in residues in food unless such use complies fully with the
FFDCA. See 40 CFR 152.112(g) and 152.113(a)(3).
2. FDA jurisdiction and authorities. FDA was (and remains)
responsible for the regulation of ``food additives'' that are not
``pesticide chemicals.'' Prior to the FQPA, the definition of ``food
additive'' included residues in food of certain FIFRA ``pesticides''
that were not FFDCA ``pesticide chemicals.'' The term ``food additive''
was defined as: ``any substance the intended use of which results or
may reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristics of any
food . . . if such substance is not generally recognized as safe . . .
'' (FFDCA section 201(s) (1990) (amended 1996)). The definition of
``food additive'' specifically excluded a ``pesticide chemical in or on
a raw agricultural commodity'' (FFDCA section 201(s)(1)(1990) (amended
1996)). Under this definition, the term ``food additive'' did not
include pesticide chemicals in or on a raw agricultural commodity but
did include pesticide chemicals in foods that were not raw agricultural
commodities. EPA
[[Page 54534]]
was responsible for the establishment of tolerances or food additive
regulations under section 409 for pesticide chemical residues in food.
FDA was responsible for the establishment of ``food additive
regulations'' for all food additives except those that were also
pesticide chemicals. FDA did set food additive regulations for food
additives that were FIFRA pesticides, but not FFDCA pesticide
chemicals.
As a practical matter, FIFRA pesticides that were regulated by FDA
as food additives prior to FQPA were for antimicrobial uses. These FDA-
regulated substances included products used as sanitizers and
disinfectants for permanent or semi-permanent food-contact surfaces; as
materials preservatives in products like adhesives, coatings, and latex
solutions that could be used to manufacture food packaging materials or
which could otherwise come into contact with food; and as slimicides
added during the process of making paper and paperboard used to package
food. In sum, for each of these categories, EPA registered
antimicrobial substances as a pesticide under FIFRA for the food uses,
only after FDA had made a determination that the use of the products
were safe under section 409 of FFDCA.
Finally, FDA was (and remains) responsible for enforcement of all
FFDCA pesticide tolerances and of food additive regulations. FDA can
request seizure of a food or other enforcement action when a pesticide
residue on food does not conform to an established tolerance or food
additive regulation, or when there is no tolerance, exemption from the
requirement of a tolerance, or food additive regulation in place.
C. Changes in EPA and FDA Authority Under FFDCA Resulting From FQPA
While FQPA made a number of changes to both FIFRA and FFDCA, this
notice focuses only on changes that alter the regulatory
responsibilities of EPA and FDA for establishing FFDCA section 408
tolerances, exemptions from the requirement for a tolerance, and food
additive regulations with respect to antimicrobials. Specifically, this
section discusses: FQPA definitions of ``pesticide chemical,''
``pesticide chemical residue,'' and ``food additive''; the authority in
FFDCA section 201(q)(3) to except substances from the definition of
``pesticide chemical''; the transition provisions in FFDCA section
408(j); and the new statutory standard in FFDCA section 408 for the
establishment of a tolerance and an exemption from the requirement for
a tolerance.
1. Definitions of ``pesticide chemical,'' ``pesticide chemical
residue,'' and ``food additive.'' FQPA redefined ``pesticide chemical''
in FFDCA to mean: ``any substance that is a pesticide within the
meaning of FIFRA, including all active and inert ingredients of such
pesticide'' (FFDCA section 201(q)(1)). Notably, this new definition
eliminates the restriction in the pre-FQPA definition of ``pesticide
chemical'' that the pesticide be used in the production, storage, or
transportation of a raw agricultural commodity.
FQPA also amended the definition of ``food additive'' (FFDCA
section 201(s)). The FQPA amendments did not affect the primary
definition of ``food additive.'' As before, the term food additive is
defined broadly and includes ``any substance the intended use of which
results or may reasonably be expected to result, directly or
indirectly, in its becoming a component or otherwise affecting the
characteristics of any food. . . '' (FFDCA section 201(s)). However,
the FQPA amendments did revise the food additive definition's
exclusions. Specifically, the term ``food additive'' now excludes ``a
pesticide chemical residue in or on a raw agricultural commodity or
processed food'' (FFDCA section 201(s)(1)). As a result of these two
changes, antimicrobial pesticides formerly regulated by FDA as ``food
additives'' under section 409 of FFDCA, are now considered ``pesticide
chemicals'' and regulated by EPA under section 408 of FFDCA .
FQPA also added a definition of ``pesticide chemical residue''
(FFDCA section 201(q)(2)). This term means any residue in or on food of
a pesticide chemical or any other substance that results primarily from
the metabolism or degradation of a pesticide chemical. This definition
makes explicit the long-standing EPA interpretation that the term
``pesticide chemical'' includes the chemical compounds formed through
the breakdown or metabolism of pesticidally active and inert
ingredients in a pesticide formulation.
2. Exception authority. FQPA added a clause to the subsection
defining ``pesticide chemical'' and ``pesticide chemical residue'' that
gives EPA the authority, in certain circumstances, to ``except'' or
exclude otherwise covered substances from these definitions (FFDCA
section 201(q)(3)). Specifically, EPA may exclude a substance from the
definition of a ``pesticide chemical'' or a ``pesticide chemical
residue'' if EPA makes two findings: (1) The presence of the substance
in a raw agricultural commodity or processed food is due primarily to
natural causes or to human activities not involving the use of the
substance for a pesticidal purpose in the production, storage,
processing, or transportation of a raw agricultural commodity or
processed food; and (2) after consultation with the Secretary of Health
and Human Services, the substance is more appropriately regulated under
provisions of the FFDCA other than section 402(a)(2)(B) and 408.
3. Transition provision. FQPA added a provision to the FFDCA to
assure an orderly transition to the new regulatory system. All
previously issued regulations under FFDCA section 406, 408, and 409,
which authorized the presence in food of any substance that is a
pesticide chemical residue, remain in effect unless modified or revoked
(FFDCA section 408(j)). Thus, existing food additive regulations issued
by FDA for antimicrobial substances that are pesticides remain valid,
and food is not adulterated by residues of such substances that conform
to the applicable food additive regulations.
4. Statutory standard for section 408 tolerances and exemptions.
FQPA amended section 408 of FFDCA to establish a new standard for
making decisions to establish tolerances or exemptions from the
requirement of a tolerance for pesticide chemical residues. In order to
establish or leave in effect either a tolerance or an exemption, EPA
must conclude that the pesticide chemical residue in food would be
``safe'' (FFDCA section 408(b)(2)(A)(i), (c)(2)(A)(i)). ``Safe'' is
further defined to mean ``a reasonable certainty that no harm will
result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information'' (FFDCA section 408(b)(2)(A)(ii),
(c)(2)(A)(ii)). The amendments also direct EPA to consider a variety of
factors in making decisions under the new standard. These factors
include: the potential for greater sensitivity or exposure for infants
and children to the pesticide chemical residue; and the cumulative
effects of the pesticide chemical residue and other substances that
have a common mechanism of toxicity. See FFDCA section 408(b)(2)(C) and
(D).
5. Summary. The FQPA amendments have expanded the definition of
``pesticide chemical'' in FFDCA to correspond in scope to the
definition of ``pesticide'' in FIFRA. As a result, so long as a
substance is a ``pesticide'' under FIFRA, EPA now has jurisdiction to
regulate the substance under both FIFRA and FFDCA. EPA also has the
authority to ``except'' substances from
[[Page 54535]]
the definitions of ``pesticide chemical'' or ``pesticide chemical
residue.'' Such an exception would transfer the regulatory
responsibility for such substances to FDA, without yielding regulatory
authority under FIFRA over the use of the pesticide. Notwithstanding
these changes, all previously issued approvals that allow residues of
pesticides in food remain valid under the transition provisions. All
pesticides that are EPA's regulatory responsibility under FFDCA are
subject to the new safety standard of FFDCA section 408.
II. Background
In addition to considering the changes to the legal framework
resulting from FQPA, EPA and FDA evaluated whether the jurisdictional
change brought about by FQPA for certain antimicrobial substances
resulted in the most efficient regulatory outcome. The agencies took
several factors into account in the deliberations and tentatively
concluded that an alternative jurisdictional approach for certain
antimicrobial substances would be more appropriate. Principally, the
two agencies have concluded that the jurisdiction under FFDCA for
antimicrobial substances should be allocated in a way that promotes
protection of public health, and uses limited public resources
efficiently. The factors that the agencies considered are discussed
more fully in sections A and B of this unit.
A. Promotion of Public Health
In recent years, the scientific community has identified the
contamination of food by pathogenic microbes as both a serious and
growing problem affecting the overall safety of the food supply. The
Federal government, working through multiple agencies such as FDA, EPA,
and the Department of Agriculture, Food Safety and Inspection Service,
is using its resources and regulatory authorities to address this
problem in a concerted fashion. Some of the more significant
initiatives are FDA's Hazard Analysis and Critical Control Point
(HACCP) program for the seafood industry, USDA's HACCP program for the
meat and poultry industry, and the possible expansion by FDA of HACCP
to other segments of the food industry. HACCP starts with the
preparation of a hazard analysis for each food processing facility and
then a plan designed to prevent hazards from occurring in the
production of food through a range of available control techniques and
to respond to deviations from the prevention plan.
FDA is especially concerned with a growing problem of pathogens in
fruits, vegetables, and unpasteurized juices. FDA's concern extends to
both domestic and imported foods. This includes contamination of foods
with Escherichia coli 0157:H7, which caused a serious human illness
outbreak involving unpasteurized apple juice in the fall of 1996,
problems associated with Listeria monocytogenes in cut vegetables, and
others. As noted, FDA considers HACCP to be a state of the art approach
to dealing with these problems. For HACCP to be effective, however,
regulatory agencies must be sure that industry HACCP plans include
controls that will ensure that the public is adequately protected from
pathogens in foods. In order to accomplish this, FDA expects that it
will, over time, establish a number of performance standards to assure
the effective control of pathogens in foods.
FDA and EPA must ensure a coordinated approach if these concerns
with microbial contamination are to be effectively addressed. For
example, one technique for reducing microbial contamination of foods is
the appropriate use of antimicrobial chemicals. Therefore, in
evaluating jurisdictional alternatives, the two agencies have
tentatively decided to recognize and give considerable weight to the
benefits that would result from FDA having broad regulatory authority
over the use of antimicrobial chemicals in food processing facilities.
This coordinated approach will allow FDA to move forward in proposing,
for instance, that juices sold for human consumption be subject to a
process that reduces, controls, or eliminates pathogens, and therefore,
will be equivalent to pasteurization in its effect. An equivalent
process may include the use of antimicrobials. Antimicrobials must not
only kill pathogens; assurance is needed that after antimicrobials are
applied, the food meets the performance standard that FDA has
determined is necessary to protect the public health. Furthermore, the
food must meet the performance standard in a real world production
environment.
The use of antimicrobials in food production may be a complex
undertaking. For example, the use of an antimicrobial that might not be
capable of meeting the performance standard by itself at one processing
step can be combined with other pathogen reduction efforts at other
processing steps. It is important that together, these controls achieve
the desired public health objective. The total process, including the
antimicrobial use, can be considered in determining whether the process
is adequate to protect the public from pathogens.
FDA and EPA, after considering these situations and FDA's role and
experience in dealing with pathogens in foods, have tentatively
concluded that FDA should have broad regulatory authority over the use
of antimicrobial substances in food processing facilities. Presently,
FDA has regulatory authority over such substances when used in or on
processed edible foods. However, the intended use of antimicrobial
substances on certain food-contact articles and on raw agricultural
commodities is within EPA's regulatory purview. Therefore, the proposed
allocation of jurisdiction, described in Unit III. of this notice,
would expand FDA's regulatory authority to include antimicrobial
substances used on certain food-contact articles and on raw
agricultural commodities in food processing facilities.
B. Efficient Use of Public Resources
Congress' amendment to the definition of ``pesticide chemical
residue'' in FFDCA, which now includes such residues on processed food
in addition to those residues on raw agricultural commodities, may be
viewed as streamlining the regulatory system by consolidating
responsibilities for regulating ``pesticides'' with antimicrobial
activity in EPA. One consequence of FQPA is to allow EPA to coordinate
the parallel decision-making process of registration under FIFRA and
tolerance setting under FFDCA for antimicrobial substances that are
``pesticides'' under FIFRA. This is consistent with other FQPA
amendments that direct EPA to streamline its registration process for
non-food use antimicrobial pesticides. See FIFRA section 3(h).
The FQPA amendments did not affect the current regulatory framework
in FIFRA which exempts, by statute, certain microbes in or on processed
food from the definition of ``pest.'' Nor did these amendments affect
the Administrator's authority to declare by regulation that certain
microbes are not ``pests.'' Thus, antimicrobials directed against
microbes that are in or on processed edible food remain subject to
FDA's regulatory authority as food additives post-FQPA.
However, this new regulatory scheme created by FQPA differs
significantly from the previous regulatory scheme in place for over 25
years for certain indirect food additives. Antimicrobial substances
applied to or incorporated in food-contact articles but not used
directly in or on edible processed food were regulated by FDA as food
additives
[[Page 54536]]
because of their potential migration to food. FDA and EPA have
extensive regulatory experience with this pre-FQPA jurisdictional
scheme and have developed considerable understanding and experience
with the policies and procedures of the respective agencies.
To the extent that the regulated community has expressed its views,
it expressed a preference for retaining, to the greatest extent
possible, the pre-FQPA regulatory scheme regarding antimicrobials in or
on food-contact articles. Such an approach, it argued, could involve
fewer delays because ongoing reviews would continue at FDA where such
reviews have historically been performed. Moreover, by retaining the
pre-FQPA scheme, products regulated by FDA would not be subject to the
requirement in FFDCA section 408 to pay a fee.
Implementing the new statutory scheme, therefore, would involve
adjustments for both the regulated industry and the Federal agencies.
During the transition, decision-making would likely experience
considerable delays. Moreover, during the transition both agencies
would face additional, new work associated with any transfer of
responsibilities. To the extent that the agencies use rulemaking to
restore the pre-FQPA allocation of jurisdiction, these problems are
reduced.
In conclusion, EPA and FDA weighed all of these considerations in
formulating the approach set forth in Unit III. of this notice
regarding the allocation of regulatory responsibility for antimicrobial
substances used in food-contact articles and food packaging materials.
The agencies reached decisions that they believe reflect the most
appropriate balance of the competing considerations based upon
currently available information. This proposed allocation of
responsibilities is described more fully in Unit III. below.
III. Allocation of Regulatory Responsibilities Under FFDCA in Light
of FQPA Amendments
A. Summary
EPA and FDA propose to divide the universe of antimicrobial
substances regulated under the FFDCA, and potentially affected by the
FQPA amendments, into the following categories. Some of these
categories are the consequence of statutory provisions; others would be
established through rulemaking. Sections B. through F. of this unit
discuss each of the following categories in detail. Section G. of this
unit provides a table summarizing the categories.
1. Antimicrobial substances directed against microbes in or on
edible food, animal drinking water, and process water that contacts
edible food (see section B. of this unit).
a. EPA: antimicrobials used in or on raw agricultural commodities,
or in process water contacting such commodities, in the field, or in a
facility where only one or more of the following activities occurs:
washing, waxing, fumigating, and packing of raw agricultural
commodities, or during transportation of such commodities between the
field and such facility; antimicrobials used in or on raw agricultural
commodities for consumer use; antimicrobials that are not drugs used in
animal drinking water.
b. FDA: antimicrobials used in or on processed food or processed
animal feed; antimicrobials used in or on raw agricultural commodities
or in process water contacting such commodities (other than those
described in section III.A.1.a. of this unit), in a facility where such
commodities are prepared, packed, or held (hereinafter ``food
processing facility'' (refer to section B. of this unit for a
description of such facilities));
2. Antimicrobial substances directed against microbes on permanent
or semi-permanent food-contact surfaces (see section C. of this unit).
[Note: impregnated antimicrobials are addresssed in paragraphs 4. and
5. below.]
a. EPA: sole jurisdiction.
b. FDA: no jurisdiction.
3. Antimicrobial substances used in the production of food
packaging materials and in or on such finished materials including
plastic, paper, and paperboard (see section D. of this unit).
a. EPA: no jurisdiction.
b. FDA: sole jurisdiction.
4. Antimicrobial substances used in production of food-contact
articles, other than food packaging, for which there is no ongoing
intended antimicrobial effect in the finished article (see section E.
of this unit).
a. EPA: no jurisdiction.
b. FDA: sole jurisdiction.
5. Antimicrobial substances incorporated into food-contact
articles, other than food packaging, that have an intended
antimicrobial effect on the finished article itself, including the
article's surface (see section F. of this unit).
a. EPA: jurisdiction over active pesticidal ingredients.
b. FDA: jurisdiction over inert ingredients in such pesticides.
B. Antimicrobial Substances Directed Against Microbes in or on Edible
Food, Animal Drinking Water, and Process Water that Contacts Edible
Food
The FQPA amendments did not change FDA's and EPA's jurisdiction
over antimicrobials used to control microbes on raw agricultural
commodities and processed food (within the meaning of the term
``processed food'' in 40 CFR 152.5). Antimicrobial substances directed
against microbes in water in which raw agricultural commodities are
washed, or directed against microbes in or on raw agricultural
commodities, whether the antimicrobials are added to the commodities
directly, or indirectly through the addition of the antimicrobial to
water in which the commodities are washed, are subject to EPA's
regulatory authority as ``pesticides'' under FIFRA and ``pesticide
chemicals'' under FFDCA. This category includes antimicrobial
substances used in the washing of fresh fruits and vegetables. EPA also
regulates antimicrobial substances added to drinking water of cattle,
poultry, and other food animals.
Antimicrobial substances directed against microbes in or on
processed food are not subject to EPA's regulatory authority either
under FIFRA or FFDCA. This is a result of a jurisdictional division
that existed both before and after the FQPA amendments. The definition
of ``pest'' in EPA's implementing regulation at 40 CFR 152.5(d)
specifically excludes ``microorganisms . . . on or in processed food .
. . .'' See Unit II.A. of this notice. Therefore, antimicrobial
substances directed against microorganisms on or in processed food are
not ``pesticides'' under FIFRA. Since these substances are not
pesticides under FIFRA, they are not ``pesticide chemicals'' under
FFDCA. This category includes substances such as those listed in 21 CFR
172.165, 173.315, and 173.320. EPA has had, and will have, no role in
the regulation of substances for these uses; they do not require
registration under FIFRA nor tolerances under FFDCA section 408.
Many existing and proposed applications involve the addition,
inside a food processing facility, of antimicrobial substances to
process water that contacts fruits, vegtables, or other foods.
According to the Memorandum of Understanding (MOU) between FDA and EPA
on the jurisdiction over substances in drinking water (44 FR 42775,
July 20, 1979), FDA has responsibility under FFDCA section 409 for
water, and substances in water (including antimicrobials) used in food
[[Page 54537]]
and for food processing.2 (44 FR 42775, July 20, 1979).
Under this MOU, EPA has, in the past, refrained from regulating such
antimicrobial substances under FIFRA, FFDCA, the Safe Drinking Water
Act, 42 U.S.C. 300f et seq., and the Toxic Substances Control Act, 15
U.S.C. 2601 et seq. More recently, however, EPA has exercised its
authority over antimicrobials added to process water inside a food
processing facility, if that water contacts a raw agricultural
commodity, whether or not such raw agricultural commodity is later
subjected to processing.
---------------------------------------------------------------------------
2Under the MOU, EPA has regulatory responsibility for substances
added to a public drinking water system before the water enters a
food processing establishment.
---------------------------------------------------------------------------
FQPA did not alter the regulatory framework in FIFRA that
determines whether antimicrobial substances used in or on raw
agricultural commodities or processed food are classified as FIFRA
``pesticides.'' Despite this fact, a more efficient allocation of
jurisdiction over antimicrobials that are used in or on both raw
agricultural commodities and processed food appears warranted, given
FDA's interest in regulatory authority over such substances in food
processing facilities.
As discussed above, under the current regulatory scheme, whether
EPA or FDA has jurisdiction over an antimicrobial used on edible food
depends on whether the antimicrobial substance is applied to a raw
agricultural commodity or processed food. Yet it is sometimes difficult
to determine whether certain activities constitute ``processing'' or
are merely post-harvest treatment activities. EPA made such a
distinction for dried commodities (61 FR 2386, January 25, 1996) and
found that, in the legislative history of FFDCA section 408, there was
ambiguity in whether certain types of drying were considered
``processing.'' Moreover, raw agricultural commodities that are treated
with antimicrobials inside a food processing establishment or facility
may be culled, with some of these commodities undergoing further
processing and others leaving the facility without any further
processing. This practice makes it difficult to determine which
specific commodities will remain ``raw agricultural commodities'' and
which will be processed.
The agencies believe that it makes little sense to have the same
antimicrobial substance require both a section 408 tolerance and a
section 409 food additive regulation when the food, whether raw or
processed, is undergoing the same activity, e.g., washing. Therefore,
EPA intends to propose an amendment to 40 CFR 152.5 to exclude from the
definition of ``pest'' microbes that are in or on raw agricultural
commodities or in process water used on such commodities in a food
processing facility. Thus, antimicrobials that are both used inside a
food processing facility and applied either directly to edible food,
whether raw agricultural commodities or processed food, or to process
water that contacts such edible food would not be FIFRA ``pesticides''
nor FFDCA ``pesticide chemicals,'' but instead would be subject to
regulation as FFDCA ``food additives'' under FFDCA section 409.
1. Facilities. The proposed change in the allocation of
jurisdiction over antimicrobials used in or on raw agricultural
commodities, described in section III.A.1.b. of this unit, is limited
to those commodities in ``food processing facilities.'' The term ``food
processing facility'' would include those locations where food is
prepared, packed, or held, except for in the field where raw
agricultural commodities are subject to certain post-harvest
treatments. Thus, the term includes slaughtering or manufacturing
facilities for meat, poultry, seafood, and produce; retail facilities
such as restaurants, grocery stores, institutions, and food vending
operations; and mobile food facilities such as trains, planes, and
vessels. FDA's jurisdiction over antimicrobials that are used on
``processed'' food in such locations remains unchanged by FQPA; such
antimicrobials remain subject to regulation as food additives under
section 409 of FFDCA.
EPA and FDA realize that certain food processing facilities are
part of a farming operation where antimicrobial use on raw agricultural
commodities would not constitute uses described in section III.A.1.a.
of this unit. For example, egg sanitizing may occur ``on the farm'' as
part of an operation with the same types of food handling activities as
those that occur in other food processing facilities. Antimicrobials
used in such an operation would be subject to food additive approval by
FDA.
2. Ethylene and propylene oxides. As a result of the agreement
between FDA and EPA, the allocation of regulatory jurisdiction under
FFDCA over antimicrobial substances used on edible food would, for the
most part, correspond to the allocation that existed prior to enactment
of FQPA. As discussed, the major change would affect antimicrobial
substances used on raw agricultural commodities inside food processing
facilities. There is, however, an additional set of antimicrobial uses-
-ethylene oxide and propylene oxide use on whole and ground spices--for
which the proposed allocation would represent a difference from the
current regulatory scheme. All uses of ethylene oxide on spices have
been regulated by EPA under FFDCA section 408. Since these uses of
ethylene oxide take place inside food processing facilities, the
proposed allocation would give FDA exclusive jurisdiction over these
uses under FFDCA section 409. This situation is further complicated by
the fact that these active ingredients also have insecticidal
properties that could only be regulated by EPA under both FIFRA and
FFDCA. EPA and FDA are considering, in light of the long history of
regulation of this chemical and these specific uses by EPA under FFDCA
section 408, whether to address the uses differently from the general
approach described above. At a minimum, EPA's proposed rule will seek
public comment on the implications for different regulatory schemes for
these uses under FFDCA.
In summary, FDA and EPA agree that because it is difficult to
ascertain whether certain food will remain a raw agricultural commodity
or become a processed food when entering food processing facilities, it
would be more efficient to allocate regulatory responsibility for
antimicrobials that are used on raw agricultural commodities in such
facilities to FDA. Moreover, it would be consistent with the promotion
of public health and FDA's interest in the application of HACCP
principles to food production. Thus, antimicrobials that are used
inside a food processing facility, including those used in process
water contacting edible food, regardless of whether the food is
``processed,'' would not be FIFRA ``pesticides'' nor FFDCA ``pesticide
chemicals,'' but instead would be ``food additives'' under FFDCA
section 409.
Antimicrobials that are directed against microbes in or on raw
agricultural commodities, as described in section III.A.1.a. of this
unit, would remain FIFRA ``pesticides'' and FFDCA ``pesticide
chemicals'' and thus require pesticide registration under FIFRA and a
tolerance or exemption from the requirement of a tolerance under FFDCA.
Antimicrobials that are used by the consumer in or on raw agricultural
commodities in the household would remain FIFRA ``pesticides'' and thus
would also require FIFRA registration. Moreover, such antimicrobials
would be FFDCA ``pesticide chemicals,'' but would not require a
tolerance or an exemption from the requirement of a tolerance where
such food is not ``held for sale'' within the meaning of FFDCA.
Nonetheless, EPA will continue to
[[Page 54538]]
conduct the same safety evaluation of dietary exposure to
antimicrobials used in consumer households as it does for tolerances
issued under FFDCA section 408.
3. Labeling of products used in retail facilities. Historically,
FDA has had limited involvement in the regulation and enforcement
activities affecting retail establishments, including restaurants and
grocery stores. FDA has directed its efforts toward providing technical
assistance to state and local governmental agencies that, as a
practical matter, have primary responsibility for regulating the retail
segment of the food industry. Providing a model food code has been the
central mechanism through which FDA, as a lead Federal food control
agency, has promoted uniform implementation of national food regulatory
policy among the several thousand Federal, state, tribal, and local
agencies that carry out the primary oversight of this industry
component.
Although the food code provides referenced information about the
approved use of antimicrobials in or on food, EPA and FDA believe that
directions for use should be included on the labeling of such
substances. The labeling would ensure that a person using such a
product in the retail setting will have adequate directions for use
readily available. Therefore, as part of its exercise of regulatory
authority over the use of those antimicrobial substances, FDA is
planning to propose to require that a manufacturer provide adequate
directions for use to ensure compliance with the applicable food
additive regulation. These directions would include the conditions of
safe use required under FFDCA section 409(c)(1). The conditions of safe
use require adequate directions to achieve the intended technical
effect.
Consistent with its authority under FFDCA section 409(c)(3)(B), FDA
believes that a product that is intended to achieve an antimicrobial
effect may require a label with adequate directions to achieve such
effect so that the use of the product would not promote deception of
the consumer. Specifically, section 409(c)(3)(B) prohibits FDA from
approving a food additive if the proposed use would result in the
misbranding of food within the meaning of FFDCA section 403(a)(1).
Under section 403(a)(1) of FFDCA, a food is misbranded if its labeling
is false or misleading in any particular.
Section 201(n) of the FFDCA provides context to what is meant by
``misleading'' in FFDCA section 403(a)(1). Under FFDCA section 201(n),
when determining whether a product is misbranded, FDA is to take into
account not only the representations made about the product, but also
the extent to which the labeling fails to reveal facts material in
light of such representations made or suggested in the labeling or
material with respect to consequences which may result from the use of
the article to which the labeling relates under the conditions of use
prescribed in the labeling or under such conditions of use as are
customary or usual. See 21 CFR 1.21. FDA believes that directions to
achieve an antimicrobial's intended technical effect may be a material
fact with respect to the consequences which may result from the use of
the antimicrobial. For example, an antimicrobial that is intended to
kill pathogenic microbes and fails to provide directions to achieve
such effect may result in adverse consequences to the consumer from
ultimate consumption if the antimicrobial is not used appropriately.
Therefore, if such labeling is required for the antimicrobial's
approval for use as a food additive, the absence of such labeling would
constitute misbranding under FFDCA section 403(a)(1). In general, FDA
believes that the concept of ``material fact'' is one that should be
applied on a case-by-case basis.
C. Antimicrobial Substances Used to Sanitize or Disinfect Permanent or
Semi-Permanent Food-Contact Surfaces
Products intended for the uses in this category have the same
regulatory status under FIFRA, both before and after FQPA. Because they
are directed against pests, i.e., against microbes that are not
excluded by FIFRA or implementing regulations from the definition of
``pest,'' antimicrobial substances used to sanitize or disinfect
environmental surfaces are ``pesticides'' under FIFRA. This category
includes antimicrobial substances that are used in or on equipment in
food production facilities such as farm bulk tanks and milking
machines; in manufacturing facilities such as meat saws/grinders,
shellfish skimmers, and in-plant product conveyance systems; in retail
food facilities such as slicers, cutting surfaces, dishwashing
machines, and kitchen utensils and tableware; and in mobile facilities
such as bulk tankers used for liquid eggs or dairy products. Such
products must be registered by EPA under FIFRA prior to marketing.
The use of these products is also widely specified and referenced
in FDA's model codes pertaining to the milk, retail food, and shellfish
industries. These products are considered to be ``public health
pesticides'' under FQPA and, therefore, EPA will coordinate with FDA as
part of the PHS in determining the safe and necessary use of these
products.
As explained in Unit I.A. of this notice, EPA does not regard food-
contact surfaces as ``processed food'' within the meaning of FIFRA
section 2(k) and the regulations at 40 CFR 152.5(d). EPA and FDA have
tentatively agreed to treat substances used to disinfect reusable food
packaging materials, e.g. beverage containers, differently from
antimicrobial pesticides used to disinfect or sanitize environmental
surfaces (refer to discussion in section D. of this unit).
Before the FQPA amendments, products used to sanitize or disinfect
permanent or semi-permanent food-contact surfaces were not considered
``pesticide chemicals'' under FFDCA because they were not used in the
production, storage, or transportation of raw agricultural commodities.
Therefore, these products were regulated as ``food additives'' by FDA
under FFDCA section 409. Food additive regulations for this category of
products appear in 21 CFR 178.1010.
Under FQPA, products in this category are ``pesticide
chemicals''because they are FIFRA pesticides, and thus, no longer
within the scope of the term ``food additive.'' Consequently, they are
regulated under FFDCA section 408 by EPA. Because of the transition
provisions in FQPA, previously issued food additive regulations remain
in effect for substances in this category.
FDA and EPA have agreed to propose that EPA should retain
jurisdiction over these products, rather than promulgate rules that
would restore the pre-FQPA regulatory scheme. Many of the products in
this category have non-food uses at other sites, especially sites
involving potential exposure to children or other potentially sensitive
groups in the general population. As a policy matter, EPA has decided
it will conduct a more extensive risk assessment of such non-food uses
to take into account the aggregate exposure of sensitive population
subgroups. See EPA PR Notice 97-1 and FFDCA section 408(b). As part of
its assessment of aggregate exposure, EPA would also evaluate the
potential dietary exposure to the antimicrobial substance. Because EPA
will be routinely evaluating the non-food uses of these products, the
two agencies believe it would be more efficient for EPA to regulate the
food uses of these products along with the non-food uses.
[[Page 54539]]
D. Antimicrobial Substances Used in the Production of Food Packaging
Materials and in or on Such Finished Materials
Under FIFRA, antimicrobial substances used in the production of
food packaging materials, or used in or on such materials, are
considered ``pesticides.'' This category of products includes
slimicides used in the manufacture of food-contact paper and
paperboard, and preservatives added to aqueous suspensions for
adhesives or coatings. Also included are antimicrobials incorporated
into polymers or finished paper and paperboard coatings to kill
microbes in the final food packaging or in the food that contacts such
packaging and sanitizers applied to food containers such as aseptic
packaging. As discussed in Unit I.A. of this notice, none of these food
packaging materials is considered a ``processed food'' under FIFRA
regulations.
The FQPA amendments altered the regulatory authority over some of
these products under FFDCA. Prior to FQPA, these antimicrobial
substances were regulated under FFDCA section 201(s) as food additives,
GRAS substances, or prior sanctioned substances. Even though many of
these substances were FIFRA ``pesticides,'' they were not used in the
production, storage, or transportation of raw agricultural commodities.
Consequently, FDA exercised authority over these chemicals in food
under FFDCA. FDA food additive regulations for some of these chemicals
appear in, for example, 21 CFR 175.105, 176.170, 176.300, and 178.1005.
After FQPA, many of these products in this category are considered
``pesticide chemicals'' under FFDCA, because they are ``pesticides''
under FIFRA. Because of the exclusion of a ``pesticide chemical'' from
the definition of ``food additive,'' these substances are no longer
``food additives'' and are not within FDA's regulatory responsibility.
Thus, EPA is now responsible for the establishment of tolerances or
exemptions from the requirement of a tolerance for their residues in
food under FFDCA section 408.
EPA and FDA have determined that antimicrobial substances in this
category should be subject to regulation as food additives. This
category includes two types of products: (1) Antimicrobial substances
that are impregnated into food packaging that have an ongoing intended
antimicrobial effect on the food or in or on the packaging itself, and
(2) antimicrobial substances used in the production of food packaging
that have no ongoing intended antimicrobial effect beyond the material
production process.
For the first category, EPA plans to propose that FDA have
regulatory authority over those antimicrobials impregnated in food
packaging that are used against microbes on raw agricultural
commodities and those used against microbes in or on the packaging
itself. Antimicrobials used to kill microbes on processed food are not
pesticides; therefore, FDA retains authority over food packaging
impregnated with an antimicrobial that is intended to kill microbes on
the packaged, processed food.
The second category includes antimicrobial substances used in the
production of food packaging that have no ongoing intended
antimicrobial effect in the finished materials. They are ``pesticides''
under FIFRA and therefore ``pesticide chemicals'' under FFDCA, post-
FQPA. EPA intends to propose a regulatory scheme that gives FDA
responsibility for this latter category of products for two reasons.
First, antimicrobial substances in this category that kill microbes in
materials used in the production of food packaging are part of the
formulation of such materials. These substances include adjuvants and
other components of the food packaging materials that are regulated as
food additives by FDA. Government resources would be better used if
these antimicrobial substances were regulated as food additives in
conjunction with the adjuvants and other packaging components in which
they are used. This approach is also more efficient for the regulated
community for the same reason. The regulated community has expressed a
strong preference for continuation of FDA regulation of these products
under FFDCA. For both categories, the control of microbes in or on food
packaging, as for example in the production of aseptically packaged
food, is a very important aspect of an effective food safety program,
such as HACCP. The two agencies believe that FDA will be better able to
protect the public health by administering these regulatory programs--
HACCP and use of antimicrobial substances in or on food packaging--than
if jurisdiction were divided between EPA and FDA.
EPA intends to propose to amend the definition of ``pest'' in 40
CFR 152.5(d) to exclude microbes in or on food packaging or in
materials used in the production of such packaging. As a result of such
an amendment, antimicrobial substances directed against such microbes
would not be ``pesticides'' under FIFRA, and thus, would not be
``pesticide chemicals'' under FFDCA. Instead, such products would be
``food additives'' subject solely to FDA's regulatory authority.
E. Antimicrobial Substances Incorporated into Food-Contact Articles,
Other Than Food Packaging, with No Pesticidal Effect in the Finished
Article
Antimicrobial substances incorporated into food-contact articles,
other than food packaging, have historically been and are still
considered by EPA as ``pesticides'' under FIFRA. This category includes
a wide variety of registered pesticide products such as: preservatives
used in latex solutions, adhesives and coatings intended for use in
food-contact articles, and antimicrobial substances used in the
manufacture of conveyer belts, cutting boards, plastic tubing, and
other articles that come in contact with food during its storage,
transportation, processing, or preparation. These antimicrobial
substances may or may not have an ongoing antimicrobial effect in the
finished food-contact article. Only those that have no intended ongoing
antimicrobial effect in the finished article are discussed in this
unit. Those with an ongoing pesticidal effect are considered in section
F. of this unit.
Similar to products described in section D. of this unit, the
regulatory status under FFDCA of antimicrobial substances incorporated
into food-contact articles, other than food packaging, with no intended
ongoing antimicrobial effect in the finished articles was changed by
FQPA. Prior to FQPA, these products were regulated as ``food
additives'' by FDA. Food additive regulations for these products appear
in 21 CFR 175.300 and 177.2600, for example. After FQPA, these products
are ``pesticide chemicals'' under FFDCA, and thus, within the
regulatory authority of EPA.
Again, just as for antimicrobials used on or in food packaging
materials, EPA and FDA have agreed that the regulatory responsibility
for these antimicrobial substances should be similar to that existing
before the FQPA amendments. EPA will propose to amend the definition of
``pest'' in 40 CFR 152.5(d) to exclude microbes in materials used in
the production of food-contact articles, other than food packaging
(which was previously discussed in section D. of this unit). The result
of such a rulemaking would be that products for uses in this category
would no longer be ``pesticides'' under FIFRA and would be subject to
regulation as ``food additives'' under FFDCA section 409, instead of as
``pesticide chemicals'' under section 408 of FFDCA.
[[Page 54540]]
The reasons for this proposed action are similar to those described
above for antimicrobial substances used in or on food packaging
materials with no intended ongoing antimicrobial effect in the finished
packaging. Again, these substances are part of the formulations of
materials used to produce food-contact articles. Regulation of these
substances as food additives along with the other adjuvants and
components would result in a more efficient use of government
resources. Further, these antimicrobial substances have no intended
ongoing antimicrobial effect in the finished food-contact article.
Therefore, no claims for antimicrobial activity (i.e., pesticidal
effect), which would be under the jurisdiction of EPA, are made for the
finished food-contact article.
F. Antimicrobial Substances Incorporated into Permanent or Semi-
Permanent Food-Contact Articles, Other Than Food Packaging, With an
Ongoing Antimicrobial Effect
This category covers antimicrobial substances incorporated into
permanent or semi-permanent food-contact articles such as conveyer
belts, cutting boards, and plastic tubing for the purpose of having a
pesticidal effect during the continuing life of the product, either on
the food-contact materials themselves (self-protection) or on food that
contacts the treated article. Antimicrobial substances intended to
control or mitigate ``pests'' are ``pesticides'' under FIFRA. Therefore
products in this category are subject to EPA regulation under FIFRA to
the extent that the target microorganisms are ``pests.'' It should be
noted that, if the presence of the antimicrobial substance in the food-
contact article is intended only to control microbes in or on
``processed food,'' such a substance would not be considered a
``pesticide'' under FIFRA because microbes in or on processed food are
not ``pests.''
At present, there are no products registered as pesticides by EPA
that are intended to be incorporated in permanent or semi-permanent
food-contact articles for a pesticidal purpose on the food that
contacts such articles. Several companies, however, have been marketing
unregistered products with such claims. For example, several companies
make plastic cutting boards impregnated with an antimicrobial substance
and have marketed these products with claims that the presence of the
pesticidal substance can kill or control specific pathogenic bacteria
or germs that cause food borne illnesses. Similar products could
include antimicrobial countertops, housewares, conveyer belts, gloves,
shelving, and sponges. Although no company has actually applied for
registration of such product, several have approached EPA concerning
their interest in marketing such products.
Prior to FQPA, products in this category would have been both
``pesticides'' and ``food additives,'' but with the FQPA amendments,
these products are ``pesticide chemicals'' subject only to EPA
regulation. FDA and EPA have tentatively decided to leave the
allocation of responsibility largely as it exists after the FQPA
amendments. Under this scheme, EPA will exercise FIFRA jurisdiction
over the products, as well as FFDCA jurisdiction over the pesticide
active ingredients, but FDA will regulate the inert ingredients in
these products. If a company seeks to market an antimicrobial food-
contact product, e.g. an antibacterial cutting board, EPA would be
responsible for registration of the product under FIFRA.
The primary reason for EPA retaining responsibility for these
products, as contrasted with its approach to the category described in
section E. of this unit, is EPA's concern about claims made for the
antimicrobial efficacy of these products. EPA believes that in
determining whether to register such products, it would be critical not
only to evaluate potential dietary and other risks, but also to ensure
that, when public health claims are made, the products actually perform
as claimed. EPA has considerable experience evaluating antimicrobial
efficacy and making decisions about the labeling of pesticide products
with differing levels of efficacy. Therefore from both an efficiency
and public health protection perspective, EPA appears to be the more
appropriate agency to exercise regulatory responsibility for these
products.
EPA would also propose to establish a tolerance or an exemption
from the requirement of a tolerance for the active ingredient in the
product, under FFDCA. EPA would further need to determine under FFDCA
that the inert ingredients were allowed to be present in food because,
as explained before, EPA will not register a pesticide unless all
ingredients in the product have the necessary approvals. Ordinarily,
because the inert ingredients are part of a pesticide product, they
would be regarded as ``pesticide chemicals'' and EPA would establish a
tolerance or exemption from the requirement for a tolerance for such
ingredients. As a practical matter, however, EPA expects that these
antimicrobial products would be manufactured by adding antimicrobial
active ingredient chemicals to products already in compliance with the
applicable food additive regulations. Therefore, all of the inert
ingredients in such products would likely already be regulated or
permitted by FDA under the FFDCA. EPA and FDA have tentatively decided
that EPA would ``except'' such products from the definition of
``pesticide chemical'' on a case-by-case basis, making the inert
substances ``food additives'' and subject to section 409 of FFDCA. Such
exceptions would be issued under the authority of FFDCA section
201(q)(3). See Unit I.C. of this notice.
G. Summary of Jurisdictional Changes
The following table summarizes the status of FDA and EPA
jurisdiction for antimicrobial substances under FFDCA both before and
after FQPA. This table also summarizes the jurisdictional allocation
that EPA intends to propose through rulemaking.
[[Page 54541]]
Table 1.--EPA and FDA Jurisdiction Under FFDCA
----------------------------------------------------------------------------------------------------------------
After Planned EPA
Product Category Before FQPA After FQPA Rulemaking
----------------------------------------------------------------------------------------------------------------
1. Antimicrobial substances directed EPA & FDA EPA & FDA EPA--antimicrobials
against microbes in or on edible that are not drugs
food, antimicrobials that are not used in animal
drugs used in animal drinking water, drinking water and
and antimicrobials used in process antimicrobials in or
water that contacts edible food on raw agricultural
(Unit III.B.) commodities or process
water contacting such
commodities in the
field, or in a
facility where only
one or more of the
following activities
occurs: washing,
waxing, fumigating,
and packing of raw
agricultural
commodities, or during
transportation of such
commodities between
the field and such
facility; and
antimicrobials used in
or on raw agricultural
commodities for
consumer use. FDA--in
or on processed food
or processed animal
feed; in or on raw
agricultural
commodities or process
water contacting such
commodities in a food
processing facility as
described in Unit
III.A.1.b.
2. Antimicrobial substances directed FDA EPA EPA
against microbes on permanent or
semi-permanent food-contact surfaces
(Unit III.C.)
3. Antimicrobial substances used in FDA EPA FDA
the production of food packaging
materials and in or on such finished
materials, including plastic, paper,
and paperboard (Unit III.D.)
4. Antimicrobial substances used in FDA EPA FDA
production of food-contact articles,
other than food packaging, for which
there is no ongoing intended
antimicrobial effect in the finished
article (Unit III.E.)
5. Antimicrobial substances FDA EPA EPA (active
incorporated into food-contact ingredients) and FDA
articles, other than food packaging, (inert ingredients)
that have an intended antimicrobial
effect on the finished article
itself, including the article's
surface (Unit III.F.)
----------------------------------------------------------------------------------------------------------------
IV. Processed Food
This section provides guidance on a term that is important in
defining the categories, and the resulting jurisdiction of FDA and EPA.
Specifically it addresses what qualifies as a ``processed food'' under
FIFRA.
Although FQPA and the agencies' subsequent policy agreement on
their proposed approach to regulation of antimicrobials largely
eliminated the importance of the distinction between raw and processed
food for purposes of FFDCA tolerance setting, this distinction still
affects the jurisdiction of EPA and FDA under both FIFRA and FFDCA over
antimicrobial substances. Three of the proposed categories (Unit
III.B., D., and F. of this notice) are based, in part, on whether the
antimicrobial substance is directed against microbes on an article that
is a ``processed food'' within the meaning of FIFRA. As explained
below, FDA and EPA have developed guidance to help in the
interpretation of this FIFRA term.
EPA has tentatively decided that the following post-harvest
activities do not constitute processing, and that food subjected to
these activities would not be considered processed food: washing,
coloring, waxing, hydro-cooling, refrigeration, shelling of nuts,
ginning of cotton, and the removal of leaves, stems, and husks. EPA has
tentatively concluded that the following activities constitute
processing and that any food subjected to these activities becomes a
``processed food'': canning, freezing, cooking, pasteurization or
homogenization, irradiation, milling, grinding, chopping, slicing,
cutting, or peeling.
In determining which operations would be considered processing, EPA
considered how such actions or operations are categorized, either
explicitly or implicitly in FFDCA or its legislative history. For
example, FFDCA defines a ``raw agricultural commodity'' as ``any food
in its raw or natural state, including all fruits that are washed,
colored, or otherwise treated in their unpeeled natural form prior to
marketing'' (FFDCA 201(r)). This definition explicitly categorizes
washing and coloring as non-processing operations and implicitly
categorizes peeling as processing.
Similarly, the statute expressly lists several operations as
qualifying as processing--canning, cooking, freezing, dehydration, or
milling (FFDCA 201(gg)); see FFDCA section 402(a)(2)(C) (1990). From
these examples EPA extracted the following guiding principle:
processing operations are ones that alter the general state of the
commodity, while non-processing operations, like harvesting, are
designed only to isolate or separate the commodity from foreign objects
or other parts of the plant. If EPA were writing on a clean slate, it
perhaps would classify coloring differently. However, given the lack of
intrusiveness involved in the coloring of certain commodities (e.g.,
oranges), EPA believes that categorizing coloring for such commodities
as not processing is consistent with the guiding principle outlined
above.
EPA has issued a policy statement under the FFDCA interpreting the
term
[[Page 54542]]
``raw agricultural commodity'' and by inference ``processed food'' for
foods that have been subjected to drying (61 FR 2386, January 25, 1996)
(FRL-4992-4). Briefly, this policy states that a ``raw agricultural
commodity'' becomes a ``processed food'' when it is dried, unless the
purpose of the drying is to facilitate transportation or storage of the
commodity prior to processing. As a practical matter, this policy means
that some vegetables and fruits, such as grapes, become processed food
when the commodity is dried. On the other hand, hay, nuts, rice, beans,
corn, other grasses, legumes, and grains remain raw agricultural
commodities even though they may have undergone some drying. EPA
believes the distinction set forth in this prior FFDCA interpretation
is reasonable and intends to follow it in implementing the term
``processed food'' under FIFRA.
The term ``food processing facility,'' described in Unit III.B. of
this notice, would include those facilities where food is subject to
activities that constitute ``processing'' unless such activities fall
within the exceptions for post-harvest treatments described earlier in
this section. Included within the meaning of the term ``food processing
facility,'' are those facilities where meat and poultry are slaughtered
or otherwise processed subject to the Federal Meat Inspection Act, 21
U.S.C. 601 et seq., and Poultry Products Inspection Act, 21 U.S.C. 451
et. seq. Also included within that term are facilities where
antimicrobials are used in egg washing or processing subject to the Egg
Products Inspection Act, 21 U.S.C. 1301 et seq. Finally, the term also
includes fish processing operations, commercial fishing vessels, and
retail food establishments.
Processing activities include most food handling activities,
including those that are done to a carcass post-slaughter. Such
activities include skinning, eviscerating, and quartering. Because such
post-slaughter activities constitute ``processing,'' the meat that is
subject to such activities is ``processed food'' within the meaning of
that term in 40 CFR 152.5(d). Therefore, the regulatory status of
antimicrobials that are used on meat after slaughter is unchanged by
FQPA and they are subject to regulation by FDA as food additives.
Similarly, seafood that is harvested is ``processed.'' Activities done
post-harvest to seafood include, among other things, handling, storing,
preparing, heading, eviscerating, shucking, or holding (21 CFR
123.3(k)(1)). Antimicrobials that are used in or on seafood, post-
harvest, would also be subject to regulation by FDA as food additives.
In summary, FDA's regulatory authority over the antimicrobial
substances used on meat, poultry, and seafood is unchanged by FQPA
because such uses constitute those that are on ``processed food,'' not
raw agricultural commodities.
V. Implementation of Legal and Policy Interpretations of FFDCA
Jurisdiction
This unit of the notice discusses how EPA and FDA propose to
implement the legal and policy interpretations. Unit V.A. discusses the
rulemaking being planned by EPA to implement the jurisdictional
allocations discussed in Unit III. of this notice. Unit V.B. describes
how EPA will handle both new and pending petitions and Threshold of
Regulation (TOR) requests (see 21 CFR 170.39), that are for
antimicrobial pesticides that the agencies have determined are now
under EPA authority. (A petition or TOR request is considered ``new''
if it is submitted after publication of this notice.) Finally, Unit
V.C. of this notice explains the regulatory status of products that are
currently registered as pesticides and bear labeling directions for use
against microorganisms that would no longer be ``pests'' under EPA's
intended rulemaking.
A. Schedule for EPA Rulemaking to Implement Legal and Policy
Interpretations
EPA and FDA have agreed that EPA will undertake rulemaking to
redefine ``pest.'' If these regulations are promulgated in final as
they are proposed, the result would be to exclude from FIFRA regulation
as ``pesticides'' any antimicrobial substance: (1) Used in or on raw
agricultural commodities in a food processing facility and in process
water contacting such commodities; (2) used in the production of food
packaging materials and in or on such finished materials; and (3) used
in materials that are incorporated into food-contact articles, other
than food packaging, that have no continuing antimicrobial effect in
the finished article. The exception for processed food and processed
animal feed in 40 CFR 152.5 remains intact. The practical effect of
this change would provide FDA with regulatory authority over
antimicrobials used in or on ``edible'' food (including both processed
food and raw agricultural commodities) in a food processing facility.
EPA plans to include this redefinition in the proposed rules being
issued under FIFRA section 3(h) and 25(a) in response to FQPA mandate
to promulgate new regulations to streamline its registration of
antimicrobial pesticides. The proposed rules should be issued in 1998,
and a final rule redefining ``pest'' should be published in the first
half of 1999.
B. Antimicrobial Substances Regulated Completely by EPA
As discussed above, EPA has several categories of antimicrobial
substances within its regulatory authority. Pursuant to the proposed
allocation of jurisdiction, EPA intends to retain regulatory authority
for antimicrobials that are: (1) Directed against microbes in or on raw
agricultural commodities or process water contacting such commodities
as described in Unit III.A.1.a. of this notice; (2) used to sanitize or
disinfect food-contact surfaces, not including food packaging (Unit
III.C. of this notice); and (3) incorporated into food-contact
articles, except food packaging, with continuing pesticidal activity,
except where the target microorganisms are in or on processed food
(Unit III.F. of this notice). EPA registers such antimicrobials under
FIFRA and establishes tolerances or exemptions from the requirement of
a tolerance for the antimicrobials and their ingredients. In addition,
EPA has current regulatory authority over the three categories of
antimicrobials described in Unit V.A. of this notice, for which it
intends to initiate rulemaking to propose that FDA have regulatory
authority over as food additives under FFDCA section 409. This portion
of the notice focuses on how new and pending petitions will be handled
by EPA, both for those antimicrobial substances over which EPA plans to
retain regulatory authority and for those that EPA plans to propose to
allocate regulatory authority to FDA through rulemaking.
EPA staff are available to meet with petitioners to discuss the
status of pending petitions and procedures for submitting a new
petition. If a petitioner or any other person considering submitting a
petition is interested in meeting with EPA, the petitioner should
contact the appropriate Branch Chief in EPA's Antimicrobials Division
to schedule a meeting. Information about how to contact EPA appears in
Unit VI. of this notice.
1. New petitions. Any petition to establish a tolerance or an
exemption from the requirement of a tolerance filed after publication
of this notice for products now regulated by EPA should be submitted to
EPA in the format described in 40 CFR 180.7. In addition, the petition
must contain an ``FQPA Addendum.'' EPA has issued detailed guidance in
PR Notice 97-1 providing direction on the format and types of
information that EPA expects to be
[[Page 54543]]
included in the petition to address the factors required by FFDCA to be
considered as part of the safety standard of FFDCA section 408.
Petitioners should address these factors as they relate to the specific
chemical and use pattern that are the subject of their petition. Copies
of PR Notice 97-1 are available from the EPA contacts listed in Unit
VI. of this notice.
In addition, each petitioner must submit a draft Notice of Filing
which EPA may use as the basis for preparing a Federal Register Notice
announcing receipt of the petition. The petitioner must include in the
draft notice or provide separately a summary of the petition and the
information, data, and arguments submitted in support of the petition.
Generally, the summary should be no longer than five pages. This
summary will be included in the Notice of Filing EPA is required to
publish (FFDCA section 408(d)(3)). EPA Branch Chiefs have examples of
such summaries which they will provide on request. Petitions for
actions on antimicrobial substances that may ultimately be under FDA's
jurisdiction, if the EPA rulemaking is finalized as it is intended to
be proposed, will be under a Notice of Filing stating that the final
action may be taken under FFDCA section 408 or section 409. The
petition must also be accompanied by the tolerance fee required under
FFDCA section 408(m) and 40 CFR 180.33.
Once EPA receives a complete, new petition, the Agency will issue a
Notice of Receipt in the Federal Register (FFDCA section 408(d)(3)).
The Notice will include the summary of petition and data, information,
and arguments supporting the petition (FFDCA section
408(d)(2)(A)(i)(I)). EPA will review the petition and take final action
as quickly as its resources and other, statutorily mandated, priorities
allow.
2. Pending petitions. EPA is working with FDA to complete work, as
expeditiously as possible, on a group of pending petitions. Prior to
enactment of FQPA, FDA received but was unable to complete action on a
number of petitions and TOR requests. FDA continued to work on these
actions and made progress in these reviews. In addition, since FQPA
became law, FDA has received additional petitions and TOR requests. FDA
has taken no action with regard to any petition submitted after
enactment of FQPA for an antimicrobial substance for which FDA
questioned its jurisdiction as a result of FQPA.
EPA places a high priority on completing the review of these
pending actions. Therefore, EPA is working with FDA to transfer the
petitions and associated FDA evaluations to EPA, so that EPA can
complete the review of these petitions as quickly as possible.
The transfer of the petitions and associated evaluations to EPA
must conform to the restrictions on transfer of CBI from FDA.
Petitioners should request FDA to transfer petitions and FDA
evaluations to EPA. Such requests should be directed to the FDA
consumer safety officer (CSO) named in the filing notice of the
petition or current CSO, if changed since the filing notice. FDA will
not transfer any petition or FDA evaluations to EPA until FDA has a
signed consent form from the petitioner to transfer such records. FDA
will provide the consent form to the petitioner after receiving the
petitioner's request for a transfer of records to EPA.
Once FDA has transferred a petition and associated files to EPA,
EPA will review the petition. However, companies will need to take some
additional steps to allow EPA to complete its review of the petition.
First, each petitioner must prepare a short summary of its petition and
the data, information, and argument submitted in support of the
petition. Second, each petitioner must address the specific factors EPA
is required by FFDCA to consider as part of its determination of
whether the safety standard in FFDCA section 408 is met. Both of these
points were discussed in detail under the ``New Petitions,'' section in
this unit.
EPA recognizes that the uncertainty about the jurisdiction of FDA
and EPA under FFDCA over antimicrobial agents has caused delays in
issuing final decisions on some of the pending petitions. EPA is taking
several steps to lessen the impact of such delay. First, EPA will not
require the submission of a new petition for any chemical which is the
subject of a petition pending with FDA. Instead, EPA will accept the
petition as it was submitted to FDA and will process it without further
delay. Second, for pending petitions, EPA will waive the required
tolerance fee required under FFDCA section 408(m). EPA has the
authority to waive or reduce the tolerance fee when waiving the payment
of the fee would be ``equitable and not contrary to the purposes of
this subsection'' (FFDCA section 408(m)(1)). In this instance, EPA
believes that it would be equitable to waive the required fee because
it partially offsets any financial burdens resulting from the delay in
taking final action on pending petitions. Finally, as noted earlier,
completion of review of these petitions holds a very high priority at
EPA.
C. EPA-Registered Products Which Would Cease to Be ``Pesticides'' Under
FIFRA Pursuant to the Proposed Rulemaking
As discussed in Unit III. of this notice, EPA and FDA have agreed
that EPA will propose a rule amending the definition of ``pest'' in 40
CFR 152.5(d). If that rule becomes final, certain antimicrobial
substances would no longer be ``pesticides'' and would no longer be
subject to regulation under FIFRA. On the effective date of such a
final rule, EPA would discontinue registration of any products,
previously registered by EPA as pesticides, and bearing labeling for
use only against microorganisms that would not be pests.
Former registrants of such products should note that the Federal
decision regarding what is a pesticide may not be definitive for the
purposes of state regulatory schemes. Former registrants are encouraged
to contact state officials to determine how such an EPA rulemaking
would affect a product's regulatory status under state law.
EPA would continue to require registration for antimicrobial
substances that continue to be ``pesticides'' under FIFRA, even though
certain uses for such substances would be ``food additive'' uses under
FFDCA. Consistent with current EPA practice, when the use of an
antimicrobial substance is both a food additive and a pesticide use as,
for example, a slimicide used in the production of food and non-food-
contact paper, EPA would review labeling for the pesticidal use and FDA
would review the non-pesticidal, i.e., food additive, use. Such a
substance may be categorically excluded from the need for an
environmental assessment under FDA's regulations implementing the
National Environmental Policy Act (NEPA) based on the fact that the
food additive use is substantially identical to the pesticide use (62
FR 40570, 40596; July 29, 1997 (citing to the categorical exclusion in
21 CFR 25.32(q))). After FDA approves a food additive that is also
regulated as a FIFRA ``pesticide,'' a petitioner would need to formally
request EPA to amend its pesticide registration label for the
antimicrobial to include the ``non-pesticidal'' use.
VI. Agency Contacts
In the event of questions about the process, EPA and FDA staff are
available to meet with petitioners to discuss the status of pending
petitions and procedures for submitting a new petition. If a petitioner
or any other person considering submitting a petition is interested in
meeting with either agency, he or she should contact the
[[Page 54544]]
appropriate Branch Chief in EPA's Antimicrobials Division to schedule a
meeting or the appropriate team leader in FDA's Indirect Additives
Branch.
The EPA Branch Chiefs can be reached at:
Dennis Edwards, Chief, Regulatory Management Branch I, Antimicrobials
Division (7510W), Office of Pesticide Programs, U.S. Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460, Telephone:
(703) 308-8087, Fax: (703) 308-8481, e-mail:
edwards.dennis@epamail.epa.gov.
Connie Welch, Chief, Regulatory Management Branch II, Antimicrobials
Division (7510W), Office of Pesticide Programs, U.S. Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460, Telephone:
(703) 308-8218, Fax: (703) 308-6466, e-mail:
welch.connie@epamail.epa.gov.
FDA can be contacted at:
Sandra L. Varner or Andrew J. Zajac, Office of Pre-market Approval
Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug
Administration, 200 C St., SW., Washington, DC 20204-0002, Telephone:
(202) 418-3075 (S. Varner) (202), 418-3095 (A. Zajac).
Mark A. Hepp, Office of Pre-Market Approval Center for Food Safety and
Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St.,
SW., Washington, DC 20204-0002, Telephone: (202) 418-3098.
VII. EPA Public Record and Electronic Submissions
The EPA official record for this notice, as well as the public
version, has been established for this document under docket control
number ``OPP-300624'' (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official record is located at the Virginia address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number ``OPP-300624.'' Electronic comments on this
notice may be filed online at many Federal Depository Libraries.
List of Subjects
Environmental Protection Agency, Food and Drug Administration,
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: September 30, 1998.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances, Environmental Protection Agency.
Dated: August 21, 1998.
Sharon Smith Holston,
Acting Commissioner, Food and Drug Administration.
[FR Doc. 98-27261 Filed 10-8-98; 8:45 am]
BILLING CODE 6560-50-F