[Federal Register Volume 63, Number 42 (Wednesday, March 4, 1998)]
[Rules and Regulations]
[Pages 10718-10721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5415]
[[Page 10717]]
_______________________________________________________________________
Part IV
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 180
Pesticides; FFDCA Jurisdiction Over Food Packaging Impregnated With an
Insect Repellent Transferred to FDA; Direct Final Rule and Proposed
Rule
Federal Register / Vol. 63, No. 42 / Wednesday, March 4, 1998 / Rules
and Regulations
[[Page 10718]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR PART 180
[OPP-300605; FRL-5766-9]
RIN 2070-AD20
Pesticides; FFDCA Jurisdiction Over Food Packaging Impregnated
With an Insect Repellent Transferred to FDA
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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Summary: The effect of this rule is to give the Food and Drug
Administration (FDA) sole jurisdiction under the Federal Food, Drug,
and Cosmetic Act (FFDCA) for food packaging (e.g., paper and
paperboard, coatings, adhesives, and polymers) which is impregnated
with an insect repellent. Currently, food packaging impregnated with an
insect repellent is regulated under FFDCA by both Agencies. Under FFDCA
section 409, FDA regulates the use of packaging material (e.g., paper
and paperboard, coatings, adhesives, and polymers) when used in food
packaging. Under FFDCA section 408, EPA would need to establish an
exemption from the requirement for a tolerance for the food packaging
material which is impregnated with an insect repellent, even though FDA
may have already established the safety and permitted the use of these
substances in food packaging pursuant to section 409. In essence, EPA's
regulation of such material under FFDCA section 408, does not add any
value or health benefits to the actions taken by FDA under section 409.
Given FDA's expertise and experience in regulating the components of
food packaging, both Agencies believe this rule will eliminate the
duplicative FFDCA jurisdiction and economize Federal government
resources while continuing to protect human health and the environment.
To effectuate the transfer of EPA's FFDCA jurisdiction to FDA, EPA is
issuing this rule to except certain inert ingredients from the
definitions of ``pesticide chemical'' and ``pesticide chemical
residue.'' Specifically, this exception applies to those inert
ingredients that are the components of the food packaging (e.g., paper
and paperboard, coatings, adhesives, and polymers) which is impregnated
with an insect repellent. Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA still regulates the food packaging
material impregnated with an insect repellent as an inert ingredient of
the pesticide product.
DATES: This action is effective May 4, 1998 unless relevant adverse
comments are received by April 3, 1998.
ADDRESSES: By mail, submit written comments to: 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 by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Follow the
instructions under Unit V. 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: By mail: Robert Torla, Biopesticides
and Pollution Prevention Division (7511W), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: 5th
Floor Crystal Station, 2800 Crystal Drive, Arlington, VA, (703) 308-
8098; torla.robert@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
Entities potentially affected by this action are those which
manufacture pesticides, sanitary paper food containers, miscellaneous
plastic products; those who process food and kindred products; and
wholesalers of sanitary food containers.
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Examples of Affected
Category Entities
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Chemical industry Persons who manufacture,
process, sell, or
distribute pesticide
products
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Manufacturers Manufacturers of sanitary
paper food containers and
miscellaneous plastic
products used as food
containers
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Wholesalers Wholesalers of sanitary food
containers, food, and
kindred products
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Processors of food and kindred products Persons who process food and
feed products for wholesale
or distribution to
consumers
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This table is not intended to be exhaustive, but rather provides
examples of the types of entities that are likely to be affected by
this action. To determine whether you or your business is affected by
this action, you should carefully examine this document and the
provisions in Sec. 180.4 of the regulatory text. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed in the ``FOR FURTHER INFORMATION
CONTACT'' unit above.
I. Background
EPA has recently received an application for the registration of an
insect repellent under FIFRA that, as proposed, will be impregnated in
food packaging materials. The active ingredient in this product, methyl
salicylate, is a synthetic version of naturally occurring wintergreen
oil, and may function as an alternative to more costly and more toxic
applications of pesticides in food storage facilities and retail
establishments. EPA refers to natural and synthetic versions of
naturally occurring active ingredients that have a non-toxic mode of
action as ``biochemicals.''
The regulatory framework for this proposed use of biochemicals
raises a number of complex jurisdictional issues for EPA and FDA.
Because the impregnated packaging materials will be sold to food
distributors for the purpose of repelling insects, as well as for
packaging food, the food packaging materials themselves will be subject
to the pesticide product registration requirements of section 3 of
FIFRA. Under FIFRA, the components of pesticides are either active
ingredients or inert ingredients. Active ingredients are those which,
among other things, will ``prevent, destroy, repel, or mitigate any
pest'' (FIFRA section 2(a)). Inert ingredients are ingredients ``which
[are]
[[Page 10719]]
not active'' (FIFRA section 2(m)). Thus, the methyl salicylate in the
packaging constitutes the active ingredient, and the components of the
food packaging (paperboard, coatings, etc.) are the inert ingredients.
To the extent that the use of these packaging materials results in
residues of the active and inert ingredients on food (which includes
both human and animal food), these active and inert ingredients are
also subject to regulation under section 408 of FFDCA. This is true
even though FDA may have previously issued regulations under section
409 of FFDCA permitting the use of these substances in the food
packaging material. As a result, food packaging impregnated with an
insect repellent is regulated under FFDCA by both Agencies. Under FFDCA
section 409, FDA regulates the use of packaging material (e.g., paper
and paperboard, coatings, adhesives, and polymers) when used in food
packaging. Under FFDCA section 408, EPA would need to establish an
exemption from the requirement for a tolerance for the food packaging
material which is impregnated with an insect repellent, even though FDA
may have already established the safety and permitted the use of these
substances in food packaging pursuant to section 409. In essence, EPA's
regulation of such material under FFDCA section 408, does not add any
value or health benefits to the actions taken by FDA under section 409.
Given FDA's expertise and experience in regulating the components of
food packaging, both Agencies believe this rule will eliminate the
duplicative FFDCA jurisdiction and economize Federal government
resources while continuing to protect human health and the environment
without additional regulatory oversight by EPA. EPA is therefore taking
today's action in order to give sole FFDCA jurisdiction over food
packaging material impregnated with an insect repellent to FDA.
II. Issuance of This Action as a Direct Final Rule
EPA is issuing this action as a direct final rule without prior
proposal because the Agency believes that this action is not
controversial and will not result in any adverse comments. The Agency
also believes that it is important to make this action effective as
soon as possible, in order to address the current overlap in
jurisdiction between EPA and FDA under FFDCA. Nevertheless, EPA is
issuing a corresponding proposed rule elsewhere in today's Federal
Register to provide an opportunity for the public to submit relevant
adverse comment on this issue. If no relevant adverse comment is
submitted within 30 days of publication, this action will become
effective 60 days after publication without any further action by the
Agency. If, however, a relevant adverse comment is received during the
comment period, this direct final rule will be withdrawn and the public
comments received will be addressed in a subsequent final rule, or EPA
may request additional public comments.
For the reasons set forth above, EPA believes that it is
appropriate to issue this rule as a direct final rule. In addition,
this rule also conforms with the ``good cause'' exemption under section
553(b)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(B)),
which allows agencies to issue an action without additional notice and
comment if further notice and comment would be unnecessary.
III. Legal Authority
Section 201(q)(3) of FFDCA, as amended by FQPA, allows the
Administrator, under specified conditions, to except certain substances
from the definition of ``pesticide chemical'' or ``pesticide chemical
residue.'' That provision reads as follows:
(3) Notwithstanding paragraphs (1) and (2) [the definitions of
``pesticide chemical'' and ``pesticidal chemical residue''], the
Administrator may by regulation except a substance from the
definition of ``pesticide chemical'' or ``pesticide chemical
residue'' if--
(A) its occurrence as a residue on or in a raw agricultural
commodity or processed food is attributable primarily to natural
causes or human activities not involving the use of any substance
for a pesticidal purpose in the production, storage, processing, or
transportation of any raw agricultural commodity or processed food;
and
(B) the Administrator, after consultation with the Secretary,
determines that the substance more appropriately should be regulated
under one or more provisions of this Act other than sections
402(a)(2)(B) and 408.
IV. Findings and Agency Decision
After consultation with FDA, EPA is today excepting from the FFDCA
definitions of ``pesticide chemical'' and ``pesticide chemical
residue'' substances that are inert ingredients in food packaging
impregnated with insect repellents, when such ingredients are the
components of the food packaging (e.g., paper and paperboard, coatings,
adhesives, and polymers). Upon the effective date of this rule, FDA
alone will regulate such substances under FFDCA. Given FDA's expertise
and experience in regulating the components of food packaging, both
Agencies believe that this rule will eliminate duplication and
economize Federal government resources without any risk to public
health.
It is important to note that this rule does not affect EPA's
regulation of such substances as inert ingredients under FIFRA. EPA
will continue to exercise jurisdiction over these substances when they
are used as inert ingredients in food packaging material that is
intended to produce an insecticidal effect. With the development of
this technology, an ingredient in food packaging may be used for two
purposes: (1) to repel pests, and (2) to be one of the materials which
make up the container for the food. As a result of this rule, under
FFDCA, EPA will continue to regulate the materials which repel pests
and FDA will regulate the materials which make up the food packaging
material. Consistent with EPA's pesticide registration regulations, EPA
will not issue a registration under FIFRA for pesticide products
containing food packaging inert ingredients if the presence of these
ingredients in or on food is not authorized or permitted by FFDCA and
the implementing regulations.
EPA believes that section 201(q)(3) is applicable to inert
ingredients in insect repellent-impregnated food packaging materials
that are the components of the food packaging (e.g., paper and
paperboard, coatings, adhesives, and polymers). When the inert
substances are the components of the food packaging material itself,
EPA believes the substance's occurrence as a residue in or on food is
not attributable primarily to the use of a substance for a pesticidal
purpose in the production, storage, processing, or transportation of
food. For this reason, and because of FDA's considerable experience
generally in regulating ingredients found in food packaging, both EPA
and FDA believe it is appropriate for FDA to regulate these inert
ingredients under section 409 of FFDCA.
While EPA has to date only received one application for the
registration of an insect repellent in packaging material containing
the active ingredient methyl salicylate, today's rule is not limited to
inert ingredients in insect repellents containing only methyl
salicylate. Rather, this regulation excepts from the definition of
pesticide chemical and pesticide chemical residue any inert ingredient
that is a component of the food packaging material of insect repellent-
impregnated food packaging. Upon consultation, both EPA and FDA believe
that the identity of the insect repellent in the packaging material is
not relevant to a determination under
[[Page 10720]]
section 201(q)(3) regarding whether it is appropriate to except an
inert ingredient from the definition of pesticide chemical or pesticide
chemical residue. As noted above, that determination turns only on
whether: (1) The occurrence of residues of the substance in or on food
is attributable primarily to the use of substances for a pesticidal
purpose in the production, storage, processing, or transportation of
food; and (2) whether it is more appropriate to regulate such
substances under another provision of FFDCA other than sections
402(a)(2)(B) and 408. Both EPA and FDA believe that inert ingredients
that are the components of the food packaging material in insect
repellent-impregnated food packaging are more appropriately regulated
by FDA under FFDCA.
The exception authority under FFDCA section 201(q)(3) is new; no
exceptions are currently established in 40 CFR part 180. The current
structure of part 180 does not provide the space for EPA to create a
new section devoted to these exceptions except at the end of subpart B,
far removed from where it should be organizationally. This rule
overcomes this difficulty by removing existing text under Sec. 180.4,
which currently contains provisions for certification of pesticide
chemical usefulness and residue estimate opinions. These provisions
were eliminated from FFDCA by FQPA and the corresponding regulations
are no longer needed.
In its place, EPA is revising Sec. 180.4 to contain exceptions
granted under FFDCA section 201(q)(3). This would locate these
exceptions close to the beginning of part 180 where they should
logically reside.
V. Public Record and Electronic Submissions
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number ``300605'' (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 rulemaking record is located at the Virginia address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at: 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-300605.'' Electronic comments on this
rule may be filed online at many Federal Depository Libraries.
VI. Regulatory Assessment Requirements
As an exception, this action does not impose any regulatory
obligations. Under Executive Order 12866 entitled Regulatory Planning
and Review (58 FR 51735, October 4, 1993), it has been determined that
this rule is not ``significant'' and is not subject to OMB review. This
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et.
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). In addition, this action
does not involve any standards that would require Agency consideration
pursuant to section 12(d) of the National Technology Transfer and
Advancement Act (NTTAA) (Pub. L. 104-113).
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Agency hereby certifies that this regulatory action will not have a
significant economic impact on a substantial number of small entities,
because this regulatory action is an exemption and imposes no
regulatory obligations. EPA will provide this information to the Small
Business Administration's office of Advocacy upon request.
VII. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency will submit a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of this rule in today's
Federal Register. This is not a ``major rule'' as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 23, 1998.
Carol M. Browner,
Administrator.
Therefore, 40 CFR part 180 is amended as follows:
1. The authority citation for part 180 is revised to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. The part heading for part 180 is revised to read as follows:
PART 180--TOLERANCES AND EXEMPTIONS FROM TOLERANCES FOR PESTICIDE
CHEMICALS IN FOOD
3. Section 180.1 is amended by revising paragraph (k) and adding
new paragraph (o) to read as follows:
Sec. 180.1 Definitions and interpretations.
* * * * *
(k) The term pesticide chemical means any substance that is a
pesticide within the meaning of the Federal Insecticide, Fungicide, and
Rodenticide Act, including all active and inert ingredients of such
pesticide.
* * * * *
(o) The term pesticide chemical residue means a residue on or in a
raw agricultural commodity or processed food of:
(1) A pesticide chemical; or
(2) Any other added substance that is present on or in the
commodity or food primarily as a result of the metabolism or other
degradation of a pesticide chemical.
4. By revising Sec. 180.4 to read as follows:
Sec. 180.4 Exceptions.
The substances listed in this section are excepted from the
definitions of ``pesticide chemical'' and ``pesticide chemical
residue'' under FFDCA section 201(q)(3) and are therefore exempt from
regulation under FFDCA section 402(a)(2)(B) and 408. These substances
are subject to regulation by the Food and Drug Administration as food
additives under FFDCA section 409.
(a) Inert ingredients in food packaging impregnated with an insect
repellent
[[Page 10721]]
when such inert ingredients are the components of the food packaging
material (e.g., paper and paperboard, coatings, adhesives, and
polymers).
(b) [Reserved]
[FR Doc. 98-5415 Filed 3-3-98; 8:45 am]
BILLING CODE 6560-50-F
