[Federal Register: April 6, 2007 (Volume 72, Number 66)]
[Proposed Rules]
[Page 17068-17071]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ap07-19]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0175; FRL-8119-8]
Pesticides; Food Packaging Treated with a Pesticide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This proposed rule would except from the definitions of
``pesticide chemical'' and ``pesticide chemical residue'' under FFDCA
section 201(q), food packaging (e.g. paper and paperboard, coatings,
adhesives, and polymers) that is treated with a pesticide as defined in
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) section
2(u). As a result, such ingredients in food packaging treated with a
pesticide would be exempt from regulation under FFDCA section 408 as
pesticide chemical residues. Further, a food that bears or contains
such ingredients would not be not subject to enforcement by the Food
and Drug Administration (FDA) under section 402(a)(2) (B) of the FFDCA
since the ingredients would no longer be pesticide chemical residues.
Instead, such ingredients would be subject to regulation by the FDA as
food additives under FFDCA section 409. FDA generally regulates such
food additives in food packaging as food contact substances under
FFDCA, section 409(h). This proposed rule would expand the scope of the
provision in 40 CFR 180.4 which currently applies only to food
packaging impregnated with an insect repellent - one type of pesticide.
This proposed rule, as with the rule it would amend, only applies to
the food packaging materials themselves; it would not otherwise limit
EPA's FFDCA jurisdiction over pesticides or limit FDA's jurisdiction
over substances subject to FDA regulation as food additives. EPA, in
consultation with FDA, and FDA believe this rule would eliminate the
duplicative FFDCA jurisdiction and economize federal government
resources while continuing to protect human health and the environment.
Even after this rule is finalized, under the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA), EPA would continue to regulate
the food packaging as an inert ingredient of the pesticide product and
regulate the pesticide active ingredient in the treated food packaging
under both FIFRA and the FFDCA. The text of this proposed rule is
identical to a direct final rule EPA issued on December 6, 2006. EPA
received several comments opposing that direct final rule and therefore
withdrew the rule on January 25, 2007, consistent with EPA policy. EPA
is now issuing the rule as a proposal for public comment.
DATES: Comments must be received on or before April 23, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0175, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
[[Page 17069]]
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0175. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Mari L. Duggard, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0028; fax
number: (703) 308-7026; e-mail address: duggard.mari@epa.gov].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are a
manufacturer or wholesaler of sanitary food packaging products or are a
pesticide manufacturer. Potentially affected entities may include, but
are not limited to:
Pesticide manufacturing (NAICS code 32532).
Food packaging manufacturers (NAICS code 32222).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR Sec. 180.4.
If you have any questions regarding the applicability of this action to
a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0175. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive Arlington, VA. The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The Docket telephone number is (703) 305-5805.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date, and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
EPA has received applications for the registration of pesticides
under FIFRA that, as proposed, will be applied to food packaging
materials. These pesticides are generally intended to function as
alternatives to more costly and more toxic applications of insecticides
in food storage and retail establishments. The regulatory framework for
this use of pesticides raises a number of complex jurisdictional issues
for EPA and FDA.\1\ Because the treated packaging materials will be
sold to food distributors for the purpose of controlling pest
infestations, as well as for packaging food, the
[[Page 17070]]
pesticide-treated food packaging materials 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] not
active.'' (FIFRA section 2(m)). Thus, the components of food packaging
(paperboards, coatings, etc.) become inert ingredients of a pesticide
product under FIFRA whenever the food packaging is treated with a
pesticide active ingredient and is distributed or sold with the purpose
of controlling pests.\2\ Such inert ingredients are not used for a
pesticidal purpose in the production, storage, processing, or
transportation of food. However, as inert ingredients, these components
of food packaging are also subject to regulation as ``pesticide
chemical residues'' under FFDCA section 408.
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\1\ This proposed rule would not include within its scope
substances which may be regulated as pesticides under FIFRA that are
used to prevent, destroy, repel or mitigate microorganisms when such
substances are included for such use in or are applied for such use
on food packaging (without regard to whether the substances are
intended to have an ongoing effect on any portion of the packaging)
(see FFDCA section 201(q)(1)(B)(ii) which excludes such substances
from the definition of ``pesticide chemical''). Because such
substances are already excluded from the definition of pesticide
chemical residue, it is unnecessary to address these substances in
this proposed rule.
\2\ It is important to understand that this proposed rule would
only apply to a very small subset of food packaging materials:
pesticide-treated food packaging that is distributed or sold with
the purpose of controlling pests. Food packaging that is not
distributed or sold to control pests is not a pesticide and is not
subject to this rule. For example, packaged products that are simply
treated with pesticides by food distributors, retailers or
homeowners solely to control pests on site do not themselves become
pesticides simply as a result of such applications. Rather, the
product itself must be distributed with the purpose of providing
pest control to become a pesticide. The treated packaging materials
addressed in this proposed rule are those that are sold for the
express purpose of providing ongoing protection from pests that may
contaminate the products made with the treated packaging.
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Under section 408 of the FFDCA, any pesticide chemical residue in
or on food is deemed unsafe, unless EPA has established a tolerance or
tolerance exemption that covers the pesticide chemical residue. This is
true even though FDA may have previously issued regulations under
section 409 of FFDCA permitting the use of these materials in food
packaging that has not been treated with a pesticide. As a result, the
same food packaging materials would be subject to regulation under
FFDCA by both Agencies. EPA is proposing today to give FDA sole
jurisdiction under section 409 FFDCA over the packaging components of
food packaging materials that have been treated with a pesticide by
excepting these materials from the definition of ``pesticide chemical''
and ``pesticide chemical residue.'' Given FDA's expertise and
experience in regulating the components of food packaging, EPA and FDA
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.
In 1998, EPA consciously limited the exception at 40 CFR 180.4 to
food packaging materials impregnated with an insect repellent, since at
the time of promulgation EPA had only received an application for a
pesticide product containing an insect repellent. EPA has now received
applications for other treated food packaging products that contain
active ingredients that are not insect repellents and will not be
applied through impregnation of the materials. EPA and FDA believe it
is appropriate to extend the 1998 rule to give FDA sole jurisdiction
under the FFDCA over the inert ingredients in such food packaging
products without regard to the application technique and mode of action
of the active ingredients in such products. Again, this proposed rule
would not affect EPA's jurisdiction under section 408 over ingredients
other than the packaging materials in such products (including the
pesticide active ingredient), nor does it affect EPA's jurisdiction
under FIFRA to regulate such products.
On December 6, 2006, EPA published a direct final rule (71 FR
70667) to expand the coverage of 40 CFR 180.4 as discussed in the
preceding paragraph. Because EPA received several comments opposing
promulgation of that rule, EPA withdrew the rule on January 25, 2007
and is today issuing this proposal for public comment prior to
developing any final rule. The regulatory text of the withdrawn direct
final rule and today's proposal are identical: both provide that the
components of food packaging material (e.g. paper and paperboard,
coatings, adhesives, and polymers) that have been treated with a
pesticide are excepted from the definition of pesticide chemical and
pesticide chemical residue under section 201(q) of the FFDCA. Again, as
explained in detail above, this proposal, like the direct final rule it
replaces, only excepts packaging material from EPA regulation under the
FFDCA - these materials will continue to be regulated by the FDA under
section 409. Further, the rule does not modify the existing regulatory
regime under the FFDCA for pesticidally active ingredients in food
packaging nor does it affect EPA regulation of pesticide products under
FIFRA. However, the comments EPA received on the direct final rule all
appeared to oppose the rule principally because the commenters were
concerned about the inclusion of pesticides in food packaging and did
not believe EPA should either be permitting or relinquishing any
authority to regulate that activity. It appears, therefore, that the
commenters either misunderstood the nature of the amendment to Sec.
180.4 or chose to submit comments to EPA on matters not specifically
addressed by the direct final rule - or by today's proposed rule. In
any case, nothing in the withdrawn direct final rule or in today's
proposal relieves EPA of the obligation to regulate pesticides in food
packaging, nor does today's action serve to approve the use of any
pesticides in food packaging. Accordingly, these comments are not
relevant to the action EPA is today proposing to take.
EPA previously provided for a 30-day comment on the withdrawn
direct final rule. As noted, the text of this proposed rule is
identical to the withdrawn direct final rule. Because interested
persons have already had an opportunity to comment on this matter
through the direct final rule, EPA is providing only for an additional
15-day comment period on this proposed rule.
B. What is the Agency's Authority for Taking this Action?
Section 201(q)(3) of FFDCA, as amended by the Food Quality
Protection Act (FQPA), allows the Administrator, under specified
conditions, to except certain substances 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.
With today's proposal, EPA would except from the definition of
``pesticide chemical'' substances that are inert ingredients in food
packaging treated with a pesticide, when such ingredients are the
components of the food packaging (e.g. paper and paperboard, coatings,
adhesives and polymers).
As previously explained, this proposed rule would not affect EPA's
regulation of such substances as inert ingredients under FIFRA. EPA
would continue to exercise jurisdiction under FIFRA over these
substances when they are used as inert ingredients in food packaging
that is intended to produce a pesticidal effect. The materials that
[[Page 17071]]
make up food packaging treated with a pesticide may serve one of two
purposes: (1) To control pests, or (2) to be one of the materials that
make up the container for food. As a result of this proposed rule, EPA
would continue to regulate the materials that control pests and FDA
will regulate the substances that 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, in consultation with FDA, believes that section 201(q)(3) is
applicable to inert ingredients in pesticide treated food packaging
materials that are the components of the food packaging (paperboard,
coatings, etc). When such inert ingredients are the components of the
food packaging itself, EPA believes the occurrence of these substances
as residues in or on food would be appropriately excepted from the
definition of ``pesticide chemical'' or ``pesticide chemical residue''
because such substances are not attributable primarily to the use of
the substances for a pesticidal purpose in the production, storage,
processing or transportation of food. Rather, the presence of such
substances as residues in food is primarily attributable to their use
for purposes of packaging food. For this reason, and because of FDA's
considerable experience in regulating such substances found in food
packaging, EPA and FDA believe it is appropriate for FDA to regulate
these inert ingredients under section 409 of FFDCA.
As noted, this proposed regulation would except from the definition
of ``pesticide chemical'' and ``pesticide chemical residue'' any inert
ingredient that is a component of food packaging material treated with
a pesticide. EPA, in consultation with FDA, believes the identity of
the pesticide in or on the packaging material is not relevant to a
determination under 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
the 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. Thus, EPA has
determined that inert ingredients that are the components of the food
packaging material in pesticide treated food packaging are more
appropriately regulated by FDA under FFDCA. This proposed rule would
therefore amend 40 CFR 180.4 to extend the exception contained therein
to any food packaging materials treated with a pesticide.
III. Statutory and Executive Order Reviews
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 proposed rule is not ``significant'' and is not subject to OMB
review. This proposed 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) (Public Law 104-4). This proposed rule has no
federalism or tribal implications, because it will not have substantial
direct effects on States or Indian tribes, on the relationship between
the Federal Government and the States or Indian tribes, or on the
distribution of power and responsibilities among the various levels of
government or between the Federal Government and Indian tribes, as
specified in Executive Orders 13132, entitled Federalism (64 FR 43255,
August 10, 1999) and 13175 entitled Consultation and Coordination with
Indian Tribal Governments, (65 FR 67249, November 6, 2000). Nor does
this rule raise issues that require special considerations under
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). This proposed rule is also not subject to Executive Order
13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution or Use (66 FR 28355, May 22, 2001),
because this action is not expected to affect energy supply,
distribution, or use. 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)
(Public Law 104-113)
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Agency hereby certifies that this proposed 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.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 26, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), and 371.
2. Section 180.4 is amended by revising paragraph (a) to read as
follows.
Sec. 180.4 Exceptions.
* * * * *
(a) Inert ingredients in food packaging treated with a pesticide,
when such inert ingredients are the components of the food packaging
material (e.g. paper and paperboard, coatings, adhesives, and
polymers).
* * * * *
[FR Doc. E7-6349 Filed 4-5-07; 8:45 am]
BILLING CODE 6560-50-S