[Federal Register Volume 73, Number 186 (Wednesday, September 24, 2008)]
[Rules and Regulations]
[Pages 54973-54977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21958]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0175; FRL-8382-3]
Pesticides; Food Packaging Treated with a Pesticide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule excepts food packaging materials (e.g. paper
and paperboard, coatings, adhesives, and polymers) from the definitions
of ``pesticide chemical'' and ``pesticide chemical residue'' under the
Federal Food Drug and Cosmetic Act (FFDCA) section 201(q), when such
food packaging materials have been treated with a pesticide regulated
under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
This final rule expands the scope of the current exception which
applies only to food packaging impregnated with an insect repellent -
one type of pesticide. This final rule, as with the rule it amends,
only applies to the food packaging materials themselves; it does not
otherwise limit EPA's FFDCA jurisdiction over the pesticidal substances
in or on such products or limit FDA's jurisdiction over substances
subject to FDA regulation as food additives. This rule eliminates
duplicative FFDCA jurisdiction and economizes federal government
resources while continuing to protect human health and the environment.
It is important to note that under the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA), EPA will 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 (except as otherwise provided by statute). The
text of this final 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 February 2, 2007,
consistent with EPA policy. EPA issued a subsequent proposed rule on
April 6, 2007 for additional public comment.
DATES: This final rule is effective September 24, 2008.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0175. All documents in the
docket are listed in the docket index available at http://www.regulations.gov.
[[Page 54974]]
Although listed in the index, some information is not publicly
available, e.g., Confidential Business Information (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 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
Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Cheryl Greene, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0352; fax
number: (703) 308-7026; e-mail address: greene.cheryl @epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this Action Apply to Me?
You may be potentially affected by this action if you are a
manufacturer/wholesaler of sanitary food packaging products or are a
pesticide manufacturer. Potentially affected entities may include, but
are not limited to:
Pesticide manufacturing (NAICS 32532).
Food packaging manufacturers (NAICS 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 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.
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\.
---------------------------------------------------------------------------
\1\ This final rule does 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 rule.
---------------------------------------------------------------------------
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 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\.
---------------------------------------------------------------------------
\2\ It is important to understand that this final rule only
applies 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.
---------------------------------------------------------------------------
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.
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 today to giving FDA sole jurisdiction
under section 409 FFDCA over the packaging components (ingredients) 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 rule will 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.
B. What is the Agency's Authority for Taking this Action?
Section 201(q)(3) of FFDCA, as amended by the Food Quality
Protection
[[Page 54975]]
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 action, EPA excepts 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 final rule will not affect EPA's
regulation of such substances as inert ingredients under FIFRA. EPA
will 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
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 rule, EPA will 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 regulation will 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 in this
unit, 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 final rule will
therefore amend 40 CFR 180.4 to extend the exception contained therein
to any food packaging materials treated with a pesticide.
III. Response to Comments
EPA received comments both on the rule when it was published as a
direct final rule on December 6, 2006 (71 FR 70667) (FRL-8084-2), and
again, following withdrawal of the direct final (February 2, 2007 (72
FR 4963) (FRL-8111-3), when the rule was published for comment as a
proposed rule on April 6, 2007 (72 FR 17068) (FRL-8119-8).
The majority of the comments opposed finalizing today's rule.
However, most of these comments did not address the substance of the
rule itself - i.e., the transfer of authority under the FFDCA from EPA
to FDA only for the purposes of regulating the actual packaging
materials in food packaging products treated with pesticides. Rather,
these comments objected to the inclusion of pesticides in treated
packaging as a general matter - which is a matter beyond the scope of
this rule. As discussed in Unit II. in this preamble, this rule does
not alter the regulatory scheme under either FIFRA or the FFDCA for
pesticidally active substances in food packaging or the products they
are contained in. Any such products, including all the ingredients in
such products, must be evaluated under FIFRA on a case-by-case basis.
Additionally, subject to the limited exception for certain
antimicrobial pesticides provided in FFDCA section 201(q)(1)(B)(ii)(see
footnote 1 in Unit II.A.), the active ingredients in such products (as
well as those inert ingredients that are not part of the food packaging
itself) will continue to be subject to EPA regulation under section 408
of the FFDCA.
EPA understands from the comments that there is some concern about
the risks that may exist from the inclusion of pesticides in treated
food packaging. As noted, EPA will continue to evaluate any
applications it receives for such products under the stringent health
and safety standards of both FIFRA and the FFDCA (except as provided by
section 201(q)(1)(B)(ii)). These laws require EPA to find that residues
of pesticides in food are safe and to determine whether pesticide
products cause unreasonable risk to human health or the environment.
Further, it should be noted that the applications for registration of
treated packaging materials EPA has received to date are for products
that may serve to limit the need for food storage establishments to use
riskier pesticides that are currently used to control pests in such
establishments. To be clear, however, the fact that these products may
serve to replace more risky pesticides does not alter EPA's obligation
to ensure that such products meet stringent food safety standards.
EPA also received a comment that the rule would eliminate
protections for infants and children and affect EPA's jurisdiction to
regulate pesticidal substances for which no pesticidal claims are made.
EPA disagrees with this comment. EPA believes the commenter has
incorrectly interpreted the import of today's action. As noted in Unit
II., this action does not alter EPA's regulation of pesticidally active
ingredients under the FFDCA - or of those inert ingredients that do not
constitute food packaging materials. Further, under FIFRA, EPA must
still evaluate the entire pesticide product (including all active and
inert ingredients) before making a registration determination. And as
noted, before
[[Page 54976]]
EPA can register a pesticide product under FIFRA, it must determine
that the product will not present unreasonable risk to human health or
the environment. The only materials that are excepted from EPA
regulation under FFDCA section 408 by this rule are those materials
regulated by the FDA as food packaging -- that is, materials that are
now found in food packaging on store shelves irrespective of whether
those products are treated with a pesticide. These materials include
the paper, cardboard, adhesives and coatings that are found in
thousands of food packaging products across America today that are
currently subject to FDA regulation. Accordingly, this rule does not
eliminate protections for infants and children. Also, as explained in
Unit II., this rule will have no impact on the regulation of substances
under either the FFDCA or FIFRA that are not themselves food packaging
materials. Finally, this rule does not, as the commenter suggests,
alter EPA's jurisdiction over certain pesticidal substances for which
no pesticidal claims are made. Substances or mixtures of substances are
subject to regulation as pesticides under FIFRA if, among other things,
they are intended for ``preventing, destroying, repelling, or
mitigating any pest'' (FIFRA section 2(u)). EPA has developed
regulations at 40 CFR 152.15 to implement this standard. Nothing in
today's action alters EPA's interpretation in that regulation of the
section 2(u) ``intent'' test.
EPA received two comments seeking clarification regarding certain
aspects of the rule. One commenter sought clarification that:
1. The rule only excepts components of packaging that exhibit no
pesticidal properties;
2. EPA will continue to regulate the active ingredients in such
products under the FFDCA; and
3. The entire treated packaging product as sold or distributed will
be regulated under FIFRA.
This is correct. As noted, this rule does not relieve EPA of its
obligation under the FFDCA to evaluate active ingredients in treated
packaging products - or for that matter, inert ingredients in such
products that are not part of the packaging materials of such products.
Further, the rule does not alter EPA's regulation of the entire product
under FIFRA. It simply eliminates duplicative federal regulation of the
actual packaging materials in treated packaging products; materials
already subject to FDA regulation under the FFDCA.
Finally, to be clear, the rule only exempts such inert ingredients
when found in treated packaging products. To the extent that these same
materials can be expected to result in residues on food from use of
pesticide products that are not treated packaging products, a tolerance
or a tolerance exemption under section 408 of the FFDCA would still be
required.
The second commenter, who apparently sells treated paper wrap
products, asked for clarification as to whether the rule alters EPA
regulation of the actual products they sell. As noted in Unit II.,
today's rule does not affect EPA's regulation of the actual treated
product under FIFRA.
IV. 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 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). ). This 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 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) (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.
V. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. EPA 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 the rule in the Federal Register.
This rule 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: September 11, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), and 371.
0
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
[[Page 54977]]
and paperboard, coatings, adhesives, and polymers).
* * * * *
[FR Doc. E8-21958 Filed 9-23-08; 8:45 am]
BILLING CODE 6560-50-S