[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]


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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.

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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:
    <bullet> Pesticide manufacturing (NAICS 32532).
    <bullet> 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\.
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    \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.
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    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\.
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    \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.
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    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

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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

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and paperboard, coatings, adhesives, and polymers).
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[FR Doc. E8-21958 Filed 9-23-08; 8:45 am]
BILLING CODE 6560-50-S