

[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
