[Federal Register Volume 63, Number 42 (Wednesday, March 4, 1998)]
[Rules and Regulations]
[Pages 10718-10721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5415]



[[Page 10717]]

_______________________________________________________________________

Part IV





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 180



Pesticides; FFDCA Jurisdiction Over Food Packaging Impregnated With an 
Insect Repellent Transferred to FDA; Direct Final Rule and Proposed 
Rule

  Federal Register / Vol. 63, No. 42 / Wednesday, March 4, 1998 / Rules 
and Regulations  

[[Page 10718]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR PART 180

[OPP-300605; FRL-5766-9]
RIN 2070-AD20


Pesticides; FFDCA Jurisdiction Over Food Packaging Impregnated 
With an Insect Repellent Transferred to FDA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

-----------------------------------------------------------------------

Summary: The effect of this rule is to give the Food and Drug 
Administration (FDA) sole jurisdiction under the Federal Food, Drug, 
and Cosmetic Act (FFDCA) for food packaging (e.g., paper and 
paperboard, coatings, adhesives, and polymers) which is impregnated 
with an insect repellent. Currently, food packaging impregnated with an 
insect repellent is regulated under FFDCA by both Agencies. Under FFDCA 
section 409, FDA regulates the use of packaging material (e.g., paper 
and paperboard, coatings, adhesives, and polymers) when used in food 
packaging. Under FFDCA section 408, EPA would need to establish an 
exemption from the requirement for a tolerance for the food packaging 
material which is impregnated with an insect repellent, even though FDA 
may have already established the safety and permitted the use of these 
substances in food packaging pursuant to section 409. In essence, EPA's 
regulation of such material under FFDCA section 408, does not add any 
value or health benefits to the actions taken by FDA under section 409. 
Given FDA's expertise and experience in regulating the components of 
food packaging, both Agencies believe this rule will eliminate the 
duplicative FFDCA jurisdiction and economize Federal government 
resources while continuing to protect human health and the environment. 
To effectuate the transfer of EPA's FFDCA jurisdiction to FDA, EPA is 
issuing this rule to except certain inert ingredients from the 
definitions of ``pesticide chemical'' and ``pesticide chemical 
residue.'' Specifically, this exception applies to those inert 
ingredients that are the components of the food packaging (e.g., paper 
and paperboard, coatings, adhesives, and polymers) which is impregnated 
with an insect repellent. Under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), EPA still regulates the food packaging 
material impregnated with an insect repellent as an inert ingredient of 
the pesticide product.

DATES: This action is effective May 4, 1998 unless relevant adverse 
comments are received by April 3, 1998.

ADDRESSES: By mail, submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, deliver comments to: 
Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Follow the 
instructions under Unit V. of this document. No Confidential Business 
Information (CBI) should be submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. A copy of the comment that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential will be included in the 
public docket by EPA without prior notice. The public docket is 
available for public inspection in Rm. 119 at the Virginia address 
given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Robert Torla, Biopesticides 
and Pollution Prevention Division (7511W), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location, telephone number, and e-mail address: 5th 
Floor Crystal Station, 2800 Crystal Drive, Arlington, VA, (703) 308-
8098; [email protected].

SUPPLEMENTARY INFORMATION:
    Entities potentially affected by this action are those which 
manufacture pesticides, sanitary paper food containers, miscellaneous 
plastic products; those who process food and kindred products; and 
wholesalers of sanitary food containers.

                                                                        
------------------------------------------------------------------------
                                                Examples of Affected    
                 Category                             Entities          
------------------------------------------------------------------------
Chemical industry                           Persons who manufacture,    
                                             process, sell, or          
                                             distribute pesticide       
                                             products                   
------------------------------------------------------------------------
Manufacturers                               Manufacturers of sanitary   
                                             paper food containers and  
                                             miscellaneous plastic      
                                             products used as food      
                                             containers                 
------------------------------------------------------------------------
Wholesalers                                 Wholesalers of sanitary food
                                             containers, food, and      
                                             kindred products           
------------------------------------------------------------------------
Processors of food and kindred products     Persons who process food and
                                             feed products for wholesale
                                             or distribution to         
                                             consumers                  
------------------------------------------------------------------------

This table is not intended to be exhaustive, but rather provides 
examples of the types of entities that are likely to be affected by 
this action. To determine whether you or your business is affected by 
this action, you should carefully examine this document and the 
provisions in Sec. 180.4 of the regulatory text. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed in the ``FOR FURTHER INFORMATION 
CONTACT'' unit above.

I. Background

    EPA has recently received an application for the registration of an 
insect repellent under FIFRA that, as proposed, will be impregnated in 
food packaging materials. The active ingredient in this product, methyl 
salicylate, is a synthetic version of naturally occurring wintergreen 
oil, and may function as an alternative to more costly and more toxic 
applications of pesticides in food storage facilities and retail 
establishments. EPA refers to natural and synthetic versions of 
naturally occurring active ingredients that have a non-toxic mode of 
action as ``biochemicals.''
    The regulatory framework for this proposed use of biochemicals 
raises a number of complex jurisdictional issues for EPA and FDA. 
Because the impregnated packaging materials will be sold to food 
distributors for the purpose of repelling insects, as well as for 
packaging food, the food packaging materials themselves will be subject 
to the pesticide product registration requirements of section 3 of 
FIFRA. Under FIFRA, the components of pesticides are either active 
ingredients or inert ingredients. Active ingredients are those which, 
among other things, will ``prevent, destroy, repel, or mitigate any 
pest'' (FIFRA section 2(a)). Inert ingredients are ingredients ``which 
[are]

[[Page 10719]]

not active'' (FIFRA section 2(m)). Thus, the methyl salicylate in the 
packaging constitutes the active ingredient, and the components of the 
food packaging (paperboard, coatings, etc.) are the inert ingredients.
    To the extent that the use of these packaging materials results in 
residues of the active and inert ingredients on food (which includes 
both human and animal food), these active and inert ingredients are 
also subject to regulation under section 408 of FFDCA. This is true 
even though FDA may have previously issued regulations under section 
409 of FFDCA permitting the use of these substances in the food 
packaging material. As a result, food packaging impregnated with an 
insect repellent is regulated under FFDCA by both Agencies. Under FFDCA 
section 409, FDA regulates the use of packaging material (e.g., paper 
and paperboard, coatings, adhesives, and polymers) when used in food 
packaging. Under FFDCA section 408, EPA would need to establish an 
exemption from the requirement for a tolerance for the food packaging 
material which is impregnated with an insect repellent, even though FDA 
may have already established the safety and permitted the use of these 
substances in food packaging pursuant to section 409. In essence, EPA's 
regulation of such material under FFDCA section 408, does not add any 
value or health benefits to the actions taken by FDA under section 409. 
Given FDA's expertise and experience in regulating the components of 
food packaging, both Agencies believe this rule will eliminate the 
duplicative FFDCA jurisdiction and economize Federal government 
resources while continuing to protect human health and the environment 
without additional regulatory oversight by EPA. EPA is therefore taking 
today's action in order to give sole FFDCA jurisdiction over food 
packaging material impregnated with an insect repellent to FDA.

II. Issuance of This Action as a Direct Final Rule

    EPA is issuing this action as a direct final rule without prior 
proposal because the Agency believes that this action is not 
controversial and will not result in any adverse comments. The Agency 
also believes that it is important to make this action effective as 
soon as possible, in order to address the current overlap in 
jurisdiction between EPA and FDA under FFDCA. Nevertheless, EPA is 
issuing a corresponding proposed rule elsewhere in today's Federal 
Register to provide an opportunity for the public to submit relevant 
adverse comment on this issue. If no relevant adverse comment is 
submitted within 30 days of publication, this action will become 
effective 60 days after publication without any further action by the 
Agency. If, however, a relevant adverse comment is received during the 
comment period, this direct final rule will be withdrawn and the public 
comments received will be addressed in a subsequent final rule, or EPA 
may request additional public comments.
    For the reasons set forth above, EPA believes that it is 
appropriate to issue this rule as a direct final rule. In addition, 
this rule also conforms with the ``good cause'' exemption under section 
553(b)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(B)), 
which allows agencies to issue an action without additional notice and 
comment if further notice and comment would be unnecessary.

III. Legal Authority

    Section 201(q)(3) of FFDCA, as amended by FQPA, allows the 
Administrator, under specified conditions, to except certain substances 
from the definition of ``pesticide chemical'' or ``pesticide chemical 
residue.'' That provision reads as follows:

    (3) Notwithstanding paragraphs (1) and (2) [the definitions of 
``pesticide chemical'' and ``pesticidal chemical residue''], the 
Administrator may by regulation except a substance from the 
definition of ``pesticide chemical'' or ``pesticide chemical 
residue'' if--
    (A) its occurrence as a residue on or in a raw agricultural 
commodity or processed food is attributable primarily to natural 
causes or human activities not involving the use of any substance 
for a pesticidal purpose in the production, storage, processing, or 
transportation of any raw agricultural commodity or processed food; 
and
    (B) the Administrator, after consultation with the Secretary, 
determines that the substance more appropriately should be regulated 
under one or more provisions of this Act other than sections 
402(a)(2)(B) and 408.

IV. Findings and Agency Decision

    After consultation with FDA, EPA is today excepting from the FFDCA 
definitions of ``pesticide chemical'' and ``pesticide chemical 
residue'' substances that are inert ingredients in food packaging 
impregnated with insect repellents, when such ingredients are the 
components of the food packaging (e.g., paper and paperboard, coatings, 
adhesives, and polymers). Upon the effective date of this rule, FDA 
alone will regulate such substances under FFDCA. Given FDA's expertise 
and experience in regulating the components of food packaging, both 
Agencies believe that this rule will eliminate duplication and 
economize Federal government resources without any risk to public 
health.
    It is important to note that this rule does not affect EPA's 
regulation of such substances as inert ingredients under FIFRA. EPA 
will continue to exercise jurisdiction over these substances when they 
are used as inert ingredients in food packaging material that is 
intended to produce an insecticidal effect. With the development of 
this technology, an ingredient in food packaging may be used for two 
purposes: (1) to repel pests, and (2) to be one of the materials which 
make up the container for the food. As a result of this rule, under 
FFDCA, EPA will continue to regulate the materials which repel pests 
and FDA will regulate the materials which make up the food packaging 
material. Consistent with EPA's pesticide registration regulations, EPA 
will not issue a registration under FIFRA for pesticide products 
containing food packaging inert ingredients if the presence of these 
ingredients in or on food is not authorized or permitted by FFDCA and 
the implementing regulations.
    EPA believes that section 201(q)(3) is applicable to inert 
ingredients in insect repellent-impregnated food packaging materials 
that are the components of the food packaging (e.g., paper and 
paperboard, coatings, adhesives, and polymers). When the inert 
substances are the components of the food packaging material itself, 
EPA believes the substance's occurrence as a residue in or on food is 
not attributable primarily to the use of a substance for a pesticidal 
purpose in the production, storage, processing, or transportation of 
food. For this reason, and because of FDA's considerable experience 
generally in regulating ingredients found in food packaging, both EPA 
and FDA believe it is appropriate for FDA to regulate these inert 
ingredients under section 409 of FFDCA.
    While EPA has to date only received one application for the 
registration of an insect repellent in packaging material containing 
the active ingredient methyl salicylate, today's rule is not limited to 
inert ingredients in insect repellents containing only methyl 
salicylate. Rather, this regulation excepts from the definition of 
pesticide chemical and pesticide chemical residue any inert ingredient 
that is a component of the food packaging material of insect repellent-
impregnated food packaging. Upon consultation, both EPA and FDA believe 
that the identity of the insect repellent in the packaging material is 
not relevant to a determination under

[[Page 10720]]

section 201(q)(3) regarding whether it is appropriate to except an 
inert ingredient from the definition of pesticide chemical or pesticide 
chemical residue. As noted above, that determination turns only on 
whether: (1) The occurrence of residues of the substance in or on food 
is attributable primarily to the use of substances for a pesticidal 
purpose in the production, storage, processing, or transportation of 
food; and (2) whether it is more appropriate to regulate such 
substances under another provision of FFDCA other than sections 
402(a)(2)(B) and 408. Both EPA and FDA believe that inert ingredients 
that are the components of the food packaging material in insect 
repellent-impregnated food packaging are more appropriately regulated 
by FDA under FFDCA.
    The exception authority under FFDCA section 201(q)(3) is new; no 
exceptions are currently established in 40 CFR part 180. The current 
structure of part 180 does not provide the space for EPA to create a 
new section devoted to these exceptions except at the end of subpart B, 
far removed from where it should be organizationally. This rule 
overcomes this difficulty by removing existing text under Sec. 180.4, 
which currently contains provisions for certification of pesticide 
chemical usefulness and residue estimate opinions. These provisions 
were eliminated from FFDCA by FQPA and the corresponding regulations 
are no longer needed.
    In its place, EPA is revising Sec. 180.4 to contain exceptions 
granted under FFDCA section 201(q)(3). This would locate these 
exceptions close to the beginning of part 180 where they should 
logically reside.

V. Public Record and Electronic Submissions

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket control 
number ``300605'' (including comments and data submitted electronically 
as described below). A public version of this record, including 
printed, paper versions of electronic comments, which does not include 
any information claimed as CBI, is available for inspection from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
official rulemaking record is located at the Virginia address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at: opp-
[email protected]
    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number ``OPP-300605.'' Electronic comments on this 
rule may be filed online at many Federal Depository Libraries.

VI. Regulatory Assessment Requirements

    As an exception, this action does not impose any regulatory 
obligations. Under Executive Order 12866 entitled Regulatory Planning 
and Review (58 FR 51735, October 4, 1993), it has been determined that 
this rule is not ``significant'' and is not subject to OMB review. This 
rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et. 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as 
specified by Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 
special considerations as required by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994), 
or require OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). In addition, this action 
does not involve any standards that would require Agency consideration 
pursuant to section 12(d) of the National Technology Transfer and 
Advancement Act (NTTAA) (Pub. L. 104-113).
    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the 
Agency hereby certifies that this regulatory action will not have a 
significant economic impact on a substantial number of small entities, 
because this regulatory action is an exemption and imposes no 
regulatory obligations. EPA will provide this information to the Small 
Business Administration's office of Advocacy upon request.

VII. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency will submit a 
report containing this rule and other required information to the U.S. 
Senate, the U.S. House of Representatives, and the Comptroller General 
of the United States prior to publication of this rule in today's 
Federal Register. This is not a ``major rule'' as defined by 5 U.S.C. 
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 23, 1998.
Carol M. Browner,
Administrator.
    Therefore, 40 CFR part 180 is amended as follows:
    1. The authority citation for part 180 is revised to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. The part heading for part 180 is revised to read as follows:
PART 180--TOLERANCES AND EXEMPTIONS FROM TOLERANCES FOR PESTICIDE 
CHEMICALS IN FOOD
    3. Section 180.1 is amended by revising paragraph (k) and adding 
new paragraph (o) to read as follows:


Sec. 180.1   Definitions and interpretations.

    *    *    *    *    *
    (k) The term pesticide chemical means any substance that is a 
pesticide within the meaning of the Federal Insecticide, Fungicide, and 
Rodenticide Act, including all active and inert ingredients of such 
pesticide.
    *    *    *    *    *
    (o) The term pesticide chemical residue means a residue on or in a 
raw agricultural commodity or processed food of:
    (1) A pesticide chemical; or
    (2) Any other added substance that is present on or in the 
commodity or food primarily as a result of the metabolism or other 
degradation of a pesticide chemical.
    4. By revising Sec. 180.4 to read as follows:


Sec. 180.4   Exceptions.

    The substances listed in this section are excepted from the 
definitions of ``pesticide chemical'' and ``pesticide chemical 
residue'' under FFDCA section 201(q)(3) and are therefore exempt from 
regulation under FFDCA section 402(a)(2)(B) and 408. These substances 
are subject to regulation by the Food and Drug Administration as food 
additives under FFDCA section 409.
    (a) Inert ingredients in food packaging impregnated with an insect 
repellent

[[Page 10721]]

when such inert ingredients are the components of the food packaging 
material (e.g., paper and paperboard, coatings, adhesives, and 
polymers).
    (b) [Reserved]

[FR Doc. 98-5415 Filed 3-3-98; 8:45 am]
BILLING CODE 6560-50-F