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

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.

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Examples of Affected

Category Entities

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Chemical industry Persons who manufacture,

process, sell, or

distribute pesticide

products

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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

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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]

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