4010 Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 82

[FRL–5132–8]

RIN 2060–AE51

Protection of Stratospheric Ozone;

Labeling Supplemental Rulemaking

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document amends EPA’s

existing labeling regulations by adding

an exemption from the labeling

requirements regulations when

controlled substances are destroyed,

adding an exemption for spare parts that

are used in repair, making revisions to

clarify the labeling of waste, and making

several other minor clarifying revisions.

EPA is promulgating these revisions in

response to numerous comments, in

order to recognize and alleviate the

burden placed on specific parties whose

activities contribute no additional

emissions of ozone-depleting

substances. While these changes

provide additional flexibility to the

regulated community, they in no way

compromise the environmental goals

and benefits of protecting public health

through the labeling regulation.

EFFECTIVE DATE: This final rule is

effective February 21, 1995.

ADDRESSES: Comments on this final rule

can be found in Public Docket No. A–

91–60, Room M–1500 (LE–131),

Waterside Mall, U.S. Environmental

Protection Agency, 401 M Street, SW,

Washington, DC 20460. The docket may

be inspected from 8:00 a.m. until 5:30

p.m., Monday through Friday. A

reasonable fee may be charged for

copying docket materials.

FOR FURTHER INFORMATION CONTACT:

Mavis Sanders, Regulatory Development

and Operations Section, Program

Implementation Branch, Stratospheric

Protection Division, Office of

Atmospheric Programs, Office of Air

and Radiation, 6205–J, 401 M Street,

SW, Washington, DC 20460. 202/233–

9737.

SUPPLEMENTARY INFORMATION: The

contents of today’s preamble are listed

in the following outline:

I. Introduction

II. Destruction Exemption from the Labeling

Requirements

A. Background on Destruction Policies

1. Background on Montreal Protocol’s

Destruction Policy

2. Fourth Meeting of the Parties to the

Montreal Protocol

B. Phaseout Regulations

C. Proposed Accelerated Phaseout

Destruction Provisions

D. Proposed Destruction Provision in the

Final Labeling Rule

E. Requirements of RCRA and the Proposed

Hazardous Organic NESHAP (HON)

1. Resource Conservation and Recovery Act

(RCRA) Standards

2. Proposed Hazardous Organic NESHAP

(HON) Regulations

F. Proposed Amendments to the Final

Labeling Regulations—Products Exempt

from Labeling Requirements Where

Manufacturers Use Protocol-approved

Destruction Technologies

1. Proposal

2. Response to Comments

3. Today’s Rule

III. Labeling Requirements of Containers of

Waste

A. Current Requirements for Containers of

Controlled Substance Waste and Wastes

Containing Trace Amounts of Controlled

Substances

B. Today’s Proposal Regarding Labeling

Requirements of Containers of Regulated

Waste

C. Response to Comments

D. Today’s Rule

IV. Labeling Requirements for Spare Parts to

be Used Solely for Repair

A. Proposal

B. Response to Comments

C. Today’s Rule

V. Clarification of the Meaning of Products

‘‘Manufactured With’’

VI. Exemption for Trace Quantities

VII. Labeling Requirements of Containers of

55 Gallons and Smaller Containing

Controlled Substances

VIII. Definition of Importer

IX. Certification Requirements for Reduced

Use Exemption

X. Imports and Products Introduced In Bond

at the U.S./Mexico Border

XI. Incidental Uses of Controlled Substances

XII. Request for Comments Regarding Plasma

Etching

XIII.Miscellaneous

XIV. Summary of Supporting Analysis

A. Executive Order 12866

B. Regulatory Flexibility Act

C. Paperwork Reduction Act

XV. Judicial Review

I. Introduction

In a final rule published on February

11, 1993 (58 FR 8136), EPA promulgated

regulations to implement section 611 of

the Clean Air Act. The regulations

mandate that, effective May 15, 1993,

labels are required on containers of class

I and class II substances and products

containing or manufactured with class I

substances. The rule also calls for labels

on all products containing or

manufactured with class I or class II

substances, beginning on January 1,

2015.

The final regulations exempt products

manufactured using class I substances

on an intermittent basis, and not as a

direct part of the manufacturing process

of the product, such as that employed in

spot cleaning textiles during the

manufacturing process. The rule

explains that such intermittent contact

use of controlled substances was found

to be incidental ‘‘contact.’’ The final

rule also explains that intermittent

‘‘contact’’ uses, though they may

involve a brief initial physical contact

between the ozone-depleting

‘‘controlled substance’’ and the product,

occur infrequently, typically as part of

an upkeep process, and that the

controlled substance does not come into

contact with every product. In other

situations, where the controlled

substance has contact on an intermittent

basis only with the surface area of

manufacturing equipment, and although

there may be an initial contact with the

first few products themselves, the

controlled substance will not contact

every product manufactured thereafter.

Labeling is therefore not required in

either of the above cases.

After the final regulations had been

published, EPA received several

comments from the regulated

community requesting clarification of

certain parts of the regulations or

requesting certain revisions to the

regulations. After review of these

comments and concerns, EPA

determined that certain revisions and

clarifications would be appropriate.

EPA therefore published a notice of

proposed rulemaking (NPRM) on

December 30, 1993 (58 FR 69568)

proposing such revisions and making

such clarifications.

The proposed amendments for the

labeling regulations provide exemptions

from labeling requirements for

companies that destroy controlled

substances used in their manufacturing

processes to a 98 percent destruction

efficiency, using any of the following

five destruction technologies approved

by the Parties to the Montreal Protocol:

liquid injection incineration, reactor

cracking, gaseous/fume oxidation, rotary

kiln incineration and cement kilns. The

proposal also proposes to provide

exemptions for waste that is to be

discarded; however, waste containers of

controlled substances that are to be

recycled or reclaimed would still

require a label. Additionally, the NPRM

proposed to exempt purchasers of spare

parts manufactured with a controlled

substance from the label pass-through

requirement when such purchasers sell

such spare parts for the sole purpose of

repair and when such products are

removed from their original packaging.

Spare parts manufactured with a class I

substance would require a label;

however, once these parts are sold to a

distributor who is to sell them to repair

persons, such distributors would not be
Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations 4011

required to pass through the label, so

long as the parts are sold to persons

using them for repair purposes only.

The NPRM also proposed other minor

amendments that would clarify the

definitions of ‘‘manufactured with,’’

‘‘import,’’ and ‘‘importer,’’ exempt

containers containing trace quantities of

controlled substances, clarify the ‘‘trace

quantities’’ exemption for products

containing, revise the label placement

requirements for containers of 55

gallons or smaller, and revise the

certification requirement for the

‘‘reduced use exemption.’’

EPA recieved several comments from

the public on the proposed rule, but no

public hearing was requested. After

review of the comments, EPA is today

promulgating a final rule amending the

labeling regulations.

II. Destruction Exemption from the

Labeling Requirements

A. Background on Destruction Policies

1. Background on Montreal Protocol’s

Destruction Policy

The Montreal Protocol, to which over

132 nations are now Parties, requires

that each Party nation control the

production and consumption of

substances that deplete the ozone layer.

Under the existing Protocol,

‘‘production’’ of controlled substances is

defined as ‘‘the amount of controlled

substances produced, minus the amount

destroyed by technologies to be

approved by the Parties.’’ At the second

meeting of the Parties to the Protocol

(the Parties) in London, a technical

advisory committee was established to

examine the existing destruction

technologies, devise criteria by which to

approve technologies, and evaluate

environmental concerns associated with

the technologies. Until the Fourth

Meeting of the Parties, no destruction

technology had been approved by the

Parties.

2. Fourth Meeting of the Parties to the

Montreal Protocol

At the Fourth Meeting of the Parties

to the Montreal Protocol, which took

place from November 23–25, 1992, in

Copenhagen, the Parties approved five

destruction technologies to be used for

destroying controlled substances. The

technologies are: liquid injection

incineration, reactor cracking, gaseous/

fume oxidation, rotary kiln incinerators,

and cement kilns. The Parties also

agreed that additional acceleration of

the phaseout of controlled substances

would result in the need for a greater

global destruction program for these

substances. With the approval of the

five technologies, the Parties noted that

the technologies could attain a

destruction efficiency of 99.99 percent

with proper controls and operating

techniques; however, they did not

require a specific efficiency. The Parties

encouraged a ‘‘Code of Good

Housekeeping Procedures,’’ set forth in

the United Nations Environmental

Programme (UNEP) Report entitled AdHoc Technical Advisory Committee on

ODS Destruction Technologies, to

minimize losses to the environment

through control systems and standards

for operating such systems. Finally, the

Parties agreed to report the quantities of

ozone-depleting substances destroyed

annually to the Protocol.

With the approval of the five

destruction technologies, Parties to the

Protocol can subtract from the definition

of production that amount of controlled

substance(s) that is destroyed by these

means, under certain conditions

discussed in the final accelerated

phaseout rule that was published on

December 10, 1993 (58 FR 65018).

B. Accelerated Phaseout Destruction

Provisions

The final accelerated phaseout

regulations,which were published in the

Federal Register on December 10, 1993,

(58 FR 65018), implement the United

States’ acceleration of the phaseout of

class I substances, consistent with the

recent adjustments to the Protocol

agreed upon last November by the

Parties in Copenhagen; accelerate the

phaseout of certain class II substances;

list and phase out

hydrobromofluorocarbons (HBFCs); list

and phase out methyl bromide; and

responded to petitions received by the

Agency from environmental and

industry groups.

In addition, in that rule, EPA revised

the definition of ‘‘production’’ such that

controlled substances that are to be

destroyed are eliminated from the

definition of production of such

chemicals. The destruction of such

substances must employ any one of the

five technologies identified above that

are approved by the Parties.

The rulemaking defines ‘‘destruction’’

in terms of technologies approved for

destruction by the Parties that result in

expiration of the chemical without any

commercially useful end product being

produced. The Agency proposed this

definition in order to distinguish

destruction from transformation, which

requires that the resulting end product

serve a commercial purpose. The

regulation indicates that to be eligible

for the destruction exemption, the

controlled substances must be destroyed

by one of the five destruction

technologies approved by the Parties.

As explained more fully in the

December 10, 1993 regulation, EPA

believes that, while it is not required to

follow the approach of the Protocol

Parties regarding destruction, it has the

authority to do so.

C. Proposed Destruction Provision in the

Final Labeling Rule

The preamble to the final labeling

regulations (58 FR 8136, February 11,

1993) requested comment on a

destruction exemption from the labeling

requirements based on the then

proposed accelerated phaseout rule,

which was being drafted at the time.

The Agency requested comment on

whether it could and should provide an

exemption from the labeling

requirements for the use of controlled

substances that are subsequently

destroyed using one of the abovementioned approved technologies with

procedures that are consistent with the

Resource Conservation and Recovery

Act (RCRA) and the United Nations

Environmental Programme (UNEP)

Report entitled Ad-Hoc Technical

Advisory Committee on ODS

Destruction Technologies. The Agency

received and reviewed several

comments on the possibility of a

destruction exemption provision for the

labeling rule. Those comments

supported the inclusion of a destruction

exemption, similar to that given for

transformation. The commenters

reasoned that the destruction exemption

was justified because destruction of

ozone-depleting substances prevents

emissions of those substances into the

atmosphere.

D. Related Requirements of RCRA and

the Proposed Hazardous Organic

NESHAP (HON)

In addition to the requirements of

Title VI of the Clean Air Act as

amended, certain controlled substances

are also regulated, under certain

circumstances, by the Resource

Conservation and Recovery Act (RCRA,

42 USC 6901 et seq.) and are regulated

under the final Hazardous Organic

NESHAPS (the HON) (59 FR 19402,

April 22, 1994). The RCRA regulations

would cover those controlled substances

that are considered to be hazardous

constituents in the waste stream (e.g.,

carbon tetrachloride bound for

incineration). The final HON addresses

air emissions of hazardous air

pollutants, a category into which carbon

tetrachloride, methyl chloroform, and

methyl bromide fall. The following

discussion outlines the coordination

among the RCRA and HON regulations

and the destruction exemption

provision of the labeling regulations.
4012 Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations

1. Resource Conservation and Recovery

Act (RCRA) Standards

The RCRA regulations currently

require that industries that incinerate

waste covered by the regulations must

meet ‘‘at stacks’’ destruction efficiency

(DE) standards of 99.99 percent. The

final accelerated phaseout regulations

grant full credit for the destruction of

controlled substances when they are

destroyed in compliance with RCRA

regulations 40 CFR 266.104. The

accelerated phaseout rule indicates that

the Agency grants 100 percent

production allowances for companies

that achieve 99.99 percent efficiency in

the destruction of class I substances

instead of only 99.99 percent in

allowances, because, otherwise, a

company would never be able to obtain

credit for the full amount of the

chemical used, and would eventually be

unable to obtain sufficient volumes to

operate.

The only substances that are covered

under both RCRA as ‘‘hazardous

constituents’’ and under Title VI of the

Clean Air Act as controlled substances

are methyl chloroform (MCF) and

carbon tetrachloride (CTC). The

remaining controlled substances are

regulated under RCRA only when they

are blended with hazardous wastes,

such as when used solvents are

incinerated. The incineration

technologies approved by the Parties

have been shown to be capable of

achieving the 99.99 percent DE required

by RCRA; however, the Parties do not

specifically require that each of the

technologies achieve such an efficiency.

The Parties supported the

recommendations of the Ad-Hoc

Technical Committee on Destruction

Technologies to require Code of Good

Housekeeping procedures to be applied

throughout a destruction facility.

2. Hazardous Organic NESHAP (HON)

Regulations

Under some situations controlled

substances are not covered by RCRA

regulations, but may be covered by the

HON regulations promulgated under

section 112 of the Clean Air Act. The

Agency published a final HON rule on

April 22, 1994 (59 FR 19402), requiring

companies to control toxic air emissions

from chemical manufacturing processes.

The HON regulates approximately 400

manufacturing processes associated

with the Synthetic Organic Chemical

Manufacturing Industry (SOCMI), as

well as 7 non-SOCMI source categories.

Section 112 of the Clean Air Act

contains a list of 189 hazardous air

pollutants (HAPS) of which a large

portion are known to be emitted by the

above-mentioned industries. Of those

listed under section 112, the only

substances controlled under Title VI of

the CAA are methyl chloroform (MCF),

carbon tetrachloride (CCL4) and methyl

bromide (newly listed as a class I

substance in the accelerated phaseout

rule). The HON covers five kinds of

emission points within such facilities

where these substances are emitted,

including process vents, wastewater

streams, transfer operations, storage

tanks, and equipment leaks. The Agency

requires that emission points be

controlled with a ‘‘reference control

technology’’ with specific applicability

criteria, such as a 98 percent control

efficiency for incinerators on process

vents. The HON establishes

performance standards for operating the

control technologies, as well as criteria

for the design of the control equipment.

The Agency established that when

organic HAPS are released through

process vent sources, companies may

route these emissions to a gaseous/fume

oxidation incinerator for destruction.

The Agency has determined that such

incinerators may operate with a

destruction efficiency of 98 percent.

The final accelerated phaseout

regulation states that when regulations

promulgated under section 112 of the

Clean Air Act apply to the destruction

of a controlled substance, and RCRA

regulations do not apply, and the 98

percent destruction efficiency is

achieved by incinerators to which

emissions of controlled substances are

routed, the Agency will grant the full

allotment of allowances to replace

chemicals that are destroyed under the

conditions of the HON. In situations

where section 112 regulations apply, but

an achieved destruction efficiency is

less than the 98% that the HON

requires, the Agency will issue

allowances only for the portion actually

destroyed.

F. Amendments to the Final Labeling

Regulations—Products Exempt from

Labeling Requirements Where

Manufacturers Use Protocol-approved

Destruction Technologies

1. Notice of Propsed Rulemaking

The ultimate goal of Title VI of the

CAA is to minimize depletion of

stratospheric ozone. A destruction

exemption, which would recognize, and

provide an incentive for, the elimination

of emissions of controlled substances

through the use of approved destruction

technologies, is therefore consistent

with the goals of Title VI. This

exemption is one method of reducing

risks of ozone depletion. The initial

labeling regulations published on

February 11, 1993 provide an exemption

from the labeling requirements if a

controlled substance used to

manufacture a product is transformed,

such that the controlled substance no

longer poses a threat to the ozone layer;

similarly, the same result comes about

if a controlled substance used in the

manufacture of a product is destroyed.

The controlled substance is not emitted

in either case and no environmental

harm occurs through exempting such

products from labeling.

EPA proposed that for any products

manufactured with a class I or class II

substance, if that substance is destroyed

according to any applicable legal or

regulatory requirements, using one of

the five technologies approved by the

Parties to the Protocol, the product

would be exempt from the labeling

requirements.

The Agency further proposed that the

labeling exemption would apply only

where a substance is destroyed to a DE

of 98 percent or greater, using one of the

five approved destruction technologies.

A definition of ‘‘completely destroy,’’

which means to destroy to 98 percent or

greater destruction efficiency, using one

of the five approved technologies, was

included in the proposed rulemaking.

Therefore, the proposed threshold at

which labeling is exempted is for those

products manufactured with controlled

substances that are ‘‘completely’’

destroyed.

Furthermore, EPA proposed that

where the destruction of a controlled

substance is regulated under RCRA, the

regulated party must achieve a

destruction efficiency of 99.99 percent,

destroying any controlled substances

using one of the five approved

technologies and complying with

applicable RCRA regulations as they

relate to destruction of ozone-depleting

substances, in order to qualify for the

exemption from labeling. If the

destruction of a controlled substance is

not regulated under RCRA but is

regulated under the HON, the regulated

party must achieve a destruction

efficiency of 98 percent, as well as meet

any other applicable standards imposed

by the HON that relate to destruction of

ozone-depleting substances, destroying

any controlled substances using one of

the five approved technologies, in order

to qualify for the exemption from

labeling.

The Agency is aware that state air

quality permit laws may establish

efficiency standards for emissions of

controlled substances where no Federal

regulations exist to cover them. In

addition, state laws may be more

stringent than comparable Federal

regulations. In either case, the Agency
Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations 4013

stated in the proposal that it expects

companies that are regulated under such

state laws governing the control of

emissions of controlled substances in

industrial processes to be in full

compliance with such laws.

EPA also proposed that those

companies that are not covered by either

RCRA regulations or the HON must

follow the Code of Good Housekeeping

Practices, as described in the UNEP AdHoc Technical Advisory Committee on

ODS Destruction Technologies, as well

as the whole of Chapter 5 of that report,

in addition to meeting the 98 percent

DE, using one of the five approved

destruction technologies.

The UNEP Ad-Hoc Technical

Advisory Committee on ODS

Destruction Technologies recommends

that atmospheric releases of controlled

substances shall be monitored at all

facilities with air emission discharges.

For controlled substances, that report

recommends that flow meters or

continuously recording weighing

equipment for individual containers

should be used. At a minimum,

containers should be weighed ‘‘full’’

and ‘‘empty’’ to establish quantities

destroyed.

While there are no recordkeeping

requirements specifically associated

with the destruction exemption from

labeling, the accelerated phaseout

regulations (58 FR 65018) provide that

companies relying on the destruction

provisions of that rule must maintain

records of destruction. For those

companies, these same records will be

consulted in inspecting eligibility for

the destruction exemption from

labeling. For manufacturers that do not

receive production or consumption

allowances, records required under

other relevant regulations that

determine the amount destroyed, the

destruction efficiency, and the

performance standards of operation

must be made available to EPA upon

request.

2. Response to Comments

The Agency requested comments on

its proposal to exempt products from

the labeling requirements where

controlled substances used to

manufacture the product are destroyed

according to the criteria proposed by

EPA. One commenter supported the use

of destruction efficiencies that will be

set in the HON, in instances where

RCRA standards do not apply.

A commenter questioned the

inclusion of the references to state

regulations in this proposal because,

according to the commenter, it makes

EPA an enforcer of state laws and can

potentially add federal penalties to state

penalties assessed as a result of an

inadvertent violation of a state law. EPA

has removed the references to state

regulations from the definition of

‘‘completely destroy’’ (§ 82.104(c)). It is

not the Agency’s intent to enforce state

regulations, though EPA of course

expects compliance with these laws.

Nine commenters agreed with the

proposed destruction exemption

requirements. However, several

commenters requested an expanded

definition of destruction technologies to

include technologies not listed as one of

the five acceptable destruction

technologies outlined by the Montreal

Protocol Parties. EPA disagrees with

these requests. The intent of the

destruction exemption under the

labeling rule is to credit processes that

emit trace quantities or no quantities of

class I substances. As a Party to the

Protocol, EPA believes that the U.S.

should not expand the destruction

exemption beyond the list of destruction

technologies approved by the Parties.

The five technologies approved by the

Parties have been carefully reviewed

and have been found to protect the

environment from the harm caused by

the release of control substances. EPA

believes that no other technologies

should be included until the Parties

have reviewed such technologies and

been assured of their safety. As the

Parties review and approve additional

technologies, EPA will explore

expanding its list under these

regulations. However, today’s

rulemaking will cover only those five

destruction technologies approved by

the Parties to the Protocol.

One commenter requested

clarification that off-site destruction can

qualify for this exemption. It is the

Agency’s intent to include off-site

destruction as part of the destruction

exemption. That same commenter

requested that EPA make the UNEP

Report available through the SPD

hotline. Chapter 5 of the UNEP Report

is currently available through the SPD

hotline and can be found in Air Docket

A–91–60.

3. Today’s Rule

In light of the above discussion, EPA

establishes in today’s rule the

destruction exemption as proposed in

the December 30, 1993 Federal Register.

Today’s action specifies that those

persons using a controlled substance in

their manufacturing process, but then

completely destroying that substance

using one of the five approved

destruction technologies, are exempt

from labeling the product.

III. Labeling Requirements of

Containers of Waste

A. Initial Requirements for Containers of

Controlled Substance Waste and Wastes

Containing Trace Amounts of

Controlled Substances

EPA indicated in the final labeling

regulations that a person handling

containers of waste that contain class I

or class II substances destined for

incineration would benefit from the

specific chemical information in the

warning statement when handling.

Though the label does not specifically

address handling practices of such

substances, it would inform technicians

handling the containers of chemicals

and would encourage them to dispose of

them or recycle them correctly. In

addition, containers of waste can be

introduced into interstate commerce

and must then be labeled as

‘‘containing’’ a controlled substance.

Under the initial final rule, EPA also

required that containers of such waste

materials destined to be recycled or

reclaimed bear the warning statement to

ensure that the technician of a

reclamation facility is aware of the

substances contained in order to

exercise proper caution. Reclaimed

substances are also resold by the

reclaimer, and thus are required under

the current rule to be labeled upon their

introduction into interstate commerce.

The Agency did not require in its

original final rule that empty containers

that once contained a controlled

substance and are subsequently recycled

and incorporated into another product

bear a label. The original rule also

permitted the removal of a label on a

container that no longer contains a

controlled substance. If such a container

is subsequently charged with a class I or

class II substance, a label is be required.

Also, the final rule excluded containers,

such as trucks, railroad cars, or crates,

used to transport a ‘‘product

containing’’ or ‘‘container containing’’

from the labeling requirements, because

only the immediate container holding

the controlled substance must be

labeled.

B. Proposed Labeling Requirements of

Containers of Regulated Waste

After the promulgation of the original

labeling regulations, EPA received new

information from the regulated

community regarding the labeling

requirements for containers of waste.

The Agency required labeling of waste

in the original labeling rule because it

believed that the labeling information

would be important to waste handlers

and recycling and reclamation facilities.

In addition, by requiring waste to be
4014 Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations

labeled, EPA attempted to encourage

industry to minimize the amount of

controlled substances in the waste

stream and ultimately in the upper

stratosphere. For this reason, the

preamble to the original rule stated that

all amounts, including trace quantities

of controlled substances in waste,

trigger the labeling requirements. The

regulated community commented to

EPA following publication of the final

rule, addressing both the final rule and

applicability determinations prepared

by EPA on labeling of waste. Written

comments on the Agency’s treatment of

waste and the relevant applicability

determinations are available in the Air

Docket A–91–60.

As a result of these comments, EPA

proposed revisions to its original

position on labeling waste containing

controlled substances, in order to better

facilitate industry’s compliance with the

regulations. The revisions that were

proposed on December 30, 1993 are

summarized below.

EPA stated in the notice of proposed

rulemaking that containers of waste

cannot be defined as products, ‘‘because

they are not manufactured from raw or

recycled materials in order to perform a

specific task, nor does waste encounter

a point of sale to an ultimate

consumer.’’ The Agency also stated that

a container (such as a dumpster or a

barrel) carrying a ‘‘product containing’’

which is ultimately disposed of or

incinerated, such as a can of adhesive or

foam scrap, does not fall within the

definition of ‘‘container containing.’’

Therefore, waste materials containing

controlled substances are not required

to be labeled under these regulations.

EPA also believes that containers of

class I or class II waste do not fall under

the definition of ‘‘container containing,’’

in that the waste is not ‘‘intended to be

transferred to another container, vessel

or piece of equipment in order to realize

its intended use.’’ EPA’s intention in

including ‘‘intended use’’ in its

definition was to target items to be

consumed, thus giving consumers

information on which to base a

purchase decision. Waste is neither

purchased nor ‘‘used’’ and thus, does

not fall into the category of items to be

consumed. In order to make this clear,

EPA proposed a new § 82.106(b)(3) of

the regulatory text, which includes

‘‘waste containing controlled substances

or blends of controlled substances

bound for discard’’ in the list of

exemptions from warning label

requirements. EPA also proposed a

definition of ‘‘waste,’’ for purposes of

this rule, that includes items or

substances discarded with the intent

that they will serve no further useful

purpose. The term discarded can

include being deposited in a landfill,

being destroyed in an incinerator or

chemical process, or undergoing some

other type of final waste handling.

Consequently, waste that is going to be

discarded is not required to be labeled

under this rulemaking.

Furthermore, the Agency stated that it

believes that there is not a significant

environmental benefit associated with

labeling wastes of controlled substances.

The labeling rule lays out requirements

that will affect consumers’ decisions,

and thus, manufacturers’ production

decisions upstream. A label applied to

the product(s) manufactured with or

containing a controlled substance will

provide such information to the

consumer. Duplicating efforts by

labeling the waste from a product that

no longer serves its useful purpose has

no influence on purchasing or consumer

decisions, since waste is neither

purchased nor used. Since waste is not

a consumer item, a waste handler,

whose business it is to handle all types

of unwanted materials, would not be

dissuaded from accepting a certain

waste because of its effect on the ozone

layer.

However, EPA stated that it believes

that containers that contain used or

contaminated controlled substances,

such as some refrigerants, methyl

chloroform, carbon tetrachloride, other

CFCs and HCFCs, and blends of

controlled substances that are bound for

recycling or reclamation do fall under

the definition of ‘‘container containing.’’

These substances will be transferred to

realize their ‘‘intended use’’ and will

later be used by consumers.

Consequently, EPA proposed to

continue requiring these containers to

be labeled and did not propose such

containers to be exempt from such

requirements under this amendment.

Such quantities are easily identifiable

and are often recycled or reclaimed for

manufacture or use in new products

which would in turn require the

mandated warning statement. Therefore,

EPA stated that it believes that the

mandated warning statement is

warranted on containers of

contaminated (or used) controlled

substances and blends of controlled

substances when they are introduced

into interstate commerce for purposes of

recycling or reclamation.

Because of the demand for and the

high cost of controlled substances, EPA

stated that it further believes that those

using controlled substances will recycle

or reclaim rather than discard them.

Regulations promulgated pursuant to

sections 608 and 609 of the Clean Air

Act require recovery and recycling of

refrigerants; efficient management of

other uses of controlled substances

would preclude discarding as a prudent

option. In cases where these substances

cannot be reused, recycled, or

reclaimed, they are most often destroyed

rather than deposited in a landfill or

disposed in some other manner that

would allow emissions of the substance.

As hazardous wastes, carbon

tetrachloride, methyl chloroform, and

methyl bromide cannot be placed in a

landfill, these chemicals most often are

incinerated if not reused. Additionally,

no non-containerized liquid wastes can

be placed in landfills.

C. Response to Comments

One commenter requested

clarification of the definition of discard.

Another commenter requested that the

definition of discard be included in the

preamble. EPA has defined discarding

to include depositing in a landfill,

destroying in an incinerator or chemical

process, or undergoing some other type

of final waste handling that does not

include re-use, recycling, or

reclamation. The use of the term

‘‘discard’’ is meant to differentiate that

which will no longer be used in any

manner because of landfilling or

incineration, from that which will

undergo some type of change or

treatment to make it appropriate for

further use.

Two commenters requested an

exemption for scrap foam and scrap

disposal products destined for

recycling, while another commenter

sought clarification for products

containing other controlled substances

that are bound for recycling. EPA’s

intent in the proposed amendment was

not to require labeling of scrap foam,

either destined for discard or for

recycling. Rather, the Agency states that

the warning statement is required on

containers of used controlled substances

and blends of controlled substances that

are introduced into interstate commerce

for purposes of recycling or reclamation.

Containers of actual controlled

substances or blends of controlled

substances (i.e. bulk containers of actual

chemical substances) can be

distinguished from products that

themselves contain controlled

substances. The latter do not require

labeling when disposed in any fashion

(including recycling or reclamation).

Two commenters stated that EPA

should exempt waste products destined

for destruction in a cement kiln or

burned for energy recovery. In the final

accelerated phaseout rule (58 FR 65018),

EPA responded to comments by making

clear that destruction of class I

substances in one of the five approved
Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations 4015

destruction technologies, which

provides energy recovery as a byproduct of the destruction process,

would fall under the definition of

destruction for purposes of the labeling

exemption for waste. Energy recovery

through the use of one of the five

approved technologies does not

disqualify a product manufactured with

a class I substance that is destroyed by

that technology from the labeling

exemption. This remains consistent

with the accelerated phaseout rule. A

parallel situation exists when waste fuel

is blended for purposes of providing

auxiliary fuels for destruction facilities.

When these fuels are intended to use

one of the five approved destruction

technologies for energy recovery, the

waste fuels do not require labeling

under today’s rule. In either case, waste

bound for energy recovery does not

require labeling because it uses an

incineration process and is ultimately

destroyed.

Several commenters agreed with the

proposed exemption for waste bound for

discard; however, these commenters

stated that the Agency should expand

the definition of waste to be consistent

with RCRA, which includes in its

definition substances to be recycled.

The purposes of the definition of waste

under RCRA and under the labeling rule

are very different. RCRA ensures that all

hazardous waste materials, whether

they are recycled, reclaimed, landfilled,

incinerated, or otherwise disposed, are

properly handled. The purpose of the

labeling rule, however, is to provide

purchasers with information upon

which to make purchasing decisions.

Therefore, since substances that are

recycled continue to be passed through

the stream of commerce to the ultimate

consumer, who should know of its

contents, bulk containers of these

recycled substances require labeling.

One of these commenters added that

reclamation/recovery facilities are not

consumers, and therefore do not serve

the intent of the labeling rule which is

to provide consumers with information

upon which to make purchasing

decisions. As stated above, recycled

waste continues to be subject to labeling

requirements because it is part of the

stream of commerce and reclaimers are

not considered ultimate consumers.

Another of these commenters stated

that waste generators may not know

how waste will be disposed of, therefore

it would be difficult properly label

waste and that warning labels on wastes

may discourage recycling. EPA believes

that since waste generators make the

decision of where products are to be

sent, they therefore have both control

and knowledge of waste disposal

methods. Additionally, it is the intent of

the labeling rule to encourage recycling

efforts as waste handlers realize the

benefits of additional availability and

supply of recycled substances.

Another commenter requested further

clarification on how an exemption

applies to waste products bound for

discard when they enter interstate

commerce. The labeling rule draws

distinctions based on materials that fall

under the definition of ‘‘container

containing’’ that are introduced into

interstate commerce. Substances to be

recycled and reclaimed that are

introduced into interstate commerce fall

under the definition of ‘‘container

containing’’ under the labeling rule. As

outlined in the original rule, substances

are defined as ‘‘container containing’’ if

they must be transferred to another

container to realize their intended use

by consumers. Because recycled and

reclaimed substances must be

transferred to other containers before

continuing in the stream of commerce,

labeling is required for such substances

under today’s rule. On the other hand,

substances bound for discard (including

destruction), are not ‘‘containers

containing’’ under the labeling rule,

because they are not ‘‘intended to be

transformed to another container in

order to realize [their] intended use.’’

D. Today’s Rule

While it could be argued that

requiring the labeling of waste provides

valuable information about the contents

of a waste to the handler, other

regulations provide for similar

information to be conveyed. For

example, any waste considered to be

hazardous (which includes carbon

tetrachloride, methyl chloroform, and

methyl bromide) must have its contents

reported on the manifest required to

accompany the waste under the

Resource Conservation and Recovery

Act (RCRA). Furthermore, EPA believes

that the intent of the section 611

labeling provisions is to provide

consumers with information upon

which to make purchasing decisions,

rather than to inform persons of

contents for purposes of handling a

substance, product or waste.

In summary, the Agency recognizes

that waste should not be defined as a

product under these regulations, nor

should containers of waste be regarded

as containers containing controlled

substances, because they are not

‘‘intended to be transferred to another

container, vessel or piece of equipment

in order to realize its intended use.’’

Consequently, as proposed, EPA adds in

today’s rule a new 82.106(b)(3), which

provides exemptions from the labeling

requirements, to include, ‘‘Waste

containing controlled substances or

blends of controlled substances bound

for discard.’’ EPA emphasizes, however,

that containers of used or contaminated

controlled substances or of blends of

these controlled substances that enter

into interstate commerce and that are

bound for recycling or reclamation are

not proposed to be exempted, and thus

would continue to require labeling. The

definition of ‘‘waste’’ for purposes of

this rulemaking means, ‘‘items or

substances that are discarded with the

intent that such items or substances will

serve no further useful purpose.’’

IV. Labeling Requirements for Spare

Parts to be Used Solely for Repair

A. Proposal

The original labeling rule did not

require a product which has already

been purchased and used to be labeled

if the product components were

manufactured with a controlled

substance or a controlled substance was

used in the repair itself. EPA believes

that such a product is not being

introduced into interstate commerce

since the product is already owned by

the ultimate consumer. In a product

labeling applicability determination,

(Letter from John Rasnic, Director EPA

Stationary Source Compliance Division,

to Michael Conlon, dated April 19, 1993

and Section 611 Applicability

Determination Record Number 6, dated

April 20, 1993), following the

promulgation of the final rule, EPA

clarified that the repair provision of the

rule allows the repair of a product using

a component manufactured with an

ODS or using an ODS in the repair of

the product without triggering labeling

requirements.

Subsequent to promulgation, the

Agency has received new information

from several companies regarding spare

parts that are intended for repair

purposes only. Many companies who

distribute spare parts stock up to several

million of these parts in inventory

purchased from vendors. These

companies then sell these spare parts

piecemeal to persons who repair

original products. Due to the passthrough exemption for persons

incorporating a product manufactured

with a controlled substance that was

purchased from a supplier, and due to

the applicability determination

regarding repairs, the repair person

would not be required to label the

repaired product. To require companies

that order spare parts in bulk from

suppliers to pass through labeling

information with each order—perhaps

containing several hundred individual
4016 Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations

spare parts from numerous bulk

shipments—is exceedingly burdensome

to those companies purchasing and

selling the spare parts. Typically, the

bulk shipment will be labeled on a

shipping crate or an invoice to indicate

that the parts within that shipment were

manufactured with a controlled

substance. The company ordering the

spare parts breaks down the shipment

into bins, currently necessitating a label

or labeling information to be generated

for each individual part contained in

that shipment. In most cases, a repair

person purchases hundreds of various

individual spare parts at a time from the

company, making the pass-through of

any labeling information extremely

cumbersome and time-consuming.

Many of the original manufacturers of

these spare parts are foreign

manufacturers, exacerbating the burden

of tracking the use of controlled

substances in the manufacture of each

spare part in inventory. Developing and

maintaining inventories of these spare

parts is extremely costly, often many

times more costly than the sale price of

the spare parts themselves.

EPA’s decision not to require

manufacturers incorporating products

manufactured with controlled

substances to comply with the labeling

pass-through requirement was based in

part on the overwhelming tracking

burden imposed in determining which

components were actually made using a

controlled substance. A similar situation

exists for those purchasing spare parts

for repair purposes. Many distributors

stock hundreds of thousands of spare

parts to be sold to repair persons. The

burden of tracking each part that is to

then be sold to a person using that part

for repair—which is exempted from the

labeling requirements—becomes

overwhelming and is without

environmental benefit.

Furthermore, the repair person has

specific requirements for a spare part

that will work with the existing product

to be repaired; consumer discretion on

his or her part based on the use of an

ODS is unlikely. Because the repair

person is not required to pass through

any labeling information in the repair of

the product, requiring the labeling of

spare parts themselves serves no

environmental benefit. Additionally,

numerous companies that stock spare

parts for the repair of their products

have themselves totally stopped using

controlled substances and are currently

encouraging suppliers to use safe

alternatives in manufacturing spare

parts that they purchase.

In light of the information above, EPA

proposed that purchasers of spare parts

manufactured with a controlled

substance and purchased from a vendor

for the sole purpose of repair, or

distributed for purposes of repair only,

not be required to pass through the

labeling information.

B. Response to Comments

EPA requested comments on its

proposal to exempt from the label passthrough requirement those spare parts

that are to be used for repair purposes.

Nine commenters agreed with the

proposed spare parts exemption.

One commenter suggested EPA

exempt repair parts that contain a de

minimis amount of class I chemicals.

The final labeling regulation states that

products containing a class I substance

and containers containing a class I or

class II substance bear warning labels.

Because spare parts containing these

substances clearly fall in the category of

‘‘products containing,’’ they are

required to be labeled. However,

products containing trace quantities of a

class I substance as an impurity or a

residue, where the controlled substance

serves no useful purpose in the product,

are exempted from the labeling

requirements.

Two commenters stated that the

labeling exemption for spare parts

should apply to manufacturers as well

as others involved in the distribution

process because tracking and labeling

requirements for these spare parts is

exceedingly burdensome and time

consuming. EPA disagrees with the

statement that labeling of these products

by the original manufacturer represents

an undue burden. Tracking and labeling

spare parts made with a controlled

substance by the original manufacturer

is comparable to that of any other

manufacturer of products which require

labeling. Therefore, pass-through

exemptions from labeling, which does

not include manufacturers, will remain

as proposed.

One of these commenters added that

there are instances where ‘‘currently or

potentially available’’ alternatives have

not been identified for specific

applications. In this case, according to

the commenter, labeling requirements

for spare parts where alternatives have

not been identified would penalize that

industry. The original final regulations

provide for exemptions from labeling

requirements for products manufactured

using a class I substance where there are

no substitute products or processes that

1) do not rely on the use of class I

substances, 2) reduce the overall risk to

human health and the environment, and

3) are currently or potentially available.

Manufacturers whose products meet

this criteria can apply to EPA for an

exemption from labeling requirements

as outlined in the original final in the

section marked Petitions (§ 82.120).

Another commenter requested

clarification that the exemption applies

to wholly-owned subsidiaries of the

manufacturers of spare parts and that

individual packages that arrive under

one airway bill with alternative labeling

are not subject to labeling upon entry

into the country. The original rule states

that wholly-owned subsidiaries are part

of a parent company and are subjected

to the labeling regulations; therefore, the

spare parts exemption also applies to

these wholly-owned subsidiaries.

Additionally, if a consolidated shipment

is properly labeled using an alternative

label, then individual packages within

that shipment do not require labeling.

For spare parts that fall under the

exemption established in today’s

rulemaking, importers and distributors

are only required to pass through the

label when moving the labeled

shipments as packaged by the

manufacturer.

C. Today’s Rule

In summary, EPA establishes in

today’s rule that purchasers of spare

parts manufactured with a controlled

substance and purchased from a vendor

for the sole purpose of repair, or

distributed for purposes of repair only,

not be required to pass through the

labeling information. EPA wishes to

emphasize that this exemption to the

pass-through requirement does not

apply to products containing a

controlled substance or containers of

controlled substances, nor does it apply

to spare parts used to manufacture

products. Manufacturers of spare parts

made with controlled substances are

still required to apply the appropriate

labels. Moreover, importers and

distributors moving the labeled

shipments as packaged by the

manufacturer must still pass through the

labeling information.

V. Clarification of the Meaning of

Products ‘‘Manufactured With’’

The original final rule discussed the

applicability of the labeling

requirements for products

manufactured with controlled

substances. Some confusion over when

labeling is required for such products

has emerged since the publication of

that final rule. The following discussion

should clarify such labeling questions.

In reviewing whether a product must

be labeled, one must examine from two

perspectives. Is labeling required

because it is a product ‘‘containing’’ a

controlled substance? If not, is labeling

then required because it is a product
Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations 4017

‘‘manufactured with’’ a controlled

substance?

The final rule states that a controlled

substance that is inadvertently

produced or remains as a residue from

a chemical reaction, leaving trace

quantities of that substance in the final

product, does not trigger the labeling

requirements. However, there may be

cases where a product is exempt from

being labeled a product ‘‘containing’’ (in

this case because it is only present in

trace quantities), but where a product

may still require labeling because it is

considered to be ‘‘manufactured with’’

that controlled substance.

The introduction of carbon

tetrachloride as an explosion

suppressant in the manufacture of

certain chemicals serves as an example.

The carbon tetrachloride is introduced,

then withdrawn from the chemical

product. Trace quantities of the carbon

tetrachloride remain in the chemical;

however, such quantities serve no

useful purpose in the final product. As

a result, the product is exempt from

being labeled as a product containing

carbon tetrachloride. However, because

the carbon tetrachloride is introduced

into the chemical product directly in the

manufacturing process, actually having

physical contact with the product, the

product would need to be labeled as

‘‘manufactured with’’ carbon

tetrachloride, unless other exemptions

apply.

In order to be consistent with this

view, EPA proposed to revise the

definition of ‘‘manufactured with.’’ The

original regulations stated that a product

is manufactured with a controlled

substance if the manufacturer used a

controlled substance directly in the

product’s manufacture, ‘‘but the product

itself does not contain a controlled

substance at the point of introduction

into interstate commerce.’’ However, to

further clarify that trace quantities may

actually be contained in a product

manufactured with a controlled

substance, EPA proposed to revise the

definition of ‘‘manufactured with,’’ to

state that a product ‘‘does not contain

more than trace quantities of the

controlled substance.* * *’’

Six commenters agreed with these

proposed changes. One commenter

disagreed with EPA’s position that

carbon tetrachloride should trigger

labeling unless the substance is

subsequently destroyed or transformed,

because the carbon tetrachloride is

withdrawn from the product and only

trace quantities remain. EPA supports

it’s original position, based on the fact

that the introduction of carbon

tetrachloride, which is used on a routine

basis, constitutes use as part of the

direct manufacturing process. As a

result, today’s rule establishes the

modified definition of ‘‘manufactured

with’’ as proposed.

VI. Exemption for Trace Quantities

The preamble to the original labeling

rule discussed the applicability of the

labeling requirements for products

containing trace quantities of controlled

substances. However, some confusion

over when labeling is required for such

products has arisen since the

publication of that rule.

The regulatory text in section 82.106,

referring to the warning statement

requirements, lists certain exemptions

from these requirements. The first of

these addresses ‘‘Products in which

trace quantities of a controlled

substance remain as a residue or

impurity.* * *’’ EPA has determined

that a trace quantity remaining in a

product can only be contained within a

chemical product; therefore, it is logical

that this exemption specifically applies

to products ‘‘containing’’ rather than

products ‘‘manufactured with.’’

Products that are manufactured using a

controlled substance, but that contain

only trace quantities of the substance,

are not required to be labeled as a

‘‘product containing’’; however, they are

required to be labeled as a ‘‘product

manufactured with.’’ To clarify this

point, EPA proposed to amend section

82.106(b)(1), which provides

exemptions from the labeling

requirements, to read: ‘‘Products

containing trace quantities of a

controlled substance remaining as a

residue or impurity due to a chemical

reaction, and where the controlled

substance serves no useful purpose in or

for the product itself.’’ However, if such

a product was manufactured using the

controlled substance, such product is

required to be labeled as a ‘‘product

manufactured with’’ the controlled

substance.

There was also some confusion as to

whether a container containing a trace

amount of a controlled substance must

be labeled. EPA understands that to

determine whether a container contains

a trace amount of a controlled

substance, where such a determination

falls outside of normal procedures, may

be difficult and costly. For example, a

container of a non-controlled substance

that may hold a trace amount of a

controlled substance as an impurity of

the manufacturing process would be

subject to labeling under current

labeling requirements. As a product,

however, that same container would be

exempt from the labeling requirements.

In many cases, expensive testing must

be conducted to determine if a trace

quantity of the controlled substance is

in fact contained in the container.

Requiring the labeling of containers

containing trace quantities of a

controlled substance is inconsistent

with the trace quantities exemption of

the current labeling rule and with the

intent of the Agency to require labeling

of ‘‘containers of’’ controlled

substances.

EPA received three comments

agreeing with the exemption for trace

quantities. One commenter asked for

clarification of the definition of trace

quantity. Another commented that trace

quantities should be defined with a

quantifying limit above which labeling

would be required. Another commenter

recommended that EPA publish

guidance on what constitutes a ‘‘trace

quantity’’, and suggests using analytical

detection limits for the exemption level.

Because the labeling rule covers a

multitude of substances, products, and

volumes, EPA believes it cannot

responsibly put forth a standardized

threshold for ‘‘trace quantity.’’ However,

EPA believes that the term ‘‘trace

amounts’’ should be interpreted

consistently with Webster’s Ninth New

Collegiate Dictionary (copyright 1990),

which defines trace amounts to mean ‘‘a

chemical element present in minute

quantities.’’ Reasonable interpretations

of what constitutes a trace amount will

likely be parallel to reasonable

interpretations made by EPA. EPA is

today revising its regulations, as

proposed, to make the exemption clear.

EPA will add the new 82.106(b)(2),

(discussed above), stating that

containers containing trace quantities of

a controlled substance, which remain as

a residue or impurity, are exempt from

the labeling requirements.

VII. Labeling Requirements of

Containers of 55 Gallons and Smaller

Containing Controlled Substances

The original labeling regulations

indicated that the use of supplemental

printed material may be used to label

containers of controlled substances that

are larger than 55 gallon drums, as long

as the information is viewed at the time

of purchase or time of delivery,

provided the purchase is not considered

complete until delivery is accepted.

EPA reasoned that such information,

rather than the containers themselves, is

usually viewed by the recipient of such

containers. The regulations also

indicated that the warning statement

must be placed directly on containers of

controlled substances that are smaller

than 55 gallon drums.

EPA proposed in the December 30,

1993 amendment that supplemental

printed material may also be used to
4018 Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations

convey the warning statement for

containers that are 55 gallons and

smaller. EPA requested comment on its

proposal to allow alternative placement

of warning statements on 55 gallon or

smaller containers. Seven commenters

agreed with this proposed change with

no requests for additional information

or clarification. Consequently, EPA is

revising section 82.108 (c) of its labeling

regulation to strike ‘‘larger than a 55

gallon drum’’ from the provision

allowing alternative placement of the

warning statement on containers of

controlled substances.

VIII. Definition of Importer

For purposes of section 611, EPA

clarifies that importers of ‘‘products

manufactured with controlled

substances’’ are included in the

definition of ‘‘importer.’’ While the

intent of the § 611 regulations was to

cover imports of products manufactured

with class I substances, the original

definition did not explicitly include

such a phrase. This came about as an

oversight in transferring the definition

from the phaseout regulations, where

imports of containers and products

containing controlled substances are

regulated. Section 611 clearly mandates

that ‘‘products manufactured with

controlled substances’’ be labeled before

they are introduced into interstate

commerce. Therefore, for purposes of

the labeling requirements and

consistency with the statute, the

definition of ‘‘importer’’ under section

611 is amended to include the phrase

‘‘products manufactured with.’’

One commenter stated that the

requirement to apply labels for imported

products at the border is highly

impractical, burdensome, time

consuming and costly. While this issue,

however, was not addressed in the

proposed labeling amendments, EPA

wishes to clarify that importers are

responsible for ensuring that labels are

properly affixed, but the labeling

regulations do not require that the label

can only be affixed at the border. The

requirements may equally be met by

ensuring that the label is affixed before

the product reaches the border. The

importer may negotiate with its supplier

to ensure that labels are affixed prior to

shipment. No other comments were

received; the change in the definition of

‘‘importer’’ is established in today’s

rule, as proposed.

IX. Certification Requirements for

Reduced Use Exemption

In section 82.122, EPA states that

companies that reduced their use of

CFC–113 and/or methyl chloroform

(MCF) by 95 percent or greater over

their 1990 usage level could certify the

reduction in writing to EPA and be

exempt from the labeling requirements.

In addition to other requirements for

inclusion in the written certification,

the regulations require that persons

certifying to EPA must state that they

will not exceed 5 percent of their 1990

use following the certification; however,

the statement conveyed was

numerically and grammatically

incorrect. It reads: ‘‘Persons certifying

must also include a statement that

indicates that their future annual use

will not at no time exceed 95 percent of

their 1990 usage’’ (p. 8169).

EPA corrects this section of the

regulations to state that a company must

certify to EPA that its future use will not

exceed 5 percent of its 1990 usage

without notifying the Agency. Such

notification would immediately result

in labeling of the company’s products.

This subpart (§ 82.122 (a)(4)) would thus

read: ‘‘Persons certifying must also

include a statement that indicates their

future annual use will at no time exceed

5 percent of their 1990 usage.’’

X. Imports and Products Introduced In

Bond at the U.S./Mexico Border

The original labeling regulations state

that products or containers introduced

‘‘in bond’’ at the Mexico border are not

considered to be ‘‘imports.’’ However,

the preamble states that such products

or containers are being introduced into

U.S. interstate commerce and are

therefore subject to the labeling

requirements.

EPA proposed in its December 30,

1993 amendment that all products and

containers subject to the labeling

requirements that are made or charged

in Mexico and subsequently brought

into the U.S. must be labeled at the

border where they are being introduced

into U.S. interstate commerce. In order

to facilitate enforcement of this rule, the

Agency only requires that warning

labels be placed on regulated products

and containers at the border by persons

introducing them into U.S. interstate

commerce, rather than at the

manufacturing facility in Mexico.

However, the importer may contract

with the Mexican manufacturer to

provide the applicable warning

statement prior to shipping.

This change supersedes EPA’s

reference to products or containers

admitted in bond in the original labeling

rule, since for purposes of the labeling

requirements, the regulated products

and containers are in fact being treated

as ‘‘imports.’’ This change makes the

definition of import somewhat different

from that in the final phaseout

regulations. For purposes of the

phaseout regulations, it is appropriate to

exempt such products of U.S. origin that

are brought back into the U.S. from

Mexico in bond from the definition of

import because allowances have already

been expended and additional

consumption allowances should not be

required to bring these products back

into the U.S.

However, it is appropriate and

consistent with the intent of § 611 to

require labeling of these imported

goods, since labeling is to occur

regardless of whether the product is

distributed domestically or imported.

The Agency therefore is striking from

the definition of ‘‘import’’ in section

82.104 (j) of the labeling regulation the

exemption for bringing controlled

substances, containers of, or products

manufactured with, controlled

substances into the U.S. from Mexico

where such substance, container or

product was admitted into Mexico in

bond and is of U.S. origin. EPA

requested and received no comments on

the changes and consequently they

remain in today’s final regulation.

In addition, EPA notes that the

preamble to the original labeling rule

contained an inaccuracy in describing

an arrangement regarding products

brought from Mexico into the United

States inbond. The preamble stated that,

‘‘Under the Maquiladora Agreement, the

United States and Mexico established a

free-trade zone along a segment of the

U.S./Mexico border.’’ There is no formal

agreement as such between the two

countries in this regard; rather, an

arrangement exists, primarily under

Mexican law, whereby controlled

substances crossing the border from the

U.S. into Mexico ‘‘inbond’’ (under a

bond ensuring that the substance will

remain in Mexico only temporarily) will

be returned to the U.S., without being

subject to Mexican import tariffs. In

addition, the preamble to the original

rule stated that ‘‘products are permitted

to be transported across [the

Maquiladora] zone without any U.S.

Customs restrictions being imposed.’’

This statement is misleading in that U.S.

Customs does assist EPA in monitoring

compliance with and enforcing U.S.

environmental laws that generally apply

without distinction to Maquiladora

products. The preamble to the final rule

should therefore be read to reflect these

corrections. EPA requested comments

on these corrections and received none.

Consequently, the changes remain as

proposed.

XI. Incidental Uses of Controlled

Substances

In the original final regulations, the

definition of ‘‘manufactured with’’
Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations 4019

excluded the use of a controlled

substance ‘‘Where the manufacturing

equipment has had physical contact

with a controlled substance in an

intermittent manner, not as a routine

part of the direct manufacturing process

* * *’’ (See p. 8165). The preamble

gave as an example the occasional

cleaning of an ink plate, where direct

contact occurs only between the

controlled substance and the

manufacturing equipment, not between

the controlled substance and the

product itself (other than the first one or

two products going through the

equipment following equipment

maintenance). However, the preamble,

in addressing this point, specifically

noted that this exclusion should also

apply in the case of a controlled

substance having intermittent contact

with the product itself, such as a textile

where direct contact occurs through

spot cleaning of some individual

textiles, but where direct contact is not

a normal or usual occurrence in the

manufacture of the product.

The Agency intended for the

regulatory text to reflect the full

discussion in the preamble to the final

rule. Therefore, EPA proposed to

exempt from the labeling requirements

products where there are intermittent

uses of controlled substances that may

involve an initial contact with the

product itself, as well as with the

equipment. The exception was proposed

to read: ‘‘[W]here the manufacturing

equipment or product has had physical

contact with a controlled substance in

an intermittent manner, not as a routine

part of the direct manufacturing process

* * *’’ EPA received no comments on

this issue. EPA therefore will revise the

regulatory text as proposed.

XII. Request for Comments Regarding

Plasma Etching

In the preamble of the original

labeling rule, EPA states that ‘‘plasma

etching’’ is considered a process that

entails transformation, and thus

products manufactured using plasma

etching need not be labeled, unless they

are otherwise subject to the

regulations.’’ Since publication of the

final rule, EPA has heard from one

plasma etcher who has discovered that

the plasma etching process may not

necessarily transform all but trace

quantities of controlled substances used

in the process. At times, it is estimated

that as much as 40 percent may not be

transformed.

EPA has not received any additional

comments on whether plasma etching

can be considered generally to

constitute transformation under the

final labeling rule, which defines

transformation as, ‘‘to use and entirely

consume a class I or class II substance,

except for trace quantities, by changing

it into one or more substances not

subject to this subpart in the

manufacturing process of a product or

chemical.’’ Consequently, without

further data illustrating that plasma

etching does or does not transform all

but trace quantities, EPA cannot make

any general statements about plasma

etching; however, if a particular plasma

etching process meets the requirements

for ‘‘transformation’’, then the

manufacturer need not label the

product.

XIII. Miscellaneous

One commenter requested

clarification on the requirements in the

original rule (February 11, 1994), to list

multiple class I or class II substances on

a warning label (§ 82.110), and whether

the word ‘‘may’’ implies that it is not

mandatory to list all applicable

substances. In situations where products

are manufactured with or contain

multiple substances, those substances

must be represented on the warning

label. These substances can be

identified by either 1) listing them

directly on the label, or 2) by using an

asterisk (*) in place of the substance

name with a corresponding list of those

substances in a legible and conspicuous

location. The word ‘‘may’’ is intended to

imply the option to use of either of the

above labeling alternatives, not to imply

that labeling is not mandatory in cases

where multiple class I or class II

substances are used.

XIV. Summary of Supporting Analysis

A. Executive Order 12866

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether this regulatory

action is ‘‘significant’’ and therefore

subject to OMB review and the

requirements of the Executive Order.

The Order defines ‘‘significant’’

regulatory action as one that is likely to

lead to a rule that may:

(1) Have an annual effect on the

economy of $100 million or more, or

adversely and materially affect a sector

of the economy, productivity,

competition, jobs, the environment,

public health or safety, or State, local,

or tribal governments or communities;

(2) Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency;

(3) Materially alter the budgetary

impact of entitlement, grants, user fees,

or loan programs or the rights and

obligations of recipients thereof; or

(4) Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in the Executive Order.

It has been determined by OMB and

EPA that this amendment to the final

rule is not a ‘‘significant regulatory

action’’ under the terms of Executive

Order 12866 and is therefore not subject

to OMB review under the Executive

Order.

B. Regulatory Flexibility Act

The Regulatory Flexibility Act, 5

U.S.C. 601–602, requires that Federal

agencies examine the impacts of their

regulations on small entities. Under 5

U.S.C. 604(a), whenever an agency is

required to publish a general notice of

proposed rulemaking, it must prepare

and make available for public comment

an initial regulatory flexibility analysis

(RFA). Such an analysis is not required

if the head of an agency certifies that a

rule will not have a significant

economic impact on a substantial

number of small entities, pursuant to 5

U.S.C. 605(b).

EPA believes that any impact that this

amendment will have on the regulated

community will serve only to provide

relief from otherwise applicable

regulations, and will therefore limit the

negative economic impact associated

with the regulations previously

promulgated under Section 608. An

examination of the impacts on small

entities was discussed in the final rule

(58 FR 28660). That final rule assessed

the impact the rule may have on small

entities. A separate regulatory impact

analysis accompanied the final rule and

is contained in Docket A–92–01. I

certify that this amendment to the

labeling rule will not have any

additional negative economic impacts

on any small entities.

C. Paperwork Reduction Act

Any information collection

requirements in a rule must be

submitted for approval to the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act, 44 U.S.C.

3501 et seq. Because no additional

informational collection requirements

are required by this amendment, EPA

has determined that the Paperwork

Reduction Act does not apply to this

rulemaking and no new Information

Collection Request document has been

prepared.

XV. Judicial Review

Under Section 307(b)(1) of the Act,

EPA finds that these regulations are of

national applicability. Accordingly,

judicial review of this action is available

only by the filing of a petition for review

in the United States Court of Appeals

for the District of Columbia Circuit
4020 Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations

within sixty days of publication of this

action in the Federal Register. Under

Section 307(b)(2), the requirements of

this rule may not be challenged later in

judicial proceedings brought to enforce

those requirements.

List of Subjects in 40 CFR Part 82

Environmental protection,

Administrative practice and procedure,

Air pollution control, Chemicals,

Chlorofluorocarbons, Exports,

Hydrochlorofluorocarbons, Imports,

Interstate commerce, Nonessential

products, Reporting and recordkeeping

requirements, Stratospheric ozone layer.

Dated: December 23, 1994.

Carol M. Browner,

Administrator.

Part 82, title 40, Code of Federal

Regulations is amended to read as

follows:

PART 82—PROTECTION OF

STRATOSPHERIC OZONE

1. The authority citation for part 82

continues to read as follows:

Authority: 42 U.S.C. 7414, 7601, 7671–

7671(q).

2. Subpart E, consisting of §§ 82.100

through 82.124, is revised to read as

follows:

Subpart E—The Labeling of Products Using

Ozone-Depleting Substances

Sec.

82.100 Purpose.

82.102 Applicability.

82.104 Definitions.

82.106 Warning statement requirements.

82.108 Placement of warning statement.

82.110 Form of label bearing warning

statement.

82.112 Removal of label bearing warning

statement.

82.114 Compliance by manufacturers and

importers with requirements for labeling

of containers of controlled substances, or

products containing controlled

substances.

82.116 Compliance by manufacturers or

importers incorporating products

manufactured with controlled

substances.

82.118 Compliance by wholesalers,

distributors and retailers.

82.120 Petitions.

82.122 Certification, recordkeeping, and

notice requirements.

82.124 Prohibitions.

Subpart E—The Labeling of Products

Using Ozone-Depleting Substances

§ 82.100 Purpose.

The purpose of this subpart is to

require warning statements on

containers of, and products containing

or manufactured with, certain ozonedepleting substances, pursuant to

section 611 of the Clean Air Act, as

amended.

§ 82.102 Applicability.

(a) In the case of substances

designated as class I or class II

substances as of February 11, 1993, the

applicable date of the requirements in

this paragraph (a) is May 15, 1993. In

the case of any substance designated as

a class I or class II substance after

February 11, 1993, the applicable date

of the requirements in this paragraph (a)

is one year after the designation of such

substance as a class I or class II

substance unless otherwise specified in

the designation. On the applicable date

indicated in this paragraph (a), the

requirements of this subpart shall apply

to the following containers and products

except as exempted under paragraph (c)

of this section:

(1) All containers in which a class I

or class II substance is stored or

transported.

(2) All products containing a class I

substance.

(3) All products directly

manufactured with a process that uses

a class I substance, unless otherwise

exempted by this subpart or, unless the

Administrator determines for a

particular product that there are no

substitute products or manufacturing

processes for such product that do not

rely on the use of a class I substance,

that reduce overall risk to human health

and the environment, and that are

currently or potentially available. If the

Administrator makes such a

determination for a particular product,

then the requirements of this subpart are

effective for such product no later than

January 1, 2015.

(b) Applicable January 1, 2015 in any

case, or one year after any determination

between May 15, 1993 and January 1,

2015, by the Administrator for a

particular product that there are

substitute products or manufacturing

processes for such product that do not

rely on the use of a class I or class II

substance, that reduce the overall risk to

human health and the environment, and

that are currently or potentially

available, the requirements of this

subpart shall apply to the following:

(1) All products containing a class II

substance.

(2) All products manufactured with a

process that uses a class II substance.

(c) The requirements of this subpart

shall not apply to products

manufactured prior to May 15, 1993,

provided that the manufacturer submits

documentation to EPA upon request

showing that the product was

manufactured prior to that date.

§ 82.104 Definitions.

(a) Class I substance means any

substance designated as class I in 40

CFR part 82, appendix A to subpart A,

including chlorofluorocarbons, halons,

carbon tetrachloride and methyl

chloroform and any other substance so

designated by the Agency at a later date.

(b) Class II substance means any

substance designated as class II in 40

CFR part 82, appendix A to subpart A,

including hydrochlorofluorocarbons

and any other substance so designated

by the Agency at a later date.

(c) Completely destroy means to cause

the destruction of a controlled substance

by one of the five destruction processes

approved by the Parties at a

demonstrable destruction efficiency of

98 percent or more or a greater

destruction efficiency if required under

other applicable federal regulations.

(d) Consumer means a commercial or

non-commercial purchaser of a product

or container that has been introduced

into interstate commerce.

(e) Container means the immediate

vessel in which a controlled substance

is stored or transported.

(f) Container containing means a

container that physically holds a

controlled substance within its structure

that is intended to be transferred to

another container, vessel or piece of

equipment in order to realize its

intended use.

(g) Controlled substance means a class

I or class II ozone-depleting substance.

(h) Destruction means the expiration

of a controlled substance, that does not

result in a commercially useful end

product using one of the following

controlled processes in a manner that

complies at a minimum with the ‘‘Code

of Good Housekeeping’’ of Chapter 5.5

of the United National Environment

Programme (UNEP) report entitled, AdHoc Technical Advisory Committee on

ODS Destruction Technologies, as well

as the whole of Chapter 5 from that

report, or with more stringent

requirements as applicable. The report

is available from the Environmental

Protection Agency, Public Docket A–91–

60, 401 M Street, SW., Washington, DC

20460 The controlled processes are:

(1) Liquid injection incineration;

(2) Reactor cracking;

(3) Gaseous/fume oxidation;

(4) Rotary kiln incineration; or

(5) Cement kiln.

(i) Distributor means a person to

whom a product is delivered or sold for

purposes of subsequent resale, delivery

or export.

(j) Export means the transport of

virgin, used, or recycled class I or class

II substances or products manufactured

or containing class I or class II
Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations 4021

substances from inside the United States

or its territories to persons outside the

United States or its territories, excluding

United States military bases and ships

for on-board use.

(k) Exporter means the person who

contracts to sell class I or class II

substances or products manufactured

with or containing class I or class II

substances for export or transfers such

substances or products to his affiliate in

another country.

(l) Import means to land on, bring

into, or introduce into, or attempt to

land on, bring into, or introduce into

any place subject to the jurisdiction of

the United States whether or not such

landing, bringing, or introduction

constitutes an importation within the

meaning of the customs laws of the

United States, with the exception of

temporary off-loading of products

manufactured with or containers

containing class I or class II substances

from a ship are used for servicing of that

ship.

(m) Importer means any person who

imports a controlled substance, a

product containing a controlled

substance, a product manufactured with

a controlled substance, or any other

chemical substance (including a

chemical substance shipped as part of a

mixture or article), into the United

States. ‘‘Importer’’ includes the person

primarily liable for the payment of any

duties on the merchandise or an

authorized agent acting on his or her

behalf. The term also includes, as

appropriate:

(1) The consignee;

(2) The importer of record listed on

U.S. Customs Service forms for the

import;

(3) The actual owner if an actual

owner’s declaration and superseding

bond has been filed; or

(4) The transferee, if the right to draw

merchandise in a bonded warehouse has

been transferred.

(n) Interstate commerce means the

distribution or transportation of any

product between one state, territory,

possession or the District of Columbia,

and another state, territory, possession

or the District of Columbia, or the sale,

use or manufacture of any product in

more than one state, territory,

possession or District of Columbia. The

entry points for which a product is

introduced into interstate commerce are

the release of a product from the facility

in which the product was

manufactured, the entry into a

warehouse from which the domestic

manufacturer releases the product for

sale or distribution, and at the site of

United States Customs clearance.

(o) Manufactured with a controlled

substance means that the manufacturer

of the product itself used a controlled

substance directly in the product’s

manufacturing, but the product itself

does not contain more than trace

quantities of the controlled substance at

the point of introduction into interstate

commerce. The following situations are

excluded from the meaning of the

phrase ‘‘manufactured with’’ a

controlled substance:

(1) Where a product has not had

physical contact with the controlled

substance;

(2) Where the manufacturing

equipment or the product has had

physical contact with a controlled

substance in an intermittent manner,

not as a routine part of the direct

manufacturing process;

(3) Where the controlled substance

has been transformed, except for trace

quantities; or

(4) Where the controlled substance

has been completely destroyed.

(p) Potentially available means that

adequate information exists to make a

determination that the substitute is

technologically feasible,

environmentally acceptable and

economically viable.

(q) Principal display panel (PDP)

means the entire portion of the surface

of a product, container or its outer

packaging that is most likely to be

displayed, shown, presented, or

examined under customary conditions

of retail sale. The area of the PDP is not

limited to the portion of the surface

covered with existing labeling; rather it

includes the entire surface, excluding

flanges, shoulders, handles, or necks.

(r) Product means an item or category

of items manufactured from raw or

recycled materials, or other products,

which is used to perform a function or

task.

(s) Product containing means a

product including, but not limited to,

containers, vessels, or pieces of

equipment, that physically holds a

controlled substance at the point of sale

to the ultimate consumer which remains

within the product.

(t) Promotional printed material

means any informational or advertising

material (including, but not limited to,

written advertisements, brochures,

circulars, desk references and fact

sheets) that is prepared by the

manufacturer for display or promotion

concerning a product or container, and

that does not accompany the product to

the consumer.

(u) Retailer means a person to whom

a product is delivered or sold, if such

delivery or sale is for purposes of sale

or distribution in commerce to

consumers who buy such product for

purposes other than resale.

(v) Spare parts means those parts that

are supplied by a manufacturer to

another manufacturer, distributor, or

retailer, for purposes of replacing

similar parts with such parts in the

repair of a product.

(w) Supplemental printed material

means any informational material

(including, but not limited to, package

inserts, fact sheets, invoices, material

safety data sheets, procurement and

specification sheets, or other material)

which accompanies a product or

container to the consumer at the time of

purchase.

(x) Transform means to use and

entirely consume a class I or class II

substance, except for trace quantities, by

changing it into one or more substances

not subject to this subpart in the

manufacturing process of a product or

chemical.

(y) Type size means the actual height

of the printed image of each capital

letter as it appears on a label.

(z) Ultimate consumer means the first

commercial or non-commercial

purchaser of a container or product that

is not intended for re-introduction into

interstate commerce as a final product

or as part of another product.

(aa) Warning label means the warning

statement required by section 611 of the

Act. The term warning statement shall

be synonymous with warning label for

purposes of this subpart.

(bb) Waste means, for purposes of this

subpart, items or substances that are

discarded with the intent that such

items or substances will serve no further

useful purpose.

(cc) Wholesaler means a person to

whom a product is delivered or sold, if

such delivery or sale is for purposes of

sale or distribution to retailers who buy

such product for purposes of resale.

§ 82.106 Warning statement requirements.

(a) Required warning statements.

Unless otherwise exempted by this

subpart, each container or product

identified in § 82.102 (a) or (b) shall bear

the following warning statement,

meeting the requirements of this subpart

for placement and form:

WARNING: Contains [or Manufactured

with, if applicable] [insert name of

substance], a substance which harms public

health and environment by destroying ozone

in the upper atmosphere.

(b) Exemptions from warning label

requirement. The following products

need not bear a warning label:

(1) Products containing trace

quantities of a controlled substance

remaining as a residue or impurity due

to a chemical reaction, and where the
4022 Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations

controlled substance serves no useful

purpose in or for the product itself.

However, if such product was

manufactured using the controlled

substance, the product is required to be

labeled as a ‘‘product manufactured

with’’ the controlled substance, unless

otherwise exempted;

(2) Containers containing a controlled

substance in which trace quantities of

that controlled substance remain as a

residue or impurity;

(3) Waste containing controlled

substances or blends of controlled

substances bound for discard;

(4) Products manufactured using

methyl chloroform or CFC–113 by

persons who can demonstrate and

certify a 95% reduction in overall usage

from their 1990 calendar year usage of

methyl chloroform or CFC–113 as

solvents during a twelve (12) month

period ending within sixty (60) days of

such certification or during the most

recently completed calendar year. In

calculating such reduction, persons may

subtract from quantities used those

quantities for which they possess

accessible data that establishes the

amount of methyl chloroform or CFC–

113 transformed. Such subtraction must

be performed for both the applicable

twelve month period and the 1990

calendar year. If at any time future usage

exceeds the 95% reduction, all products

manufactured with methyl chloroform

or CFC–113 as solvents by that person

must be labeled immediately. No person

may qualify for this exemption after

May 15, 1994;

(5) Products intended only for export

outside of the United States shall not be

considered ‘‘products introduced into

interstate commerce’’ provided such

products are clearly designated as

intended for export only;

(6) Products that are otherwise not

subject to the requirements of this

subpart that are being repaired, using a

process that uses a controlled substance.

(7) Products, processes, or substitute

chemicals undergoing research and

development, by which a controlled

substance is used. Such products must

be labeled when they are introduced

into interstate commerce.

(c) Interference with other required

labeling information. The warning

statement shall not interfere with,

detract from, or mar any labeling

information required on the labeling by

federal or state law.

§ 82.108 Placement of warning statement.

The warning statement shall be

placed so as to satisfy the requirement

of the Act that the warning statement be

‘‘clearly legible and conspicuous.’’ The

warning statement is clearly legible and

conspicuous if it appears with such

prominence and conspicuousness as to

render it likely to be read and

understood by consumers under normal

conditions of purchase. Such placement

includes, but is not limited to, the

following:

(a) Display panel placement. For any

affected product or container that has a

display panel that is normally viewed

by the purchaser at the time of the

purchase, the warning statement

described in § 82.106 may appear on

any such display panel of the affected

product or container such that it is

‘‘clearly legible and conspicuous’’ at the

time of the purchase. If the warning

statement appears on the principal

display panel or outer packaging of any

such affected product or container, the

warning statement shall qualify as

‘‘clearly legible and conspicuous,’’ as

long as the label also fulfills all other

requirements of this subpart and is not

obscured by any outer packaging, as

required by paragraph (b) of this section.

The warning statement need not appear

on such display panel if either:

(1) The warning statement appears on

the outer packaging of the product or

container, consistent with paragraph (b)

of this section, and is clearly legible and

conspicuous; or

(2) The warning statement is placed in

a manner consistent with paragraph (c)

of this section.

(b) Outer packaging. If the product or

container is normally packaged,

wrapped, or otherwise covered when

viewed by the purchaser at the time of

the purchase the warning statement

described in § 82.106 shall appear on

any outer packaging, wrapping or other

covering used in the retail display of the

product or container, such that the

warning statement is clearly legible and

conspicuous at the time of the purchase.

If the outer packaging has a display

panel that is normally viewed by the

purchaser at the time of the purchase,

the warning statement shall appear on

such display panel. If the warning

statement so appears on such product’s

or container’s outer packaging, it need

not appear on the surface of the product

or container, as long as the statement

also fulfills all other requirements of

this subpart. The warning statement

need not appear on such outer

packaging if either:

(1) the warning statement appears on

the surface of the product or container,

consistent with paragraph (a) of this

section, and is clearly legible and

conspicuous through any outer

packaging, wrapping or other covering

used in display; or

(2) the warning statement is placed in

a manner consistent with paragraph (c)

of this section.

(c) Alternative placement. The

warning statement may be placed on a

hang tag, tape, card, sticker, invoice, bill

of lading, supplemental printed

material, or similar overlabeling that is

securely attached to the container,

product, outer packaging or display

case, or accompanies the product

containing or manufactured with a

controlled substance or a container

containing class I or class II substances

through its sale to the consumer or

ultimate consumer. For prescription

medical products that have been found

to be essential for patient health by the

Food and Drug Administration, the

warning statement may be placed in

supplemental printed material intended

to be read by the prescribing physician,

as long as the following statement is

placed on the product, its packaging, or

supplemental printed material intended

to be read by the patient: ‘‘This product

contains [insert name of substance], a

substance which harms the environment

by depleting ozone in the upper

atmosphere.’’ In any case, the warning

statement must be clearly legible and

conspicuous at the time of the purchase.

(d) Products not viewed by the

purchaser at the time of purchase.

Where the purchaser of a product

cannot view a product, its packaging or

alternative labeling such that the

warning statement is clearly legible and

conspicuous at the time of purchase, as

specified under paragraphs (a), (b), or (c)

of this section, the warning statement

may be placed in the following manner:

(1) Where promotional printed

material is prepared for display or

distribution, the warning statement may

be placed on such promotional printed

material such that it is clearly legible

and conspicuous at the time of

purchase; or

(2) The warning statement may be

placed on the product, on its outer

packaging, or on alternative labeling,

consistent with paragraphs (a), (b), or (c)

of this section, such that the warning

statement is clearly legible and

conspicuous at the time of product

delivery, if the product may be returned

by the purchaser at or after the time of

delivery or if the purchase is not

complete until the time of delivery (e.g.,

products delivered C.O.D.).

§ 82.110 Form of label bearing warning

statement.

(a) Conspicuousness and contrast.

The warning statement shall appear in

conspicuous and legible type by

typography, layout, and color with other

printed matter on the label. The warning
Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations 4023

statement shall appear in sharp contrast

to any background upon which it

appears. Examples of combinations of

colors which may not satisfy the

proposed requirement for sharp contrast

are: black letters on a dark blue or dark

green background, dark red letters on a

light red background, light red letters on

a reflective silver background, and

white letters on a light gray or tan

background.

(b) Name of substance. The name of

the class I or class II substance to be

inserted into the warning statement

shall be the standard chemical name of

the substance as listed in 40 CFR part

82, appendix A to subpart A, except

that:

(1) The acronym ‘‘CFC’’ may be

substituted for ‘‘chlorofluorocarbon.’’

(2) The acronym ‘‘HCFC’’ may be

substituted for

‘‘hydrochlorofluorocarbon.’’

(3) The term ‘‘1,1,1-trichloroethane’’

may be substituted for ‘‘methyl

chloroform.’’

(c) Combined statement for multiple

class I substances. If a container

containing or a product contains or is

manufactured with, more than one class

I or class II substance, the warning

statement may include the names of all

of the substances in a single warning

statement, provided that the combined

statement clearly distinguishes which

substances the container or product

contains and which were used in the

manufacturing process.

(d) Format. (1) The warning statement

shall be blocked within a square or

rectangular area, with or without a

border. (2) The warning statement shall

appear in lines that are parallel to the

surrounding text on the product’s PDP,

display panel, supplemental printed

material or promotional printed

material.

(e) Type style. The ratio of the height

of a capital letter to its width shall be

such that the height of the letter is no

more than 3 times its width; the signal

word ‘‘WARNING’’ shall appear in all

capital letters.

(f) Type size. The warning statement

shall appear at least as large as the type

sizes prescribed by this paragraph. The

type size refers to the height of the

capital letters. A larger type size

materially enhances the legibility of the

statement and is desirable.

(1) Display panel or outer packaging.

Minimum type size requirements for the

warning statement are given in Table 1

to this paragraph and are based upon

the area of the display panel of the

product or container. Where the

statement is on outer packaging, as well

as the display panel area, the statement

shall appear in the same minimum type

size as on the display panel.

TABLE 1 TO § 82.110(f)(1)

Area of display panel (sq. in.)

0–2 >2–5 >5–10 >10–15 >15–30 >30

Type size (in.) 1

Signal word ...................................................................................... 3⁄64 1⁄16 3⁄32 7⁄64 1⁄8 5⁄32

Statement ......................................................................................... 3⁄64 3⁄64 1⁄16 3⁄32 3⁄32 7⁄64

>Means greater than.

1 Minimum height of printed image of letters.

(2) Alternative placement. The

minimum type size for the warning

statement on any alternative placement

which meets the requirements of

§ 82.108(c) is 3⁄32 inches for the signal

word and 1⁄16 of an inch for the

statement.

(3) Promotional printed material. The

minimum type size for the warning

statement on promotional printed

material is 3⁄32 inches for the signal

word and 1⁄16 of an inch for the

statement, or the type size of any

surrounding text, whichever is larger.

§ 82.112 Removal of label bearing warning

statement.

(a) Prohibition on removal. Except as

described in paragraph (b) or (c) of this

section, any warning statement that

accompanies a product or container

introduced into interstate commerce, as

required by this subpart, must remain

with the product or container and any

product incorporating such product or

container, up to and including the point

of sale to the ultimate consumer.

(b) Incorporation of warning

statement by subsequent manufacturers.

A manufacturer of a product that

incorporates a product that is

accompanied by a label bearing the

warning statement may remove such

label from the incorporated product if

the information on such label is

incorporated into a warning statement

accompanying the manufacturer’s

product, or if, pursuant to paragraph (c)

of this section, the manufacturer of the

product is not required to pass through

the information contained on or

incorporated in the product’s label.

(c) Manufacturers that incorporate

products manufactured with controlled

substances. A manufacturer that

incorporates into its own product a

component product that was purchased

from another manufacturer, was

manufactured with a process that uses

a controlled substance(s), but does not

contain such substance(s), may remove

such label from the incorporated

product and need not apply a warning

statement to its own product, if the

manufacturer does not use a controlled

substance in its own manufacturing

process. A manufacturer that uses

controlled substances in its own

manufacturing process, and is otherwise

subject to the regulations of this subpart,

must label pursuant to § 82.106, but

need not include information regrading

the incorporated product on the

required label.

(d) Manufacturers, distributors,

wholesalers, retailers that sell spare

parts manufactured with controlled

substances solely for repair.

Manufacturers, distributors,

wholesalers, and retailers that purchase

spare parts manufactured with a class I

substance from another manufacturer or

supplier, and sell such spare parts for

the sole purpose of repair, are not

required to pass through an applicable

warning label if such products are

removed from the original packaging

provided by the manufacturer from

whom the products are purchased.

Manufacturers of the spare parts

manufactured with controlled

substances must still label their

products; furthermore, manufacturers,

importers, and distributors of such

products must pass through the labeling

information as long as products remain

assembled and packaged in the manner

assembled and packaged by the original

manufacturer. This exemption shall not

apply if a spare part is later used for

manufacture and/or for purposes other

than repair.
4024 Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations

§ 82.114 Compliance by manufacturers

and importers with requirements for

labeling of containers of controlled

substances, or products containing

controlled substances.

(a) Compliance by manufacturers and

importers with requirements for labeling

of containers of controlled substances,

or products containing controlled

substances. Each manufacturer of a

product incorporating another product

or container containing a controlled

substance, to which § 82.102 (a)(1), or,

(a)(2) or (b)(1) applies, that is purchased

or obtained from another manufacturer

or supplier, is required to pass through

and incorporate the labeling information

that accompanies such incorporated

product in a warning statement

accompanying the manufacturer’s

finished product. Each importer of a

product, or container containing a

controlled substance, to which § 82.102

(a)(1), (a)(2), or (b)(1) applies, including

a component product or container

incorporated into the product, that is

purchased from a foreign manufacturer

or supplier, is required to apply a label,

or to ensure that a label has been

properly applied, at the site of U.S.

Customs clearance.

(b) Reliance on reasonable belief. The

manufacturer or importer of a product

that incorporates another product

container from another manufacturer or

supplier may rely on the labeling

information (or lack thereof) that it

receives with the product, and is not

required to independently investigate

whether the requirements of this

subpart are applicable to such

purchased product or container, as long

as the manufacturer reasonably believes

that the supplier or foreign

manufacturer is reliably and accurately

complying with the requirements of this

subpart.

(c) Contractual obligations. A

manufacturer’s or importer’s contractual

relationship with its supplier under

which the supplier is required to

accurately label, consistent with the

requirements of this subpart, any

products containing a controlled

substance or containers of a controlled

substance that are supplied to the

manufacturer or importer, is evidence of

reasonable belief.

§ 82.116 Compliance by manufacturers or

importers incorporating products

manufactured with controlled substances.

(a) Compliance by manufacturers or

importers incorporating products

manufactured with controlled

substances, or importing products

manufactured with controlled

substances. Each manufacturer or

importer of a product incorporating

another product to which § 82.102

(a)(3), or, (b)(2) applies, that is

purchased from another manufacturer or

supplier, is not required to pass through

and incorporate the labeling information

that accompanies such incorporated

product in a warning statement

accompanying the manufacturer’s or

importer’s finished product. Importers

of products to which § 82.102 (a)(3) or

(b)(2) applies are required to apply a

label, or to ensure that a label has been

properly applied at the site of U.S.

Customs clearance.

(b) Reliance on reasonable belief. The

importer of a product purchased or

obtained from a foreign manufacturer or

supplier, which product may have been

manufactured with a controlled

substance, may rely on the information

that it receives with the purchased

product, and is not required to

independently investigate whether the

requirements of this subpart are

applicable to the purchased or obtained

product, as long as the importer

reasonably believes that there was no

use of controlled substances by the final

manufacturer of the product being

imported.

(c) Contractual obligations. An

importer’s contractual relationship with

its supplier under which the supplier is

required to accurately label, consistent

with the requirements of this subpart,

any products manufactured with a

controlled substance that are supplied

to the importer, or to certify to the

importer whether a product was or was

not manufactured with a controlled

substance is evidence of reasonable

belief.

§ 82.118 Compliance by wholesalers,

distributors and retailers.

(a) Requirement of compliance by

wholesalers, distributors and retailers.

All wholesalers, distributors and

retailers of products or containers to

which this subpart applies are required

to pass through the labeling information

that accompanies the product, except

those purchasing from other

manufacturers or suppliers spare parts

manufactured with controlled

substances and selling those parts for

the demonstrable sole purpose of repair.

(b) Reliance on reasonable belief. The

wholesaler, distributor or retailer of a

product may rely on the labeling

information that it receives with the

product or container, and is not

required to independently investigate

whether the requirements of this

subpart are applicable to the product or

container, as long as the wholesaler,

distributor or retailer reasonably

believes that the supplier of the product

or container is reliably and accurately

complying with the requirements of this

subpart.

(c) Contractual obligations. A

wholesaler, distributor or retailer’s

contractual relationship with its

supplier under which the supplier is

required to accurately label, consistent

with the requirements of this subpart,

any products manufactured with a

controlled substance that are supplied

to the wholesaler, distributor or retailer

is evidence of reasonable belief.

§ 82.120 Petitions.

(a) Requirements for procedure and

timing. Persons seeking to apply the

requirements of this regulation to a

product containing a class II substance

or a product manufactured with a class

I or a class II substance which is not

otherwise subject to the requirements,

or to temporarily exempt a product

manufactured with a class I substance,

based on a showing of a lack of

currently or potentially available

alternatives, from the requirements of

this regulation may submit petitions to:

Labeling Program Manager,

Stratospheric Protection Division, Office

of Atmospheric Programs, U.S.

Environmental Protection Agency,

6202–J, 401 M Street, S.W., Washington,

D.C. 20460. Such persons must label

their products while such petitions are

under review by the Agency.

(b) Requirement for adequate data.

Any petition submitted under paragraph

(a) of this section shall be accompanied

by adequate data, as defined in

§ 82.120(c). If adequate data are not

included by the petitioner, the Agency

may return the petition and request

specific additional information.

(c) Adequate data. A petition shall be

considered by the Agency to be

supported by adequate data if it

includes all of the following:

(1) A part clearly labeled ‘‘Section

I.A.’’ which contains the petitioner’s full

name, company or organization name,

address and telephone number, the

product that is the subject of the

petition, and, in the case of a petition to

temporarily exempt a product

manufactured with a class I substance

from the labeling requirement, the

manufacturer or manufacturers of that

product.

(2) For petitions to temporarily

exempt a product manufactured with a

class I substance only, a part clearly

labeled ‘‘Section I.A.T.’’ which states

the length of time for which an

exemption is requested.

(3) A part clearly labeled ‘‘Section

I.B.’’ which includes the following

statement, signed by the petitioner or an

authorized representative:
Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations 4025

‘‘I certify under penalty of law that I

have personally examined and am

familiar with the information submitted

in this petition and all attached

documents, and that, based on my

inquiry of those individuals

immediately responsible for obtaining

the information, I believe that the

submitted information is true, accurate,

and complete. I am aware that there are

significant penalties for submitting false

information.’’

(4) A part clearly labeled ‘‘Section

I.C.’’ which fully explains the basis for

the petitioner’s request that EPA add the

labeling requirements to or remove them

from the product which is the subject of

the petition, based specifically upon the

technical facility or laboratory tests,

literature, or economic analysis

described in paragraphs (c) (5), (6) and

(7) of this section.

(5) A part clearly labeled ‘‘Section

II.A.’’ which fully describes any

technical facility or laboratory tests used

to support the petitioner’s claim.

(6) A part clearly labeled ‘‘Section

II.B.’’ which fully explains any values

taken from literature or estimated on the

basis of known information that are

used to support the petitioner’s claim.

(7) A part clearly labeled ‘‘Section

II.C.’’ which fully explains any

economic analysis used to support the

petitioner’s claim.

(d) Criteria for evaluating petitions.

Adequate data in support of any petition

to the Agency to add a product to the

labeling requirement or temporarily

remove a product from the labeling

requirement will be evaluated based

upon a showing of sufficient quality and

scope by the petitioner of whether there

are or are not substitute products or

manufacturing processes for such

product:

(1) That do not rely on the use of such

class I or class II substance;

(2) That reduce the overall risk to

human health and the environment; and

(3) That are currently or potentially

available.

(e) Procedure for acceptance or denial

of petition. (1) If a petition submitted

under this section contains adequate

data, as defined under paragraph (c) of

this section, the Agency shall within

180 days after receiving the complete

petition either accept the petition or

deny the petition.

(2) If the Agency makes a decision to

accept a petition to apply the

requirements of this regulation to a

product containing or manufactured

with a class II substance, the Agency

will notify the petitioner and publish a

proposed rule in the Federal Register to

apply the labeling requirements to the

product.

(3) If the Agency makes a decision to

deny a petition to apply the

requirements of this regulation to a

product containing or manufactured

with a class II substance, the Agency

will notify the petitioner and publish an

explanation of the petition denial in the

Federal Register.

(4) If the Agency makes a decision to

accept a petition to temporarily exempt

a product manufactured with a class I

substance from the requirements of this

regulation, the Agency will notify the

petitioner and publish a proposed rule

in the Federal Register to temporarily

exempt the product from the labeling

requirements. Upon notification by the

Agency, such manufacturer may

immediately cease its labeling process

for such exempted products.

(5) If the Agency makes a decision to

deny a petition to temporarily exempt a

product manufactured with a class I

substance from the requirements of this

regulation, the Agency will notify the

petitioner and may, in appropriate

circumstances, publish an explanation

of the petition denial in the Federal

Register.

§ 82.122 Certification, recordkeeping, and

notice requirements.

(a) Certification. (1) Persons claiming

the exemption provided in

§ 82.106(b)(2) must submit a written

certification to the following address:

Labeling Program Manager,

Stratospheric Protection Division, Office

of Atmospheric Programs, 6205–J, 401

M Street, S.W., Washington, D.C. 20460.

(2) The certification must contain the

following information:

(i) The exact location of documents

verifying calendar year 1990 usage and

the 95% reduced usage during a twelve

month period;

(ii) A description of the records

maintained at that location;

(iii) A description of the type of

system used to track usage;

(iv) An indication of which 12 month

period reflects the 95% reduced usage,

and;

(v) Name, address, and telephone

number of a contact person.

(3) Persons who submit certifications

postmarked on or before May 15, 1993,

need not place warning labels on their

products manufactured using CFC–113

or methyl chloroform as a solvent.

Persons who submit certifications

postmarked after May 15, 1993, must

label their products manufactured using

CFC–113 or methyl chloroform as a

solvent for 14 days following such

submittal of the certification.

(4) Persons certifying must also

include a statement that indicates their

future annual use will at no time exceed

5% of their 1990 usage.

(5) Certifications must be signed by

the owner or a responsible corporate

officer.

(6) If the Administrator determines

that a person’s certification is

incomplete or that information

supporting the exemption is inadequate,

then products manufactured using CFC–

113 or methyl chloroform as a solvent

by such person must be labeled

pursuant to § 82.106(a).

(b) Recordkeeping. Persons claiming

the exemption under section

82.106(b)(2) must retain supporting

documentation at one of their facilities.

(c) Notice Requirements. Persons who

claim an exemption under § 82.106(b)(2)

must submit a notice to the address in

paragraph (a)(1) of this section within

30 days of the end of any 12 month

period in which their usage of CFC–113

or methyl chloroform used as a solvent

exceeds the 95% reduction from

calendar year 1990.

§ 82.124 Prohibitions.

(a) Warning statement. (1) Absence or

presence of warning statement. (i)

Applicable May 15, 1993, except as

indicated in paragraph (a)(5) of this

section, no container or product

identified in § 82.102(a) may be

introduced into interstate commerce

unless it bears a warning statement that

complies with the requirements of

§ 82.106(a) of this subpart, unless such

labeling is not required under

§ 82.102(c), § 82.106(b), § 82.112 (c) or

(d), § 82.116(a), § 82.118(a), or

temporarily exempted pursuant to

§ 82.120.

(ii) On January 1, 2015, or any time

between May 15, 1993 and January 1,

2015 that the Administrator determines

for a particular product manufactured

with or containing a class II substance

that there are substitute products or

manufacturing processes for such

product that do not rely on the use of

a class I or class II substance, that

reduce the overall risk to human health

and the environment, and that are

currently or potentially available, no

product identified in § 82.102(b) may be

introduced into interstate commerce

unless it bears a warning statement that

complies with the requirements of

§ 82.106, unless such labeling is not

required under § 82.106(b), § 82.112 (c)

or (d), § 82.116(a) or § 82.118(a).

(2) Placement of warning statement.

(i) On May 15, 1993, except as indicated

in paragraph (a)(5) of this section, no

container or product identified in

§ 82.102(a) may be introduced into

interstate commerce unless it bears a

warning statement that complies with
4026 Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Rules and Regulations

the requirements of § 82.108 of this

subpart, unless such labeling is not

required under § 82.102(c), § 82.106(b),

§ 82.112 (c) or (d), § 82.116(a),

§ 82.118(a), or temporarily exempted

pursuant to § 82.120.

(ii) On January 1, 2015, or any time

between May 15, 1993 and January 1,

2015 that the Administrator determines

for a particular product manufactured

with or containing a class II substance

that there are substitute products or

manufacturing processes for such

product that do not rely on the use of

a class I or class II substance, that

reduce the overall risk to human health

and the environment, and that are

currently or potentially available, no

product identified in § 82.102(b) may be

introduced into interstate commerce

unless it bears a warning statement that

complies with the requirements of

§ 82.108 of this subpart, unless such

labeling is not required under

§ 82.106(b), § 82.112 (c) or (d),

§ 82.116(a) or § 82.118(a).

(3) Form of label bearing warning

statement. (i) Applicable May 15, 1993,

except as indicated in paragraph (a)(5)

of this section, no container or product

identified in § 82.102(a) may be

introduced into interstate commerce

unless it bears a warning statement that

complies with the requirements of

§ 82.110, unless such labeling is not

required pursuant to § 82.102(c),

§ 82.106(b), § 82.112 (c) or (d),

§ 82.116(a), § 82.118(a), or temporarily

exempted pursuant to § 82.120.

(ii) On January 1, 2015, or any time

between May 15, 1993 and January 1,

2015 that the Agency determines for a

particular product manufactured with or

containing a class II substance, that

there are substitute products or

manufacturing processes that do not

rely on the use of a class I or class II

substance, that reduce the overall risk to

human health and the environment, and

that are currently or potentially

available, no product identified in

§ 82.102(b) may be introduced into

interstate commerce unless it bears a

warning statement that complies with

the requirements of § 82.110, unless

such labeling is not required pursuant to

§ 82.106(b), § 82.112 (c) or (d),

§ 82.116(a), or § 82.118(a).

(4) On or after May 15, 1993, no

person may modify, remove or interfere

with any warning statement required by

this subpart, except as described in

§ 82.112.

(5) In the case of any substance

designated as a class I or class II

substance after February 11, 1993, the

prohibitions in paragraphs (a)(1)(i),

(a)(2)(i), and (a)(3)(i) of this section shall

be applicable one year after the

designation of such substance as a class

I or class II substance unless otherwise

specified in the designation.

[FR Doc. 95–343 Filed 1–18–95; 8:45 am]

BILLING CODE 6560–50–P