[Federal Register Volume 60, Number 12 (Thursday, January 19, 1995)]
[Rules and Regulations]
[Pages 4010-4026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-343]




[[Page 4009]]

_______________________________________________________________________

Part VI





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 82



Protection of Stratospheric Ozone; Labeling Supplemental Rulemaking; 
Final Rule

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

[[Page 4010]]


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 

[[Page 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 Ad-Hoc 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 above-mentioned 
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. 

[[Page 4012]]

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 

[[Page 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 Ad-Hoc 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'' 
(Sec. 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 

[[Page 4014]]
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 Sec. 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 

[[Page 4015]]
destruction technologies, which provides energy recovery as a by-
product 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 pass-through 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 

[[Page 4016]]
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 
pass-through 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 (Sec. 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 

[[Page 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 

[[Page 4018]]
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 Sec. 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 (Sec. 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 
Sec. 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'' 

[[Page 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 (Sec. 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 

[[Page 4020]]
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 Secs. 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


Sec. 82.100  Purpose.

    The purpose of this subpart is to require warning statements on 
containers of, and products containing or manufactured with, certain 
ozone-depleting substances, pursuant to section 611 of the Clean Air 
Act, as amended.


Sec. 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.


Sec. 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, Ad-Hoc 
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 

[[Page 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.


Sec. 82.106  Warning statement requirements.

    (a) Required warning statements. Unless otherwise exempted by this 
subpart, each container or product identified in Sec. 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 

[[Page 4022]]
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.


Sec. 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 
Sec. 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 Sec. 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.).


Sec. 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 

[[Page 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 Sec. 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 
Sec. 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.


Sec. 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 Sec. 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. 

[[Page 4024]]



Sec. 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 Sec. 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 
Sec. 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.


Sec. 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 Sec. 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 Sec. 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.


Sec. 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.


Sec. 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 Sec. 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: 

[[Page 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.


Sec. 82.122  Certification, recordkeeping, and notice requirements.

    (a) Certification. (1) Persons claiming the exemption provided in 
Sec. 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 
Sec. 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 
Sec. 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.


Sec. 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 
Sec. 82.102(a) may be introduced into interstate commerce unless it 
bears a warning statement that complies with the requirements of 
Sec. 82.106(a) of this subpart, unless such labeling is not required 
under Sec. 82.102(c), Sec. 82.106(b), Sec. 82.112 (c) or (d), 
Sec. 82.116(a), Sec. 82.118(a), or temporarily exempted pursuant to 
Sec. 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 
Sec. 82.102(b) may be introduced into interstate commerce unless it 
bears a warning statement that complies with the requirements of 
Sec. 82.106, unless such labeling is not required under Sec. 82.106(b), 
Sec. 82.112 (c) or (d), Sec. 82.116(a) or Sec. 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 Sec. 82.102(a) may be introduced into interstate commerce 
unless it bears a warning statement that complies with 

[[Page 4026]]
the requirements of Sec. 82.108 of this subpart, unless such labeling 
is not required under Sec. 82.102(c), Sec. 82.106(b), Sec. 82.112 (c) 
or (d), Sec. 82.116(a), Sec. 82.118(a), or temporarily exempted 
pursuant to Sec. 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 
Sec. 82.102(b) may be introduced into interstate commerce unless it 
bears a warning statement that complies with the requirements of 
Sec. 82.108 of this subpart, unless such labeling is not required under 
Sec. 82.106(b), Sec. 82.112 (c) or (d), Sec. 82.116(a) or 
Sec. 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 Sec. 82.102(a) may be introduced 
into interstate commerce unless it bears a warning statement that 
complies with the requirements of Sec. 82.110, unless such labeling is 
not required pursuant to Sec. 82.102(c), Sec. 82.106(b), Sec. 82.112 
(c) or (d), Sec. 82.116(a), Sec. 82.118(a), or temporarily exempted 
pursuant to Sec. 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 Sec. 82.102(b) may be introduced 
into interstate commerce unless it bears a warning statement that 
complies with the requirements of Sec. 82.110, unless such labeling is 
not required pursuant to Sec. 82.106(b), Sec. 82.112 (c) or (d), 
Sec. 82.116(a), or Sec. 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 Sec. 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