[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
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[[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.
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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
