Vol. 58 No. 249 Thursday, December 30, 1993 p 69568 (Proposed Rule
1/2029
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-4818-4]
Protection of Stratospheric Ozone; Labeling Supplemental Proposal
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking.
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SUMMARY: This document proposes to amend EPA's existing labeling
regulations by adding an exemption from the regulations where
destruction of controlled substances takes place, 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 proposing 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.
DATES: Written comments on this proposed rule must be received
on or before January 31, 1994, unless a public hearing is
requested.
In the case where a public hearing is requested, the public
hearing will be scheduled at 9 a.m. on January 14, 1994. Comments
must then be received on or before 30 days following the public
hearing. Any party requesting a public hearing must notify EPA
by 5 p.m. Eastern Standard Time on January 7, 1994. All requests
for and inquiries regarding a public hearing should be directed
to Sue Stendebach at 202/233-9117.
ADDRESSES: Comments on this proposed rulemaking should be submitted
(in duplicate if possible) to: 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 8:30 a.m. until 12 noon, and from 1:30
p.m. to 3 p.m., Monday through Friday. A reasonable fee may
be charged for copying docket materials. A hearing, if requested,
will be held at the EPA auditorium, 401 M Street, SW., Washington,
DC.
FOR FURTHER INFORMATION CONTACT: Sue Stendebach, 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. 202/233-9117.
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
Neshaps (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
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
IV. Labeling Requirements for Spare Parts to be Used Solely
for Repair
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. Additional Information
A. Executive Order 12866
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
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, as amended by the Clean Air Act Amendments of
1990 (CAA). 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 regulations provide an exemption for manufacturers that
have achieved a reduction in the total use of CFC-113 and/or
methyl chloroform (MCF) for products manufactured using those
substances as solvents by 95 percent as compared to their 1990
use levels. This provision is based on a 1991 United Nations
Environment Programme report, Solvents, Coatings and Adhesives.
EPA provided the exemption in order to compensate for the lack
of technically and economically viable substitutes for an estimated
5 percent of the uses of CFC-113 and MCF in the solvent sector.
In addition, this provision recognizes the early efforts by
those companies to attain a near elimination of such substances,
and to provide an incentive for other companies to strive towards
the same goal.
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.
The placement of the warning statement is explained in terms
of its conspicuousness and legibility, as well as ready
availability
to the actual person responsible for the purchase at the time
of purchase, or at the time of product delivery. The provision
for product delivery was added to the rule for products purchased
through the mail, by telephone, and where the consumer does
not view the product at the time of purchase. Other options
for placement discussed are the display panel area of a product,
alternative labeling such as hang tags, and supplemental printed
materials, all to be available to the consumer at the time of
purchase.
Products made for export are exempt from the final regulations
because such products primarily affect foreign commerce and
because the label on such a product will not be viewed by any
consumer until after it has left the jurisdiction of the Agency.
Moreover, such products would be put at a competitive disadvantage
in the world marketplace with the same products manufactured
in countries where there are no similar labeling requirements.
In contrast, imports are covered under the labeling
requirements.
The regulations require importers to ensure that a product is
properly labeled at the site of U.S. Customs clearance. The
importer must have a ``reasonable belief'' that the imports
are properly labeled or are not subject to the labeling
requirements.
Two options discussed in the preamble to the final rule for
demonstrating reasonable belief are to investigate at least
one step back into the manufacturing process of the import,
or to draft a contractual agreement with the importer's supplier
abroad, indicating that the import is/is not manufactured with,
or containing, controlled substances.
The final regulations exempt research and development (R&D)
activities from the labeling requirements, since the products
being developed are not being introduced into interstate commerce.
However, products that have completed the R&D process and are
then manufactured must be labeled when they are introduced into
interstate commerce.
Manufacturers were required to label their products containing
or manufactured with class I substances, and containers containing
class I or class II substances, beginning on May 15, 1993.
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 125 nations are now
Parties, requires that each nation that is a Party to it 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.
Liquid injection incinerators are typically single-chamber
units with waste burners. They may also include liquid injection
stages of a multiple-chamber incinerator. These incinerators
are used to destroy wastes with a low ash content and can be
used to destroy sludge, slurry, vapor, or combustible liquid.
Liquid wastes are burned in suspension after being injected
through burners and atomized to fine droplets.
A reactor cracking process uses a cylindrical graphite, water-
cooled reactor and an oxygen-hydrogen burner system. Since 1983,
this process has treated waste gases resulting from the production
of chlorofluorocarbons (CFCs). The gases are converted to
hydrofluoric
acid, hydrochloric acid, carbon dioxide, chlorine, and water.
The two acids are usable in-house and/or marketable, and the
chlorine is scrubbed, leaving only water vapor, oxygen, and
carbon dioxide as waste gases.
Gaseous/fume oxidation destroys waste vapor streams, most
often volatile organic compounds. A combustion temperature of
around 1100 degrees centigrade is needed to destroy most ozone-
depleting compounds. Acid gas scrubbers are required for
incineration
of halogenated waste vapors, such as those from controlled
substances.
Fume incinerators can be direct flame incinerators, consisting
of the combustion chamber and a burner, or recuperative fume
incinerators that use heat exchangers to preheat the waste vapor
feed stream or the combustion air. Fume incinerators are usually
found in chemical process or manufacturing plants.
Rotary kiln incinerators can handle a wide variety of both
solid and liquid wastes. Rotary kiln incinerators typically
have at least two combustion chambers, the afterburner ensuring
that complete combustion of exhaust gases takes place. Liquid
wastes can be fed either into the rotary kiln area or directly
into the afterburner chamber. If fed into the afterburner chamber,
the liquid is atomized in the burner or combustion zone.
Cement kilns, under proper operation, can destroy most organic
chemical wastes. Tests have been conducted using CFC-113, with
a destruction efficiency of greater than 99.99 percent
demonstrated.
Destruction of ozone-depleting substances in cement kilns appears
beneficial; however, each unit must be reviewed on a case-by-
case basis to determine its appropriateness for this use.
With the approval of these 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 proposed
accelerated phaseout rule that was published on March 18, 1993
(57 FR 33754).
B. Phaseout Regulations
On July 30, 1992, the EPA published final regulations
implementing
section 604 of the Clean Air Act (57 FR 33753), which established
the phaseout schedule for class I and class II substances set
forth in the Clean Air Act. Destruction was also addressed in
the regulations in terms of those class I substances that are
coincidental and unavoidable by-products (CUBPs) of a manufacturing
process. Associated with this exemption is a set of reporting
requirements. Companies are required to document the amount
of ``CUBPs'' produced and destroyed in a manner consistent with
the requirements of the Resource Conservation and Recovery Act
(RCRA) or other applicable rules. These destruction technologies
are also required to meet the Maximum Available Control Technology
(MACT) standards for efficiency. For purposes of Title VI of
the Act, EPA stated that companies that destroy CUBPs of carbon
tetrachloride using technologies that achieve a 99.99 percent
destruction efficiency may obtain an exemption from production
allowances. Based on a report submitted by a company destroying
CUBPs, the Administrator would evaluate the merits of the document
and decide whether to grant an exemption for that company's
annual production and consumption allowances.
The phaseout regulations reported that further data was
necessary
on destruction technologies in order to exempt more than CUBPs
from the phaseout allowance system. Since the Parties approved
the five destruction technologies in November 1992, EPA has
proposed regulations accelerating the phaseout of controlled
substances (58 FR 15013, March 18, 1993). That proposal also
contained proposed regulations concerning destruction.
C. Proposed Accelerated Phaseout Destruction Provisions
The proposed accelerated phaseout regulations, published
on March 18, 1993, would 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 NPRM EPA proposed revising the definition
of production such that controlled substances that are to be
destroyed are eliminated from the definition of production and
credit is allowed for destruction of controlled substances similar
to credit received for the transformation of such chemicals.
The destruction of such substances must employ any one of the
five technologies identified above that are approved by the
Parties. Due to the proposed credit for destruction, EPA proposed
eliminating the now unnecessary CUBP provision, since all such
destruction would be credited.
The proposal 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
proposal indicated 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 March 18, 1993 proposal, 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.
D. 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 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 has 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.
E. Related Requirements of RCRA and the Proposed Hazardous Organic
Neshaps (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 would be regulated
under the proposed Hazardous Organic NESHAPs (HON, 57 FR 62608
). The RCRA regulations would cover those controlled substances
that are considered to be hazardous constituents in the waste
stream (eg., carbon tetrachloride bound for incineration). The
proposed 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 proposed HON regulations and
the proposed destruction exemption provision of the labeling
regulations.
1. Resource Conservation and Recovery Act (RCRA) Standards
The RCRA regulations currently require that industries that
incinerate waste covered by the regulations must meet ``at stacks''
destruction efficiency (DE) standards of 99.99 percent. The
proposed accelerated phaseout regulations would grant full credit
for the destruction of controlled substances when they are
destroyed
in compliance with RCRA regulations 40 CFR 343(a) and 40 CFR
266.104. The proposed accelerated phaseout rule indicated that
the Agency will grant 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. Proposed Hazardous Organic NESHAP (HON) Regulations
Under some situations controlled substances are not covered
by RCRA regulations, but may be covered by the HON regulations
to be promulgated under section 112 of the Clean Air Act. The
Agency published a proposed HON rule on December 31, 1992 (57
FR 62608), proposing that companies be required to control air
emissions occurring in chemical manufacturing processes. The
HON regulates approximately 400 manufacturing processes associated
with the Synthetic Organic Manufacturing Industry (SOCMI), as
well as 7 non-SOCMI source categories. Section 112 of the Clean
Air Act contains lists of 189 hazardous air pollutants (HAPS)
of which a 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 (proposed to
be 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 proposed that each emissions
source would require a ``reference control technology'' with
specific applicability criteria, such as a 98 percent control
efficiency for incinerators on process vents. The HON would
establish performance standards for operating the control
technologies,
as well as criteria for the design of the control equipment.
The Agency proposed 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 proposed that such incinerators may operate with a destruction
efficiency of 98 percent.
In the proposal for the accelerated phaseout, the Agency
proposed 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 would
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 what the HON proposes, the Agency proposed
to issue allowances only for the portion actually destroyed.
F. Proposed Amendments to the Final Labeling Regulations-Products
Exempt from Labeling Requirements Where Manufacturers Use Protocol
approved Destruction Technologies
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 current labeling regulations 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 today is proposing 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 intent of today's proposal is to provide a
destruction exemption parallel to the destruction provision
in the accelerated phaseout proposal. If the destruction provision
in the final accelerated phaseout differs substantially from
that which is proposed, EPA will need to revisit the destruction
exemption proposed today in order to maintain consistency between
the rules.
For purposes of today's proposed destruction exemption from
the labeling requirements, the Agency proposes that only where
a substance is destroyed to a DE of 98 percent or greater, using
one of the five approved destruction technologies, will the
labeling exemption apply. This differs from the approach used
in the accelerated phaseout proposal, under which producers
of controlled substances are granted credit for that percentage
of the controlled substance actually destroyed (if destroyed
at a DE of less than 98 percent). This approach is not being
used in the labeling context because, while under the proposed
accelerated phaseout it is possible to grant credit for that
portion actually destroyed, under the labeling rule a label
is either placed on a product or it is not. Therefore, the Agency
needs to determine a threshold at which labeling is exempted.
It is consistent then, for EPA to provide a labeling exemption
only for those products manufactured with controlled substances
that are ``completely'' destroyed. A new definition of ``completely
destroy,'' which means to destroy to 98 percent or greater
destruction
efficiency, will be included in the labeling rule through today's
proposed amendment.
Furthermore, 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
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.
If the final HON requires a destruction efficiency of greater
than 98 percent, EPA will need to revisit the minimum destruction
efficiency of 98 percent in today's proposed rule, in order
to provide consistency with the regulation of hazardous air
pollutants.
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 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 in order to qualify for the destruction exemption.
Those companies that are not covered by either RCRA regulations
or the HON, and are not otherwise covered by state or local
laws more stringent than the comparable Federal regulations,
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 Agency requests comment on its proposal to require companies
that are neither regulated by RCRA nor the HON to adhere to
the performance standards of the UNEP report of the Ad-Hoc
Technical
Advisory Committee on ODS Destruction Technologies, while meeting
a destruction efficiency of 98 percent or greater, in order
to obtain an exemption from the labeling requirements.
The regulatory language of this rulemaking requires that
parties taking advantage of this destruction exemption must
be in compliance with regulations and requirements applicable
to such destruction.
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, this 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, EPA
proposed in the accelerated phaseout regulations (58 FR 15013),
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.
EPA requests comment on its requirement that records maintained
under the phaseout regulations, as well as those maintained
under other applicable regulations be made available to the
Agency in determining eligibility for the labeling exemption.
The Agency also requests comment as to the adequacy of these
recordkeeping requirements for purposes of this proposal. Comments
on the possibility that a facility taking advantage of this
destruction exemption may not be covered by RCRA regulations,
the HON, or the accelerated phaseout of ozone-depleting substances
rule are also requested.
EPA also requests comment generally on the destruction exemption
from the labeling requirements. EPA will reopen the comment
period if the final accelerated phaseout rule changes materially
from the proposal relative to destruction.
III. Labeling Requirements of Containers of Waste
A. Current 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 its current rule, EPA also requires 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 to be labeled upon
their introduction into interstate commerce.
The Agency did not require that empty containers that once
contained a controlled substance and are subsequently recycled
and incorporated into another product bear a label. EPA also
permits 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 would
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. Today's Proposal Regarding Labeling Requirements of Containers
of Regulated Waste
Since the publication of the final regulations, EPA has received
new information from the regulated community regarding the labeling
requirements for containers of waste. The Agency required labeling
of waste in the final rule because it believed that the labeling
information is important to waste handlers and recycling and
reclamation facilities. In addition, by requiring waste to be
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 current rule states that all amounts, including trace
quantities
of controlled substances in waste, trigger the labeling
requirements.
The regulated community has commented to EPA, addressing both
the final rule and applicability determinations prepared by
EPA on labeling of waste.
After reviewing many of the comments urging EPA to reconsider
its policy on the labeling of waste, EPA agrees that a revision
is necessary to its current position on labeling waste containing
controlled substances, in order to better facilitate industry's
compliance with the regulations. Written comments on the Agency's
treatment of waste and the relevant applicability determinations
are available in the Air Docket A-91-60. These comments are
summarized below.
Numerous commenters stated that waste clearly does not fall
under the definition of ``product containing,'' as promulgated
in the final labeling rule; therefore, commenters concluded
that waste cannot be required to be labeled as such. EPA agrees.
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.
Others commented that a container of waste does not fit the
definition of ``container containing'' in the regulations. For
example, commenters expressed concern that in the current rule,
a container, such as a bulk waste receptacle that holds a used
``product containing'' (i.e., an aerosol or scrap material),
might require labeling. However, EPA believes that the controlled
substance remaining in the product contained in the receptacle
no longer serves a function, nor is it required to be transferred
to another container in order to realize its intended use, as
would normally be the case for ``containers containing.'' EPA
agrees that a container 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.''
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 is proposing 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 would not be required to
be labeled under this proposal.
EPA does believe, however, that containers of 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, these containers trigger
labeling and are not proposed 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 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.
Furthermore, the Agency believes that there is not a significant
environmental benefit associated with labeling wastes of controlled
substances. The final 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.
Because of the demand for and the high cost of controlled
substances, EPA further believes that those using controlled
substances will recycle or reclaim rather than to 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. Additionally, no non-containerized liquid wastes can
be placed in landfills.
The section 608 regulation mentioned above specifically
addresses
disposal of appliances containing refrigerants; compliance will
be monitored via a variety of provisions in section 608. The
proposed accelerated phaseout rule refers to the use of destruction
technologies approved by the Parties to the Montreal Protocol
in granting an exemption to the allowance program for production
and consumption. Today's proposed amendment specifies that those
persons using a controlled substance in their manufacturing
process, but then destroying that substance using one of the
five approved technologies, are exempt from labeling the product
manufactured with the destroyed controlled substance. In both
proposed rules, the actual disposal or destruction would not
be regulated.
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.
Consequently, EPA proposes to add a new 82.106(b)(3), which
provides exemptions from the labeling requirements, to include,
``Waste containing 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. In order to provide clarity, EPA
also proposes a definition of ``waste'' for purposes of this
rulemaking, which would mean, ``items or substances that are
discarded with the intent that such items or substances will
serve no further useful purpose.'' EPA requests comment on its
proposal to exempt waste from the labeling requirements.
IV. Labeling Requirements for Spare Parts To Be Used Solely
for Repair
Section 82.116 of the current labeling regulations exempts
manufacturers who incorporate another product, manufactured
with a class I substance and purchased from another manufacturer
or supplier, from having to pass through the label from the
incorporated product to the final product. Section 82.118 goes
on to state, however, that distributors, wholesalers, and retailers
of labeled products are required to pass through the labeling
information. The current labeling requirements provide an exemption
from labeling when repairs are made using components manufactured
with a controlled substance or using a controlled substance
in the repair itself. In an applicability determination made
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.
Subsequent to promulgation, the Agency has received new
information
regarding spare parts that are intended for repair purposes
only. Evidently, many companies have up to several million spare
parts in inventory that are purchased from vendors, and then
sold piecemeal to persons who repair the original product. 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 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 is today proposing
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.
EPA requests comments on its proposal to exempt from the
label pass-through requirement those spare parts that are to
be used for repair purposes.
V. Clarification of the Meaning of Products ``Manufactured With''
The final rule discusses 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 the 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 ``manufactured
with'' a controlled substance?
The final rule states that a controlled substance that is
inadvertently produced or remaining 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 as a result of 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 is proposing
to revise the definition of ``manufactured with''. The final
regulations currently state 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.'' To further clarify
that trace quantities may actually be contained in a product
manufactured with a controlled substance, EPA proposes to revise
the definition of ``manufactured with,'' to state that a product
``does not contain more than trace quantities of the controlled
substance * * *.'' Comment on this proposed revision is requested.
VI. Exemption for Trace Quantities
While the final labeling rule discussed the applicability
of the labeling requirements for products containing trace
quantities
of controlled substances, some confusion over when labeling
is required for such products has also arisen since the publication
of the final rule.
The regulatory text in 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 * * *.'' 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 proposes to amend 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 substances.
There has also been 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.
Consequently, EPA is today proposing to revise its regulations
to make clear that containers containing trace quantities of
controlled substances do not have to be labeled. EPA proposes
to add a new 82.106(b)(2) stating that containers containing
trace quantities of a controlled substance, which remain as
a residue or impurity, are exempt from the labeling requirements,
and requests relevant comment.
VII. Labeling Requirements of Containers of 55 Gallons and Smaller
Containing Controlled Substances
The final labeling regulations indicate 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.
Today, EPA proposes that supplemental printed material may
also be used to convey the warning statement for containers
that are 55 gallons and smaller. Since the publication of the
regulations, numerous commenters have indicated that bulk shipments
of 55 gallon drum containers are often documented in various
printed materials, such as the RCRA Manifest or a Land Disposal
Restriction Form which companies are required to develop under
the RCRA Land Disposal Restrictions Program. Such a form tracks
waste codes that EPA developed specifically for that program.
EPA agrees that shipments of containers of 55 gallons or smaller
containing bulk quantities of controlled substances or waste
containers of controlled substances may be labeled on supplemental
printed material as an alternative to the direct labeling of
individual containers, as long as the warning statement is clearly
legible and conspicuous in such materials and the materials
accompany the containers or are available to the consumer/waste
recipient at the time of purchase. Consequently, EPA is revising
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.
EPA requests comment on its proposal to allow alternative placement
of warning statements on 55 gallon or smaller containers.
VIII. Definition of Importer
For purposes of section 611, EPA today clarifies that importers
of ``products manufactured with controlled substances'' are
included in the definition of ``importer.'' While the intent
of the section 611 regulations was to cover imports of products
manufactured with class I substances, the current definition
does 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.''
IX. Certification Requirements for Reduced Use Exemption
In 82.122, EPA stated 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 proposes to correct this section of the regulations to
state that a company must certify to EPA that its future use
will not exceed 5 percent of its 1990 usage without notifying
the Agency. Such notification would immediately result in labeling
of the company's products. This subpart ( 82.122 (a)(4)) would
thus read: ``Persons certifying must also include a statement
that indicates their future annual use will at no time exceed
5 percent of their 1990 usage.''
X. Imports and Products Introduced In Bond at the U.S./Mexico
Border
The final 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.
Today, EPA proposes 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 final 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 in today's proposal somewhat different
from that in the current 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 section 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
proposes to strike from the definition of ``import'' in 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.
In addition, EPA notes that the preamble to the final 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. Similarly, the preamble to
the final rule states 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 requests
comments on these corrections.
XI. Incidental Uses of Controlled Substances
In the final regulations, the definition of ``manufactured
with'' excludes the use of a controlled substance ``[W]here
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 today also proposes to except in the regulatory text
intermittent
uses of controlled substances which may involve an initial contact
with the product itself, as well as with the equipment. Thus
the exception shall 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 requests any comments in this
regard.
XII. Request for Comments Regarding Plasma Etching
In the preamble of the final 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. Therefore, plasma
etching in general may not fall under the definition of
``transformation''
in the final labeling rule.
Consequently, EPA requests comments on the whether plasma
etching can be considered generally to constitute transformation
under the final labeling rule definition, which states, ``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.''
XIII. Additional Information
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1994),
the Agency must determine whether the 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 entitlements,
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.
EPA has determined that this rule is not ``significant''
under the terms of Executive Order 12866; however, OMB requested
the opportunity to review the proposal. The Agency prepared
an analysis to assess the impact of the final labeling regulations
promulgated on February 11, 1993 (see Regulatory Impact Analysis
of the Rule Requiring Labeling of Products Containing or
Manufactured
With Ozone Depleting Substances, January 1993) which is available
for review in the docket for the final labeling rule. This
supplemental
proposal does not impose any additional burdens as defined by
E.O. 12866.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act, 5 U.S.C. 601-612, 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).
The Agency prepared a regulatory flexibility analysis, as
part of the overall regulatory impact analysis (see p.40 of
Regulatory Impact Analysis of the Rule Requiring Labeling of
Products Containing or Manufactured With Ozone Depleting
Substances,
January 1993) for the February 11, 1993, regulations that these
proposed regulations supplement. No additional RFA need be prepared
for this proposal because the details of this amendment did
not alter the original analysis.
C. Paperwork Reduction Act
An information collection request was prepared by EPA (ICR
No. 2060-0259) for the February 11, 1993, final rule. The contents
of this amendment do not alter that analysis. A copy of the
ICR may be obtained by writing to the Information Policy Branch
(PM-223), U.S. EPA, 401 M Street, SW., Washington, DC 20460
or by calling (202) 260-2740.
List of Subjects for 40 CFR Part 82
Environmental protection, Air pollution control, Chemicals,
Chlorofluorocarbons, Destruction, Exports, Imports, Interstate
commerce, Pass-through requirement, Reporting and recordkeeping
requirements, Stratospheric ozone layer.
Dated: December 17, 1993.
Carol Browner,
Administrator.
Title 40, Code of Federal Regulations, part 82, is proposed
to be 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. 7601; 42 U.S.C. 7671-7671(q).
2. Subpart E, 40 CFR 82.100-82.124, 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.
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.
82.102 Applicability.
(a) In the case of substances designated as class I or class
II substances as of February 11, 1993, the effective date of
the requirements in this paragraph is May 15, 1993. In the case
of any substance designated as a class I or class II substance
after February 11, 1993, the effective date of the requirements
in this paragraph of this section is either one year after the
effective date of such designation or the date provided in the
rulemaking designating such substance as a class I or class
II substance, whichever comes first. On the effective date
indicated
in this paragraph, 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) Effective January 1, 2015 in any case, or one year after
any determination between May 15, 1993 and January 1, 2015,
by the Administrator for a particular product that there are
substitute products or manufacturing processes for such product
that do not rely on the use of a class I or class II substance,
that reduce the overall risk to human health and the environment,
and that are currently or potentially available, the requirements
of this subpart shall apply to the following:
(1) All products containing a class II substance.
(2) All products manufactured with a process that uses a
class II substance.
(c) The requirements of this subpart shall not apply to products
manufactured prior to May 15, 1993, provided that the manufacturer
submits documentation to EPA upon request showing that the product
was manufactured prior to that date.
82.104 Definitions.
(a) Class I substance means any substance designated as class
I in 40 CFR part 82, appendix A to subpart A, including
chlorofluorocarbons,
halons, carbon tetrachloride and methyl chloroform and any other
substance so designated by the Agency at a later date.
(b) Class II substance means any substance designated as
class II in 40 CFR part 82, appendix A to subpart A, including
hydrochlorofluorocarbons and any other substance so designated
by the Agency at a later date.
(c) Completely destroy means to cause the expiration 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 state and 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:
(1) Liquid injection incineration;
(2) Reactor cracking;
(3) Gaseous/fume oxidation;
(4) Rotary kiln incineration; or
(5) Cement kiln.
in a manner that complies at a minimum with the ``Code of Good
Housekeeping'' of Chapter 5.5 of the 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.
(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 with
or containing class I or class II 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; or
(2) Where the manufacturing equipment or the product has
had physical contact with a controlled substance in an intermittent
manner, not as a routine part of the direct manufacturing process;
(3) Where the controlled substance has been transformed,
except for trace quantities; or
(4) Where the controlled substance has been completely
destroyed.
(p) Potentially available means that adequate information
exists to make a determination that the substitute is
technologically
feasible, environmentally acceptable and economically viable.
(q) Principal display panel (PDP) means the entire portion
of the surface of a product, container or its outer packaging
that is most likely to be displayed, shown, presented, or examined
under customary conditions of retail sale. The area of the PDP
is not limited to the portion of the surface covered with existing
labeling; rather it includes the entire surface, excluding flanges,
shoulders, handles, or necks.
(r) Product means an item or category of items manufactured
from raw or recycled materials, or other products, which is
used to perform a function or task.
(s) Product containing means a product including, but not
limited to, containers, vessels, or pieces of equipment, that
physically holds a controlled substance at the point of sale
to the ultimate consumer which remains within the product.
(t) Promotional printed material means any informational
or advertising material (including, but not limited to, written
advertisements, brochures, circulars, desk references and fact
sheets) that is prepared by the manufacturer for display or
promotion concerning a product or container, and that does not
accompany the product to the consumer.
(u) Retailer means a person to whom a product is delivered
or sold, if such delivery or sale is for purposes of sale or
distribution in commerce to consumers who buy such product for
purposes other than resale.
(v) Spare parts means those parts that are supplied by a
manufacturer to another manufacturer, distributor, or retailer,
for purposes of replacing similar parts with such parts in the
repair of a product.
(w) Supplemental printed material means any informational
material (including, but not limited to, package inserts, fact
sheets, invoices, material safety data sheets, procurement and
specification sheets, or other material) which accompanies a
product or container to the consumer at the time of purchase.
(x) Transform means to use and entirely consume a class I
or class II substance, except for trace quantities, by changing
it into one or more substances not subject to this subpart in
the manufacturing process of a product or chemical.
(y) Type size means the actual height of the printed image
of each capital letter as it appears on a label.
(z) Ultimate consumer means the first commercial or
non-commercial
purchaser of a container or product that is not intended for
re-introduction into interstate commerce as a final product
or as part of another product.
(aa) Warning label means the warning statement required by
section 611 of the Act. The term warning statement shall be
synonymous with warning label for purposes of this subpart.
(bb) Waste means, for purposes of this subpart, items or
substances that are discarded with the intent that such items
or substances will serve no further useful purpose.
(cc) Wholesaler means a person to whom a product is delivered
or sold, if such delivery or sale is for purposes of sale or
distribution to retailers who buy such product for purposes
of resale.
82.106 Warning statement requirements.
(a) Required warning statements. Unless otherwise exempted
by this subpart, each container or product identified in 82.102(a)
or (b) shall bear the following warning statement, meeting the
requirements of this subpart for placement and form:
WARNING: Contains [or Manufactured with, if applicable] [insert
name of substance], a substance which harms public health and
environment by destroying ozone in the upper atmosphere.
(b) Exemptions from warning label requirement. The following
products need not bear a warning label:
(1) Products containing trace quantities of a controlled
substance remaining as a residue or impurity due to a chemical
reaction, and where the controlled substance serves no useful
purpose in or for the product itself. However, if such product
was manufactured using the controlled substance, the product
is required to be labeled as a ``product manufactured with''
the controlled substance, unless otherwise exempted.
(2) Containers containing a controlled substance in which
trace quantities of that controlled substance remain as a residue
or impurity.
(3) Waste containing controlled substances or blends of
controlled
substances bound for discard.
(4) Products manufactured using methyl chloroform or CFC-
113 by persons who can demonstrate and certify a 95% reduction
in overall usage from their 1990 calendar year usage of methyl
chloroform or CFC-113 as solvents during a twelve (12) month
period ending within sixty (60) days of such certification or
during the most recently completed calendar year. In calculating
such reduction, persons may subtract from quantities used those
quantities for which they possess accessible data that establishes
the amount of methyl chloroform or CFC-113 transformed. Such
subtraction must be performed for both the applicable twelve
month period and the 1990 calendar year. If at any time future
usage exceeds the 95% reduction, all products manufactured with
methyl chloroform or CFC-113 as solvents by that person must
be labeled immediately. No person may qualify for this exemption
after May 15, 1994.
(5) Products intended only for export outside of the United
States shall not be considered ``products introduced into
interstate
commerce'' provided such products are clearly designated as
intended for export only.
(6) Products that are otherwise not subject to the requirements
of this subpart that are being repaired, using a process that
uses a controlled substance.
(7) Products, processes, or substitute chemicals undergoing
research and development, by which a controlled substance is
used. Such products must be labeled when they are introduced
into interstate commerce.
(c) Interference with other required labeling information.
The warning statement shall not interfere with, detract from,
or mar any labeling information required on the labeling by
federal or state law.
82.108 Placement of warning statement.
The warning statement shall be placed so as to satisfy the
requirement of the Act that the warning statement be ``clearly
legible and conspicuous.'' The warning statement is clearly
legible and conspicuous if it appears with such prominence and
conspicuousness as to render it likely to be read and understood
by consumers under normal conditions of purchase. Such placement
includes, but is not limited to, the following:
(a) Display panel placement. For any affected product or
container that has a display panel that is normally viewed by
the purchaser at the time of the purchase, the warning statement
described in 82.106 may appear on any such display panel of
the affected product or container such that it is ``clearly
legible and conspicuous'' at the time of the purchase. If the
warning statement appears on the principal display panel or
outer packaging of any such affected product or container, the
warning statement shall qualify as ``clearly legible and
conspicuous,''
as long as the label also fulfills all other requirements of
this subpart and is not obscured by any outer packaging, as
required by paragraph (b) of this section. The warning statement
need not appear on such display panel if either:
(1) The warning statement appears on the outer packaging
of the product or container, consistent with paragraph (b) of
this section, and is clearly legible and conspicuous; or
(2) The warning statement is placed in a manner consistent
with paragraph (c) of this section.
(b) Outer packaging. If the product or container is normally
packaged, wrapped, or otherwise covered when viewed by the
purchaser
at the time of the purchase the warning statement described
in 82.106 shall appear on any outer packaging, wrapping or
other covering used in the retail display of the product or
container, such that the warning statement is clearly legible
and conspicuous at the time of the purchase. If the outer packaging
has a display panel that is normally viewed by the purchaser
at the time of the purchase, the warning statement shall appear
on such display panel. If the warning statement so appears on
such product's or container's outer packaging, it need not appear
on the surface of the product or container, as long as the
statement
also fulfills all other requirements of this subpart. The warning
statement need not appear on such outer packaging if either:
(1) The warning statement appears on the surface of the product
or container, consistent with paragraph (a) of this section,
and is clearly legible and conspicuous through any outer packaging,
wrapping or other covering used in display; or
(2) The warning statement is placed in a manner consistent
with paragraph (c) of this section.
(c) Alternative placement. The warning statement may be placed
on a hang tag, tape, card, sticker, invoice, bill of lading,
supplemental printed material, or similar overlabeling that
is securely attached to the container, product, outer packaging
or display case, or accompanies the product containing or
manufactured
with a controlled substance or a container containing class
I or class II substances through its sale to the consumer or
ultimate consumer. For prescription medical products that have
been found to be essential for patient health by the Food and
Drug Administration, the warning statement may be placed in
supplemental printed material intended to be read by the
prescribing
physician, as long as the following statement is placed on the
product, its packaging, or supplemental printed material intended
to be read by the patient: ``This product contains [insert name
of substance], a substance which harms the environment by depleting
ozone in the upper atmosphere.'' In any case, the warning statement
must be clearly legible and conspicuous at the time of the
purchase.
(d) Products not viewed by the purchaser at the time of
purchase.
Where the purchaser of a product cannot view a product, its
packaging or alternative labeling such that the warning statement
is clearly legible and conspicuous at the time of purchase,
as specified under paragraph (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 paragraph (a), (b), or (c) of this section, such that the
warning statement is clearly legible and conspicuous at the
time of product delivery, if the product may be returned by
the purchaser at or after the time of delivery or if the purchase
is not complete until the time of delivery (e.g., products
delivered
C.O.D.).
82.110 Form of label bearing warning statement.
(a) Conspicuousness and contrast. (1) The warning statement
shall appear in conspicuous and legible type by typography,
layout, and color with other printed matter on the label.
(2) The warning 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 and are based
upon the area of the display panel of the product or container.
Where the statement is on the 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
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÂÄÄÄÄÄÄÄÄÄÂÄÄÄÄÄÄÄÄÄÂÄÄÄÄÄÄÄÄÄÂÄÄÄÄÄÄÄÄÄÂÄÄÄÄÄÄÄÄÄÂÄÄÄÄÄÄÄÄÄÄÄ
³ ³ ³
³ ³ ³
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÅÄÄÄÄÄÄÄÄÄÅÄÄÄÄÄÄÄÄÄÅÄÄÄÄÄÄÄÄÄÅÄÄÄÄÄÄÄÄÄÅÄÄÄÄÄÄÄÄÄÅÄÄÄÄÄÄÄÄÄÄÄ
³ ³ ³
³ ³ ³
Area of Display ³ 0-2 ³ >2-5 ³
>5-10 ³ >10-15 ³ >15-30 ³ >30
Panel (sq. in.). ³ ³ ³
³ ³ ³
Type size (in.)* ³ ³ ³
³ ³ ³
Signal word .... ³ 3/64 ³ 1/16 ³ 3/32
³ 7/64 ³ 1/8 ³ 5/32
Statement ...... ³ 3/64 ³ 3/64 ³ 1/16
³ 3/32 ³ 3/32 ³ 7/64
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÁÄÄÄÄÄÄÄÄÄÁÄÄÄÄÄÄÄÄÄÁÄÄÄÄÄÄÄÄÄÁÄÄÄÄÄÄÄÄÄÁÄÄÄÄÄÄÄÄÄÁÄÄÄÄÄÄÄÄÄÄÄ
> Means greater than.
* Minimum height of printed image of letters.
(2) Alternative placement. The minimum type size for the
warning statement on any alternative placement which meets the
requirements of 82.108(c) is 3/32 inches for the signal word
and 1/16 of an inch for the statement.
(3) Promotional printed material. The minimum type size for
the warning statement on promotional printed material is 3/32
inches for the signal word and 1/16 of an inch for the statement,
or the type size of any surrounding text, whichever is larger.
82.112 Removal of label bearing warning statement.
(a) Prohibition on removal. Except as described in paragraph
(b) or (c) of this section, any warning statement that accompanies
a product or container introduced into interstate commerce,
as required by this subpart, must remain with the product or
container and any product incorporating such product or container,
up to and including the point of sale to the ultimate consumer.
(b) Incorporation of warning statement by subsequent
manufacturers.
A manufacturer of a product that incorporates a product that
is accompanied by a label bearing the warning statement may
remove such label from the incorporated product if the information
on such label is incorporated into a warning statement accompanying
the manufacturer's product, or if, pursuant to paragraph (c)
of this section, the manufacturer of the product is not required
to pass through the information contained on or incorporated
in the product's label.
(c) Manufacturers that incorporate products manufactured
with controlled substances. A manufacturer that incorporates
into its own product a component product that: (1) Was purchased
from another manufacturer, (2) was manufactured with a process
that uses a controlled substance(s), but (3) does not contain
such substance(s), may remove such label from the incorporated
product and need not apply a warning statement to its own product,
if the manufacturer does not use a controlled substance in its
own manufacturing process. A manufacturer that uses controlled
substances in its own manufacturing process, and is otherwise
subject to the regulations of this subpart, must label pursuant
to 82.106, but need not include information regarding 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.
82.114 Compliance by manufacturers and importers with
requirements
for labeling of containers of controlled substances, or products
containing controlled substances.
(a) Compliance by manufacturers and importers with requirements
for labeling of containers of controlled substances, or products
containing controlled substances. Each manufacturer of a product
incorporating another product or container containing a controlled
substance, to which 82.102 (a)(1), or, (a)(2) or (b)(1) applies,
that is purchased or obtained from another manufacturer or
supplier,
is required to pass through and incorporate the labeling
information
that accompanies such incorporated product in a warning statement
accompanying the manufacturer's finished product. Each importer
of a product, or container containing a controlled substance,
to which 82.102 (a)(1), (a)(2), or (b)(1) applies, including
a component product or container incorporated into the product,
that is purchased from a foreign manufacturer or supplier, is
required to apply a label, or to ensure that a label has been
properly applied, at the site of U.S. Customs clearance.
(b) Reliance on reasonable belief. The manufacturer or importer
of a product that incorporates another product containing from
another manufacturer or supplier may rely on the labeling
information
(or lack thereof) that it receives with the product, and is
not required to independently investigate whether the requirements
of this subpart are applicable to such purchased product or
container, as long as the manufacturer reasonably believes that
the supplier or foreign manufacturer is reliably and accurately
complying with the requirements of this subpart.
(c) Contractual obligations. A manufacturer's or importer's
contractual relationship with its supplier under which the supplier
is required to accurately label, consistent with the requirements
of this subpart, any products containing a controlled substance
or containers of a controlled substance that are supplied to
the manufacturer or importer, is evidence of reasonable belief.
82.116 Compliance by manufacturers or importers incorporating
products manufactured with controlled substances.
(a) Compliance by manufacturers or importers incorporating
products manufactured with controlled substances, or importing
products manufactured with controlled substances. Each manufacturer
or importer of a product incorporating another product to which
82.102 (a)(3), or, (b)(2) applies, that is purchased from
another manufacturer or supplier, is not required to pass through
and incorporate the labeling information that accompanies such
incorporated product in a warning statement accompanying the
manufacturer's or importer's finished product. Importers of
products to which 82.102 (a)(3) or (b)(2) applies are required
to apply a label, or to ensure that a label has been properly
applied at the site of U.S. Customs clearance.
(b) Reliance on reasonable belief. The importer of a product
purchased or obtained from a foreign manufacturer or supplier,
which product may have been manufactured with a controlled
substance,
may rely on the information that it receives with the purchased
product, and is not required to independently investigate whether
the requirements of this subpart are applicable to the purchased
or obtained product, as long as the importer reasonably believes
that there was no use of controlled substances by the final
manufacturer of the product being imported.
(c) Contractual obligations. An importer's contractual
relationship
with its supplier under which the supplier is required to
accurately
label, consistent with the requirements of this subpart, any
products manufactured with a controlled substance that are supplied
to the importer, or to certify to the importer whether a product
was or was not manufactured with a controlled substance is evidence
of reasonable belief.
82.118 Compliance by wholesalers, distributors and retailers.
(a) Requirement of compliance by wholesalers, distributors
and retailers. All wholesalers, distributors and retailers of
products or containers to which this subpart applies are required
to pass through the labeling information that accompanies the
product, except those purchasing from other manufacturers or
suppliers spare parts manufactured with controlled substances
and selling those parts for the demonstrable sole purpose of
repair.
(b) Reliance on reasonable belief. The wholesaler, distributor
or retailer of a product may rely on the labeling information
that it receives with the product or container, and is not required
to independently investigate whether the requirements of this
subpart are applicable to the product or container, as long
as the wholesaler, distributor or retailer reasonably believes
that the supplier of the product or container is reliably and
accurately complying with the requirements of this subpart.
(c) Contractual obligations. A wholesaler, distributor or
retailer's contractual relationship with its supplier under
which the supplier is required to accurately label, consistent
with the requirements of this subpart, any products manufactured
with a controlled substance that are supplied to the wholesaler,
distributor or retailer is evidence of reasonable belief.
82.120 Petitions.
(a) Requirements for procedure and timing. Persons seeking
to apply the requirements of this regulation to a product
containing
a class II substance or a product manufactured with a class
I or a class II substance which is not otherwise subject to
the requirements, or to temporarily exempt a product manufactured
with a class I substance, based on a showing of a lack of currently
or potentially available alternatives, from the requirements
of this regulation may submit petitions to: Labeling Program
Manager, Stratospheric Protection Division, Office of Atmospheric
Programs, U.S. Environmental Protection Agency, 6202-J, 401
M Street, SW., Washington, DC 20460. Such persons must label
their products while such petitions are under review by the
Agency.
(b) Requirement for adequate data. Any petition submitted
under paragraph (a) of this section shall be accompanied by
adequate data, as defined in 82.120(c). If adequate data are
not included by the petitioner, the Agency may return the petition
and request specific additional information.
(c) Adequate data. A petition shall be considered by the
Agency to be supported by adequate data if it includes all of
the following:
(1) A part clearly labeled ``Section I.A.'' which contains
the petitioner's full name, company or organization name, address
and telephone number, the product that is the subject of the
petition, and, in the case of a petition to temporarily exempt
a product manufactured with a class I substance from the labeling
requirement, the manufacturer or manufacturers of that product.
(2) For petitions to temporarily exempt a product manufactured
with a class I substance only, a part clearly labeled ``Section
I.A.T.'' which states the length of time for which an exemption
is requested.
(3) A part clearly labeled ``Section I.B.'' which includes
the following statement, signed by the petitioner or an authorized
representative:
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).
(5) A part clearly labeled ``Section II.A.'' which fully
describes any technical facility or laboratory tests used to
support the petitioner's claim.
(6) A part clearly labeled ``Section II.B.'' which fully
explains any values taken from literature or estimated on the
basis of known information that are used to support the
petitioner's
claim.
(7) A part clearly labeled ``Section II.C.'' which fully
explains any economic analysis used to support the petitioner's
claim.
(d) Criteria for evaluating petitions. Adequate data in support
of any petition to the Agency to add a product to the labeling
requirement or temporarily remove a product from the labeling
requirement will be evaluated based upon a showing of sufficient
quality and scope by the petitioner of whether there are or
are not substitute products or manufacturing processes for such
product:
(1) That do not rely on the use of such class I or class
II substance;
(2) That reduce the overall risk to human health and the
environment; and
(3) That are currently or potentially available.
(e) Procedure for acceptance or denial of petition. (1) If
a petition submitted under this section contains adequate data,
as defined under paragraph (c) of this section, the Agency shall
within 180 days after receiving the complete petition either
accept the petition or deny the petition.
(2) If the Agency makes a decision to accept a petition to
apply the requirements of this regulation to a product containing
or manufactured with a class II substance, the Agency will notify
the petitioner and publish a proposed rule in the Federal Register
to apply the labeling requirements to the product.
(3) If the Agency makes a decision to deny a petition to
apply the requirements of this regulation to a product containing
or manufactured with a class II substance, the Agency will notify
the petitioner and publish an explanation of the petition denial
in the Federal Register.
(4) If the Agency makes a decision to accept a petition to
temporarily exempt a product manufactured with a class I substance
from the requirements of this regulation, the Agency will notify
the petitioner and publish a proposed rule in the Federal Register
to temporarily exempt the product from the labeling requirements.
Upon notification by the Agency, such manufacturer may immediately
cease its labeling process for such exempted products.
(5) If the Agency makes a decision to deny a petition to
temporarily exempt a product manufactured with a class I substance
from the requirements of this regulation, the Agency will notify
the petitioner and may, in appropriate circumstances, publish
an explanation of the petition denial in the Federal Register.
82.122 Certification, recordkeeping, and notice requirements.
(a) Certification. (1) Persons claiming the exemption provided
in 82.106(b)(2) must submit a written certification to the
following address: Labeling Program Manager, Stratospheric
Protection
Division, Office of Atmospheric Programs, 6202-J, 401 M Street,
SW., Washington, DC 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 that their future annual use will not at no time exceed
95% of their 1990 usage.
(5) Certifications must be signed by the owner or a responsible
corporate officer.
(6) If the Administrator determines that a person's
certification
is incomplete or that information supporting the exemption is
inadequate, then products manufactured using CFC-113 or methyl
chloroform as a solvent by such person must be labeled pursuant
to 82.106(a).
(b) Recordkeeping. Persons claiming the exemption under
82.106(b)(2) must retain supporting documentation at one of
their facilities.
(c) Notice Requirements. Persons who claim an exemption under
82.106(b)(2) must submit a notice to the address in paragraph
(a)(1) of this section within 30 days of the end of any 12 month
period in which their usage of CFC-113 or methyl chloroform
used as a solvent exceeds the 95% reduction from calendar year
1990.
82.124 Prohibitions.
(a) Warning statement-(1) Absence or presence of warning
statement. (i) Effective May 15, 1993, except as indicated in
paragraph (a)(5) of this section, no container or product
identified
in 82.102(a) may be introduced into interstate commerce unless
it bears a warning statement that complies with the requirements
of 82.106(a) of this subpart, unless such labeling is not
required under 82.102(c), 82.106(b), 82.112 (c) or (d), 82.116(a),
82.118(a), or temporarily exempted pursuant to 82.120.
(ii) On January 1, 2015, or any time between May 15, 1993
and January 1, 2015 that the Administrator determines for a
particular product manufactured with or containing a class II
substance that there are substitute products or manufacturing
processes for such product that do not rely on the use of a
class I or class II substance, that reduce the overall risk
to human health and the environment, and that are currently
or potentially available, no product identified in 82.102(b)
may be introduced into interstate commerce unless it bears a
warning statement that complies with the requirements of 82.106
of this subpart, unless such labeling is not required under
82.106(b), 82.112 (c) or (d), 82.116(a) or 82.118(a).
(2) Placement of warning statement. (i) On May 15, 1993,
except as indicated in paragraph (a)(5) of this section, no
container or product identified in 82.102(a) may be introduced
into interstate commerce unless it bears a warning statement
that complies with the requirements of 82.108 of this subpart,
unless such labeling is not required under 82.102(c), 82.106(b),
82.112 (c) or (d), 82.116(a), 82.118(a), or temporarily exempted
pursuant to 82.120.
(ii) On January 1, 2015, or any time between May 15, 1993
and January 1, 2015 that the Administrator determines for a
particular product manufactured with or containing a class II
substance that there are substitute products or manufacturing
processes for such product that do not rely on the use of a
class I or class II substance, that reduce the overall risk
to human health and the environment, and that are currently
or potentially available, no product identified in 82.102(b)
may be introduced into interstate commerce unless it bears a
warning statement that complies with the requirements of 82.108
of this subpart, unless such labeling is not required under
82.106(b), 82.112 (c) or (d), 82.116(a) or 82.118(a).
(3) Form of label bearing warning statement. (i) Effective
May 15, 1993, except as indicated in paragraph (a)(5) of this
section, no container or product identified in 82.102(a) may
be introduced into interstate commerce unless it bears a warning
statement that complies with the requirements of 82.110 of
this subpart, unless such labeling is not required pursuant
to 82.102(c), 82.106(b), 82.112 (c) or (d), 82.116(a), 82.118(a),
or temporarily exempted pursuant to 82.120.
(ii) On January 1, 2015, or any time between May 15, 1993
and January 1, 2015 that the Agency determines for a particular
product manufactured with or containing a class II substance,
that there are substitute products or manufacturing processes
that do not rely on the use of a class I or class II substance,
that reduce the overall risk to human health and the environment,
and that are currently or potentially available, no product
identified in 82.102(b) may be introduced into interstate
commerce unless it bears a warning statement that complies with
the requirements of 82.110 of this subpart, unless such labeling
is not required pursuant to 82.106(b), 82.112 (c) or (d),
82.116(a), or 82.118(a).
(4) On or after May 15, 1993, no person may modify, remove
or interfere with any warning statement required by this subpart,
except as described in 82.112 of this subpart.
(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 effective one year after the effective date of designation
of such substance as a class I or class II substance or effective
on the date provided in the rulemaking designating such substance
as a class I or class II substance, whichever comes first.
[FR Doc. 93-31859 Filed 12-29-93; 8:45 am]
BILLING CODE 6560-50-P
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Air programs:
Stratospheric ozone protection-
Labeling requirements, 69568
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