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►REGULATIONS OF DIFFERENT COUNTRIES
Coalition of Northeastern Governors (CONEG)
Created in 1976,
the Coalition of Northeastern Governors (CONEG)
is a non-partisan association of the Governors of eight Northeastern states.
Members include the Governors
of
CONEG encourages
intergovernmental cooperation in the Northeast on shared issues relating to the
economic, environmental and social well-being of the Northeast states. The
Governors identify priority interests in transportation and the economy,
environment and energy which set the framework for CONEG's agenda. Working
through CONEG, the Governors share information and experiences on common
interests and, where appropriate, forge agreements and undertake cooperative
actions on a wide range of regional and state-federal issues.
CONEG works with
the states to identify regional
issues and provide a forum for discussion and exchange of information about
issues of shared interest. CONEG tracks selected national and regional issues,
assesses their implications for the Northeast, conducts policy studies and
seminars, and helps coordinate the region's response. In this manner, it also
provides an ongoing, informational exchange through which the Governors and
their senior advisors keep abreast of national and regional policy and program
initiatives important to the economic, environmental, energy and social
well-being of the region.
The
Governors established the CONEG Policy Research Center, Inc. (Center),
an incorporated 501(c)(3) non-profit organization, as the staff arm of CONEG.
The Toxics
in Packaging Clearinghouse (TPCH)
was formed in 1992 to promote the Model Toxics in Packaging Legislation.
This model legislation was originally drafted by the Source Reduction Council
of CONEG in 1989. It was developed in an effort to reduce the amount of heavy
metals in packaging and packaging components that are sold or distributed
throughout the
Specifically,
the law is designed to phase out the use and presence of mercury, lead, cadmium
and hexavalent chromium in packaging within four years in states that enact the
legislation.
Since
packaging comprises approximately one-third of the waste stream, it is hoped
that this legislation will curb the amount of heavy metals entering the
municipal solid waste stream and, ultimately, landfills and incinerators.
A reduced contribution of these metals to the waste stream will gradually lower
their harmful presence in the environment.
The
Clearinghouse includes a states-only voting membership and an industry/public
interest advisory group. The legislation has been successfully adopted by
nineteen states:
The Toxics in Packaging Clearingouse (TPCH)
is now located at the Northeast Recycling Council, Inc. (NERC) in
Requirements of the “Toxics in Packaging Clearinghouse (TPCH)”
Toxic Elements of pa
Pa
Limit for individual
element
Lead (Pb) 100 mg/kg
Cadmium (Cd) 100
mg/kg
Mercury (Hg) 100 mg/kg
Chromium VI (Cr VI) 100
mg/kg
_______________________________
Accumulative limit of Pb + Cd + Hg + Cr VI 100
mg/kg
Environmental Pollution
The toxic elements
Cadmium / Lead / Mercury / Chromium (VI) can be released from waste hauling,
disposal activities and manufacturing process. Higher levels of these toxic
elements may be found in soil or water near industrial areas or hazardous waste
sites, posing health hazards to human beings through the food chain. The main
objective of the regulation is to protect the environment and safeguard public
health.
Frequently asked questions
Q: Is the supplier of a package or package
component required under the law to certify to the purchaser that the four (4)
heavy metals were not intentionally added during the manufacturing process or
must the supplier also certify that the package or component was tested and falls at or
under the parts-per-million threshold set in the law?
A:
The certification would require the following: The actual certificate stating
that the four heavy metals were neither intentionally introduced nor are
incidentally present in excess of the allowable maximum concentrations.
The
state agencies responsible for enforcing this law will assume, when receiving a
Certificate of Compliance consistent with the Toxics in Packaging Legislation,
that the company has done what is reasonably necessary to stand behind its
certification. In cases where the company has existing documentation to
verify that each package complies, further testing will not be necessary and
that documentation may be substituted for actual test results. A
certification prepared without testing should be based on verifiable evidence
that there has been "no intentional addition." However, for those
companies that cannot document the amount of heavy metals in their package or
packaging components, or know them to be present as incidental trace
contaminants, a certain level of testing will be necessary. The test method
chosen and its lower detection limit are at the discretion of the company and
may vary from company to company and from package type to package type,
provided that the test is capable of conclusively proving that the total of the
four regulated metals is below regulatory limits. It is not expected that each
and every package will be individually tested, although that is certainly the
company's option. Instead, random sampling on a reasonable statistical basis is
considered to be a sufficient level of testing to comply with the legislative
requirements.
Q: Can a manufacturer or supplier use one
Certificate of Compliance for all of its packages or packaging components, or
is a separate Certificate of Compliance necessary for each type?
A: Packages and packaging components that use the same materials and differ only in size, shape and/or use can be included in the same Certificate of Compliance.
Q: How long
are companies required to keep on file documentation such as Certificates of
Compliance and laboratory test results?
A: The
Model Legislation requires that the Certificate of Compliance shall be retained
“for as long as the package or packaging component is in use.” Laboratory test
results that support the certification should be retained as well. Although
some state laws differ, it is recommended that documentation of compliance with
toxics in packaging requirements be kept on file by the product manufacturer
and supplier of the package or packaging component for 3 years after the
package is sold, distributed, or in use by the purchaser. If the package holds
a product for retail sale, it is recommended that documentation be kept on file
until the product is no longer distributed or sold by retailers, even if
product manufacturing has been discontinued. If the package or packaging
component design, formulation or supplier changes, the Certificate of
Compliance and supporting documentation must be updated by the manufacturer or
distributor of the packaging component.
Q: What authority does the TPCH have in
requesting Certificates of Compliance and test reports to prove packages are
compliant with the state toxics in packaging laws?
A: The
Toxics in Packaging Clearinghouse (TPCH) requests Certificates of Compliance
from manufacturers and distributors of packaging, packaging components or
packaged products on behalf of its member states. The authority of individual
states to request such information can be found in the legislation and/or regulations
of each state. One of the roles of the TPCH is to reduce the paperwork
burden for both states and the regulated community by providing a single point
of contact for such requests. If manufacturers or distributors do not respond
to the TPCH request, the matter is referred to individual states for follow up
action.
Q: What is the consequence or penalty if a
company fails to present a Certificate of Compliance or supporting
documentation such as actual test reports?
A: Enforcement
is at the discretion of individual states and subject to the provisions of
their statutes. Most states have penalties associated with making or submitting
false or misleading statements or certificates of compliance.
Test reports are generally not required, however, if a complaint is received or
if screening tests indicate a potential problem, then test reports may be
required to confirm the basis for the Certificate of Compliance.
Enforcement
Q: How is enforcement coordinated by the
states?
A:
Enforcement is on a state-by-state basis. However, the states have
established the Clearinghouse for the purpose of leading a coordinated effort
on implementation and enforcement of the toxics in packaging legislation.
Exemptions - General
Q: Which exemptions require petitioning to
the States and which are automatic, simply requiring mention in the Certificate
of Compliance?
A: The
exemption for package and packaging components involving use of recycled
material or date of manufacture prior to the effective date of the legislation
do not require petitions, but must be cited in the Certificate of Compliance
and must be verifiable. All other exemptions require a petition and must
include supporting documentation.
Exemptions – Effective Date
Q: Is packaging manufactured before the
effective date exempt even if it is sold after the effective date?
A: Yes.
If the package has a date of manufacture or the producing company can provide
documentation that the package in question was manufactured prior to the
effective date, or was in the process of being manufactured prior to the
effective date, it is exempt. Situations that are beyond the control of the
manufacturer -- e.g., old stock being held by retailers -- should be dealt with
on a case-by-case basis by the States. In all cases, packaging that was
manufactured after the effective date must be in compliance or else it cannot
be sold or distributed in that State. Packaging that does not bear a date of
manufacture on its label, and would be considered out of compliance due to its
regulated metals content, may be sold only if the manufacturer can supply other
supporting documentation to the State that it was manufactured prior to the
effective date.
Exemptions – Recycled Content
Q: What is meant by the term
"recycled materials" as used in Section 5, paragraph c?
A:
Recycled materials are those materials generated by a business or a consumer
that have been separated from solid waste for the purpose of recycling as a
secondary material feedstock. For purposes of this legislation, recycled
materials include paper, plastic, wood, glass or ceramics, metals such as
steel, aluminum, stainless steel or copper, and other materials. However,
recycled materials under the toxics in packaging law do not include the four
regulated metals (lead, cadmium, hexavalent chromium and mercury) when the
metals have been separated into their elemental or other chemical state for
recycling as a secondary material feedstock. For example, lead processed from
used automotive batteries and intentionally added as a component to manufacture
an ink pigment that is then used to print labels on packaging would not be a "recycled"
material for the purposes of Section 5 paragraph c.
Q: Would a package or package component be
exempt from the law if it were made wholly or in part from post-industrial
waste (e.g., metal scrap purchased from automobile manufacturing plants that
was subsequently made into cans or other packaging components)?
A: Yes.
The exemption applies to both post-consumer and post-industrial waste. This
example illustrates post-industrial waste. It should be noted that packages or
packaging components manufactured from non-packaging post-consumer materials
(e.g., used appliances and automobiles made into cans) would also be eligible
for this exemption.
Q: Would lead chromate pigment be exempt
if it were made from post-consumer recycled materials, such as scrap automobile
batteries?
A: No.
The exemption applies only to recycled composite materials such as plastic or
paper, which might coincidentally contain a regulated metal but are being
reprocessed for their primary material content, and not to the four regulated
metals or their compounds that have been separated or isolated from recycled
materials. This includes pigments.
Q: If a regulated metal were deliberately
added to a package otherwise made of totally recycled material, for example a
cadmium pigment added to change the color of a pail made of recycled plastic,
would the package be exempt based on recycled content?
A: No.
The intentional addition of a regulated metal to change the appearance or
characteristics of a final package is not permitted, regardless of the source
of starting material used to manufacture the package, unless the package
qualifies under the "reuse" exemption whereby each individual package
is reused many times and its distribution and retrieval are closely controlled
and documented throughout its lifetime. To qualify for the recycling exemption,
the regulated metal in question must have been present as a minor ingredient in
the discarded waste material before that waste material was designated for
recycling.
Q: For the recycled content exemption,
does the exemption/definition apply to the complete package, or only that
portion of the package that is made from post- consumer recycled material?
A: The
model legislation language differentiated between the package and packaging
components; therefore, the exemption could apply to either or both. For a
package where all components contain post consumer recycled content that
exceeds the compliance level, the entire package is exempt. However, in the
case where one packaging component contains post consumer recycled content and
the other components do not, only the component containing post consumer
recycled content would be exempt and not the entire package.
Exemptions – Vitrified Labels
Q: Are ceramic enamels or decals that have
been vitrified, such that they become part of the glass or ceramic matrix,
subject to the toxics in packaging requirements?
A: Glass
and ceramic containers with vitrified labels or decorations that can pass the
leachability test specified in the law are exempt from the restriction on
“intentional use” of the regulated metals. The exemption applies when the
sample is prepared according to ASTM C1606-04 and tested in accordance with the
Toxicity Characteristic Leaching Procedures of US EPA Test Method and publication
SW 846, 3rd edition, Test Methods for Evaluating Solid Waste, and does not
exceed 1.0 ppm for cadmium, 5.0 ppm for hexavalent chromium and 5.0 ppm for
lead. Mercury is not exempt.
It
has been demonstrated that ceramic and/or glass packaging having non-vitrified
surface glazes, paint or enamels containing lead or cadmium may release these
regulated metals upon being discarded, even where they appear to be stable
under normal conditions of use, at or around room temperature. The metals may
volatilize during high-temperature incineration or solubilize after landfilling
(including the landfilling of incinerator ash). It has been shown that
vitrification of the label before use generally prevents this release from
occurring.
Imports
Q: What about packaging, including cans or
other containers imported from outside the
A:
All packaging, including cans or other containers, imported from outside the
country into states that have passed the legislation must be in full compliance
with the limits on the regulated metals. It should be further noted that on
June 21, 1993 the Food and Drug Administration announced that it was
promulgating regulations to ban the use of lead solder in food cans sold
anywhere within the United States. This regulation applies equally to imported
cans that might still contain lead solder as well as domestically produced
cans. It is the responsibility of the importer to test or otherwise ensure that
any such cans proposed to be brought anywhere into the United States have not
been fabricated with lead-containing solder.
Q: How are importers subject to the state
toxics in packaging laws?
A: Packaging,
packaging components or products in packaging are subject to toxic in packaging
laws upon entering any state with toxics in packaging legislation. If a company
imports packaging, packaging components or a product in a package directly into
a state with legislation, then the state has authority to request a Certificate
of Compliance from the importer. If, however, the packaging, packaging
components or packaged products are imported into a state without legislation
by Company A and ownership is transferred to Company B, who subsequently
distributes such packaging into a state with legislation, it is the
responsibility of Company A to provide a Certificate of Compliance to Company B
since the Model Legislation and state laws require manufacturers or suppliers
to provide a Certificate of Compliance to its purchaser. An importer is
considered a supplier to its purchaser.
Q: Are mugs, steins, tumblers, vases and
similar items subject to the law when holding candy, beverages, flowers or
other products?
A: In
cases where the items are manufactured as products (e.g., decorative mugs) and
only incidentally hold other items during final distribution to the end user,
the product is not considered a package. One or more of the following would
have to apply. The items: are not designed solely to contain and protect
the goods inside for transport and handling during distribution; have intrinsic
value as an artistic or useful object in themselves which is often reflected in
the selling price if sold; and are intended to be retained beyond the life of
the item inside and not promptly discarded after the contents have been
consumed or used.
In
cases where the item is used solely to deliver another product (e.g., a
beverage sold at a food counter), the item is considered a package. An
exemption for “controlled distribution and reuse” may apply if the item is not
normally discarded after the product inside has been consumed. Further, a
container sold without being filled with a product, such as an empty coffee cup
or empty decanter for home use, is a product itself and not subject to the law.
Q: Does the law apply to gift-wrapping
paper (and related items) -- items purchased solely for the use of individual
consumers to wrap presents in the home, or to be attached to those presents?
A: No.
Wrapping paper, ribbons or tape, items attached to a product and related items
are products, not packages, if sold to the consumer for home use and as such
are not subject to the law. Packages that are sold to the consumer as
"gift-wrapped" items would be subject to the law. Promotional items
such as candy or toys that are attached externally to "gift-wrapped"
packages are not considered part of the package and are not subject to the law
(except, of course, for any additional packaging which might surround those
items themselves).
Q: Are envelopes used by a business
considered to be a "package" under the law?
A: Yes.
The definition of a package in the law under ASTM D-996 includes the term
"envelope" (85a, page 222, ASTM D-996). This would include envelopes
or shipping cartons supplied by Federal or Airborne Express, U.P.S. and others.
It is recommended that users of such packaging ask their respective express
carrier agencies for Certificates of Compliance.
Q: Does the law apply to "country of
origin" stickers which are required by US Federal law (19 CFR 134) on all
products manufactured or assembled outside the
A:
No. These stickers are not considered packaging for the purpose of this
legislation.
Q: Does the law apply to stickers, labels,
tags or protective films which are: 1) not required by Federal law; 2) affixed
directly to the product; 3) not required to remain affixed for proper or
safe functioning or use of the product?
A:
Yes. These stickers, labels, tags and protective films are considered
packaging under this legislation.
Q: Does the law apply to all such cans,
regardless of size or use?
A: Yes.
The definition of a package under the law includes all steel cans and,
therefore, the law applies regardless of size or use.
Q: Are railroad tank or box cars,
refillable propane tanks, chlorine cylinders, bulk tank trucks/trailers and
shipping containers considered packages under the legislation?
A: Railroad
tank or box cars and bulk tank trucks/trailers are not packages, while
refillable propane tanks, chlorine cylinders and shipping containers are
considered packages under the legislation. These distinctions are based on the
definition of "package" in the law under ASTM D 996.
Restrictions on the Use of Heavy Metals
Q: May a manufacturer sell a package or
packaging component that has 100 parts per million or less of the regulated
metal that resulted from deliberate addition during the manufacturing process,
with the knowledge and intent that its presence would change the appearance or
characteristics of the final package or packaging component?
A: No.
The intent of the law is to prohibit any intentional addition of the
four heavy metals in packaging, even if the concentration levels are below the
threshold for incidental amounts.
Q: In a situation where one or more of the
heavy metals were used in the manufacturing process but were not intended to be
part of the final package (i.e., used as a cleaning or oxidizing agent), would
the package be in compliance with the law if it contained trace amounts of
heavy metal below 100 parts per million?
A: Yes.
The package would be in compliance since the regulated heavy metal was used
only to aid in a step of the manufacturing process, and any residual metal
would be incidentally present if it is neither desired in, nor its continued
presence imparts any desirable characteristic or appearance to, the final
package. Trace amounts of residual metal resulting from the use of a processing
aid or similar material during production of a product from which a package or
packaging component is manufactured, and which processing aid is reasonably
expected to be consumed, transformed into a non-regulated chemical during the
process, washed or dissolved away, or otherwise nearly all removed during
processing, would not make the final package or packaging component
non-compliant if the total residual metal level were below 100 ppm, as this is
not considered intentional addition of the regulated heavy metal.
Q: What is meant by "sum of the
concentration levels" for single-component vs. multi-component packages?
A:
Single-component Package -- The concentration level, expressed in parts per
million (ppm), should be determined for each of the four metals and these
numbers added together (summed). This summation must be within the limit of 100
ppm. Multi-component Package -- The four regulated metals are not summed or
averaged across all packaging components that together comprise a package.
Rather, the concentration level, expressed in ppm, should be individually
determined for each metal and summed for each packaging component within the package.
Each packaging component must comply individually with the legal limit of 100
ppm.
Q: Does the law apply equally to
water-soluble or insoluble forms of the four heavy metals? Does it
make a difference with regard to soluble vs. insoluble forms if the package is
incinerated?
A: The
law applies to both soluble and insoluble forms of the four heavy metals and no
distinction is made between them. For example, the effects of lead
uptake in the human body due to ingestion of paint chips, ink, etc. are
essentially the same for the various forms of lead regardless of their initial
water solubility. With regard to incineration, it is well documented that
maximizing the removal of heavy metals in waste prior to incineration reduces
air emissions and leachate problems from ash (bottom ash and fly ash),
including when such ash is subsequently disposed of on land. High-temperature
combustion normally converts the heavy metal compounds (whether initially
water-soluble or insoluble) in the waste being burned into other compounds,
primarily oxides, hydroxides, chlorides or other salts, or into metallic
particulates, which can enter either the stack gas or the ash streams. The sole
exception demonstrated to date is vitrified labels on glass or ceramic
packaging, provided that such packaging has passed the test methods specified
in the law. This unique behavior of vitrified glass and ceramic labels during
incineration, which thus far has not been satisfactorily demonstrated for other
materials, is recognized by an exemption for these labels. The exemption does
not apply to non-vitrified labels or to mercury and its compounds.
Q: Is there an exemption for packaging
that is manufactured using solder that contains lead?
A: No.
The Model Legislation specifically prohibits the intentional introduction of
the four regulated heavy metals into packaging such as from leaded solder.
Originally there was a four-year period allowed for cans and other containers
to achieve compliance. During that period both the can industry and the solder
industry were able to come up with technical breakthroughs (i.e., deep-drawn
seamless cans and lead-free tin solder, respectively) that negated any future
need to exempt lead-containing solder.
Q: Is hexavalent chromium more toxic than
other forms of chromium?
A: The
toxicological information available on chromium compounds clearly indicates
that the hexavalent form is more toxic than other forms.
Test Methods
Q: What test methods are acceptable?
A: TPCH
cannot recommend specific test methods (with the exception of glass and ceramic
containers with vitrified labels), since test methods vary depending on the
metal and base material being tested. The analytic laboratory should be capable
of performing tests to determine the total
concentration of each of the 4 restricted metals – lead,
cadmium, mercury and hexavalent chromium. TPCH recognizes the use of x-ray
fluorescent (XRF) analysis, as well as traditional analytic procedures that
measure total concentration of metals. Test methods that measure “leachable”
metals are not appropriate (except under the permanent glass exemption).
Particular attention should be paid to the sample preparation methods to
determine whether the metals of interest are properly solubilized prior to
testing. The selected sample preparation and test methods should be
documented in the laboratory test report.
Testing
should be performed and reported on individual packaging components (e.g.,
inks, resin, paperboard, adhesives). Analytic laboratories must have appropriate
certifications by recognized certification organizations or authorities (e.g.,
National Environmental Laboratory Accreditation Program). As many analytical
laboratories are not accustomed to testing the variety of package materials
available in the market, it is critical to ensure the laboratory follows strict
quality assurance/quality control procedures (QA/QC). TPCH recommends
requesting QA/QC data be provided with analytical reports.
Note: To qualify for the glass exemption for glass and ceramic packages
with vitrified labels, the sample must be prepared according to ASTM C1606-04
and tested in accordance with the Toxicity Characteristic Leaching Procedure of
US EPA Test Method and publication SW-846, 3rd edition, Test Method for
Evaluating Solid Waste. The concentration of metals in packaging cannot exceed
1.0 ppm for cadmium, 5.0 ppm for hexavalent chromium and 5.0 ppm for lead.
Mercury is not exempted by this provision
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