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12. The child hazard warning should immediately
precede the signal world and other statements of
hazard.
13. The contents declaration should be moved into
the bottom 30% of the front label panel.
14. The ingredients statement must be placed on the
front label panel immediately following the
product name.
Similarly, a proposed label for a typical insecticide
was submitted to the EPA with front and back panels as
shown in Label II on page 528.
The EPA asked for the following changes before the
label could be accepted for registration:
1. The claim that the product is "non-flammable"
would have to be either proved or omitted. The
flame projection test result of 7 " indicates that
flammable components and characteristics are
present.
2. Deletion of the claim "Safe when used as
directed''. The EPA considers that the use of the
word "safe" or similar claims detracts from the
statement of hazard.
3. The signal word '' WARNING" must follow the
child hazard warning.
4. Underlining must be removed from "Active
Ingredients". In the final label the words "Ac-
tive Ingredients" and "Inert Ingredients" must
be of equal type size, placement, margin, color
and readability.
5. The ingredients statement should appear di-
rectly below the product name.
6. The contents declaration must appear in the bot-
tom 30% of the front label panel.
7. Permission should be obtained from the sup-
plier^) to authorize use of their confidential for-
mula^) in support of the product's registration.
Alternatively, the suppliers) should be asked to
submit to EPA their complete formula(s) giving
names and percentages of both active and inert
ingredients.
8. Under the claim for control of houseflies, mos-
quitoes and gnats, directions should be revised to
read "direct the mist to all parts of the room
especially windows and other light sources which
attract these insects."
Federal Environmental Pest Control Act of 1971
(FEPCA)
About 1970 it was recognized that FIFRA regula-
tions were designed to provide firm registrational and
labeling control of pesticide products, but that they
tended to leave broad environmental and public protec-
tion issues alone to a great extent. These omissions were
addressed by HR 10729 with the aim of expanding
FIFRA coverage. New legislation has now acted to:
a. Create two classes of pesticides: those for general
use and those for restricted use. "Restricted use"
products can be applied only by licensed pesticide
treaters and applicators.
b. Require factory (establishment) registration and
permit factory inspections.
c. Require consideration of environmental factors
during the process of registration.
d. Permit a hearing and review in the event the EPA
turns down a request for the registration of a new
product. In addition, the applicant may ask the
National Academy of Science to pass judgment on
relevant scientific issues.
e. Provide specific federal pre-emption of state and
local laws regarding the labeling and packaging of
pesticides. However, the states would be permit-
ted to ban the shipment of any restricted pesticide
within their borders for cause.
f. States would be permitted to adopt local regula-
tions governing pesticides, which might be more
stringent than the federal controls.
The concept that the states may be permitted to
develop pesticide regulations different from those in use
by the federal government is one that is particularly
onerous to the pesticide industry. Manufacturers,
marketers and users feel quite strongly that regulations,
standards and registration procedures should be
uniform throughout the U.S.A. to facilitate the
manufacture, formulation, packaging and distribution
of pesticide chemicals—in fact, all chemicals and com-
modities. The industry, therefore, strongly suppports
the concept of federal preemption in this area.
While the industry accepts the idea that the states
may have different local needs and should have some-
thing to say about uses and applications, it is felt that
they should not participate in such areas as registration,
labeling, standard-making and regulations different
than those at the federal level. Industry feels that labels
registered by the EPA should either be accepted for
state registrations, or else made exempt from state
registration requirements.
Starting about 1979 there have been several prob-
lems with the FIFRA implementation at both the fed-
eral and state level. Congress is attempting to deal with
these situations via HR 5203 and other bills. By 1982 at
least six states have attempted to expand their pesticide
programs to exceed the federal requirements. Califor-
nia, in particular, has imposed unnecessary and
burdensome regulations upon the industry, requiring a
second registration (by CDFA) before marketing can
begin. One insect spray registered by the EPA in 1976
required 594 days for the CDFA to register it. Lengthy
registration delays may result from the slightest label
changes, and it has taken from 15 to 24 months to add a
new use or a new pest to the California label, even after
approval by the EPA. California has sometimes
changed test data requirements in mid-stream, result-
ing in delays and increased data requirements by the
registrant. Attempts are now being made to amend
FIFRA's Section 24(a) which covers the authority of the
states. Two key provisions can be cited. A state's
request for data, which does not come within the realm
of special local concern data, is to be reviewable by
EPA, and products in this category are to be granted
registrations pending further review. Also, an obliga-
tion is imposed upon the states to act on most registra-
tion applications within 60 days of receipt or the prod-
uct is deemed registered. It can finally be noted that
California now exacts a registration maintenance fee on
an annual basis, plus another, based upon the number
of units sold within the state and the retail price of each.
The annual fees are paid by the registrant and the per-
unit fees are handled by the marketer. They reportedly
go into the financial support of the state program for
registration, plus safety educational activities in the
pesticides area.
Where pesticides are to be used in or around food
handling establishments, a USDA registration is
required in addition to the EPA registration. This is
normally done by coordinating the activities of these
two authorities at the same time, advising each of the
progress of the other. The USDA Registration No. may
then appear on the label of the finished product.
Various federal and state agencies, as well as univer-
sities, may analyze the active ingredient levels of insec-
ticides and disinfectants and report their findings to the
marketer. Because of the high cost of some insecticide
ingredients (over $200/lb, or $440/kg) most of the acti-
vity centers on insect sprays. Companies are then often
obliged to respond in a fixed time period, to show that
the assay is correct. In some cases, the insecticidal acti-
vity may be questioned, aside from any percentage con-
siderations, and here the response is normally the sub-
mission of the results of the Aerosol and Pressurized
Spray Insecticide Test (Large Group Method), where
the product is assayed in comparison to the Official Test
Aerosol (OTA-II).
The Toxic Substances Control Act
Added powers have been provided to the EPA under
this complex legislation. Some are:
a. Restriction of prohibition of the use of hazardous
chemicals in industry or commerce if they
threaten the health of the environment.
b. Premarket clearance of all new chemicals and cer-
tain existing products.
c. Power to summarily seize chemical substances
deemed to be imminent hazards.
The EPA enjoyed these powers with respect to
pesticides, but the TSCA greatly expands these
prerogatives. The activities of the agency in controlling
2,4-D and 2,4,5-T type herbicides is well known and
has been linked to almost unimaginable costs to both
government and industry.
The CSMA has now completed a massive study of
the effects of TSCA and Premanufacture Notification
(PMN) on innovation in the chemical specialties indus-
try. The so-called Kirschner Report of 1981 showed
that ingredient suppliers produced 26% fewer new
substances since 1979, that 72% of these surveyed firms
planned to reduce such new substance developments,
and the cost of filing a PMN averaged $16,000 plus at
least $5,000 in toxicity tests. The CSMA has used this
documentation to suggest changes under Sections 4 and
5 of TSCA, which would either limit the amount of
information required for a PMN (facilitated by using a
simpler form), or that flexibility could be achieved by
using model protocols rather than set guidelines for tox-
icological testing. The agency should also establish
exemptions for substances with small risks and those
chemicals not worth the expense of a full premanufac-
ture review.
During mid-1981 the EPA proposed further testing
of methylene chloride, 1,1,1-trichloroethane and
nitrobenzene under TSCA Section 4 test rules, for a
total cost of up to $2 million. In the case of methylene
chloride, such tests as acute toxicity to birds and
bioconcentration in plants seem to have little practical
merit. By this time, methylene chloride may well be the
most thoroughly toxicologically tested of all known
chemicals. It has had an exceptionally good record in
these tests. The value of the proposed tests under TSCA
may be questioned both in general and from the stand-
point of the very minimal exposure levels of the target
life forms.
The Resource Conservation and Recovery Act
(RCRA)
This act was signed into law in 1976, and concerns
the disposal of hazardous waste materials. Sub-title C of
the act contains the famous "cradle-to-grave"
approach of tracking and regulating hazardous waste
from the generator to the transporter and to the
ultimate disposal site.
Hazardous waste regulations were proposed in
1978 by EPA. They contain a definition of' 'hazardous
waste" based on criteria covering ignitability, corro-
sivity, reactivity, and toxicity. Specific chemical wastes
are also cited as hazardous. Standards covering storage
facilities and disposal sites are included in the proposed
regulations. Any person generating, transporting,
treating, storing or disposing of a hazardous waste must
file a preliminary notification with EPA. Wastes that
are not "hazardous" are still regulated under RCRA.
Strangely enough, aerosols are regulated under the
broad category of "solid waste", which includes solid,
liquid, semi-solids or contained gaseous materials. As
mentioned in the chapter on Aerosol Flammability, the
aerosol dispenser as such is not considered hazardous,
but the contents may be if they are "Flammable" or
"Extremely Flammable", caustic (as in some oven
cleaners) or relatively poisonous. Because of the bur-
densome requirements, there has been a marked
decrease in the number of disposal sites handling haz-
ardous wastes, resulting in higher disposal prices and
more paperwork. Operators of disposal sites assume
certain risks. For example, in 1981 a site near Wilson-
ville, IL was closed down by an action of law as a '' com-
mon nuisance", after five years of operations. The site
was operated by SCA Services, Inc., the nation's third
largest waste management firm, with 1980 revenues of
$230 million. Nevertheless, the business of waste dis-
posal is increasingly lucrative under TSCA. The
Chemical Waste Management Division of Waste Man-
agement, Inc. —the largest firm in this business—has
30% of the chemical waste disposal business (in 1981
and 1982) and is expected to grow by 30-35% during
each of the next five years. A key to their success was the
foresight to acquire large, hazardous waste landfill
capacity ahead of time.
In September 1980 Congress passed the Superfund
Hazardous Waste Clean-Up bill to assist RCRA in its
waste management activities. As an example, iso-
butane is considered a hazardous waste item (within a
specific listing of about 40 chemicals), and the pro-
ducers must forward a fee to go into the superfund
according to the amount sold each quarter. The fee is
less than 1 % of the selling price, so the impact upon the
aerosol industry is negligible in this case.
Clean Air Act
This act was initiated in 1977, to protect and enhance
the quality of the nation's air resources so as to protect
the public health and welfare and the productive capa-
city of its population. This act was the one invoked dur-
ing the CFG/ozone controversy. In time, it may be used
to control the emission of hydrocarbon gases at filling
establishments.
The average filler loses 7 to 10% of his hydrocarbon
propellent purchases into the atmosphere, from a var-
iety of leakage points and operations. Where products
such as shave creams are filled, because they have so lit-
tle propellent in the formula, the loss rate for the filling
operation may get as high as 25% or so. The entrap-
ment or burning-off of hydrocarbon vapors is imprac-
tical, except that a catalytic combustion system might
be placed in the venting system of gas houses, at con-
siderable expense, to change this portion of the loss into
innocuous CO2 and water vapor.
Another long-term problem attaches to the produc-
tion of GK-45 and similar Flowed-In™ valve mounting
cup gaskets under the CAA, since toluene is lost into the
air during the heat-curing operations. This is one of the
rationales used by Precision Valve Corp. in pioneering
their polyethylene sleeve gasket, since here no curing
stage is involved. PVC's Aeroco Division, where these
operations are done, is located in New Jersey, which
has been an extremely difficult state to deal with on
clean air and environmental issues.
Under Section 112 of the act, there is a listing of
specific hazardous air pollutants. As of 1982 it included
asbestos, beryllium and its compounds, mercury and its
compounds, vinyl chloride monomer, radionucleides,
benzene and inorganic arsenic compounds. The listing
will undoubtedly be lengthened in the future.
CONSUMER PRODUCT SAFETY ACT OF 1972
This act was created to " protect the public against
unreasonable risk of injury associated with consumer
products . . . and . . . to assist consumers in evaluating
the comparative safety of consumer products.'' The act
is designed to control the safety aspects of the dispenser
and contents of "household products", but it has been
applied in a broader sense to cover packages for all
classes of consumer products. The "household prod-
ucts" area specifically excludes products that fall under
the FDA, the EPA, and the Treasury Department
(under the Alcohol, Tobacco and Firearms Act -
AT&FA), as well as those that are produced only for
institutional and/or industrial uses and will never get
into domestic areas.
The Federal Hazardous Substances Act of 1960
Originally designated as a labeling act, the FHSA
has taken on larger regulatory parameters. It has, as its
principal thrust, the protection of the consumer by
means of regulating the precautionary labeling on the
container. Specific definitions and test methods are
described for hazards such as toxicity, corrosivity, irri-
tancy, sensitization, flammability, pressure generation
and radioactivity. Aerosol formulas may become in-
volved with all of these hazards except the last.
Specific hazards are defined in a cursory fashion as
follows, but for a more precise rendering one must refer
to the official interpretations of the act:
a. Toxicity
Products which are classified as highly toxic are required
to carry warnings of a strong character and those classed
as toxic must carry modified warnings. Divisions are
made based upon LD5o or LCso- The LD5o is the weight
of the substance in mg related to the kg weight of the test
animal, which results in the death of 50 % of the animals.
The LC50 indicates the concentration of a gas or mist of
the product in air which results in the death of 50% of
the test animals.
b. Irritant
Irritants are classified on the basis of a numerical score
determined by conducting prescribed patch tests on the
skin or albino rabbits. A score of higher than 5 classifies
the product as a primary irritant. Eye irritation ratings
reflect the irritational effect of the substance in the eyes
of these rabbits.
c. Corrosivity
A product is corrosive if it causes visible destruction or
irreversible alteration of the skin tissues at the point of
contact.
d. Strong Sensitizer
A product that produces an allergenic sensitization in a
substantial number of persons who come into contact
with it. (Also covered in FDA regulations, Sec. 191.6)
e. Flammability
"Extremely Flammable" aerosols are those where, in
the flame projection test, a flashback (a flame extending
back to the dispenser) is obtained at any degree of valve
opening, and the flashpoint, by the Modified Tag Open
Cup Flashpoint Test, is less than 2O0F (-6.70C).
"Flammable" aerosols are those where, in the flame pro-
jection test, a flame projection exceeding 18 " (457 mm)
is obtained at full valve opening or a flashback (a flame
extending back to the dispenser) is obtained at any
degree of valve opening.
f. Pressure Generation
The particular definition applicable to aerosols is that a
product is hazardous if it comprises the contents of a self-
pressurized container. (All aerosols are hazardous from a
pressure generation standpoint and require precau-
tionary labeling accordingly. However, the pressure
generating substance need not be identified on the label.)
In addition to these classes of hazardous materials,
there are a number of specific hazardous materials iden-
tified in the regulations which, above certain percen-
tages, must be identified on the label. They include
petroleum distillates and turpentine, in amounts of
10% or more, methanol over 4%, sodium hydroxide or
potassium over 2%, ethylene glycol and so forth.
Labeling provisions are set forth, stating that the
immediate package label must contain the name and
place of business of that manufacturer, packer,
distributor or seller, the common name of each compo-
nent that contributes to the hazard (aerosol propellents
exempted), precautionary measures to be taken, first
aid instructions when necessary and appropriate, and
the statement, "Keep out of the reach of children" or
the practical equivalent. For products designed for use
by children this last caution would be revised to "Keep
out of the reach of children except under adult supervi-
sion. "
Where the only hazard is that the contents are under
pressure, under the regulations in Chapter II, Sub-
chapter C, Part 1500.130(b), the label must state:
"WARNING - CONTENTS UNDER PRESSURE
Do not puncture or incinerate container. Do not expose
to heat or store at temperatures above 12O0F. Keep out
of the reach of children." (Note: 12O0F = 48.90C). If
desired, the word "CAUTION" may be substituted
for the word "WARNING".
 If a particular hazard has been identified by clinical
tests, then additional information must be presented on
the label. If the aerosol is "highly toxic", such as cer-
tain tear gas products used for personal defense, the
label must contain the words "POISON" and
"DANGER" on the principal display panel, followed
by such phrases as, "Keep out of the reach of children.
Contains (name of toxic chemical). See cautions on
back panel." The back panel must then contain a sec-
tion tided "Precautions", where first aid and safety in-
formation is provided. In many cases the phrase "Can-
not be made non-toxic," is included.
The minimum labeling for an "Extremely Flam-
mable" areosol will involve statments such as:
"DANGER - EXTREMELY FLAMMABLE"
(principal display panel - 18 point type), "Keep out of
the reach of children" (principal display panel - 10
point type) and "See precautions on back panel"
(principal display panel - 10 point type). On the back
panel, in not less than 10 point type, "Keep away from
heat, sparks or open flame. Use with adequate ventila-
tion. Do not puncture or incinerate container. Do not
store at temperatures above 12O0F" (Note: 12O0F =
48.90C) If desired, all the precautions may be placed on
the principal display panel.
The signal word and statement of the principal
hazard(s) must appear on the front panel of the label,
along with the words "Keep out of the reach of
children." and the reference "See other cautions on
back panel.", or the equivalent. The signal word must
be in capital letters and in not less than 18 point type
(6.35 mm high), while the statement of hazard must be
in a minimum of 12 point type size (4.23 mm high) and
the other statements must be in not less than 10 point
type size (3.52 mm high). Other precautions, usually
found on the back or side label panel, must be at least 10
points (3.52 mm high). An exception is made in the case
of small labels, but in no event may the type size be
smaller than 6 point (2.12 mm high).
The Poison Prevention Packaging Act of 1970
This is one of the least known acts administered by
the CPSC, but an important one for the aerosol indus-
try. It establishes regulatory standards for special
packaging of any household substance dangerous to
children. Sometimes it is erroneously called the Child
Resistant Closure Act, since these closures are its most
visible attribute. The act is specific and detailed, and
one which requires close analysis during product
development.
Household product aerosols are subject to "special
packaging'' if they are corrosive to the eye or skin, have
an acute dermal LDso of 2000 mg/kg or less, have an
inhalation LC5o of 2 mg/liter or less or have an acute
oral LDso of 1.5 g/kg or less. The Commission may find
that products other than household products may
qualify for ' 'special packaging'', wherever they present
a serious hazard of accidental injury which such pack-
aging might act to reduce. Finally, should a product be
so dangerous that "special packaging'' is deemed insuf-
ficiently effective in removing or reducing the hazard,
the Commission may ban them. For example, this was
done in the case of a water repellent based upon an
organo-titanium (IV) compound dissolved in a highly
flammable solvent/propellent system, and designed to
be sprayed on very large areas of concrete or concrete
blocks. After several explosions, caused by vapor igni-
tions from nearby pilot lights or furnaces, the product
was banned. Later it returned to the market in a
modified formula.
The testing protocols for child-resistant closures
have already been described. They involve 200 children
and 100 adults of specific age and sex distributions. The
full protocol test currently costs about $5,000 (1982),
and a "half-size" partial protocol screening test runs
about $3,600 (1982). Firms such as the California Con-
sultants Testing Division (Woodbridge, CA 95258) are
able to perform these studies. Rather interestingly, a
machine has been developed by the National Bureau of
Standards (NBS) and the CPSC to test child-resistant
closures. This tester can be used in screening tests, but
the full human testing program is still required. The
CPSC plans to use the device for testing child-resistant
closures on the market, to make sure they are perform-
ing as stipulated. Blueprints are available from CPSC.
Most aerosol formulations are outside the realm of
child-resistant packaging requirements. Some that are
affected, however, include caustic oven cleaners, a few
heavy duty or high-alkaline cleaners (such as some
toilet bowl cleaners), personal protection aerosols and
some paint strippers (such as those that contain both
methylene chloride and a gelling agent). Both EPA and
CPSC product categories are subject to "special
packaging"; other aerosols are not.
The CPSC National Electronic Injury Surveillance
System (NEISS)
Early in the 1970s the CPSC set up a "NEISS
Study" system, where 119 hospitals and selected doc-
tor's emergency rooms reported a variety of accidents
 TABLE XI
NEISS* Results on Aerosol Injuries; 1974 - 1978
With Estimated U.S.A. Totals
Actual Number of Statistical
Year Accidents Reported Adjustment Factor
1974 162 27.5
1975 250 22.6
1976 229 25.3
1977 233 26.0
1978 165 25.4
* National Electronic Injury Surveillance System.
caused by various products. With reference to accidents
involving aerosols, data is summarized in Table XI.
About 25% of the injuries treated in emergency
rooms are due to minor dermatitis and conjunctivitis.
Minor chemical burns (caustic, etc.) formed the second
largest category. Taking the 1978 inventory as an ex-
ample, reported deaths due to aerosols were listed by
the CPSC as 9, due to intentional inhalation abuses,
one, due to an explosion, and one, due to inhalation
where there was no intentional abuse.
The industry has always been concerned about these
particular inputs of the NEISS reports. Much of the
data is vague and much is improperly categorized. For
example, a laceration could result from a thrown
aerosol can. A baby's broken finger resulted from drop-
ping an aerosol can on it. The inclusion of these acci-
dents in the overall statistics make aerosols seem more
hazardous than they really are. The statistical treat-
ment of the data has been the subject of much criticism,
and finally, these data do not give any hint of the sever-
ity ratings, simply numbers of visits. It is easily shown
that aerosol-related accidents are, on the average, far
less severe than many other types, such as those caused
by power mowers. Products that pose greater risks to
consumers than aerosols include cleaning compounds,
household products in general, fuels, paints, solvents,
waxes and polishes, pesticides, cosmetics and even
prescription drugs. In this sense the NEISS report is
positive in that it shows that aerosols are usually the
safest way to present a product to consumers. Finally,
according to the NEISS data, even when an aerosol is
misused, the chances for a person suffering an injury
are less than one per 300,000.
According to present CPSC Chairman Nancy
Steorts, the recent decision to cut the agency's budget
by 30% in fiscal 1982 will have its effect in reducing the
NEISS program. The number of reporting hospitals
will be diminished. This and other modifications in the
system will save the agency over $500,000 and 100 staff-
months of time. Some of the savings will be redirected
Estimated 'to allow for added special hazard identification studies.
U.S.A. Total
4,457 CPSC Aerosol Ingredient Labeling Program
5,656
5,798 Since 1976 the CPSC has made use of a product
6,059
4,191 ingredient data base called the CCHI (Chemical Con-
sumer Hazard Information) file, which is referred to
more commonly as the Auerbach file, from the contrac-
tor who developed it. Formulation data on some 8200
household products is listed and available, including
well over 100 aerosols. Since the half-life of formulary
data is about ten years, and the file was compiled in
1973 and 1974, the data are rapidly becoming obsolete.
In 1981, the CPSC announced plans for a new survey
(sometimes called CHIP II) to update their file at a cost
of about $100,000. As before, the collected data would
be used by those trying to establish what chemicals were
being used in household products, various formula
trends and so forth.
Industry has always objected to this overall activity,
partly from a finding that numbers of confidential for-
mulations were made public as a result of the Auerbach
survey. Obviously, another route toward the unveiling
of formulations is for the CPSC to require formula
labeling, much as the FDA now requires it for foods,
drugs and cosmetics, and as the EPA requires it for
pesticides. In 1980, the CPSC launched a formal inves-
tigation of such labeling. Their options were to require
only propellent labeling, full ingredient labeling, the
labeling only of hazardous ingredients, or no labeling.
Full ingredient labeling, patterned after the semi-
quantitative "descending order of percentage by
weight" method used by the FDA, seemed to be their
choice. The staff estimated that the proposed regulation
would affect 5,500 different type products with a sales
volume of 800 billion units annually and would cost in-
dustry only about $2.8 million (1980 dollars). There
was also a suggestion that the CPSC might want to
demand pre-clearance for such labels, which, techni-
cally, they have no authority to implement. Pre-
introduction testing and certification would be a half-
way measure.
The implementation of such a labeling program
would first require a multi-year cooperative project,
where industry and CPSC personnel would develop a
huge list of standard names for household product
ingredients, much like the CTFA did in developing
their CTFA Cosmetic Ingredient Dictionary, in cooperation
with the FDA during the early 1970s. (This big book of
thousands of ingredients sold for $160 including ship-
ping in 1982).
Possibly because of a delayed realization of the true
costs and time involved in such an undertaking, the
CPSC has not done anything substantive during 1981
and 1982 in this area. However, this hiatus period may
only be due to recent budgetary constraints, and
perhaps the recognition of higher priority items by the
agency within that framework.
Other CPSC Activities
During the beginning of the 1980s a great deal of
attention has been focused on chronic hazards. Under
new legislation, the CPSC has to set up a Chronic
Hazards Advisory Panel (CHAP) to review proposed
rulemaking relating to chronic hazards defined as con-
sisting of cancer, birth defects or gene mutations. The
panel of seven persons will be drawn by the President of
the National Academy of Sciences from state employ-
ees, academia and other non-federal and non-industry
experts. The panels are ad hoc, designed to handle an
existing investigation and then dissolve.
The questions of chronic hazard are also addressed
under the EPA's TSCA program and under OSHA
mandates, with OSHA undoubtedly having assumed a
lead role in cancer policies.
During late 1981, the CPSC became involved in a
new issue: indoor air pollution. During periods in
winter when houses and offices are tightly shut, it was
found that build-ups of formaldehyde, carbon monox-
ide, hydrocarbon carcinogens such benzopyrene, nit-
rogen (IV) oxides (NO2/N2O4) and even traces of
radioactive radon gas, could take place to the extent
where physiological or medical problems would result.
The well-sealed house of the 1980s was perhaps 4 to 10
times as tight as the average house of the 1970s, so that
the rate of air flow was reduced to only about 2 to 5
turnovers in a day. Under these conditions, a number
of chemicals produced or released in situ were said to
cause such nagging symptoms as "perpetual cold",
headaches, respiratory problems, colds, skin rashes,
eye irritation, lethargy, dizziness, memory lapses and
cancer.
Formaldehyde was the most worrisome air pollutant,
seeping into the confined air space from urea-formal-
dehyde insulating foam, particle board, rugs and
carpets, clothing and specialty chemicals. The CPSC
acted to ban all new uses of urea-formaldehyde insula-
tion. Some aerosol formulators have replaced formal-
dehyde with other broad spectrum microbicides in such
products as fabric finishes, starch, various lotions and
creams. Some marketers have considered replacing the
usual weekly formaldehyde bactericidal treatment of
de-ionizer beds with weekly treatments using some
other broad-spectrum bactericide.... not because the
formaldehyde will enter formulated products (it is all
flushed down the drain) but from a sense of responsi-
bility to personnel in the compounding area.
Various articles on indoor air pollution also recite
aerosols as culprits, causing various chemicals to enter
the air, so that they are breathed by everyone in the
building before they finally circulate to the outside.
Actually, after normal spraying and distribution,
aerosol ingredients generally drop into a concentration
range of about 100 ppt to 100 ppb in the confined air-
space, where most of them cannot even be measured
with present-day instrumentation. There does not seem
to be any ready or realistic solution to the "aerosol
problem", if indeed there is one.
The Occupational Safety and Health Act of 1970
This act was passed in order to better ensure the
safety and health of workers. It is administered by the
Occupational Safety and Health Agency, within the
Department of Labor. They are authorized to require
labeling of industrial products, to set standards for
chemical exposure levels, to investigate worker grie-
vances relating to health and/or safety, to perform
inspections of suspect plants and to cause employers to
provide workers with detailed information regarding
the products they are asked to work with. During 1979,
OSHA conducted 58,000 inspections, wrote out
132,000 violations and assessed fines of over $25
million. One of their inspections almost invariably
results in substantial expenses to the business involved,
for the correction of some purported violation (written
or verbalized), or for the preparation of formal
responses to prove innocence. In one plant, a group of
vengeful employees showered the local OSHA office
with so many grievances that almost 200 inspections
were initiated in one year alone, causing such heavy
distraction of management that profits sagged seriously
and were a major factor in the closing of that operation
in 1982.
In 1980, OSHA published their second cancer
policy, a 100 page document in 45 Federal Register Part
5001 titled "Identification, Classification and Regula-
tion of Potential Occupational Carcinogens". An
amendment was published in 1981 (46 FR 4889), and
further rulemaking was under study (47 FR 187) in
1982. Thus far over 250,000 pages of hearing testimony
and an awesome volume of written submissions have
resulted, but the legal battle will probably not be as dif-
ficult as was the one over OSHA's first carcinogen
policy, where over two years of hearings resulted and
paperwork was generated by the truckload.
Some of the industry points are that OSHA should
not attempt to define scientific criteria, but rather,
should define guidelines. Similarly, mandating techni-
ques for defining carcinogens is poor science, since this
is a fast changing and developing field. The OSHA goal
appears to be to establish the nation's first overall
cancer policy. If this is the case, the White House Office
of Science and Technology, National Academy of
Sciences (NAS), Interagency Regulatory Liaison
Group (IRLG) and several other bodies should be con-
sulted for the best overall approach.
Under the Carcinogen Policy (as it is usually called),
OSHA moves through three stages in the screening of
potential carcinogens for regulatory action. First, they
briefly review certain available data and publish a Can-
didate List. Then they conduct a more thorough search
and assemble two Priority Lists often substances each.
And finally, OSHA selects high priority substances for
rulemaking.
As of mid-1982, OSHA has published a Candidate
List, but has not issued a Priority List. Industry's con-
cern with these compilations is that they could readily
develop into blacklists that are unsupported by an ade-
quate review of the data. (The EPA also publishes so-
called candidate lists for interim review.) In all pro-
bability, OSHA may abandon these potentially damag-
ing lists as they reconsider talking a generic approach to
carcinogeniety.
The OSHA Carcinogen Policy's provision that expo-
sure limits for Category I carcinogens must be set at
zero if a substitute is available for one or more uses is a
"zero-risk" idea. This is inconsistant with Executive
Order 12291 and its cost/benefit considerations, also
with the Supreme Court's ruling in the celebrated
benzene case in 1980. Any publication of Category I or
Category II lists will probably be contested by industry.
A problem in this area is that the EPA's TSCA policy
covers much of the same responsibilities in its aim of
preventing unreasonable risks of injury or health from
exposure to toxic substances. TSCA personnel, work-
ing with OSHA people, are assembling Category I and
II listings which will probably total some 3,500
chemicals—from 6 to 9% of all chemicals in commercial
use, according to definition. If either agency eventually
require the labeling of industrial containers of these
substances as "DANGER" — Contains (Chemical
Name) — Cancer Hazard", there will be an unprece-
dented level of resistance by the business community.
Behind all this there are some deep-seated dichot-
omies. For example, OSHA has suggested that from 60
to 90% of all cancers in the U.S.A. are associated with
environmental factors caused by industrial substances
and pollution. Industry feels the figure is more properly
less than 5% and receding; that personal habits —
smoking, drinking alcoholic beverages, eating charred
meat or caramelized glazed doughnuts—are more im-
portant by far. Also, both OSHA and TSCA consider
that if a substance produces cancer in a test animal,
regardless of dosage level or time of administration, that
it should be sanctioned. Industry feels otherwise,
recognizing that there are broad response differences
between animals and that humans appear to be less
susceptable to carcinogens in general. These points are
more fully described in the chapter on Aerosol Tox-
icology.
OSHA is highly interested in having industry pro-
vide employees with data and training that may act to
help them avoid health and safety problems. The
Materials Safety Data Sheet (OSHA Form 20) was
designed to supply toxicological data and precautions
against undue exposure to specific chemicals. Copies of
these forms (for individual chemicals and also for
aerosol formulations) are shown in the Aerosol Tox-
icology chapter. In practice, firms that consistantly deal
with 1000 to 3000 chemicals, such as aerosol fillers, find
it difficult to produce these forms for all their chemicals
and finished formulations. When they do, the forms
seem to go into the back of a cabinet and be largely
forgotten by the employees they were designed to help.
The OSHA health standards, such as the benzene
standard 1910.1028, the coke oven emissions standard
1910.1029, and so forth have quite specific and detailed
requirements for the instruction and training of
employees exposed to these hazards. Broader safety
standards, such as the respiratory protection standard
1910.134, also contain references to instruction and
training. OSHA's Employment Safety and Health
Guide, Chapter VIII, Part 4360.1 Section 5(a)(l) is
being used increasingly by OSHA Compliance Officers
as the basis for violations for employers who fail to train
and properly instruct the employee in the hazards asso-
ciated with his/her work. For example, under the
General Duty Clause, an aerosol filler must advise an
employee about the possible hazards of hot tank opera-
tions, the flammability of various solvents used in com-
pounding, the danger of hand-puncturing power-aero-
sol units and even, in one case, the danger of delib-
erately inhaling nitrous oxide (№0) gas to achieve a
psychedelic high.
During 1981 OSHA proposed either mandatory
standards or guidelines to protect laboratory workers
against exposure to toxic chemicals. Part of the back-
ground was a recognition that many laboratory and
research chemicals are more toxic than those used in
industry in general, and that the greater professional
training of chemists and technicians may not be a suffi-
cient offset. Industry has objected, stating that the
agency should work through professional groups who
routinely publish such guidelines. As of mid-1982 the
matter was still unresolved.
The OSHA position on a worker's "right to know"
is the object of much controversy at this time. A Hazar-
cjous Materials Identification System (HMIS) labeling
proposal in being implemented to promote worker
safety when using chemical raw materials. The use of
Material Safety Data Sheets (MSDS) is still voluntary,
except for the U.S. Coast Guard and a few other small
areas, but it will probably be mandated ultimately by
either OSHA or EPA (TSCA). Under Section 6(b)(7)
OSHA is now attempting to provide workers with vast
files of data relative to the identification of chemical
ingredients in industrial mixtures, even though they
might constitute confidential information of extreme
importance to the business interests of the suppliers
involved. The agency feels that confidentialities, trade
secrets, patient/doctor communications and records are
all subsidiary to the basic health and safety of the
worker and should be accessible. In the near future they
may follow up this presumed role more closely and
agree with the EPA to leave chemical hazard warnings
up to TSCA.
Provisions of the "right to know" issue that are con-
tested by industry include the right of workers to walk
off the job if they feel that hazard information is not pro-
vided or is inadequate, responsibility of the employer to
provide lists of hazardous substances that are being
used, requirements for the employer to maintain safety
records over long periods of time, and the publication of
trade secret information. There is some concern that
tanks and filling machines will perhaps have to be
placarded with hazardous product data on contained
products, although pipelines, pumps and so forth
would be exempted. Under their proposed new Hazard
Communication Rule, OSHA plans to phase in these
standards by 1985. A hazardous mixture is also defined
as any combination of chemicals containing at least 1 %
of a hazardous chemical. On this basis, even a shaving
cream could be cited as hazardous. The "right to
know" proposed standard could pose an initial cost of
$590 million, with annual costs of $230 million there-
after, in 1982 dollars. It is regarded as the most impor-
tant regulatory action to affect the aerosol industry in
1982 and 1983.
Department of Transportation (DOT)
This relatively new federal unit operates under Title
49 of the Code of Federal Regulations, having replaced the
older Interstate Commerce Commission (ICC) as the
regulatory body dealing with interstate transportation.
In the regulations, virtually all aerosols are covered
under Section 173.500(a)(4) of the Official Tariff.
They are considered as ORM-D commodities: mate-
rials that present a limited hazard during transporta-
tion, due to their form, quantity or packaging. These
materials must be subject to the exemptions recited in
Section 172.101. A specific shipping description is
required, as provided in Section 172.101.
Those regulations specific to aerosols are listed in
Sections 173.300(a) definitions of compressed gas,
173.300(b) definitions of flammable compressed gas,
173.306(a) requirements for limited quantities of (non-
flammable and flammable) compressed gases and
173.1200(8) requirements for (non-flammable and
flammable) compressed gases. Definitions are pre-
sented in the Aerosol Flammability chapter. Most aero-
sol shipments are covered under 173.306(a), and these
requirements are given as follows:
Limited quantities of compressed gases,
(a) Limited quantities of compressed gases for which excep-
tions are permitted as noted by reference to this section in
$172.101 of this subchapter are exception, specification
packaging requirements of this subchapter when packed in
accordance with the following paragraphs. In addition,
shipments are not subject to Subpart F of Part 172 of this
subchapter, to Part 174 of this subchapter except §174.24
and to Part 177 of this subchapter except $177.817. (1)
When in containers of not more than 4 fluid ounces capacity
(7.22 cubic inches or less) except cigarette lighters. Special
exceptions for shipment of certain compressed gases in the
ORM-D class are provided in Subpart N of this part. (2)
When in metal containers filled with a material that is not
classed as a hazardous material to not more than 90 per cent
 of capacity at 7O0F then charged with nonflammable, non-
liquefied gas. Each container must be tested to three times
the pressure at 7O0F and when refilled, be retested to three
times the pressure of the gas at 7O0F. Also, one of the follow-
ing conditions must be met:
(i) Container is not over 1 quart capacity and charged to
not more than 170 psig at 7O0F and must be packed in
strong outside packaging, or
(ii) Container is not over 30 gallons capacity and charged
to not more than 75 psig at 7O0F
(3) When in metal container charged with a solution of
materials and compressed gas or gases which is non-
poisonous, provided all of the following conditions are met.
Special exceptions for shipment of aerosols in the ORM-D
class are provided in Subpart N of this part.
(i) Capacity must not exceed 50 cubic inches (27.7 fluid
ounces).
(ii) Pressure in the container must not exceed 180 psig at
13O0F. If the pressure exceeds 140 psig at 14O0F but does
not exceed 160 psig at 13O0F, a specification DOT 2P
($178.33 of this subchapter) inside metal container must
be used; if the pressure exceeds 160 psig at 13O0F, a
specification DOT 2Q ($178.33a of this subchapter) in-
side metal container must be used. In any event, the
metal container must be capable of withstanding without
bursting a pressure of one and one-half times the
equilibrium pressure of the content at 13O0F.
(iii) Liquid content of the material and gas must not
completely fill the container at 13O0F.
(iv) The container must be packed in strong outside
packagings.
(v) Each completed container filled for shipment must
have been heated until the pressure in the container is
equivalent to the equilibrium pressure of the content at
13O0F. (550C.) without evidence of leakage, distortion,
or other defect.
(vi) Each outside packaging must be marked INSIDE
CONTAINERS COMPLY WITH PRESCRIBED
REGULATIONS.
The Section 173.1200 requirements are provided in
the introductory statements and then specifically in
173.1200(8). These are provided as follows:
If the material meets the definition of an ORM-D then the
material may be transported using the proper shipping
name: Consumer Commodity. The material may be hazard
classed as an ORM-D material provided that an ORM-D ex-
ception is authorized in the Hazardous Materials Table of
Section 172.101, and that it is prepared in accordance with
the following: (The gross weight of each package must not
exceed 65 pounds and each package offered for trans-
portation aboard aircraft must meet the requirements of
Section 173.6)
(Paragraphs 1 through 7 are omitted as inapplicable.)
(8) Compressed gases must be:
(i) In inside containers, each having a water capacity of
4-fluid ounces or less (7.22 cubic inches or less), packed
in strong outside packagings.
(ii) In inside metal container charged with a solution of
materials and compressed gas or gases which is non-
poisonous, meeting all of the following:
(A) Capacity may not exceed 50 cubic inches (27.7 fluid
ounces).
(B) Pressure in the container may not exceed 180 psig at
13O0F (550C) but does not exceed 160 psig at 13O0F (550C) a
specification DOT 2P (§178.33 of this subchapter) inside
metal container must be used; if the pressure exceeds 160
psig at 13O0F (550C), a specification DOT 2Q($178.33a of
this subchapter) inside metal container must be used. In any
event the metal container must be capable of withstanding,
without bursting, a pressure of one and one-half times the
equilibrium pressure of the contents at 13O0F (550C);
(C) Liquid content of the material and gas not completely
fill the container at 13O0F (550C);
(D) The containers must be packed in strong outside
packagings; and
(£) Each completed container filled for shipment must have
been heated until the pressure in the container is equivalent
to the equilibrium pressure of the content at 13O0F (550C)
without evidence of leakage, distortion, or other defect,
(iii) In a non-refillable inside metal container of 50
cubic-inch capacity or less (27.7 fluid ounces), with
foodstuffs or soaps and with soluble or emulsified com-
pressed gas, provided the pressure in the container does
not exceed 140 psig at 13O0F (550C). The metal container
must be capable of withstanding, without bursting, a
pressure of one and one-half times the equilibrium
pressure of the contents at 13O0F (550C) and must comp-
ly with the following provisions:
(A) Containers must be packed in strong outside packag-
ings, and
(B) Liquid content of the material and gas may not com-
pletely fill the container at 13O0F (550C).
(iv) In refillable inside metal containers with cream and
soluble or emulsified compressed gas packed in strong
outside packagings. Containers must be of such design
that they will hold pressure without permanent deforma-
tion up to 375 psig and must be equipped with a device
so as to release pressure without bursting of the container
or dangerous projection of the parts at higher pressures,
(v) In non-refillable inside metal containers charged
with a solution, containing biological products or a
medical preparation which could be deteriorated by
heat, and compressed gas or gasses which is non-
poisonous and non-flammable. The capacity of each con-
tainer may not exceed 35 cubic inches (19.3 fluid
ounces). The pressure of the container may not exceed
140 psig at 13O0F (550C) and the liquid content of the
product and gas may not completely fill the container at
13O0F (550C). One completed container out of each lot of
500 or less, filled for shipment, must be heated, until the
pressure in the container is equivalent to the equilibrium
pressure of the content at 13O0F (550C). There may not
be any evidence of leakage, distortion, or other defect.
Container must be packed in strong outside packagings.
(vi) In electronic tubes, each having a volume of not
 more than 30 cubic inches and charged with gas to a
pressure of not more than 35 psig and packed in strong
outside packagings.
(vii) In an inside metal container as a component of an
audible fire alarm system powered by a compressed gas
meeting the following provisions:
(A) Each inside container must have contents which are not
flammable, poisonous or corrosive and defined under this
Part;
(B) Each inside container may not have a capacity ex-
ceeding 35 cubic inches (19.3 fluid ounces);
(C) Each inside container may not have a pressure ex-
ceeding 70 psig at 7O0F (210C) and the liquid portion of the
gas may not completely fill the inside container at 13O0F
(550C);
(D) Each inside container must be designed and fabricated
with a burst pressure of not less than five times its charged
pressure or more than the pressure of the content at 13O0F
(550C); and
(E) Each fire alarm system must be packed in a strong out-
side packaging.
At the present time (1982), the only DOT-approved
' * strong outside packaging'' for aerosol units is 175 Ib or
heavier weight corrugate, depending upon package
weight, unless one considers wood or metal containers.
In Europe it is now commonplace to find aerosols six-
packed in light plastic trays and PE shrink-wrapped. In
the U.S.A. this substantially less expensive wrap is not
permitted, and several well-documented petitions
based upon extensive tests have been rejected. One
minor consolation is that, in a warehouse fire, cor-
rugate cases were found to be highly beneficial as heat
insulators, acting to slow down dramatically the
bursting and possible fire-balling of aerosol cans.
Shrink-wrapped palletloads did not demonstrate this ef-
fect. Despite the much lower BTU (cal/g) rating of the
shrink-wrap, fires involving it were much more intense
and harder to control.
In summary, the industry has very few problems
with the DOT at the present time. A good, reasonable
relationship has been established, and is likely to con-
tinue for a number of years to come.
The U.S. Department of Agriculture (USDA)
Until about 1970 the USDA administered the FIFRA
and other acts important to the aerosol industry, but at
that time they were transferred to the newly created
EPA and the Department took a subsidiary role. How-
ever, marketers have found that USDA must authorize
the use of various products within "official establish-
ment" operating under the Federal meat, poultry, shell
egg grading and egg products inspection programs.
Depending upon their composition, products may be
approved by the USDA for use in non-edible product
processing areas, non-processing areas and/or exterior
areas of these establishments, or actually within such
areas, provided they do not come into direct contact
with food products. A number of restrictions apply. For
pesticides, in addition to EPA registrational require-
ments, the product must have precautionary labeling
and use directions relating to such processing plants. In
general, no product may be used which masks odors
resulting from insanitary conditions, or which emits an
odor that can penetrate into an edible product area. A
stainless steel cleaner, for example, should be for-
mulated with an absolute minimum of fragrance if
USDA "exterior" approval is desired.
In pesticides areas the USDA wait for EPA approval,
after which they will then provide separate approval. It
is best to work simultaneously with both regulating
bodies when attempting to obtain both EPA and USDA
registrations for a given product, showing each the
correspondence received from the other.
After registration by the USDA, any distributor pro-
posing to sell the product to official establishments must
submit a completed MP Form 28 to the USDA for that
specific item. A letter of authorization is then issued. If
the registrant is not the distributor, a copy of the letter is
issued to the registrant as well, but no formal authoriza-
tion is issued to a non-distributor. Correspondence with
the USDA on these matters should be directed to:
Chemist-In-Charge
Compounds Evaluation Unit, CPS
Product Safety Branch
Food Ingredient Assessment Division
Food Safety and Quality Service
Science Division
U.S. Department of Agriculture
Building 306, Bare. East
Beltsville, MD 20705
An estimated 5 to 12 million aerosols per year are
registered with the USDA. Many are industrial pro-
ducts designed for use in restaurants, food kitchens,
meat processing plants and poultry house. A significant
number are packaged in large monobloc aluminum
cans with paper labels.
State Regulations
Under the constitutional scheme, in the U.S.A.
those powers not specifically ceded to the Federal
Government by the states are retained by the states and
may be exercised through the use of "police powers'' or
local state authority on all matters which concern the
health and welfare of the citizens of the state, or the state
itself. During the 1970s and especially during the open-
ing years of the 1980s (under Reagan) the states have
greatly increased their activity—especially in areas of
consumer protection and environmental matters. Both
have a profound effect upon the aerosol industry.
Usually, state regulations are designed to dove-tail
with and further support federal regulations in the same
area. But often some states will attempt to do more,
citing special problems of their cities, such as clean air
control in the Los Angeles basin, or storage in congested
New York City warehouses. In such cases, industry
must adapt to new "local" regulations that further
complicate the business process.
Some U.S.A. communities have large new settle-
ments of immigrants, who cannot read English labels
and who may therefore use pesticides or other products
they purchase incorrectly. More than one marketer has
been penalized for selling an English-labeled product in
communities with a high percentage of non-English
speaking people.
The deliberate inhalation of toluene-containing
aerosols (such as paints and coatings) has become a
major regional social problem in the southwest. An
example of local legislation to counter this situation is
the California Legislature amendment to Section 380 of
the Penal Code passed as Assembly Bill 797 in March
1980. This amendment prohibits retailers from selling
products containing toluene or any other item or com-
bination of hydrocarbons capable of inducing toxication
to minors. Penalties extended from $2500 fines to six-
month jail terms and even loss of license. In the back-
ground of this legislature was a fast growing problem of
substantive inhalent abuse, with no easy solutions. In
one city, aerosol drug abuse increased 40 times from
1974 to 1979.
In addition to the obvious commercial and legal
problems resulting from aerosol drug abuse, the per-
sonal and community injury is substantial. Irreversible
damage to the central nervous system of the abuser may
occur after the first or second year of "sniffing''. Brain
and liver damage may also result. These symptoms
would indicate that toluene and the xylenes are more
insidious than heroin when misused in this manner
(heroin does not attack the nervous system.) Any such
abuse is a strain on the community. An increase in
violent crime seems to occur along with such drug
abuse problems. The physical care of the "victims"
adds further to strains on their families and the com-
munity.
The original version of California AB-797 would
simply have banned the sale of any toluene type pro-
duct in California, except gasoline. Similar legislation
was considered in Texas, as a consequence of serious
abuse cases in Houston, Austin and Corpus Christi,
but was reduced to a ban on sale to persons under 18
years of age. Most aerosols used for "sniffing" are said
to have been stolen, so such partial bans are of doubtful
utility. To help in this situation industry has con-
tributed funds for model educational programs and
other worthwhile activities, but the problem still re-
mains a serious one for the paints and coatings segment
of the aerosol industry.
Regulations Concerning Weights and Measures.
Regulatory powers over weights and measures of
commodities are enjoyed by both the Federal Govern-
ment and the several states. Federal activities are han-
dled by the Bureau of Weights and Measures, National
Bureau of Standards, Office of Productivity, Tech-
nology and Innovation of the U.S. Department of
Commerce in Washingtion, D.C. One of the main
objectives of the Bureau is to coordinate and standar-
dize state regulations covering weights and measures in
the interest of uniformity and improved interstate com-
merce. Many of these activities are finalized each year
at the National Conference on Weights and Measures.
Attendees at these gatherings are mostly state officials
with direct responsibilities in this area. After agree-
ments are reached, sometimes by conference approval
of suggested model laws, these officials return and
generally take actions necessary to bring their states in-
to compliance.
The NBS became interested in aerosols about 1963,
at a time when they were actively promoting the con-
cept that certain packages, such as aerosols and fire
extinguishers, were basically "devices" and as such,
must deliver the declared contents, rather than just con-
tain a stated quantity. Until then, the aerosol industry
had always operated on a "contained" or dry-tare
quantity basis. Shortly afterward, they changed to a
"delivered" or wet-tare basis.
The method to determine quickly the delivered
weight became rather important. The ideal method was
to dispense as much as the consumer did over a period
of weeks or even months. Originally, and up to about
1981 there were four methods, one for foods, one for
high-viscosity products, one for non-food foam pro-
 ducts and finally one for low-viscosity products.
Various test allowances were stipulated, since it was
thought that the quick test method left slightly more in
the can than a consumer would. In the case of low-
viscosity products the allowance was set at Vie-oz (1.8 g)
for packages containing 1 H> oz to 3 oz (42.5 to 85.0 g)
and at % oz. (3.5 g) for all larger sizes.
About 1967, industry discovered that test allowances
were not really needed, and they were rarely used after
that. This information and data was presented to the
NBS, but they failed to act on it until about 13 years
later, when some Pennsylvania weights and measures
officials examined a huge number of aerosol products
and discovered the same facts, with the possible excep-
tion of a small variation for foams. Consequently the
Model Law and methods of test were changed.
The procedure involves selecting the lightest gross
weight dispenser from at least ten like containers,
without overcaps. The unit is shaken as specified on the
label. Holding the container, as per label instruction, it
is then actuated until commercially empty of liquid and
gas, with the operator recording the weight of the emp-
tied unit and determining the wet tare net weight
accordingly. If the net weight equals or exceeds the
declared weight, then the NBS suggest "it may be
reasonable to assume that the lot is satisfactory." If the
net weight is less than the declared weight, it is
necessary to treat the ten packages as a sample of the
lot. They may all be tested as was done for the lightest
can, but a more rapid and approved procedure is to go
through the test only for the heaviest gross weight
package. The wet tare weights of the lightest and
heaviest units are averaged to obtain the average wet
tare. This weight can then be subtracted from the gross
weights of all ten cans to determine the wet tare net
weight of each to the nearest 1A6 oz (1.8 g). (Note: Actu-
ally, most balances available to officials are accurate to
at least 0.1 g.)
Errors that are "unreasonably" large are circled.
For aerosol packages in the range of 2 to 8 oz (56.7 to
226.8 g) an unreasonble error is outside the range Of-3A6
to + % oz (-5.3 to -I-10.6 g) from the declared weight.
For aerosols containing 8 to 32 oz (226.8 to 907.0 g) an
unreasonable error is outside the range of - J4 to + Vi oz
(-7.1 to -»-14.2 g) from the declared weight. (Reference:
NBS Handbook No. 67 & 130, Section 5.1.3 Step 3.) If
one unit in the ten has an unreasonably large negative
error, the inspector may elect to examine more units,
order the lot repackaged or relabeled, or hold it in viola-
tion of the statute and taken in evidence, at his discre-
tion. If two units in ten have an unreasonably large
negative error the entire lot must be held in violation,
without looking at any further packages. Large plus
errors are merely reported to the store operator by
inspectors.
Several viscous aerosol products may leave as much
as 1 Vi oz (42.5 g) in the can when commercially emp-
tied. They are commonly filled by at least this much
extra in order to meet wet tare declared weight require-
ments. Most non-viscous products will only leave 1 to 2 g
in the cans when commercially emptied, even in the case
of large package sizes.
European Regulations
This area can be approached best from a considera-
tion of the European Economic Community Directives,
plus those of various other multi-national organiza-
tions.
Net Contents
The EEC Directives require that aerosols must be
marked with a statement of quantity, declared in
volume terms using the metric system. The declared
volume is corrected to a reference temperature of 680F
(2O0C). Minimum type sizes are stipulated. For
volumes to 50 ml the declaration must be 2 mm high,
for 50 to 200 ml it must be 3 mm high and for 200 to the
maximum fill of 750 ml it must be 4 mm high.
In the EEC Prescribed Quantities Directive, thirteen
volume fills are stipulated for metal containers, ranging
from 25 to 750 ml. Six volumetric fills are prescribed for
glass and plastic containers, and these range from 25 to
150 ml. Fills below 25 ml are not subject to the Direc-
tive. In every instance the capacity of the container itself
must also be shown on the label, but in such a way that
consumers will not confuse it with the quantity declara-
tion. The metal containers normally have capacities
about 20 to 25% greater than the volume of their con-
tents. Additional information in this complex area can
be obtained in the chapter on Metal Aerosol Con-
tainers, in the Code of Practice of the British Aerosol
Manufacturer's Association (BAMA), Fourth Edition,
1980, available at 9 pounds-sterling by applying to
them at the Alembic House, 93 Albert Embankment,
London SEl.7TU, or from the EEC Directive itself.
In order to indicate compliance with the EEC Pre-
packaging Directive and other EEC rules, an epsilon or
"e" must be shown in the same field of vision as the
quantity declaration, with a height of at least 3 mm.
The form of the "e" is specifically defined (see Aerosol
Flammability chapter). In the absence of this qualifying
sign the finished product will be immediately subject to
the labeling requirements of the country where it is
offered for sale. If these are different from those of the
EEC, it is likely that product seizure or other sanctions
will be applied.
EEC Directive No. 75/324 restricts aerosol container
sizes to 1000 ml for metal, 220 ml for protected glass
and 150 ml for plain glass. Plastic containers are classed
with either protected glass or plain glass, depending on
whether they shatter or not when impacted.
The degree of filling is defined as a minimum of
75v% at 680F (2O0C) and a maximum of 90v% at
1220F (5O0C), for all products with container capacities
greater than 50 ml. The EEC directives do not discuss
limit temperatures for the liquid-filling of aerosols, but
the West German Technical Regulations for Pres-
surized Gases (TRG - New Version) specifies that this
shall not occur below 1580F (7O0C) and other national
regulations cover this aspect as well.
Transportation
In Europe, both national and international organiza-
tions legislate the transportation by road, railroad, sea
and air. There is a high degree of regulatory harmony
between these rule-making bodies, as might be antici-
pated. EEC regulations and UN recommendations are
consistant with these transport regulations.
The Accord Europeen Relatif Ie Transport Inter-
national Dangereuses par Route (ADR) controls inter-
national road transportation in Europe. Aerosols (offi-
cially called pressurized packages) are grouped into the
"Danger Class 2", and further differentiations are
made according to (a) non-flammability, (b) flamma-
bility, with less than 45% flammable materials, and (c)
flammability, with more than 45% flammable
materials. Note that a "flammable material" for these
purposes is a substance with a Tag Closed Cup Flash-
point of 2120F (10O0C), although different flashpoint
testers are usually used.
Units with over 45% flammable content must be
marked with the word "Aerosol" plus a symbol show-
ing a black flame on a red background. Other aerosols
must be simply identified with the word "Aerosol" on
the outer packings.
All transport papers muist be filled out carefully. The
propellent used must be entered specifically with a red
underline, together with the class, number and letter of
the ADR specification. For example, if an aerosol con-
tains more than 45% flammables and propane/butane
is the propellent, the identification needs to be, "Pres-
surized packages with propane/butane, Class 2,
Number 1Ob, 2".
The Reglement International Concernant Ie Trans-
port de Merchandise Dangereuses par Chemin de Fer
(RID) controls the international railroad transportation
in Europe. The grouping of dangerous goods categories
is very similar to that described for the ADR. The
definition and classification of aerosols is identical, as is
the numbering system, but RID uses only the last three
digits of the ADR numbers. All types of aerosols can be
transported by express.
The International Maritime Dangerous Goods Code
(IMDG), formerly IMCO covers the shipment by sea
of aerosols of more than 50 ml content. The grouping of
aerosols according to the regulations in Annex "A",
also called the IMCO code, is much more complicated
than in the ADR or RID regulations. Depending upon
the container content, aerosols can be grouped very
differently:
Not dangereous: Aerosols containing no flammable
gases and not more than 10% of
flammable liquids.
Class 9: Aerosols containing no flammable
gases but more than 10% flam-
mable liquids.
Class 2: Aerosols containing more than 10%
of flammable gases.
Class 3: Aerosols containing either more
than 45 % of flammable liquids and
no flammable gases — or — more
than 35% flammable liquid in the
presence of flammable gases.
The class grouping, with UN-number and page
number of the IMCO Code defines the necessary kind
of packaging, declaration and marking, weight of trans-
port unit and the location on board the freight-carrying
ship.
The prescribed warning signs are similar to those in
use by the ADR and RID, but the flame symbol carries
the wording "Inflammable Gas" and also the number
of the Danger Class.
The International Air Transportation Association
(IATA) control worldwide shipments of aerosols by air,
subject to many additional restrictions by the individual
carriers themselves. Aerosols are listed in the alphabeti-
cal article compilation under numbers 2164-2166. The
compilation describes the official transport description
of the goods, the classification, the prescribed danger
symbol and the permission for transport by passenger
or freight planes. The IATA warning specifications are
different than those discussed under ADR, RID, and
IMDG.
If aerosols contain flammable gases or liquids the
transport unit must carry a prescribed red flame synlbol
(red label) with a specific warning statement on it.
Otherwise a green label is required, with the imprint,
"Non-flammable compressed gas. Keep cool."
German national regulation TRG-300 is very com-
plete and has served as an unofficial European standard
for countries not having developed their own internal
regulations. The EEC may adapt parts of it in time.
The regulation differentiates between warehouse
rooms, storage rooms and sales rooms. Warehouse
rooms are divided up into Size I (up to 646 ft2 or 60 m2),
Size II (to 5,380 ft2 or 500 m2) and Size III (above 5,380
ft 2 or 500 m2). Only 60% of these spaces must be used
for actual storage. Each room must be equipped with
adequate fire extinguishing pipelines and devices, and
the fire protection system has to be coordinated with the
local fire department.
No warehouse room may be located in a building
used also for residential purposes. Rooms of Size II
must not be below any other rooms continuously occu-
pied by people. Rooms of Size III must only be in
buildings used exclusively for warehousing. Each room
must have fire resistant walls, ceilings and floor
material, and be equipped with two separate exits with
fire-retardant doors. The rooms must not have any
heating devices with open fire and no chimney closures
for cleaning.
Storage rooms are rooms not larger than 215 ft 2 (20
m2) where aerosol packages may be kept before they are
moved to the sales rooms, and sales rooms must not be
used to store more product than is presumably required
for one day. Filled aerosols must not be permitted in
store windows, and aerosol sales stands are not permit-
ted near store exists. They must not be stored in
passages, stairway rooms, hallways or directly under
roofs. All warehouses must be adequately ventilated
and provide for easy escape in case of danger. Smoking
or open fire is not permitted in any storage room con-
taining aerosols, and such rooms must not contain
wastes or other flammable materials that are easily igni-
ted. The rooms must show the required warning signs.
The European regulations are sometimes rather
mind-boggling in their complexity. For example, in
Germany the transport of dangerous goods is covered
by two international recommendations, five inter-
national regulations and three national regulations,
totalling over 4000 pages of printed text. The portions
valid for aerosols are sprinkled throughout these com-
pendia and must be ferreted out for any real under-
standing of their portent.
Regulations Outside the U.S.A. and Europe
In Canada, new multi-model regulations are under
development covering all kinds of transport.
Previously the "Red Book" regulations for rail were
seen as highly effective and had been in use for many
years. National sea and air regulations were similar. No
federal regulations were applied to highway transporta-
tion, since this was classed as a provincial responsibili-
ty. These are now all replaced with the new Transpor-
tation of Dangerous Goods Act of 1980 and equivalent
provincial acts developed in 1981 and 1982. Regula-
tions under the basic act are still in development
(mid-1982) and are being published piecemeal in The
Canada Gazette as Transportation Canada's Dangerous
Goods Branch Codes 1,2,3,4 and so forth, still in draft
form. Industry sees these as giving them an uncon-
scionable economic burden. Infractions carry penalties
of up to $100,000 or two years in prison. Specific prob-
lems are that there will be an unnecessary degree of
container obsolescence due to mandated discard of low
lifespan tankcars, drums and so forth. The laws will de-
mand Canadian labeling, even in aerosols sent down to
Canada's largest customer: the U.S.A. The proposed
regulations would discard proven IATA regulations in
favor of unproven UN ideas. Added definitions are
needed. A total of nine classes are being developed for
dangerous goods.
During 1969, a tough Canadian Hazardous Prod-
ucts Act was enacted and went into effect on February
28, 1972 because of the difficulties experienced by
industry in complying with some of the more onerous
provisions. The act is fairly complex. It mandates a
series of twelve bold danger, warning and caution sym-
bols for product labeling, in accordance with the degree
of hazard and also requires bilingual (English and
French) label warnings for many household products.
Consumer commodities covered under the regulation
include bleaches, polishes, sanitizers, glues, aerosols
and cleaners. Every type of aerosol is required to carry
an explosive warning symbol, unless it can be rendered
non-explosive by means of RVR or PRM can dome, a
special pressure-relieving valve or some other author-
ized fitment. At the time the law went into effect,
Minister Ronald Bashford, head of Canada's Con-
sumer and Corporate Affairs, indicated that the octa-
gon around an exploding bomb signifies "DANGER
— Explosive—it can kill you." A diamond around the
bomb would mean "WARNING—Explosive—it can
severely injure you.'' And a triangle shape would mean
"CAUTION — Explosive — it can injure you/' A
typical aerosol furniture polish, sold in Canada, would
carry three symbols: "DANGER—Poison—WARN-
ING — Flammable — CAUTION — Explosive.
The twelve symbols and their significance are illu-
strated in Figure 1.
They are required for all regulated products and are
placed on the principal display panel below the com-
mon name or brand name of the product. The area of a
circle circumscribing the symbol may not be less than
4% of the area of the principal disply panel and, in no
event, can it be less than V 8 " in diameter. Despite their
approximate size equivalency, the danger symbol is
most prominent, followed by the warning sign and then
the caution symbol.
The signal word, at least 3 / 3 2" in height, is inscribed
just below the symbol. The statement of primary
hazard is inscribed just below the signal word, and in a
height of Vi 6 " for smaller cans and V8 " for the larger
sizes. Statements of the nature of a secondary hazard,
statements of precaution, first-aid treatment and so
forth are presented anywhere on the label in type not
Figure 1.
DANGER/POISON DANGER/FLAMMABLE
DANGER/EXPLOSIVE
WARNING/POISON WARNING/FLAMMABLE WARNING/EXPLOSIVE
CAUTION/POISON CAUTION/FLAMMABLE CAUTION/EXPLOSIVE
less than Vie " high for all aerosol can sizes, except the
300 x 709 cans, where they are V8 " high.
Flammable products are judged as to relative hazard
by means of flashpoint, but it now appears, because of
industry protests, the aerosols will be assessed accor-
ding to the general concepts for "Extremely Flam-
mable", "Flammable" and "Combustible" classifi-
cation as used in the United States FHSL Act. The
government may also cause the manufacturer of any
product to disclose the complete formulation in order to
ensure adequate regulations.
The appearance of one, two or three prominent sym-
bols in the middle of the front panel of Canadian
aerosols and other regulated products is quite disastrous
from an aesthetic standpoint. It will undoubtedly result
in more expensive and often less effective products as
marketers attempt to avoid this stigma.
The Canadian Consumer Packaging and Labeling
Act of 1972 became effective in 1973 and was patterned
after the U.S. Fair Packaging and Labeling Act
(FPLA). However, it has a considerably tougher make
up. Like the CHPA, it is administered by the Canadian
Department of Corporate and Consumer Affairs. It has
a number of important features. Some are recited as
follows:
a. Covers all household products and is intended to
facilitate rational choice of products by consumers
at the point of purchase.
b. The net weight must appear in both the appro-
priate English units (pounds, etc.) and in the
equivalent metric units. (This continues
Canada's move toward total metrication.)
c. Bilingual labeling is specified for all but a few
exempted products.
d. A provision encourages voluntary package-size
standardization by industry, but empowers the
government to seize products if it determines that
there are too many sizes and shapes.
e. Gives the government the power to issue "on the
DANGER/CORROSIVE
spot" regulations, justifying them on the grounds
that they are beneficial to consumer.
The net effect of these and other legislated restric-
tions have led industry observers to suggest that the
Canadian aerosol industry will have a significantly
WARNING 1 CORROSIVE tougher time coping with the regulatory burden than
will be the case for the industry in the U.S.A., at least
for the foreseeable future.
(Brief comments for registration in other countries
CAUTION/CORROSIVE
are listed on Page 484)