17

Regulations and Data

This chapter contains information on regulations which are relevant for antiblock-
ing, release, and slip agents use. Some relevant properties are also illustrated with
data characterizing the severity of their influence on health and safety. The follow-
ing effects are considered:
• toxic substance control
• carcinogenic effect
• workplace exposure limits
• food regulatory acts

17.1 TOXIC SUBSTANCE CONTROL

The United States Congress enacted the Toxic Substances Control Act.1 The fol-
lowing are the premises of the Act: “Human beings and the environment are being
exposed each year to a large number of chemical substances and mixtures; among
the many chemical substances and mixtures which are constantly being developed
and produced, there are some whose manufacture, processing, distribution in
commerce, use, or disposal may present an unreasonable risk of injury to health or
the environment”
The chemical substances in the Chemical Substances Inventory contain
chemical compounds which are permitted for use by industry. New compounds,
not available on this list, must undergo a process established by the Environmental
Protection Agency, EPA.
The Inventory is not created to list substances but for the purpose stated in
Section 2624: “The Council on Environmental Quality, in consultation with the
Administrator, the Secretary of Health and Human Services, the Secretary of
Commerce, and the heads of other appropriate Federal departments or agencies,
shall coordinate a study of the feasibility of establishing a standard classification
system for chemical substances and related substances, and a standard means for
storing and for obtaining rapid access to information respecting such substances.”
This very useful regulation, after more than a quarter century of practice,
nevertheless does not give sufficient information. The EPA has selected a group of
High Production Volume, HPV, chemicals, which constitutes 2,863 organic chem-
icals produced or imported at or above 1 million pounds per year in the United
States. These chemicals have a large impact on health and safety because of their
306 17.1 Toxic substance control

widespread application. The EPA’s analysis found that no basic toxicity informa-
tion, i.e., neither human health nor environmental toxicity, is publicly available for
43% of the high volume chemicals manufactured in the US, and that a full set of
basic toxicity information is available for only 7% of these chemicals. More infor-
mation is available elsewhere.2-4
The lack of this basic toxicity information, on most high volume chemicals,
is a serious issue for risk assessment, safeguarding children’s health, expanding
the public’s right-to-know, and promoting the pollution prevention ethic, which
are important EPA initiatives.
Table 17.1 lists antiblocking, release and slip agents which are HPV chemi-
cals, and information on data availability on acute toxicity, AT, chronic toxicity,
CT, teratogenicity, T, or developmental and reproductive toxicity, mutagenicity,
M, ecotoxicity, E.

Table 17.1 Additives on HPV chemicals list and data availability5

Data available (Y − yes; N − no)
CAS # Additive name
AT CT T M E
56815 Glycerin Y Y Y Y Y
57114 Stearic acid Y N Y Y Y
93834 N,N’-bis(2-hydroxyethyl) oleamide N N N N Y
110305 N,N’-ethylene bisoctadecanamide Y N N Y N
112845 Erucamide N N N N N
112925 Stearyl alcohol Y N N N Y
115833 Pentaerythritol tetrastearate N N N N N
120401 N,N-bis(2-hydroxyethyl) dodecanamide Y N N N N
123955 Butyl stearate Y N Y Y N
124265 Stearamide N N N Y Y
301020 Oleamide N N N Y N
532321 Sodium benzoate Y N Y Y Y
557040 Magnesium stearate N N Y N N
557051 Zinc stearate Y N N N N
637127 Aluminum stearate Y N N N N
1338438 Sorbitan monooleate N N N Y Y
1592230 Calcium stearate Y N N Y N
8002742 Paraffin wax Y Y N N N
31566311 Glycerol monostearate Y N N N Y
Regulations and Data 307

The above table shows that only some additives were tested for these basic
indicators of toxicity. Many generic compounds present in antiblocking, release,
and slip additives in use today were not tested.

17.2. CARCINOGENIC EFFECT

To regulate carcinogenic substances, Federal agencies follow rulemaking proce-
dures. Rulemaking procedures may be:
• risk-based (for example, the Delaney clause that bans a food additive
shown to cause cancer in humans or in animal tests)
• technology-based, which might require the use of “best available technol-
ogy” or “best practical technology” to control emissions from a particular
source
• risk-benefit or cost-benefit balancing, which permits the consideration of
competing health risks and benefits (for example, cancer-causing drugs
treat fatal illnesses but may affect other organs).6
The Occupational Safety and Health Act of 1970 established the Occupa-
tional Safety and Health Administration, OSHA, and the National Institute for
Occupational Safety and Health, NIOSH. OSHA is a regulatory agency which,
among its other duties, issues and enforces regulations that limit exposure to car-
cinogens in the workplace. NIOSH is a research agency that has supported epide-
miological and toxicological research, and makes recommendations to OSHA
concerning changes in occupational health standards.6
In its rulemaking procedure, OSHA has used two different approaches for
limiting exposures: setting permissible exposure limits, and requiring specific
process technology and procedures. In addition to the data from the National Tox-
icology Program, NTP, OSHA also considers the classification of the International
Agency for Research on Cancer, IARC. Based on this data OSHA makes its own
decisions. Table 17.2 contains information on substances used as antiblocking,
release, and slip additives and included on lists of carcinogens.

Table 17.2. Antiblocking, release, and slip additives on carcinogen

lists7
Chemical substance IARC NTP OSHA-Z
Asbestos (friable) 1 K Z
Silica (crystalline) 1 K -

1 known human carcinogen

K known to be human carcinogen
Z The chemical appears at 29 CFR part 1910 Subpart Z.

Table 17.2 shows that only potential admixtures to some antiblocking agents
are found on carcinogen lists.
308 17.3 Workplace exposure limits

17.3 WORKPLACE EXPOSURE LIMITS

There are numerous limiting values set to protect employees against workplace
exposures. The definitions of these values are given below:
1. Threshold Limit Value, TLV, is an exposure standard set by a committee of
the American Conference of Governmental Industrial Hygienists, ACGIH.
The TLVs are published annually. The guidelines are based on available ani-
mal and human exposure studies. The rationale for setting the TLVs is given
in an ACGIH publication.8 The ACGIH committee is independent and flexi-
ble, incorporates new data rapidly, and is relatively free of bureaucratic con-
strains of official government agencies. The TLV’s are recommended values,
not legal limits. They do not guarantee protection to all workers, and they are
not intended to be used for community exposure. TLVs are values that should
not be exceeded. The goal is to minimize workers’ exposure to hazardous
concentrations as much as possible.9
2. Recommended Exposure Limits, REL, are set by the National Institute for
Occupational Safety and Health, NIOSH, which is a part of the department of
Health and Human Services. NIOSH scientists recommend exposure limits
to OSHA, based on animal and human studies. NIOSH RELs are often more
conservative than the TLV, and NIOSH’s consideration of available research
and studies is regarded as thorough.9
3. Permissible Exposure Limits, PEL, are set by the Occupational Safety and
Health Administration, OSHA, and are the law of the land in the United
States. Workers' exposure may not exceed these standards, and OSHA has
the power to warn, cite, and fine violators. The Act required OSHA to set
standards that will provide safe working conditions by negotiation and con-
sensus. As a result, only about 25 permanent standards have been set since
1973. To protect workers in the meantime, OSHA was allowed to adopt
existing standards or develop Emergency Temporary Standards (ETS).
OSHA adopted the ACGIH TLV as the interim standard, giving legal status
to what was meant to serve as recommended limits. The permanent standards
are thorough and reflect the extensive effort invested in their preparation.
They include action levels that are typically half the TWA exposure limits.
When the action limit is exceeded, several steps must be taken such as medi-
cal monitoring, air sampling, and control measures. Each permanent standard
includes recommendations for air sampling procedures, regulations for
record keeping, engineering control methods, labeling and warning, and
other pertinent regulations.9 The PELs are published in 29 CFR 1910.1000.10
Time-Weighted Average, TWA, is the concentration of contaminants over an
8-hour period. It is determined by sampling the breathing zone of the worker
for 8 hours. It is expressed as follows, when a series of successive samples
have been taken:

 Ci ti
i
TWA = --------------
- [17.1]
 t i
i
Regulations and Data 309

where:
ti the period of time during which one sample is taken
Ci the average concentration over time period ti.

To determine the level of exposure, the TWA reading is compared with a

standard such as the threshold limit value, TLV, or permissible exposure
limit, PEL. If the reading exceeded the standard, overexposure occurred.9
4. Short-Term Exposure Limit, STEL, is a 15-minute TWA concentration that
may not be exceeded, even if the 8-hour TWA is within the standards. TWA-
STEL are given for contaminants for which short-term hazards are known.
For the rest, an excursion factor of 3 has been often used: STEL should not
exceed 3 times the TWA limit.9
5. Ceiling is a concentration that should not be exceeded at any time. Note that
both TWA and STEL permit limited excursion if, in the end, the average is
below the exposure limit. The ceiling value, however, may not be exceeded.9
6. Immediately Dangerous to Life and Health, IDLH, is defined as conditions
that pose immediate danger to life or health, or conditions that pose a threat
of severe exposure. IDLH limits are created mainly to assist in making deci-
sions regarding respirator use: above the IDLH only supplied air respirators
should be used, below the IDLH, air purifying respirators may be used, if
appropriate. Two factors were considered when establishing the IDLH limits:
• workers must be able to escape such an environment without suffering
permanent health damage
• workers must be able to escape without severe eye or respiratory tract irri-
tation or other conditions that might impair their escape
The current definition has no exposure duration associated with it. Workers
should not be in an IDLH environment for any length of time, unless they are
equipped and protected to be in that environment. IDLH values were determined
based on animal and human data. They may be found in the NIOSH Pocket Guide
to Chemical Hazards.11
Occupational Exposure Limits, OELs, are set by the European Union. In
1990, at the request of the Council, the European Commission had set up an infor-
mal group of scientists, known as the Scientific Expert Group, SEG, to give advice
on setting limit values, after having reviewed the different approaches in the
Member States. To encourage the Occupational Exposure Limits, OELs, the Euro-
pean Commission decided to formalize the SEG, and with its Decision 95/320/EC
of 12 July 1995 has set up a formal base for the work on the scientific evaluation
of risk at the workplace related to chemical substances.12 The proposed values
include:
• the eight-hour time weighted average, TWA
• short-term/excursion limits, STEL
Table 17.3 gives limits for air contaminants for all antiblocking, release, and slip
agents available from OSHA10 and NIOSH.11 European Union approved TWA and
310 17.4 Food regulatory acts

STEL limits for approximately 50 chemicals, but none of them was either anti-
blocking, release, or slip agent.2

Table 17.3. Limits for air contaminants from OSHA10 and NIOSH11
Additive PEL, mg m-3 REL, mg m-3 IDLH, mg m-3
Diatomaceous earth 80 6 3,000
Glycerin (mist) 15 (t), 5 (r)
Graphite (natural) 2.5 (r) 1250
Graphite (synthetic) 15 (t), 5 (r)
Particulates not regulated 15 (t), 5 (r)
Silica amorphous 80 6 3,000
Silica crystalline (respirable dust) 30 (t), 10 (r) 0.05 25-50
Talc (no asbestos, quartz < 1%) 80 2 1,000
Zinc stearate 15 (t), 5 (r) 10 (t), 5 (r)

(r) respiratory
(t) total

Only some, mostly antiblocking, additives are regulated.

17.4 FOOD REGULATORY ACTS

In the United States, the Food and Drug Administration is entrusted by a Code of
Federal Regulations13 to control use of different materials in the production of
food and its packaging. Two types of additives are used in connection with food:
additives permitted to be added to food directly, and additives which are used in
materials in contact with food products.
Table 17.4 shows the relevant parts of Regulation13 and additives which may
be directly added to food.

Table 17.4. Agents permitted as direct additives to food13

Part
Part 172. Food Additives Permitted for Direct Addition to Food for Human Consumption
172.260 Oxidized polyethylene
172.480 Silicon dioxide
172.811 Glyceryl tristearate
172.863 Salts of fatty acids
172.864 Synthetic fatty alcohols
172.866 Synthetic glycerin produced by the hydrogenolysis of carbohydrates
Regulations and Data 311

Table 17.4. Agents permitted as direct additives to food13

Part
172.886 Petroleum wax
172.888 Synthetic petroleum wax

Table 17.4 shows the relevant parts of the Regulation,13 and additives sanc-
tioned as indirect food additives. This further reinforces the notion of low toxicity
of these additives.
Table 17.5 shows the relevant parts of the Regulation13 and antiblocking,
release, and slip agents sanctioned as indirect food additives.
Table 17.5. Agents permitted as indirect additives to food13

Part Description Additives

Part 175 - Indirect food additives: Adhesives and components of coatings
175.105 Adhesives butyl stearate, cetyl alcohol, erucamide, fatty acid salts of Al, Ca, K, Mg, Na and Zn,
montan wax, oleamide, palmitamide, pentaerythritol tetrastearate, petroleum waxes,
polyethylene oxidized, sorbitan monooleate, stearamide, stearic acid
175.125 Pressure-sensitive polyethylene oxidized
adhesives
175 C Coatings aluminum stearate, cetyl alcohol, fatty acid salts of Al, Ca, K, Mg, Na and Zn, glycerol,
glyceryl monostearate, lauryl amide, lecithin, N,N’-distearoyl ethylenediamine, ole-
amide, palmitamide, paraffin wax, polyethylene wax, polytetrafluoroethylene, silica, sil-
icone oil, stearic acid
Part 176. Indirect Food Additives: Paper and Paperboard Components
176.170 Paper components calcium isostearate, fatty acid salts of Al, Ca, K, Mg, Na and Zn, pentaerythritol tet-
rastearate, polyethylene oxidized, silicone oil
Part 177 - Indirect food additives: Polymers
177.1010 Acrylics fatty acids derived from animal and vegetable fats and oils, and fatty alcohols derived
from such acids used as release agents
177.1200 Cellophane behenamide, erucamide, fatty acid salts of Al, Ca, K, Mg, Na and Zn, pentaerythritol tet-
rastearate (0.1%), petroleum wax, silica
177.1210 Closures erucamide (5%), stearamide (5%)
177.1580 Polycarbonate resins pentaerythritol tetrastearate (0.5%)
177.1620 Polyethylene oxidized as part of food contact materials
177.1900 Urea-formaldehyde zinc stearate
177.2420 Polyester resins glycerol, petroleum wax, silicon dioxide
177.2600 Rubber calcium stearate, fatty acids, montan wax, petroleum wax, silica, sodium stearate
Part 178. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
178.3450 Esters palmityl stearate, stearyl palmitate
178.3480 Fatty alcohols cetyl alcohol, stearyl alcohol
178.3500 Glycerin
178.3690 Pentaerythritol pentaerythritol tetrastearate
178.3710 Petroleum wax
178.3860 Release agents erucamide, N,N’-dioleoylethylenediamine, oleyl palmitamide, poly(vinyl acetate/vinyl
N-octadecylcarbamate), rice bran wax, saturated fatty acid amides, stearyl erucamide
312 References

REFERENCES
1 Title 15 - Commerce and Trade. Chapter 53. Toxic Substances Control. Subchapter I - Control
of Toxic Substances.
2 Wypych, G., Handbook of Plasticizers, Wypych G., Ed., ChemTec Publishing, Toronto 2004.
3 Chemical Hazard Data Availability Study. What Do We Really Know About the Safety of
High Production Volume Chemicals? EPA’s 1998 Baseline of Hazard Information that is
Readily Available to the Public Prepared by EPA’s Office of Pollution Prevention and Toxics,
April 1998.
4 EPA information on 2863 U.S. HPV Chemicals from 1990 IUR Update.
5 Master Summary for the Chemical Hazard Data Availability Table, EPA.
6 Identifying and Regulating Carcinogens, NTIS, November 1987.
7 2001 Toxic Release Inventory. Public Data Release. Appendix C. Basis of OSHA Carcinogen
Listing for Individual Chemicals.
8 Documentation of the Threshold Limit Values and Biological Exposure Indices, 7th Ed.
ACGIH, 2001.
9 Office of response and Restoration, National Ocean Service, National Oceanic and
Atmospheric Administration. Occupational Exposure Limits, March 2002.
10 US Department of Labor. Occupational Safety & Health Administration. Standards - 29 CFR.
Table Z-1. Limits for Air Contaminants. - 1910.1000.
11 NIOSH Pocket Guide to Chemical Hazards. NIOSH Publication No. 97-140. January 2003.
12 Occupational Exposure Limits, OELs, Official J., L188, p.14, (1995).
13 Code of Federal Regulations. Title 21. Food and Drugs. Chapter 1. Food and Drug
Administration, Department of Health and Human Services.