INTEGRATED MULTIMEDIA
CONTROL ALTERNATIVES
DRAFT Phase I Case Study
NITROSAMINES
Contract 68-01-6020
Gene E. Fax, Project Manager
John Reinhardt, Principal Author
May 18, 1981
Submitted for review to:
Arnold Edelman
Office of Toxics Integration
U.S. Environmental Protection
Abt Associates Inc., Cambridge, Massachusetts
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ABT ASSOCIATES INC.
55 WHEELER STREET. CAMBRIDGE. MASSACHUSETTS 02138
TELEPHONE • AREA S 1 T - 4 S 2 - 7 1 O O
INTEGRATED MULTIMEDIA
CONTROL ALTERNATIVES
DRAFT Phase I Case Study
NITROSAMINES
Contract 68-01-6020
Gene E. Fax, Project Manager
John Reinhardt, Principal Author
May 18, 1981
Submitted for review to:
Arnold Edelman
Office of Toxics Integration
U.S. Environmental Protection
Agency
Washington, D. C. 20560
71oh—\ \jL
Reviewer Manag8mei
Contract Manager
I
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DRAFT
SUMMARY OF FINDINGS
Nitrosamines from a large class of compounds many of which are proven
carcinogens. These toxic substances have been of great concern to the
regulators of different media. Unlike most pollutants, however, nitros-
amines are not generally emitted to the environment; rather, they form in
various media when their chemical precursors are present. To the extent
that nitrosamines have been controlled, most of the present regulations are
narrow in scope, dealing with specific media and routes of contamination.
For example, FDA regulations limit nitrosamines in malt beverages and EPA
regulations limit nitrosamines in certain presticides. The hazardous
waste management system regulations include nitrosamines in a general list
of toxic constituents, but do not address specific wastes known to contain
these chemicals.
Since the regulations have been developed for the most part in
response to specific situations, there has not been a systematic multi-
agency effort to assess the environmental problems associated with nitros-
amines. For instance, FDA's recommendation to burn sulfur during the malt
drying process cold result in unforeseen air emissions of SO . The ad hoc
approach is further evidenced by the absence of materials flow analyses.
Such an analysis would be very complex because of the problem of formation
from precursors in water, air, soil, and animal digestive tracts. The
absence of a materials flow analysis prevents estimating overall population
exposures to nitrosamines. Further, since there is no estimate of overall
population exposure, there can be no accurate assessment of health risks
due to exposures from known sources, either individually or collectively.
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DRAFT
Table of Contents
SUMMARY OF FINDINGS
3.0 NITROSAMINES 1
3.1. INTRODUCTION AND FINDINGS 1
3.1.1 Introduction 1
3.1.2 Findings: Multimedia Considerations in Rulemaking 3
3.1.3 Findings: Unanticipated Effects of Regulations 6
3.1.4 Findings: Regulatory Gaps 6
3.2 Regulatory Histories 9
3.2.1 Office of Water Regulations and Standards (EPA/OWRS) 9
3.2.1.1 Toxic Pollutant Effluent Standards 9
3.2.1.2 Water Quality Criteria 10
3.2.1.3 Designation of Hazardous Substances and Reportable 16
Quantities
3.2.2 Office of Solid Waste (EPA/OSW) 20
3.2.2.1 Hazardous Waste Management System (EPA/OSW) 20
3.2.3 Office of Pesticide Programs (OPP) 23
3.2.3.1 Registration of Pesticides 23
3.2.4 Occupational Safety and Health Administration (OSHA) 27
3.2.4.1 Occupational Exposure to Dimethylnitrosamine (DMN) 27
3.2.5 Food and Drug Administration (FDA) 32
3.2.5.1 Nitrosamines (DMN and NDELA) 32
3.2.5.2 Nitrites/Nitrates 33
3.6.1 Food Safety and Quality Service (Department of Agricul- 37
ture/FSQS)
3.6.1.1 Entry Into Official Establishments, Remspection 37
and Preparation of Products
APPENDIX
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3.0 NITROSAMINES
3.1 INTRODUCTION AND FINDINGS
3.1.1 Introduction
The subject of this case study is the degree to which Federal
regulatory agencies have taken multimedia effects into account in their
rulemaking procedures to control nitrosamines in the environment. Three
major issues are the focus of attention:
1. The degree to which each agency, during rulemaking,
considered the presence of nitrosamines in media
other than the one or ones being regulated at the time.
2. Whether regulatory actions aimed at a particular medium
had unanticipated effects on releases of nitrosamines
to other media.
3. Whether any gaps in regulatory coverage are apparent.
Other issues are also discussed. These include the extent to which parti-
cular regulatory efforts acknowledged similar past or ongoing efforts in
other agencies; the technical basis for the standards; and the degree to
which economic impacts were included in the decision-making. Findings on
these subjects will be incorporated into a cross-substance analysis in a
later phase of the project.
There are two issues of particular interest with respect to the
regulation of nitrosamines. First, they are mostly formed as a result of
chemical reactions in the environment and in food. Second, their presence
is a function of the presence of precursors, mainly mtroso compounds and
amines. These themes recur in the regulatory histories described in Sec-
tion 3.2. Substitution of other hazardous products for nitrosamines is not,
practically speaking, an important concern, because they usually occur as
contaminants, not intentional ingredients. It should be emphasized that
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the technical interactions illustrated in Exhibit 3.1 are those which are
evident from the agency documentation for each action: that is, the
preambles to the proposed and final rules, and formal background documents
such as Environmental Impact Statements, Criteria Documents, etc. Other
interactions between programs - memoranda, meetings, etc.- have not been
accessed for this analysis. Therefore, it is likely that more technical
interactions took place than are shown. Nevertheless, the formal documen-
tation constitutes the public record of the technical interchange, and this
is what the Exhibit reflects.
The outstanding feature of Exhibit 3.1 is the lack of regulatory
interactions. Those which took place mostly occurred within EPA. The
designation of nitrosamines as toxic pollutants resulted in the promul-
gation of a Water Quality Criterion and listing by OSW in its disposal and
transportation regulations. However, while the hazardous waste disposal
regulations usually were influenced by other programs controlling hazardous
materials, this was not the case with nitrosamines, which were merely
identified. The RCRA regulations do not specifically discuss the disposal
of nitrosamines, but mandate that they should be treated as hazardous waste
by reason of their toxicity.
FDA and FSQS also have regulatory interactions because of
their common regulatory medium, food. FDA has authority to restrict
the use of food additives, except for those additives to which USDA had
given approval prior to the food additives amendments to the FFCDA. FSQS
has authority to classify food as adulterated if it contains delete-
rious substances.
The scope of the analysis and the sources of information for this
study have been described in the introduction to the Lead case study
(Section 1.1.1). Also, the general provisions of applicable toxic sub-
stance regulations (such as those under RCRA) have already been treated
there. In this case study, we examine chiefly those regulatory provisions
which deal specifically with nitrosamines.
Nitrosamines were selected for a case study because they exhibit
certain interesting characteristics as a pollutants and as regulatory
problems. Nitrosamines comprise a large group of substances that are
composed of nitroso-compounds and amines. As a group they have a variety
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of characteristics. They are found in the air, water, soil, food, and the
workplace. While nitrosamines are in general highly toxic to animals and
humans through acute and chronic exposures, their precursors are less
suspect of being directly toxic. Many nitrosamines are considered to be
systemic carcinogens; that is, they have been found to induce cancer in
certain organs regardless of the route of administration. The environ-
mental ubiquity of nitrosamine precursors , coupled with unknown nitros-
amine formation rates, yields a highly uncertain picture of overall expo-
sure. While the seriousness of the health threat posed by nitrosamines
demands strict scrutiny and regulatory control, the uncertain magnitude of
the exposures denies regulators much of the data needed to delineate and
assess the problem. For these reasons, nitrosamines are an interesting
subject for a multimedia case study.
3.1.2 Findings: Multimedia Considerations in Rulemaking
Exhibit 3.1 shows the major regulatory actions regarding nitros-
amines and the interrelationships among them. Two types of connections are
shown: technical interactions (dotted arrows) and intermeshmg of regula-
tory provisions (dashed arrows). The details of these interactions, or
rather the lack of interactions, are described in Section 3.2. It is
important to note that to the extent past regulatory coordination has taken
place among jurisdictions concerned with nitrosamines, it has occurred
because of the structures of the relevant acts themselves, not because of
initiative among the affected agencies.* Thus, the water programs are
statutorily required to give priority to toxic pollutants, and RCRA is
intended to regulate wastes generated in part as a result of other regula-
tory.
For the purposes of this report, "regulatory coordination" is defined
as occurring when the provision of one rule are specifically designed to
complement, supplement, or otherwise take account of the provisions of
another rule. Liaison among regulatory agencies occurs constantly; this
is not included in the definition of "regulatory coordination" unless the
results are visible in the provisions of the regulations.
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Turning to the technical interactions among regulatory programs,
the Exhibit shows an even more sparse picture. Regulatory programs common-
ly acknowledged the toxic nature of nitrosamines through the American
Conference of Governmental Industrial Hygienists (ACGIH) list of "Indus-
trial Substances suspect of Carcinogenic Potential to Man." OSHA and OWRS
both cited the ACGIH, while the FDA and FSQS cited a NIOSH "Hazard Assess-
ment" that was done for OSHA (Reference 1 m Section 3.2.4). However, the
impression given by the chart is that there has been little technical
interaction across jurisdictions, and hence across media. Section 3.1.2
describes the extent to which intermedia analysis has been included in past
and ongoing regulatory efforts.
The attention which regulatory agencies have paid to estimating
the flows of nitrosamines into and among the various media has been rudi-
mentary and speculative. The main stumbling block to assessing materials
flows of nitrosamines is their characteristic of being contaminants and
the products of natural processes, rather than being emitted to the en-
vironment directly. This, coupled with the numerous sources of precursors
of nitrosamines and their unknown rates of formation, yields too many
unknowns to conduct a materials flow analysis. For example, nitroso
compounds are found in food, sewage sludge and human saliva. Also, amines
are present in air emissions from coking plants and petroleum refinery
emissions, in the soil and in the water. These precursors can combine in
the environment, in food, or in the human body. Furthermore, formation
rates of nitrosamines from precursors can be inhibited by the presence of
certain other substances and by pH levels. To further confuse prospective
regulators, nitrosamines as a class of substances have a variety of charac-
teristics among themselves. For example, some are volatile while others
are not. The complexity of assessing nitrosamines has generally resulted
in ad hoc efforts to control a specific form of contamination that has been
discovered to pose a health hazard.
The FDA and FSQS regulatory efforts have been mainly concerned with
nitrosamine formation resulting from the addition of nitrites to certain
foods. The source of nitrosamines was well known to be the addition of the
nitrite preservative; therefore, a materials flow analysis would have been
inappropriate.
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OSHA's regulations do not set standards for nitrosamines in terms
of allowable concentrations. Rather, they prescribe methods to minimize
worker's exposures. This approach, coupled with the emergency nature of
the rulemaking proceedings, gave OSHA little reason or time to study the
overall picture of nitrosamines' occurrence in the environment.
Although listed as toxic pollutants, nitrosamines have received
little multimedia analysis at EPA's Office of Water Regulations and Stan-
dards. The one background document reviewed assessed the probable aquatic
fate of three individual nitrosamines. Too little was known about one of
the nitrosamines to make a statement about its aquatic fate. The other two
were thought to ultimately be destroyed by photolysis. However, the
document did not assess the magnitude of the problem of nitrosamines in
water.
Most of EPA's regulations treat individual nitrosamines. The
regulations do not deal with nitrosamines as a group of substances with a
common set of characteristics. However, the Water Quality Criteria Docu-
ment gave consideration to nitrosamines as a class. This document gave
consideration of exposure contributions from other media, but most of the
assessment was cursory due to a lack of information. Consequently, the
estimates of nitrosamine exposure and accompanying risk factors are based
solely on the consumption of water and aquatic organisms. No consideration
was given to total exposure risks from other media, such as air, food and
the workplace. Documentation for the other two water-related programs,
i,e, hazardous spill control and designation of reportable quantities of
hazardous spills, did not directly discuss the multimedia effects of
including nitrosamines in their programs.
In a report for the Office of Air Quality Planning and Standards
(OAQPS), nitrosamine exposure from the air is calculated*. This report
does not support any standards specifically regulating nitrosamine levels.
However, it is the only attempt at a materials balance approach in the
literature. It does not address sources of precursors or multimedia
considerations.
OAQPS, "Human Exposure to Atmospheric Concentrations of Selected Chemi-
cals: Appendix II - Volume II," May 1980.
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3.1.3 Findings: Unanticipated Effects of Regulations
The general lack of quantitative information on intermedia flows
of nitrosamines raises the possibility that controlling its emissions in
one medium may inadvertently cause its release to another. In this section
we examine the extent to which the overall environmental impacts of their
actions were foreseen by the rulemakers.
There is a general lack of regulations that specifically limit
nitrosarmne levels. Consequently, their indirect impacts will be few.
However, there are two important unanticipated effects of current regula-
tions. The first arises from the hazardous waste management system order
RCRA. The system identifies hazardous waste constituents and then subjects
them to a comprehensive "cradle to grave" management system. The onus of
identification of hazard constituents is largely with the generator of the
waste. None of the RCRA background documents mentioned nitrosamine conta-
minants in the various industrial waste streams that the OSW analyzed.
Therefore, unexpected waste constituents, such as nitrosamines, could
escape the management system. The second unanticipated effect is due to
FDA's recommended changes in production practices in order to reduce
nitrosamine contamination of malt beverages. The FDA recommendation to
burn sulfur during the drying of malt could create new contaminants or
increase sulfur emissions. Since the FDA recommendation was not an
official regulatory action, it did not require the same scrutiny of
possible impacts.
3.1.4 Findings: Regulatory Gaps
Detailed analysis of gaps in the control of environmental
nitrosamines will be performed in the Phase II report. Nitrosamines
present special problems to regulators because they occur as contaminants
that may be formed in any medium when their precursors are present.
Formation rates can depend on localized conditions, such as pH level. Most
of the present regulations address specific known mechanisms of nitrosamine
contamination. Consequently, regardless of the medium being regulated,
other cases of contamination can be overlooked because of the general lack
of data on actual nitrosamine formulation rates. However, in addition to
this general problem, certain specific observations have been made in the
course of this case study which are described here.
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Ambient Air
There are no regulations specifically controlling emissions
of nitrosanunes into the air. The EPA's OAQPS has estimated that about
215,000 pounds of dimethylamine - a nitrosamine precursor - is emitted in
to the air annually, from the actual use of over 71 million pounds of
dimethylamine.
Water
Toxic effluent guidelines under the Clean water Act (Section
307) have not been promulgated for nitrosamir.es, although it is classified
as a toxic substance.
Spills of hazardous substances from industries operating under
NPDES permits or from publicly owned treatment works (POTWs) are currently
unregulated under the CWA (Section 311). Nitrosammes are classified as
hazardous substances.
Soil
POTWs which accept hazardous waste exclusively from small gene-
rators are exempt from disposal regulations under Subtitle C of RCRA.
Instead, they are allowed to send their sludges to municipal landfills
which are approved by states under the provisions of Subtitle D. As noted
above, however, approval standards under Subtitle D have not yet been
promulgated.
Work place Air
OSHA does not actually limit exposures to DMN, but recommends
engineering controls. Unforeseen sources of DMN contamination are unregu-
lated. In addition, mixtures containing 1% of DMN or less are exempt from
OSHA's rules. These regulations control DMN only, without regard to the
numerous other nitrosammes. OSHA's regulations are based on their assess-
ment that exposures are rare. The number of nitrosanunes and the ubiquity
of their precursors raise serious doubts concerning OSHA's assessment of
the probability of exposure.
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Food
Many of the regulatory actions of FDA and FSQS controlling
nitrosamine levels have been implemented through notices of warning.
Consequently, formal regulations exist for very few foods such as malt
beverages and bacon. These formal regulations were developed in response
to specific discoveries of contamination. Presumably other smoked foods,
for which FDA has not proposed rules, could also be contaminated.
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3.2 Regulatory Histories
3.2.1 Office of Water Regulations and Standards (EPA/OWRS)
3.2.1.1 Toxic Pollutant Effluent Standards
Current Status of Action
Pursuant to Section 307(a)(1) of the Water Pollution Control Act,
33 USC 1317(a)(1), nitrosamines are listed as toxic pollutants (otherwise
known as "priority pollutants:" 40 CFR 401.15). As such, they are subject
to effluent limitations reflecting "the best available technology ecnomi-
cally achievable" (BAT), compliance with which must be attained no later
than July 1, 1984 ( 33 USC si 311(b)(2), 1317 (a)(2)). Furthermore, modifi-
cation or waiver of the BAT requirements, available for conventional
pollutants pursuant to 33 USC sl311(c) and 1311(g), are not allowed for
priority pollutants.
EPA policy is to give priority to toxic pollutants in setting
industry-based effluent limitations and pretreatment standards. Only one
industry's wastewater profiles under these programs have included nitros-
amines specifically as a wastewater constituent; that industry was ink
formulating. However, nitrosamines were found to be only a contaminant to
one plant's wastewater since there is no evidence in the literature to
support the finding of nitrosamines in such wastewater, no further regula-
tory action was taken.
Section 307(a) of the Clean Water Act authorizes EPA to promul-
gate effluent standards for toxic pollutants. Section 304(a) authorizes
EPA to prescribe "best management practices" to prevent the release of
toxic pollutants from "plant site runoff, spillage or leaks, sludge or
waste disposal, and drainage from raw material storage." Thus far, no
regulations have been promulgated for nitrosamines under either of these
sections.
Multimedia Considerations
Since there have been no final roles concerning nitrosamines, it
is difficult to assess how the OWRS considers the health hazard presented
by nitrosamines in water. The one report described below, discussed
information gained from a literature search. The discussions of the three
nitrosamines describe their physical chemistry and do not include policy
implications.
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The only report issued in support of these actions by the OWRS
was released in December of 1979 and was entitled "Water-Related Environ-
mental Fate of 129 Priority Pollutants"(2). This document comprehensively
reviews three nitrosamines' persistance and fate as a water pollutants.
Seven environmental processes were examined, six of them representing
transfers to or within media other than water. The processes were:
Volatilization to air
Photolysis in air
Oxidation m air
Hydrolysis in water
Sorption to sediments
Bioaccumulation in organisms
Biotransformation and biodegradation by organisms
Process rates and residence times in various media were estimated on the
basis of secondary sources; the results are shown in Exhibits 3.2, 3.1, and
3-4. While the most probable fate of diphenylnitrosamines in the aquatic
environments is presently unknown, the most likely fate of the other two
nitrosamines examined is photolytic degradation. The two compounds
vulnerable to photolytic degradation also have low volatilization rates.
The low volitalization could prevent significant photolysis and consequent-
ly these nitrosamines could persist in the aquatic environment.
3.2.1.2 Water Quality Criteria
Current Status of Action
While water quality criteria published by EPA pursuant to Section
304(a)(1) of the Clean Water Act do not have regulatory force, they may be
used in setting water-quality-based effluent limitations under Section 30 2,
toxic pollutant effluent standards under Section 307, and state water
quality standards under Section 30 3. These latter standards, in turn, are
to be used in establishing individualized effluent limitations for NPDES
point source discharge permits under Section 40 2, as well as best management
practices for nonpoint sources under Section 208.
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Water quality criteria for nitrosamines are based on protection of
human health and of aquatic life. The EPA has determined nitrosamines to
be carcinogens (45 FR 79338). Consequently, the safe level for nitros-
amines is zero. Nitrosamine levels protective of human health are calcu-
lated parametrically on the basis of various expected levels of incremental
cancer risk resulting from ingestion of a) aquatic organisms only and b)
aquatic organisms plus water. The derived allowable concentrations are
shown in the following table:
Exposure Assumptions
Risk Levels and Corresponding Criteria
(per day)
ng/1
2 liters of drinking water
0
io-7
io-6
10-5
and consumption of 6.5
grams fish and shellfish (2)
N-n i trosod imethylami ne
0
0.14
1.4
14
N-nitrosodiethyl amine
0
0.08
0.8
8
N-n i trosod i-n-butylami ne
0
0.64
6.4
64
N-nitrosopyrrolidine
0
1.60
16.0
160
N-nitrosodiphenyl amine
0
490
4,900
49,000
Consumption of fish and
shellfish only. —
N-mtrosodimethylamine
0
1,600
16,000
160,000
N-nitrosodlethyl amine
0
124
1,240
12,400
N-nitrosodi-n-butylamine
0
58.7
587
5,868
N-nitrosopyrrolidine
0
9,190
91,900
919,000
N-nltrosodiphenyl amine
0
1,610
16,100
161,000
The criteria for acute toxicity to salt water and fresh water aquatic
species ranged to 3, 300,000 yg/ I and 5,850 y g/ I respectively. Chronic
toxicity was not calculated because of lack of data.
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Exhibit 3.2
Summary of Aquatic Fate of Diphenylnitrosamine
(Source: Reference 2, p. 100-4)
Envi cottmental
Process3
Summary
Sta teinent
tla 1 f-Llfe
Conf Idence
of Data
Plio tolys is
OkIdatlon
llydrolya Is
Volat111zntIon
Sorptloa
BlaaccumulatIon
Bio t rons forma don/
Dlodegraddt ion
Photolysis may be an
Important Eate process.
Probably not important
Probably not important.
Probably not important
No specific data found,
may huve significance.
No specific data found,
Importance difficult to assess.
Diphenylnitrosamlne is both
trio re easily degraded ond
synthesized than dialkylnitro-
Buiri lne s.
I^ow
LOW
Lou
Low
Low
Low
Low
There Is Insufficient information in the reviewed literature to permit assessment of a most probable fate.
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Exhibit 3.3
Summary of Aquatic Fate of Dimethylmtrosamine
(Source: Reference 2, p. 99-5)
Knv I roiimrul n I
Prm €1.3
Photo 1yslsfl
Mnninn i y
Slnlpincill
Rnic
llnl r-l.] fo
(W
f I ili'iti C
of Dotn
Slow photolysis appears
to be the only fate pro-
cess of any consequence.
Medlum
Ox Ida t Lon
MydrolysIs
Volotlllzutlon
Sorption
bloucioroolation
Ulotraitbfurinatloiv/
b lode^radac. lon
Probably not Important.
Probably not Important.
Probably not Important.
Probably not Important.
Probably not Important.
Slow degradation la re-
ported to occur tn sew-
age anil soil, but this
pollutant appears to be
resistant to blodegrad-
otlon in surface waters.
Low
Low
Low
Lou
Low
Med 1 ucr
a The predominant environmental process which Is thought to determine the fate of the compound.
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Exhxbit 3.4
Summary of Aquatic Fate of Di-n-prophylnitrosamine
(Source: Reference 2, p. 101-5)
"in l ""I f , . \MMII IIIOIM 1
Proma* StfUcmcnt Unl q \/2 ufllntn
Photolysis3
Slow photolysis appears to be
Che only face process of any
consequence.
Medina
Oxidation
Trobably not
Important.
-
-
Low
Hydrolysis
Probobly noc
Important*
-
-
Lou
Volatlllzatlon
Probably not
lcoportant.
-
-
Low
SorpCIon
Probably noc
loiportant.
-
-
Low
BloaccucoulaC tort
Probably not
Important,
-
-
Low
Biotransformation/
B lodeg.radnt 1 on
Slou degradation is reported
to occur In 6ewagc and soil,
but this polLutant Appeara to
be realsCanC to blode&radation
in surface watera.
Med iun
a. The predominant environmental process which is thought to determine the fate of the compound.
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Multimedia Considerations in the Regulatory History
The developmental history of the present water quality criteria
for toxic pollutants was reviewed in detail in the Lead case study (Section
1.2.3.3). In this discussion, we shall deal only with those actions
specific to nitrosamines.
The first mention of nitrosamines in the water quality criteria
program was in the Federal Register notice of 15 March 1979 (44 FR 15926)
asking for comments on proposed criteria for 27 of the 65 toxic pollutants.
The introduction to the proposed criteria made clear that in the case of
confirmed or suspected carcinogens, EPA would assume that there is no
scientific basis for estimating "safe" levels. Instead, the agency would
give a range of concentrations estimated to pose alternate degrees of
-7 -5
incremental cancer risk ranging from 10 to 10 . These concentra-
tions were to be presented for informational purposes, and were not to be
interpreted as being "safe," the only known safe level being zero. The
risk estimates were to be extrapolated from animal experiments to humans
using the conservative "one-hit" model endorsed by the IRLG agencies.
The 15 March notice provided discussions of individual pollutants
which were summaries of the respective Draft Water Quality Criteria Docu-
ments. While the salt water and fresh water aquatic toxicology of nitros-
amines were still being researched, nitrosamines' carcinogenicity had been
well established in the literature. The Federal Register on November 28,
1980 announced the availability of the final versions of the water quality
criteria documents for several pollutants, including nitrosamines (45 FR
79 318). The level of nitrosamines calculated to present the various levels
of risk of cancer to humans as extrapolated from animals studies were
generally lower in the final criteria than in the proposed criteria. Since
the EPA. did not note any methodological change, the differences must have
been due to inclusion of new data from new animal toxicology studies.
The Water Quality Criteria Document (3) for nitrosamines was
divided into aquatic and mammalian toxicology. The document reviewed the
routes of exposure (see Exhibit 3.5) and discussed the relative importance
of each route's contribution. The risks of exposure were calculated based
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on a person's probable consumption of water and/or aquatic organisms.
While other routes of exposure were discussed, they were not incorporated
because of inadequate data. An attempt to quantify total exposure was
deemed inappropriate by the EPA because exposures would have had to include
nitrosamines and their precursers. The problem of estimating precursors
and their rate of formation into nitrosamines is confounded by the impact
of a variety of environmental factors, such as temperature, pH, and the
presence of other substances. To further confuse the undertaking of such
a risk assessment, the chapter on pharmacokinetics concluded that the
metabolic pathways of nitrosamines were indeterminable at the present
time.
In reviewing the literature, the water quality criteria document
found that nitrosamines were acutely toxic to every animal species tested,
poisonous to humans, powerfully mutagenic, teratogenic, and possibly
carcinogenic. Nitrosamines were found to induce cancer in small multiple
dosages and in the EPA's "one dose" method when administered orally. While
other routes of exposure, such as inhalation, were not proven to induce
cancer, nitrosamines were regarded as systemic carcinogens, i.e., able to
induce cancer in a number of body sites regardless of the route of exposure.
The document presented a brief description of the contributions of various
media, including through food, air and occupation. However, the lack of
information on the of extent nitrosanune contamination, because of the
numerous unknown factors in nitrosamine formation, prevented a fully
comprehensive risk assessment.
3.2.1.3 Designation of Hazardous Substances and Reportable Quantities
Current Status of Action
Nitrosamines (specifically diethylnitrosamine and dimethylnitros-
amine) have been proposed as hazardous substances pursuant to Section
311(b)(2)(A) of the Clean Water Act (45 FR 46094). No final action has
been taken. Under 40 CFR Part 117, reportable quantities have been estab-
lished for all hazardous substances identified in 40 CFR Part 116. Any
discharge into navigable waters of the United States or adjoining shore-
lines of a hazardous substance that is equal to or in excess of its
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Exhibit 3.5
Calculated Daily Human Exposure to N-nitroso Compounds **
(Source: Reference 3, p. c-15)
Daily intake
(yq)
0)
c
OJ
c
o
f—
¦r"
o
_c
u
_C
o
o> +
V-
c
e
s-
•r-
•r—
>>
o
"O
T3
GL
c
O
O
O
o
m
«/>
L/>
\A
O
o
O
o
J-
u
S-
+->
4->
•r*
*r-
»—
•r*
2:
sz
z
Z -
Nitrite preserved foods, 100 g.
1
5
Tobacco smoke, 20 cigarettes
2
3
Drinking water, New Orleans
8*
Air, factory site
40
10*
Herbicide formulation, 1 ml spill
640
~Tentative, unconfirmed identification as N-nitroso compound.
'*+Source: Fine, et al. 1977a
17
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DRAFT
reportable quantity must be immediately brought to the attention of the
Coast Guard (40 CFR 117.21), and the discharger is subject to cleanup
liability and civil penalities (40 CFR 117.22-23).
Certain types of discharges are excluded from regulation under
40 CFR parts 116 and 117, including those in compliance with permits issued
under the Marine Protection, Research and Sanctuaries Act; the Federal
Insecticide, Fungicide and Rodenticide Act; the Resource Conservation and
Recovery Act; and the dredge and fill provisions and NPDES provisions of
the Clean Water Act. Under certain circumstances, discharges from a point
source in violation of its NPDES permit are also exempt.
Multimedia Considerations in the Regulatory History
The general history of how hazardous substances were designated
has been described in the Lead case study (Section 1.2.2.4), and will not
be repeated here. It is useful to recall in discussion of nitrosamines,
however, that while the hazardous substance determination was originally
based on aquatic toxicity, EPA announced in February of 1979 the intent to
expand the criteria to include carcinogenicity, mutogenicity, teratogeni-
city, bioaccumulation, and other long-term effects (44 FR 10270).
Nitrosamines were not on the initial list of hazardous substances
which was promulgated on 13 March 1978 (43 FR 10474). The proposal to
include nitrosamines on that list was made on 9 July, 1980 (45 FR 46094).
The reason for including nitrosamines was based on their suspected carcino-
genicity to humans.
18
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DRAFT
References for Section 3.2.1
U.S. Environmental Protection Agency, Effluent Guidelines Division,
"Development Document for Proposed Effluent Limitations Guidelines, New
Source Performance Standards and Pretreatment Standards for the Ink
Formulating Point Source Category," December, 1979, EPA-440/1-79/090-6.
Callahan, M.A., et. al., "Water Related Environmental Fate of 129
Priority Pollutants," 2 volumes, December, 1979, Report EPA - 440/4-79-
0299a.
U.S. Environmental Protection Agency, "Ambient Water Quality Criteria
for Nitrosamines," October, 1980, EPA 440/5-80-064.
19
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DRAFT
3.2.2 Office of Solid Waste (EPA/OSW)
3.2.2.1 Hazardous Waste Management System (EPA/OSW)
A full discussion of the hazardous waste management system
authorized by the Resource Conservation and Recover Act (RCRA) has been
presented in the Lead case study (Section 1.2.5). It includes a descrip-
tion of the following components 1) identification and listing mechanism
for hazardous wastes, 2) standards for generators, 3) standards for
transporters, and 4) standards for owners and operators of treatment,
storage, and disposal facilities for hazardous waste.
Hazardous wastes containing nitrosamines are subject to regula-
tion under RCRA's Hazardous Waste Management System via three identifica-
tion and listing routes. The first is through nitrosamines' listing in 40
CFR 261 (Appendix VIII) as a toxic waste constituent. Another is through
nitrosamines' inclusion as one of the 65 toxic pollutants under the CWA,
Section 307. Lastly, nitrosamine is also specifically listed for regula-
tions pertaining to discarded commercial chemical products, off-specifica-
tion species, containers, and spill residues thereof (40 CFR 261.3 3).
Multimedia Considerations
Congress intended the hazardous waste management system under
RCRA to have a very broad scope. Consequently, regulations under RCRA are
process oriented rather than pollutant~oriented because of the wide variety
of hazardous waste stream constituents in existence. In order to create a
comprehensive list of hazardous waste constituents, the OSW analyzed a
number of industrial waste streams. This analysis not only served to
identify the variety of currently used disposal practices, but to enumerate
waste constituents. The voluminous background document (1) that reviewed
the various industrial processes did not identify nitrosamines in any of
the industries included in the report. The environmental impact statement
for Subtitle C of RCRA (2) also reviews certain industrial waste streams.
The EIS identifies nitrosamines in the following two industrial waste
streams: 1) miscellaneous acyclic chemicals and chemical products industry
and 2) the "red water" wastestream from the explosives industry. The "red
20
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DRAFT
water" waste stream was specifically included in the regulations as a
specific source of hazardous wastes (40 CFR Part 261.32). While the other
industry was not specifically included in the identification portion of the
RCRA regulations. The "red water" waste stream was classified by the EPA
as a reactive waste, not a toxic waste. Since nitrosamines are toxic and
not reactive, nitrosamines were probably not considered in EPA's analysis
of disposal methods and potential health risks.
Nitrosamines are listed in the regulations under RCRA as a
toxic waste constituent (40 CFR Part 261.11). These constituents have been
shown by scientific studies to be toxic, carcinogenic, mutagenic, or
teratogenic to humans or other forms of life (45 FR 3 3121). Wastes with
toxic waste constituents would be classified as hazardous unless the
administrator specifically determines through specified criteria that the
waste was not capable of posing a health hazard to humans (45 FR 33121).
While the hazardous waste management system regulations indicated a strong
effort to coordinate efforts within EPA and with other agencies, no
mention of other regulatory efforts concerning nitrosamines were specifi-
cally mentioned.
21
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DRAFT
References for Section 3.2.2
1. Environmental Protection Agency, "Subtitle C-Background Document
for Identification and Listing of Hazardous Wastes 40 CFR Part 261.31
and 261.32," April, 1980.
2- Environmental Protection Agency, "Draft-Final Environmental Impact
Statement - Part 1: Subtitle C, Resource Conservation and Recovery Act
of 1976," April 1980.
3. Environmental Protection Agency, Carcinogen Assessment Group, "Risk
Assessment on Trifluralin," October 18, 1978.
22
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DRAFT
3.2.3. Office of Pesticide Programs (OPP)
3.2.3.1 Registration of Pesticides
Current Status of Actions
The Office of Pesticide Programs (OPP) has published a Notice of
Rebuttable Presumption against Registration (RPAR) for the pesticide
trifluralin, which contains greater than 1 part per million of the nitros-
amine N-nitroso-di-n-propylamine (NDPA) (44 FR 50911). The registration
process is fully discussed in the Lead Case Study (Section 1.2.6). The
other action taken by OPP on nitroso-contaminated pesticides was a notice
of proposed policy in June of 1980 (45 FR 42854). The proposed policy
requires manufacturers of nitroso-contaminated pesticides to submit infor-
mation on nitrosamine level and composition. This information will be used
to eliminate pesticides that do not have sufficient nitrosamine contamina-
tion to warrant the costly RPAR process. The lack of information concern-
ing nitroso-contamination was stated as the reason for delay of their
regulation.
Multimedia Considerations in the Regulatory History
On October 28, 1976, the EPA stopped registration of new pesti-
cides that were probably contaminated with nitroso-compounds (45 FR 42855).
A preamble to a later regulation notice stated that this action was initi-
ated because nitrosamines were generally toxic and frequently carcinogenic.
Since that moratorium on registration, the OPP has analyzed 300 compounds
and has found three main routes of contamination (45 FR 42855).
• during manufacturing processes
• during storage with corrosive inhibitors
• contamination of ingredients, e.g., dimethyLamines
in amine reagents
In 1977, the OPP first required nitroso-containing pesticide
manufacturers to submit analytical data concerning nitrosamine contamina-
tion of their products (42 FR 51640). The information requested concerned
instances of nitrosamine contamination of products during the manufacturing
process. The Notice also mentioned the presence of nitrosamines in
pesticide containers as anti-corrosive agents.
23
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DRAFT
On 30 August, 1979, the OPP took its first action to limit
nitrosamine contamination of pesticides (44 FR 50911). The action estab-
lished an RPAR on the basis of NDPA's oncogenic risk (40 CFR Part 162.11(a)
(3)[nl). NDPA's orcogenic effects were stated as a matter of fact,
without references. The RPAR refused to grant registration to trifluralin
with greater than 1 ppm of NDPA. The position document appearing with the
RPAR stated that the OPP used information from the Department of Agricul-
ture and other sources to develop its risk assessment of trifluralin use
(45 FR 50914). Populations at risk included agricultural workers, nursery
workers, and the population at large. No specific exposure rates were
stated in the document. The economic consequences of the cancellation of
the use of trifluralin were also calculated. OPP calculated that the 5
years following cancellation would produce a $300 million dollar loss in
farm income; but the benefits of lower exposure levels of nitrosamines were
not discussed. It was noted that the nation's sole producer of trifluralin
currently produced the pesticide with less than 1 ppm of NDPA. The risk
assessments done by the EPA's Carcinogen Assessment Group (CAG) m 1977 and
1978 had assumed a much higher level of NDPA contamination (1 and 2).
The CAG study done in 1978, at OPP's request, analyzed the risk of triflu-
ralin use In addition to reviewing the medical studies' findings that
NDPA contaminant was oncogenic, the study calculated exposure risks to
the general population and to herbicide applicators (see Exhibits 3.6 and
3.7). The risk to the general population eating contaminated food was
calculated assuming an NDPA level of 5 ppm in the trifluralin. The conser-
vative estimates concluded a very low risk to the population at large.
These estimates were outdated at the time of the RPAR because of reductions
m NDPA levels achieved in the interim by the sole producer of trifluralia.
In June of 1980, the OPP requested more information to achieve
regulation of nitroso-contaminated pesticides within a reasonable time.
This information will be used to eliminate pesticides that do not have
sufficient nitrosamine contamination to warrant the costly RPAR process.
The OPP stated that the reduction of the number of pesticides requiring
revieww was necesary because subjecting over 900 pesticides to the RPAR
process was impractical.
24
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Exhibit 3-6
Estimate of Cancer Risk to the General Population from Ingestion
of NDPA Associated with the Use of Treflar (Tnf luralin) on Food Crops
(reference ; see pg. 36)
Food
Type
Tnf luralin
Tolerance, t
(mg/kg of diet)
Fraction
of Food
in Diet, a
Maximum Daily NDPA
Intake, X (X10~ )
(mg/kg of diet)
Lifetime
Individual
Risks (x10 )
Total Number
of Cases in
2
Lifetime
NJ
i_n
Asparagus
Carrots
Citrus Fruits
Corn, grain
Cottonseed
Curcurbits
Fruiting Veg.
Grapes/Raisins
Hops
Leafy Veg.
Mung beans
Nuts
Peanuts
Peppermint
Root Crop Veg.
Safflower
Seed/pod Veg.
Spearmint
Stone Fruits
Sugar, cane and
beet
Sunflower
Wheat
All Foods
.05
.95
.05
.05
.05
.05
.05
.05
.05
.05
2.0
.05
.05
2.0
.05
.05
.05
2.0
.05
.05
.05
.05
.0014
.0048
.0381
.01
.0015
.0284
.0299
.0049
.0003
.0276
.0003
.001
.0036
.0003
. 1 1
.0003
.0366
.0003
.0 125
.0364
.0003
.1036
.35
22.8
9.53
2.5
.375
7.1
7.48
1.23
.075
6.9
3.0
.25
.90
3.0
27.5
.075
9.15
3.0
3.13
9.1
.075
25.9
143.4
.14
9.12
3.8 1
1.0
. 15
2.84
2.99
.49
.03
2.76
1 .2
.10
.36
1 .2
11.0
.03
3.66
1.2
1.25
3.64
.03
10.4
57.4
.0308
2.0 1
.838
.22
.033
.625
.546
.108
.0066
.607
.2 64
.022
.0792
.264
2.42
.0066
.805
.264
.275
.801
.0066
2.28
12.6
Column entrie| are multiplied by the factor in the column heading, i.e. for asparagus the daily intake
is 0.35 x 10 mg/kg/day and the individual risk is 0.14 x 10
2 8
Assuming 2.2 x 10 people are exposed to food.
a
J3
>
~T\
a
x
o
T-
o
_ o
CD
X
Co
c;.-
i, La
I"
2
a
rn
Co
-------
bil
Risk Estimates for Treflar (Tnfluralin) Applicators
(reference (2); see pg. 34)
Crop
Number
of
People
Inhalation
Exposure, 1
(ug/year)
Dermal
Exposure, D
(ug/year)
Lifetime
Individual^
Risk (x10 )
Lifetime
Number of
Cases
(x10 3)
Soybeans
Cotton
Tomatoes
Cole Crops
Beans
Tree and Vine
Hops
Potatoes
Carrots
Okra
Greens
Spanish Peanuts
Celery
Peppers
Mint
Dill
Alfalfa
Spring Wheat
Mustard Seed
Safflower
Sunflower
Sugar Beets
Sugar Cane
Cucumbers
Cantaloupes
Watermelon
Dry Peas
English Peas
Field Peas
156,491
55,576
13,490
4,162
23,689
3,985
51
1 ,800
647
856
3,259
4,474
166
2,267
55
16
320
890
68
933
5,523
5,178
116
3,030
335
2,718
202
2,776
156
0.12
0.11
0.04
0.04
0.07
0.07
0.23
0.05
0.07
0.02
0.0 1
0.06
0.11
0.02
0.18
0.08
0.07
0.34
0.12
0.27
0.13
0.14
0 .40
0.0 1
0.03
0 .02
0.13
0.04
0 .04
1 .33
1 .08
0.42
0.50
0.75
0.75
2.74
0.50
0.83
0.17
0.17
0.59
1 .33
0.17
2.16
0.9 1
0.83
4.07
1.33
3.24
1 .50
1 .66
4.65
0.17
0.33
0.25
1 .4 1
0.42
0.42
1.3
1. 1
.43
.49
.76
.76
2.7
.52
.82
.19
. 1 5
.61
1.3
.19
2.1
.91
.82
4.0
1.3
3.2
1.5
1.6
4.6
.15
.33
.24
1 .4
.43
.43
21 .0
6.2
.58
.20
1 .8
.30
.0 14
.093
.053
.0 16
.050
.27
.022
.042
.0 12
.00 14
.026
.36
.0091
.30
.82
.84
.053
.046
.0 11
.066
.029
. 1 2
.0067
Commercial
Applicators
(all crops)
Totals
3,800
297,029
0.14
1 .74
1 .7
.64
34.0
Column entries are multiplied by the factor in the column heading; i.e.
1.1 and the number of cases os 6.2 x 10
for cotton the risk is
-------
DRAFT
References for Section 3.2.3
1. U.S. Environmental Protection Agency, Carcinogen Assessment Group,
"Carcinogenic Risks of Contamination of the Herbicides Treflar, Trysber
and Benzae," May 10, 1977.
2. U.S. Environmental Protection Agency, Carcinogen Assessment Group,
"Risk Assessment on Trifluralm," October 18, 1978 (Revised December 20,
1978) .
26
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DRAFT
3.2.4 Occupational Safety and Health Administration (OSHA)
3.2.4.1 Occupational Exposure to Dimethylnitrosamine (DMN)*
Current Status of Action
No permissible exposure limit is stated for DMN; instead, the
current OSHA regulation (29 CFR 1910.1016) specifies engineering controls
for workplaces where the chemical is handled. Manufacturing, processing,
storing or other handling must take place in a "regulated area;" access to
such an area is restricted to workers wearing protective clothing. DMN
handling or processing must be done in closed systems or with adequate
ventilation; ventilation exhaust air must be "decontaminated" before it can
be released to the general environment. However, specific methods for
decontamination, and maximum DMN concentrations in the treated exhaust air,
are not specified.
Processing and handling of mixtures containing less than 1% DMN
by weight or volume are exempt from OSHA regulations.
Multimedia Considerations in the Regulatory History
Immediately after the passage of the Occupational Safety and
Health Act of 1970, the Administrator of OSHA used his powers under Section
6(a) to promulgate as mandatory standards the Threshold Limit Values
(TLV's) adopted by the American Conference of Governmental Industrial
Hygienists.** These TLV's, and hence the resulting OSHA standard, did not
include tolerances for nine substances, including DMN, which the ACGIH had
identified as human or animal carcinogens. As a result, OSHA was in the
position of having acknowledged these substances as workplace carcinogens
without having required any corresponding remedial measures. To correct
this discrepancy, OSHA requested assistance from the National Institute of
Occupational Safety and Health (NIOSH) in developing occupational health
standards for carcinogens. In response, NIOSH published a list of fifteen
substances (taken from the 1972 ACGIH TLV document, plus alpha-napthylamine)
with a request for any information which could be helpful in writing
Criteria Documents for these materials (37 FR 13285).
*The OSHA designation for the chemical name of DMN is N-Nitrosodimethyl-
amine.
**ACGIH, Threshold Limit Values of Airborne Contaminants in Workroom Air,
1971 .
27
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DRAFT
The regulation of DMN, among the other carcinogens listed by
NIOSH, was accelerated in December of 1972 when the Oil, Chemical and
Atomic Workers' Union (OCAW) submitted to OSHA a petition which proposed an
emergency standard for 10 alleged carcinogens. The proposed standard
specified that "no exposure or contact by any route, respiratory, oral, or
skin shall be permitted for any of the following substances or other
substances containing them." DMN was one of the listed substances. The
proposal went on to specify housekeeping, personal protection, environmen-
tal monitoring, medical examinations, recordkeeping, and labelling proce-
dures. The OCAW proposal also provided that the Assistant Secretary of
Labor should promulgate additional regulations specifying safe methods of
disposal for carcinogen-contaminated materials and carcinogens (including
DMN), after consulting with the Administrator of EPA.
In response to the OCAW petition and subsequent public comments
on it, OSHA issued an Emergency Temporary Standard (ETS) on 3 May 1973 (38
FR 10929). Rejecting the union's "no-exposure" approach, the ETS specified
a system of restricted-access handling areas, protective clothing, change
rooms, and other work practices to minimize employee contact with DMN and
the other carcinogens. Mixtures containing less thanl% by weight of any
carcinogen were exempted from the standard. The brief preamble to the ETS
contained no statements bearing on technical or policy issues surrounding
the standards' provisions.
The promulgation of the Emergency Temporary Standard for carcino-
gens resulted automatically in the initiation of rulemaking proceedings for
a permanent standard, under the provisions of Section 6(c) of the Occupa-
tional Safety and Health Act. Accordingly, a permanent standard identical
to the ETS was proposed by OSHA in July of 1973 (38 FR 18900) . The brief
preamble contained no technical discussion, but referred to the Draft
Environmental Impact Statement, issued at the same time, in support of the
proposal. This Draft EIS is not now available; however, on the basis of
the Final EIS (reviewed below) we may conclude that it dealt with no media
other than workplace air, and even in that case it did not discuss concen-
trations or the extent of employee exposure.
28
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DRAFT
In preparation for the final rule, OSHA and NIOSH produced
several background studies. In July of 197 3, NIOSH published a "Hazard
Review of N-Nitrosodimethylamme" (1), which reviewed the experimental
evidence for DMN's carcinogenicity. It concluded that the substance had
been demonstrated to produce cancers at many sites, by a variety of admini-
stration routes, and in many animals, including nu.ce, hamsters, guinea
pigs, rabbits, and several species of fish. No discussion of DMN in the
workplace or the general environment was provided. The second report,
issued by OSHA in August of 197 3, was entitled, "Some Economic Aspects of
an Occupational Safety and Health Standard for the Use of Fourteen Carcino-
genic Compounds" (2). The report contained two- to three-page writeups on
each of the fourteen carcinogens, describing the chemicals themselves,
their origins, uses, users, and the costs of complying with the proposed
rule. No analysis was contained in the report; most of its content was
based on statements made by manufacturers and users themselves. Neverthe-
less, the descriptions contained OSHA's first official statement of
the scope of the problem. In the case of DMN, the agency was solely
concerned with its use in research laboratories. This use was reported by
four firms and one university, and a total of 2 3 employees were judged to
be potentially exposed. The document acknowledged that DMN had been used
as an industrial solvent, in the synthesis of rocket fuel, and for several
other end uses. However, it concluded that the use of the chemical in
these capacities must have ceased, since "none of the respondents to the
standard reported any of these uses." Total production for 1972 was
estimated at "less than 6 kilograms." No account was taken of DMN as a
contaminant of other workplace chemicals (e.g., cutting oils), or as a
breakdown product in foods.
OSHA's 197 3 portrayal of DMN as a rare substance exposing only a
few laboratory workers to risk is dramatically contradicted by recent EPA
data showing that in 1978 approximately 71.8 million lb/yr was produced;
that the chemical was being used in many chemical manufacturing processes;
and that about 215,000 lb/yr was being emitted to the atmosphere.* OSHA's
~
Science Applications Inc., "Human Exposure to Atmospheric Concentrations
of Selected Contaminants", 1981.
29
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DRAFT
oversight can likely be ascribed to the fact that the backup data for the
Fourteen Carcinogens standard was assembled in only three months, and the
agency was forced to rely almost exclusively on submissions by users and
manufacturers.
The third document prepared in support of the rule was the "Final
Environmental Impact Statement: Proposed Regulation—Handling of Certain
Carcinogens" (3). The technical content of the Final EIS was derived
almost entirely from the two reports mentioned earlier. OHSA did include a
discussion of the relation between the proposed rule and other federal
actions, but none of the actions mentioned related to DMN. The EIS did not
mention any environmental media other than the workplace.
The final carcinogens rule was promulgated on 29 January, 1974
(39 FR 3756); its provisions have already been summarized above. Besides
reiterating the toxicological evidence reported in the NIOSH Hazard Survey,
the preamble clarified several points which arose in OSHA's development of
the rule. One issue was the relevance of animal tests to standards design-
ed to protect humans; OSHA's position was that substances proven carcino-
genic in animals, but not in humans, should be treated as if they were
known hazards to people. This policy was chosen because it was "respon-
sible and correct;" no scientific support was offered. The zero-tolerance
standard proposed by the OCAW petition was rejected, because
. .no possible exposure to the carcinogens under any
circumstances could only be guaranteed by a total ban
on the manufacture, use (even for cancer research), and
transportation of the substances . . . Accordingly, the
intent of the standards is to reduce exposure of workers
to any of the listed substances to the maximum extent
possible consistent with continued use."
Finally, exclusions of liquids or mixtures containing less than a specified
percentage of the controlled substances was justified in order
"to avoid substantial obstruction, if not stoppage, of
the use of many processes and products which are con-
sidered useful in industry and even in cancer research,
and about which the record contains very little infor-
mation. "
Exempted concentrations were set at 1% for the eight substances (including
DMN) designated as animal carcinogens, and 0.1% for the six substances
considered to be human carcinogens. The inconsistency with the earlier
argument, that the two categories should be treated equally, was not
noted.
30
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DRAFT
References for Section 3.2.4
1. National Institute for Occupational Safety and Health, Office of
Research and Standards Development; "Hazard Review of N-Nitroso-
dimethylamine (DMN)," July, 1973.
2. Occupational Safety and Health Administration, Office of Standards;
"Some Economic Aspects of an Occupational Safety and Health Stand-
ards for the Use of Fourteen Carcinogenic Compounds," undated
(pose-August 10, 1973).
3. , Final Environmental Impact Statement: Proposed
Regulation—Handling of Certain Carcinogens," September 28, 1973.
31
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DRAFT
3.2.5 Food and Drug Administration (FDA)
3.2.5.1 Nitrosamines (DMN and NDELA)
Current Status of Actions
On April 10, 1979 the FDA issued a notice requesting the cosmetic
industry to reformulate a variety of products in order to reduce the
probability of nitrosamine formation (44 FR 21365). The notice requested
removal of aklarolamine-containing ingredients that may act as mtrosating
agents to form N-nitrosodietharolamine (NDELA). Thus far, the FDA is
satisfied with the industry's response and no further regulatory action is
being considered.
Pursuant to Section 406 of the Federal Food, Drug and Cosmetic
Act, the FDA set an action level for dimethylnitrosamines (DMN) in malt
beverages at 5 parts per billion (45 FR 39341). The FDA, in the June 10,
1980 Federal Register notice, stated that it will take regulatory action
upon discovery of an excess of the DMN action level for malt beverages.
Multimedia Considerations in the Regulatory History
The only action the FDA has taken to control mtrosamines in
cosmetics has been a Federal Register Notice warning industry of the
problem on April 10, 1979.
The industry warning on NDELA contamination in cosmetics was
based on 1) toxicological studies of NDELA and 2) recent studies showing
percutaneous absorption of NDELA. While aklarolamine-containing ingre-
dients were cited as the main mtrosating agent to be removed, its substi-
tutes and their impacts were not discussed. Since this notice was merely a
recommendation to industry, and not an exercise of specific regulatory
authority, no documentation of the notice's impact was generated.
The FDA regulated another nitrosamine, this time in malt beve-
rages, by publishing an "action level" in the Federal Register on June 10,
1980. While the FDA had established the action level in a press release of
October 29, 1979, it incorporated the "administrative guideline" into its
regulations officially in June of 1980. As an adminsitrative guideline,
the action level did not require a public comment period.
32
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DRAFT
The action level for DMN in malt beverages was based on the
lowest level that DMN can be reliably measured, not because 5 ppb is
considered safe. The justification for the action level is provided in an
"action guide" that accompanied the notice (45 FR 39341). The FDA stated
in the policy guide that since DMN is a carcinogen, that there was no safe
dosage. The FDA concluded that a safe dosage for a carcinogen had not been
determined to date.
The carcinogenicity of DMN was formally documented in 1973 in a
review of its hazard potential.^ This document reviews the experiments
conducted that tried to assess DMN1s acute and chronic toxicity. The
review concludes that because of DMN's potency in inducing cancer in a
variety of sites, administration methods and animals, that DMN is a poten-
tial human carcinogen. To accomplish the reduction of levels of DMN in
malt beverages, the FDA recommended the burning of sulfur during the drying
of the barley, since the kiln-drying of malt was identified as the primary
path of contamination. The FDA did not discuss possible adverse impacts of
burning sulfur such as newly created air emissions or the formation of
other hazardous substances in combination with the sulfur or contaminants
thereof.
3.2.5.2 Nitrites/Nitrates
Current Status of Actions
The FDA has proposed a rule giving nitrites and nitrates food
additive status in poultry products under the Federal Food, Drug and
Cosmetic Act (44 FR 75662). This action proposes that no prior regulation
authority exists for this use of nitrites and nitrates in poultry products
by the Food Safety and Quality Service (FSQS). The FSQS, under the Federal
Meat Inspection Act, that predates the Food Additive Amendments to the
Federal Food, Drug and Cosmetic Act of 1958, has approved the use of
nitrites to certain meat and meat products as preservatives. The FSQS
approval is considered a preemption of FDA's jurisdiction by providing
approval to nitrites used as preservatives in meats before they had been
scrutinized by FDA's Food additive approval process. The FDA is contending
in the proposed regulations for nitrites in poultry, that no such prior
approval, i.e., prior sanction, exists.
33
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DRAFT
The use of nitrites in bacon was considered for regulation under
the color additive provisions of the Act. However FDA's final action
withdrew nitrites from consideration as a color additive because it was
determined that they do not impart color.
Nitrites in meat and fish were regulated in about 1960 by the FDA.
The following standards are found in 21 CFR 172.160-172.177:
Potassium nitrate in cod roe 200 ppm
Potassium nitrate in sable fish, salmon, shad,
and meat 500 ppm
Sodium nitrite in tuna 10 ppm
Sodium nitrite in chub 100-200 ppm
Sodium nitrite in sable fish, salmon and
shad 200 ppm
The FDA has no recent final rules regulating nitrite levels in
food.
Multimedia Considerations in the Regulatory History
Nitrites are included in this case study of nitrosamines because
they are precursors of nitrosamines. The formation of nitrosamines through
the combination of nitrites and amines (a class of substances that are
ubiquitous in the environment) occurs in the environment, in food process-
ing, theoretically during digestion, and possibly in the process of inhala-
tion. Nitrates are also included, because their tendency to be transformed
into nitrites.
Since the FSQS and the FDA have regulatory authority of the
levels of nitrites in foods, the two agencies have closely coordinated
regulatory efforts. On August 15, 1980, the two agencies published a
report questioning the recent finding that nitrites themselves were car-
cinogenic (2). A 1978 study at the Massachusetts Institute of Technology
(MIT)* was responsible for the regulatory community's consideration of
nitrite's carcinogenicity. The jointly published report concluded that the
MIT study was not sufficient to suspect nitrites of being carcinogens. The
Dr. Newberne, "Final Report to FDA for Contract FDA 74-2181, August,
1978.
34
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DRAFT
FDA has published its own assessment of the MIT study which concurred that
the matter required more investigation (3). If nitrites themselves had
been shown to be cardinogenic, then the FDA would have been required to ban
its use by mandate of the Delaney Clause to the FFDCA (to be discussed
below). Consequently nitrites are regulated solely on the basis of their
being precursers of nitrosamines. However, the carcinogenicity of nitros-
amines is thoroughly referenced throughout the preambles of the FDA's
regulations.
The fact that nitrites produce nitrosamines in food is delaying
the setting of final permissible nitrite levels. The delay is due to the
interpretation of the Delaney Amendment to the Federal Food, Drug and
Cosmetic Act of 1962. Originally, this amendment was interpreted to
disallow any presence of carcinogens in food. However, due to advances in
measurement techniques, the discovery of ever smaller amounts of contami-
nants has forced the FDA to reinterpret the Delaney Amendment through the
establishment of a "constituent policy" (see Exhibit 1). The constituent
policy when it is proposed, will state the methodology for developing
dosages of carcinogens that will present an acceptable risk level to
exposed populations (44 FR 17070). This policy, to be proposed in the
Federal Register around June, 1981, will heavily influence the final
resolution of permissible nitrite levels.
Regulation and control of nitrosamine levels in foods is not as
simple as the FDA setting limits on allowable levels of nitrosamines
because of the problem of precursors. Nitrites and amines, precursors of
nitrosamine formation, combine in several media and under a variety of
circumstances. The contamination of foods with nitrosamines through a
variety of exposure routes has required the FDA to formulate the consti-
tuent policy. The constituent policy will enable the FDA to determine at
what minimum level that the nitrosamine contaminant will be considered
too small to have a significant impact. The FDA will use this policy
to regulate a number of carcinogens including nitrosamines. The
35
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DRAFT
FDA's need for the constituent policy has precluded any quantification of
the magnitude of various routes of nitrosamine contamination. Since the
FDA does not have jurisdiction over the routes of contamination, there was
very little consideration of regulations.
Coordination between FDA and FSQS was caused by the question of
prior regulatory authority of nitrites by the FSQS. No multimedia issues
needed to be resolved, merely a definition of which agency had the legal
authority to regulate nitrite levels in various foods.
36
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DRAFT
3.2.6 Food Safety and Quality Service (Department of Agnculture/FSQS)
3.2.6.1 Entry Into Official Establishments, Reinspection and Preparation
of Products
Current Status of Action
The Food Safety and Quality Service (FSQS) of the DOA has promul-
gated only one final rule that limits nitrosamines directly. This rule
requires that nitrosamines in bacon be lower than the lowest confirmable
level, i.e., 5 parts per billion (ppb) (43 FR 20992). However, the FSQS
also regulates the levels of nitrites and nitrates because they are precur-
sors to nitrosamine formation in certain foods. In general, the FSQS must
get approval for food additive usage from the FDA as mandated by the
Federal Food, Drug and Cosmetic Act. Nitrites and nitrates, however, are
exempt from the need for FDA approval because their use as preservatives
predates the amendments that require FDA approval of food additives. Use
of nitrates in bacon has been banned since May 16, 1978 (43 FR 20992).
Nitrites serve as a preservative and inhibit the formation of Clostridium
botulinum. Since nitrites serve such important functions, they were not
banned but limited in bacon to 120 ppb (43 FR 20992). In addition, the
regulations required that if nitrites are added to bacon, then prescribed
amounts of sodium ascorbate or sodium erythorbate must also be added.
Sodium ascorbate and sodium erythorbate prevent the combination of nitrites
and amines into nitrosamines. Also on May 16, 1980, the FSQS proposed
rules to further reduce nitrite use to 40 ppm (43 FR 21007), but no final
action has taken place. Final action will occur pending the substantiation
of the prevention of botulism at 40 ppm of nitrites.
The other final ruling by FSQS in February, 1979, authorizes the
use of acid-producing microorganisms in the processing of bacon to inhibit
nitrosamine formation (44 FR 9372).
The FSQS proposed a ban on nitrite use in baby, junior and
toddler meat products in April, 1978 (43 FR 18193). While no final action
has been taken on this ban, the preamble to the proposed ban noted that
industry had voluntarily taken nitrites out of baby, junior and toddler
foods.
37
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DRAFT
Multimedia Considerations in the Regulatory History
DOA first limited nitrite use in 1925, restricting residual
nitrite levels in products to 200 parts per million. The proposed reduc-
tion of nitrites in November of 1975 was based on the recommendations by a
multiagency study group, including the FDA, HEW and USDA <40 FR 52614).
Since there was some controversy about whether or not the regulation of
nitrites was under the authority of the USDA the FDA has been consulted
frequently on this issue. A panel of experts of agencies and private
industry, cited in the preamble above, published a report of recommenda-
tions and minutes of their meetings. In Final Report on Nitrites and
Nitrosamines: Report to the Secretary of Agriculture (1), the panel
recommended the measures which were subsequently promulgated. The discus-
sions centered on the carcinogenicity of nitrites, mitigating agents
that could be added, the process of the formation of nitrosamines, and the
value of nitrites in curbing botulism. The carcinogenicity of nitrosamines
themselves was considered to be well established and was consequently not
discussed in detail in the report.
The other document generated in support of DOA's actions on
nitrites was "An Analysis of A Ban on Nitrite Use in Curing Bacon" <2).
This analysis reviewed current regulation and speculated on the impact of a
ban of the use of nitrites in bacon. It did not compare economic and
health benefits because of the complexities of quantifying increased health
due to unknown reductions in cancer rates. Most of the report dealt with
the economic impact of such a ban. The study described two scenarios with
different substitution assumptions for nitrite-preserved bacon. It con-
cluded that farm income would drop 2.5 percent over the first 5 years of
the ban. No mention of multimedia considerations were included in the
report.
The final rule allowing acid-producing micro-organisms in meat
products to mitigate nitrosamine production by lowering the pH was accom-
plished as an emergency measure on February 13, 1979 <44 FR 9372). The
emergency measure is authorized by Executive Order 12044 and Secretary of
38
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DRAFT
Agriculture's Memorandum of 1955. Consequently no proposed rule was
issued. An Impact Analysis statement was noted in the preamble, but was
unavailable for review and inclusion in this report.
At present, the FSQS is still monitoring and studying the problem.
The agency's consideration of nitrosamines in a multimedia perspective is
limited by its narrow statutory authority.
References for Section 3.2.6
1. United States Department of Agriculture, "Final Report on Nitrite
and Nitrosamines: Report to the Secretary of Agriculture," Febru-
ary, 1978.
2. United States Department of Agriculture, Ecoomics, Statistics and
Cooperatives Service, "An Analysis of a Ban on Nitrite Use in Curing
Bacon," March, 1979.
39
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DRAFT
APPENDIX
Federal Register Notices Reviewed for
Nitrosamines Case Study
-------
DRAFT
CHEMICAL: Nitrosamines
AGENCY: EPA
STATUTE: Water Pollution Control Act, 33 USC sl251 et. seq.
PROGRAM: Effluent limitations; Section 301(b), 33 USC sl311(b),
40 CFR Parts 402-699
FR/DATE
CFR
ACTION
DESCRIPTION
40 FR 8302
2/26/75
40 FR 31724
7/28/75
45 FR 928
1/3/80
40 CFR
Part 447
40 CFR
Part 447
40 CFR
Part 447
Proposed
Rule
Final
Rule
Proposed
Rule
Proposed BPT and BAT
effluent limitations
for Ink Formulating
Point Source Category
Final BPT and BAT
effluent limitations
for Ink Formulating
Point Source Category;
zero discharge of pro-
cess wastewater pollu-
tants required
Proposed BPT and BAT
effluent limitations
for revised Ink Formu-
lating Point Source
Category; zero discharge
of process wastewater
pollutants required
(nitrosodiphenylamme
found in wastewater).
-------
DRAFT
CHEMICAL: Nitrosamines
AGENCY: EPA
STATUTE: Water Pollution Control Act, 33 USC sl251 et. Seq.
PROGRAM: New Source Performance Standards, Section 306, 33 USC sl316
40 CFR Parts 402-699
FR/DATE
CFR
ACTION
DESCRIPTION
40 FR 8302
2/26/75
40 CFR
Part 447
Proposed
Rule
Proposed NSPS for Ink
Formulating Point
Source Category; zero
discharge of process
wastewater pollutants
required
40 FR 31724
7/28/75
40 CFR
Part 447
Final
Rule
Final NSPS for Ink
Formulating Point Source
Category; zero discharge
of process wastewater
pollutants required
45 FR 928
1/3/80
40 CFR
Part 447
Proposed
Rule
Proposed NSPS for
revised Ink Formulating
Point Source Category;
zero discharge of pro-
cess wastewater pollu-
tants required (nitroso-
diphenylamine found in
wastewater)
-------
DRAFT
CHEMICAL: Nitrosamines
AGENCY: EPA
STATUTE: Water Pollution Control Act, 33 USC sl251 et. Seq.
PROGRAM: Pretreatment Standards - Existing Sources; Section 307(b),
33 USC sl317(b); 40 CFR Parts 402-699
FR/DATE
CFR
ACTION
DESCRIPTION
40 FR 31730
7/28/75
40 CFR
Part 447
Proposed
Rule
Proposed PSES for
Ink Formulating
Point Source Category;
zero discharge of
pollutants into POTWs
required
45 FR 928
1/3/80
40 CFR
Part 447
Proposed
Rule
Proposed PSES for Ink
Formulating Point
Source Category; zero
discharge of pollutants
into POTWs required
(nitrosodiphenylamine
found in wastewater)
-------
DRAFT
CHEMICAL: Nitrosamines
AGENCY: EPA
STATUTE: Water Pollution Control Act, 33 USC sl251 et. Seq.
PROGRAM: Pretreatment Standards - New Sources; Section 307(c),
33 USC sl317(c); 40 CFR Parts 402-699
FR/DATE
CFR
ACTION
DESCRIPTION
40 FR 8302
2/26/75
40 FR 31724
7/28/75
45 FR 928
1/3/80
40 CFR
Part 447
40 CFR
Part 447
40 CFR
Part 447
Proposed
Rule
Final
Rule
Proposed
Rule
Proposed PSNS for
Ink Formulating
Point Source Category;
zero discharge of
wastewater pollutants
required
Final PSNS for revised
Ink Formulating Point
Source Category; zero
discharge of process
wastewater pollutants
required
Proposed PSNS for revised
Ink Formulating Point
Source Category; zero
discharge of process
wastewater pollutants
required (nitrosodipheny-
lamine found in waste-
water)
-------
DRAFT
CHEMICAL: Nitrosammes
AGENCY: EPA
STATUTE: Water Pollution Control Act, 33 USC sl251 et. Seq.
PROGRAM: Water Quality Standards and Criteria; Sections 30 3, 304(a),
33 USC 1313, 1314(a); 40 CFR Parts 120
FR/DATE
CFR
ACTION
DESCRIPTION
44 FR 15926
3/15/79
Notice
Notice of avail-
ability for public
comment of water
quality criteria for
27 of the 65 toxic
pollutants, inclu-
ding mtrosamine
standards for fresh
and salt water
aquatic life and
and human health
45 FR 79 318
11/28/80
Notice
Notice of avail-
ability of water
quality criteria
documents, including
mtrosamine standards
for fresh and salt
water aquatic life
and human health
-------
DRAFT
CHEMICAL: Nitrosamines
AGENCY: EPA
STATUTE: Water Pollution Control Act, 33 USC sl251 et. Seq.
PROGRAM: Toxic Pollutant Effluent Standards; s307(a)(l),
33 USC sl317(a)(1); 40 CFR Parts 129, 401
FR/DATE
CFR
ACTION
DESCRIPTION
43 FR 4109
1/31/78
Notice
List of toxic
pollutants, in-
cluding nitrosa-
mines, published
pursuant to s307
(a)(1)
44 FR 44501
7/30/79
40 CFR
S401.15
Final
Rule
List of toxic pollu-
tants, including
nitrosamines, re-
listed at 40 CFR
S401.15
-------
DRAFT
CHEMICAL: Nitrosammes
AGENCY: EPA
STATUTE: Water Pollution Control Act, 33 USC sl251 et. Seq.
PROGRAM: Designation of Hazardous Substances and Reportable
Quantities; s311(b)(2)(A), 33 USC sl321(b)(2)(A);
40 CFR Parts 116, 117
FR/DATE
CFR
ACTION
DESCRIPTION
44 FR 10270
2/16/79
45 FR 46094
7/9/80
45 FR 46097
7/9/80
40 CFR
Part 116
40 CFR
Part 116
40 CFR
Part 117
Advance
Notice of
Proposed
Rulemaking
Proposed
Rule
Proposed
Rule
Notice that EPA is
considering the ex-
pansion of selection
criteria for hazar-
dous substances to
include chronic and
long-term effects,
including carcino-
genicity
Proposed addition to
hazardous substance
list of 14 carcino-
gens, including DMN
and diethylnitosamine
Proposed reportable
quantities for DMN
(1 lb.) and diethyl-
nitrosamine (1 lb.)
-------
DRAFT
CHEMICAL: Nitrosamines
AGENCY: EPA
STATUTE: Resource Conservation and Recovery Act, 42 USC s. 6901 et. seq.
PROGRAM: Hazardous Waste Management System, Sections 1006, 2002 (a),
3001-7, 3010, 7004; 42 USC ss.6905, 6912(a), 6924-25;
40 CFR Parts 260-65
FR/DATE
CFR
ACTION
DESCRIPTION
45 FR 33119
5/19/80
40 CFR
Part 261
Interim
Final
Rule
Listing of hazar-
dous wastes; Nitro-
samines listed as
hazardous waste
constituent (40 CFR
Part 261, App. VIII)
45 FR 74884
11/12/80
45 FR 78532
11/25/80
46 FR 11127
2/5/81
40 CFR
Part 261
40 CFR
Part 261
40 CFR
Part 264
Final
Rule
Final
Rule
Proposed
Rule
Final listing of
hazardous constituents
(40 CFR Part 261,
App. VIII)
Final listing of
hazardous wastes and
toxic wastes (40 CFR
ss.261.33[e] and [f]
Proposed standards for
hazardous waste facili-
ties, including prohi-
bition on discharging
nitrosamines into pre-
sent or future drinking
water sources (40 CFR
s.264.20 [b])
-------
DRAFT
CHEMICAL: Nitrosamines
AGENCY: EPA
STATUTE: Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),
(as amended by the Federal Environmental Pesticide Control
Act (FEPCA)), 7 USC 136 et. seq.
PROGRAM: Pesticide Registration, 40 CFR Parts 162, 165, 180
FR/DATE
CFR
ACTION
DESCRIPTION
42 FR 51640
9/29/77
Notice
In anticipation of
EPA policy statement
on pesticides con-
taining N-nitroso
contaminants, appli-
cants and registrants
of these products are
required to submit
data
44 FR 50911
8/30/79
40 CFR
Part 162
Notice
Statement of policy;
issuing an RPAR for
Trifluralin and
restricting NDPA levels
to
-------
DRAFT
CHEMICAL: Nitrosamines
AGENCY: FDA
STATUTE: Federal Food, Drug and Cosmetic Act, 21 (JSC s.201 et. seq.
FR/DATE
CFR
ACTION
DESCRIPTION
42 FR 44 376
9/22/77
Notice
Notice of FDA deter-
mination that nitrites
and Nitrates used in
poultry products are
food additives, out-
lining conditions
under which they can
continue to be used
and establishing of
issues concerning
their safety
44 FR 21365
4/10/79
Notice
Notice that FDA has
detected nitrosamines
in certain topically
applied cosmetics;
manufacturers requested
to take steps to eli-
minate them while FDA
continues to study the
problem
44 FR 75659
12/21/79
21 CFR
Part 7 0
Proposed
Rule
Proposed ruling that
nitrites in bacon
and other meat products
qualify for exception
to the color additive
definition of the
FFDCA and hence are
not to be regulated
under the act
44 FR 75662
12/21/79
21 CFR
Part 170
Proposed
Rule
Proposed ruling that
use of nitrites and
nitrites and nitrates
in poultry products
does not have prior
sanction and hence
can be regulated as a
food additive
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DRAFT
CHEMICAL: Nitrosamines
AGENCY: FDA
STATUTE: Federal Food, Drug and Cosmetic Act, 21 USC s.201 et. seq.
FR/DATE
45 FR 39 341
6/10/80
CFR
21 CFR 109.6
ACTION
Notice
45 FR 7704 3
11/21/80
21 CFR
Part 70
Withdrawal of
Proposed Rule
DESCRIPTION
Notice of avail-
ability of FDC
Compliance Policy
Guide setting regu-
latory action level
for DMN in beer at
5 ppb.
FDA decision that nitri-
tes in bacon are not
color additives under
FFDCA; proposed rule of
12/21/79 withdrawn be-
cause there is no longer
any need to decide
whether nitrites in
bacom qualify for excep-
tion to color additive
provisions
-------
CHEMICAL: Nitrosamines
DRAFT
AGENCY: FSQS (also Animal and Plant Health Inspection Service)
STATUTE: Federal Meat Inspection Act, 21 USC 601 et. seq.
Poultry Products Inspection Act, 21 USC 451 et. seq.
PROGRAM:
FR/DATE
CFR
ACTION
DESCRIPTION
40 FR 52614
11/11/75
9 CFR
Parts 318, 381
Proposed
Rule*
Limits nitrites and
nitrates used in
meat and poultry
products; limits
residual nitrite to
200 pram; bans nitrite
use in infant and
junior food; limits
nitrites in bacon to
125 ppm with ascor-
bate or erythorbate
added.
42 FR 55626
10/18/77
Notice
Request for data from
industry on whether
use of nitrates and/or
nitrites in meat pro-
ducts results in for-
mation of carcinogenic
nitrosamines
43 FR 18193
4/28/78
9 CFR
Part 318
Proposed
Rule
Proposed ban on use of
nitrites and nitrates
in baby, junior and
toddler meat products;
proposed regulation
allowing use of same
name on products con-
taining reduced levels
of nitrites and nitrates
4 3 FR 20992
5/16/78
9 CFR
Part 318
Final
Rule
* By Animal and Plant Health Inspector
Service before FSQS was formed.
Final regulations prohi-
biting use of nitrates in
bacon, requiring the use
of 125 ppm of nitrites
and 550 ppm of sodium
or sodium eythorbate;
creating a monitoring
program for nitrosamines
levels; also requires
maximum of 10 ppb nitro
samines in bacon and 5 ppb
within one year of the
ruling
-------
DRAFT
CHEMICAL: Nitrosammes (continued)
AGENCY: FSQS (also Animal and Plant Health Inspection Service) (continued)
STATUTE: Federal Meat Inspection Act, 21 USC 601 et. seq.
Poultry Products Inspection Act, 21 USC 451 et. seq.
PROGRAM:
FR/DATE
CFR
ACTION
DESCRIPTION
43 FR 21007
5/16/78
9 CFR
Part 318
Proposed
Rule
Proposed reduction
44 ppm - Na
49 ppm - K and
potasium sorbate
of the amount of
nitrites required
to be used in bacon
43 FR 39120
9/1/78
9 CFR
Part
38
Proposed
Rule Revision
Includes a requirement
to include 550 ppm of
sodium ascorbate or
sodium erytharbate with
nitrite reduction to
block nitrosamine forma-
tion in 4 3 FR 21007
44 FR 9 372
9 CFR
45 FR 4 34 25
6/27/80
9 CFR
Part 318
45 FR 4 3447
6/27/80
Final Rule
(No proposed
rule, because
under emer-
gency)
Proposed
Rule
Notice
Final rule authorizing;
the use of acid pro-
ducing micro-organisms
in the processing of
bacon for the purpose of
inhibiting information
of nitrosamines
i
Proposed rule extending
monitoring program to
dry-cured bacon and re-
quired use of certain
preservative techniques
Report of FSQS on its
continuing study of the
use of nitrites and
nitrates in cured meat
products
-------
DRAFT
CHEMICAL: Nitrosammes
AGENCY: OSHA
STATUTE: Occupational Safety and Health Act of 1970, 29 USCs ss.651-78
PROGRAM: Occupational Safety and Health Standards, Sections 6 and 8,
29 USC ss.655 and 657; 29 CFR Parts 1910, 1927 and 1990
FR/DATE
CFR
ACTION
DESCRIPTION
37 FR 13285
7/6/72
Notice
Request for data on
15 inspected carcino-
gens, including DMN;
notice of intent to
develop workplace
standards for these
substances
38 FR 4037
2/9/7 3
Notice
Notice of receipt
of petition for
issuance of emergency
temporary workplace
standards for 10
inspected carcmo-
gems, including DMN
38 FR 10929
5/3/7 3
29 CFR
Part 1910
Notice
Emergency temporary
standard prescribing
workplace standards
and procedures for
14 carcinogens, in-
cluding DMN
38 FR 18900
7/16/7 3
29 CFR
Parts 1910, 1927
Proposed
Rule
Proposed adoption of
above temporarily
standards as permanent
workplace standards
and procedures for 14
carcinogens, including
DMN (Part 1910); Pro-
posed permit program
for employers using
any of the carcinogens
identified in Part
1910 (Part 1927)
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DRAFT
CHEMICAL: Nitrosamines
AGENCY: OSHA
Occupational Safety and Health Act of 1970, 29 USCs ss.651-78
STATUTE:
PROGRAM:
Occupational Safety and Health Standards, Sections 6 and 8,
29 USC ss.655 and 657; 29 CFR Parts 1910, 19 27 and 1990
FR/DATE
CFR
ACTION
DESCRIPTION
38 FR 20074
7/27/7 3
39 FR 3756
1/29/74
12/17/74
40 FR 2 3072
5/28/75
29 CFR
Part 1910
29 CFR
Part 1910
29 CFR
Part 1910
29 CFR
sl910.1016
Final
Rule
Final
Rule
Notice
Revision of emergency
temporary standards
adopted at 38 FR 10929
Final workplace stan-
dards and procedures
for 14 carcinogens,
including DMN (29 CFR
s.1910 .9 3p)
3rd Cir Ct of App
vacates laboratory
provisions for all
14 carcinogens,
including DMN
DMN regulation (29
CFR sl910.93p)
renumbered 29 CFR
sl910.1016
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DRAFT
CHEMICAL: Nitrosamines
AGENCY: OSHA
STATUTE: Occupational Safety and Health Act of 1970, 29 USCs ss.651-78
PROGRAM: Occupational Safety and Health Standards, Sections 6 and 8,
29 use ss.655 and 657; 29 CFR Parts 1910, 1927 and 1990
FR/DATE
42 FR 54148
10/4/77
CFR
29 CFR
Part 1990
ACTION
Proposed
Rule
DESCRIPTION
Proposed general
rule concerning the
identification and
regulation of toxic
substances in work-
place that may pose
carcinogeic risk
45 FR 5002
1/22/80
29 CFR
Part 1990
Final
Rule
Final general rule
concerning the iden-
tification, classi-
fidation and regula-
of toxic substances
in workplace that
pose carcinogrenic
risk
45 FR 536 7 2
8/12/80
Notice
List of substances
that may be reviewed
for possible regula-
tion as carcinogens,
including Diphenyl-
amine 4 nitroso, and
Diphenylamine-N-
mtroso
-------
DRAFT
CHEMICAL: Nitrosamines
AGENCY: CPSC
STATUTE: Consumer Product Safety Act, 15 (JSC s 2051 et. seq.
PROGRAM: Chronic Chemical Hazards Program
FR/DATE
CFR
ACTION
DESCRIPTION
45 FR 61344
9/16/80
Notice
Request for public
comment on list of
91 chemicals that
CPSC has preliminarily
determined are not
present in products
under its jursidiction,
including DMN and
other nitrosamines
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