Subject:  #531: The True Story of Alar, Part 2

=======================Electronic Edition========================
.                          HEADLINES:                           .
.                THE TRUE STORY OF ALAR, PART 2                 .
.                          ==========                           .
.               Environmental Research Foundation               .
.              P.O. Box 5036, Annapolis, MD  21403              .
.      Fax (410) 263-8944; Internet: erf@rachel.clark.net       .
.                          ==========                           .
.  Back issues available by E-mail; to get instructions, send   .
.   E-mail to INFO@rachel.clark.net with the single word HELP   .
.    in the message; back issues also available via ftp from    .
.    ftp.std.com/periodicals/rachel and from gopher.std.com     .
.            and from http://www.monitor.net/rachel/            .
. Subscribe: send E-mail to rachel-weekly-request@world.std.com .
.  with the single word SUBSCRIBE in the message.  It's free.   .
=================================================================

HOW THEY LIE--PART 4: THE TRUE STORY OF ALAR--PART 2

Continuing our history of Alar from last week (and filling in a
few more details prior to 1986):

Alar is a growth-regulating hormone sprayed on apples to hold
them on the tree longer and reduce bruising. Keeping apples on
the tree longer darkens their red color, making consumers happy.
Alar therefore provides economic benefits to apple growers, who
can harvest their crop during a 5-week period instead of a 3-week
period (which reduces their labor troubles, among other
benefits).[1] The benefit to consumers is a cosmetically-
enhanced apple that stays a bit crunchier a bit longer. Alar was
voluntarily withdrawn from the U.S. market by its manufacturer,
Uniroyal Chemical corporation, in 1989 after 10 years of
controversy.

Despite the benefits of Alar, studies in 1967, 1973, 1977, 1978,
and 1979 indicated that Alar (and its contaminant and breakdown
byproduct, UDMH) causes several kinds of cancer in both sexes of
two species of animals, mice and hamsters. There is also evidence
of cancer in a third species, rats, exposed to Alar in a study
conducted by the National Cancer Institute in 1978.[2]

By the early 1980s, the public health community had reached
agreement that Alar/UDMH causes cancer in laboratory animals and
is a "probable human carcinogen:"

** The International Agency for Research on Cancer (IARC) in
Lyon, France, listed UDMH as a probable human carcinogen in
1982.[3]

** The Carcinogen Assessment Group within U.S. Environmental
Protection Agency (EPA) in January, 1984 reached this same
conclusion, and calculated a cancer potency number for UDMH.[4]

** The U.S.'s National Toxicology Program (NTP) in its 1984
report to Congress listed UDMH in the category, "may reasonably
be anticipated to be carcinogens."  The NTP's 1984 statement on
UDMH began, "There is sufficient evidence for the carcinogenicity
of 1,1-dimethyl hydrazine (UDMH) in experimental animals."[5]  At
that time, the NTP report was a consensus statement by nine U.S.
federal agencies: Centers for Disease Control; National Institute
for Occupational Safety and Health; Consumer Product Safety
Commission; EPA; Food and Drug Administration (FDA); National
Cancer Institute; National Institute of Environmental Health
Sciences; National Library of Medicine; Occupational Safety and
Health Administration.

During 1985, EPA hired independent auditors to visit the
laboratory of Bela Toth at University of Nebraska to check his
work.  It was Toth who had conducted the 3 screening studies that
had first revealed carcinogenicity of Alar/UDMH in mice and
hamsters.  The auditors criticized some of Toth's laboratory
practices but in each case they concluded that the basic finding
of carcinogenicity was supportable.[6]

In late summer, 1985, EPA announced it was preparing to ban Alar
from use on food crops (its use on flowers would continue).  EPA
submitted its proposed ban plan to the 8-member Science Advisory
Panel (SAP) established by federal law.  The SAP held a one-day
meeting and concluded, "The Toth Alar studies do give rise to
concern over the potential oncogenicity of daminozide [Alar]."[7]
Oncogenicity is the ability to cause tumors.  However, the SAP
said, the available studies would not permit EPA to calculate the
SIZE of the cancer hazard posed by Alar and UDMH in food.  If
this were true, the legal effort to ban Alar would be an uphill
battle.

The judgment of the SAP itself may have had a political bias.  A
Senate oversight subcommittee revealed that 7 of the 8 members of
the SAP had been "paid consultants to the chemical industry or to
organizations supported by the chemical industry at the time they
served on the [Alar-decision] panel."  At least one member of the
SAP developed a direct financial connection to Uniroyal, Alar's
manufacturer, shortly after the SAP rendered judgment on the Alar
data.  Uniroyal hired Chris Wilkinson a few months after he left
the SAP, and sent him back to Washington to lobby EPA scientists
on Uniroyal's behalf, trying (unsuccessfully) to alter the
protocols that EPA had set for Uniroyal's mouse studies of
Alar.[8]   Neither Wilkinson nor Uniroyal saw anything wrong with
such a revolving door arrangement.

EPA was not required by law to follow the recommendations of the
SAP, and EPA staff scientists disagreed with the SAP conclusion,
but this was a political matter, to be judged at the highest
levels of EPA.  In January, 1986, EPA announced it would not seek
to ban Alar, but would require apple growers to reduce its use by
50%, and would require Uniroyal, for the first time, to conduct
its own studies of the carcinogenicity of Alar.  Alar had then
been on the market for 18 years and Uniroyal had never studied
its carcinogenicity.  Uniroyal says it has studied the health of
its manufacturing workers exposed to Alar and found no problems,
but the company refuses to release the data from those studies.[1]

Entering 1986, Alar was still legal but had fallen under a pretty
severe cloud.  During 1986, the following events occurred:

** Gerber, the baby food manufacturer, announced finding Alar in
its apple juice and apple sauce.

** The American Academy of Pediatrics urged EPA to ban Alar.[10]

** Gerber, Heinz, and Beech Nut stopped accepting Alar-treated
apples for use in baby foods.[9]

** The makers of Mott's apple products, Veryfine apple juice, and
Red Cheek apple juice, among others, announced they would not
accept Alar-treated apples.[9]

** The Washington Apple Commission urged apple growers in the
state of Washington to stop using Alar.[10]  More than half the
nation's apple crop is grown in Washington state.

** The State of Massachusetts passed legislation to phase out (by
1988) the use of Alar for apples that would later be processed
and/or used for infant or baby foods.[1]

** The State of Maine followed the example of Massachusetts, but
restricted the use of Alar even more rapidly, by October, 1986.[1]

** Despite its continuous claims of safety for Alar, Uniroyal
voluntarily sent an advisory to apple processors recommending
that Alar-treated apples not be used for apple sauce because its
intensive processing might cause Alar to release UDMH.[9]

** At least four of the country's major grocery chains notified
their apple suppliers that they would no longer accept apples
treated with Alar.  Safeway, the nation's largest chain; Kroger,
the second-largest; Giant, the biggest chain in the Washington,
D.C., area; and Grand Union, in the New York area pledged to stop
stocking Alar-treated apples.[11]

Events of 1987

** In January, 1987, EPA's Carcinogen Assessment Group (CAG) did
what the Science Advisory Panel (SAP) in 1985 had said couldn't
be done (and which the CAG had previously done in 1984[4]): CAG
developed a quantitative estimate of the cancer potency of
Alar/UDMH.[12]  This was the cancer potency estimate used in 1989
by Natural Resources Defense Council (NRDC) in its now-famous
report, INTOLERABLE RISK: PESTICIDES IN OUR CHILDREN'S FOOD.

** In March, NRDC, Ralph Nader, the State of New York, the Maine
Department of Human Services, several pediatricians, and several
children, filed suit in the U.S. Court of Appeals in San
Francisco to try to force EPA to ban Alar.  This same group had
petitioned EPA in 1986 to ban Alar, but the agency had refused.

** By now, NRDC has initiated a study of the hazards of 23
pesticides in the diet of American children during the first 6
years of life, focusing on three things: (a) the cancer hazard;
(b) toxicity to the central nervous system; (c) inadequate
protection of public health provided by a pesticide regulatory
system that seems incapable of responding in a timely way to
widely-acknowledged chemical hazards. This is the study that will
eventually be accused of creating the "Alar scare."  The fuse is
lit.

[To be continued]
                                                --Peter Montague
                (National Writers Union, UAW Local 1981/AFL-CIO)

===============
[1] Additional apple growers' benefits from Alar are described in
Beth Rosenberg, "The Story of the Alar Ban: Politics and
Unforeseen Consequences," NEW SOLUTIONS (Winter 1996), pgs. 34-50.

[2] Alar is the trade name of daminozide, also known as succinic
acid-2,2-dimethylhydrazide, which is CAS #1596-84-5.  UDMH is
unsymmetrical 1,1-dimethylhydrazine, which is CAS #57-14-7. Alar
is manufactured by reacting succinic anhydride with UDMH, a toxic
component of rocket fuel. Therefore UDMH has always been a
contaminant present in Alar. Furthermore, Alar de-grades into
UDMH when it is heated --as in cooking apple sauce, or
sterilizing apple juice for bottling --or when Alar is digested
in the human stomach.  So when we discuss the dangers of Alar, we
are always necessarily discussing the dangers of Alar and UDMH
combined.  For citations to sources for this information, see
REHW #530.

One 1973 cancer study and two 1977 cancer studies were described
and cited in REHW #530; other studies indicating carcinogenicity
of Alar or UDMH are: F.J.C. Roe and others, "Carcinogenicity of
hydrazine and 1,1-dimethylhydrazine for mouse lung," NATURE Vol.
216 (1967) pgs. 375-376.  And: National Cancer Institute [NCI],
BIOASSAY OF DAMINOZIDE FOR POSSIBLE CARCINOGENICITY [DHEW
Publication No. (NIH) 78-1333; NTIS document No. PB-285 073]
(Port Royal, Virginia: National Technical Information Service
[NTIS], March, 1978); this NCI study showed carcinogenicity among
male rats.  And: C.C. Haun and others, "A six month chronic
inhalation exposure of animals to UDMH to determine its oncogenic
potential," PROCEEDINGS OF THE NINTH CONFERENCE ON ENVIRONMENTAL
TOXICOLOGY (Dayton, Ohio: Wright-Patterson Air Force Base,
Aerospace Medical Research Laboratory, March, 1979).

[3] International Agency for Research on Cancer [IARC], IARC
MONOGRAPHS ON THE EVALUATION OF THE CARCINOGENIC RISK OF
CHEMICALS TO HUMANS, SUPPLEMENT 4 (Lyon, France: IARC, 1982).
See Appendix 2.  The IARC can be contacted at: IARC, 150 Cours
Albert Thomas, 69372 Lyon, France.

[4] U.S. Environmental Protection Agency, HEALTH AND
ENVIRONMENTAL EFFECTS PROFILE FOR 1,1-DIMETHYLHYDRAZINE
[EPA/600/X-84-134] (Port Royal, Va.: National Technical
Information Service [NTIS], January, 1984).  The NTIS document
number is PB88-130083.

[5] United States Public Health Service, National Toxicology
Program, FOURTH ANNUAL REPORT ON CARCINOGENS --SUMMARY 1985
(Washington, D.C.: U.S. Government Printing Office, 1986), pgs.
92-93.

[6] U.S. Environmental Protection Agency, Office of Pesticides
and Toxic Substances, REPORT OF THE AUDITS OF THE STUDIES ON THE
CARCINOGENIC POTENTIAL OF SUCCINIC ACID 2,2-DIMETHYLHYDRAZIDE
(DAMINOZIDE) AND 1,1-DIMETHYLHYDRAZINE IN SWISS MICE, STUDIES
CONDUCTED AT THE EPPLEY INSTITUTE, THE UNIVERSITY OF NEBRASKA
MEDICAL CENTER, OMAHA, NEBRASKA, AUDITS CONDUCTED JANUARY 21-24,
1985 (Washington, D.C.: U.S. Environmental Protection Agency,
1985).  And: D.G. Goodman, REVIEW OF THE BLOOD VESSEL NEOPLASMS
OF LUNG, KIDNEY, AND LIVER IN SWISS MICE ADMINISTERED
1,1-DIMETHYLHYDRAZINE IN DRINKING WATER, PREPARED FOR DYMAC
CORPORATION, 1140 ROCKVILLE PIKE, ROCKVILLE, MARYLAND, AUGUST 19,
1985 (Washington, D.C.: U.S. Environmental Protection Agency,
1985).

[7] Philip H. Gray, Jr., "Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) Scientific Advisory Panel: Review of a
Set of Scientific Issues being Considered by EPA in Connection
with the Special Review of Daminozide [Alar]," (Washington, D.C.:
U.S. Environmental Protection Agency, October 4, 1985).

[8] Eliot Marshall, "Science advisers need advice," SCIENCE Vol.
245, No. 4913 (July 7, 1989), pgs. 20-22; and see Beth Rosenberg,
"The Story of the Alar Ban: Politics and Unforeseen
Consequences," NEW SOLUTIONS (Winter 1996), pg. 37.

[9] Winston Williams, "Polishing the Apple's Image," NEW YORK
TIMES May 25, 1986, pg. C4.

[10] Paul Roberts, "The Big Red Machine; Washington's
battle-scarred billion-dollar apple industry has proved there is
life after Alar," SEATTLE [Washington] WEEKLY February 23, 1994,
pgs. 16-23.

[11] Irvin Molotsky, "Consumer Saturday; A Ban on Treated
Apples," NEW YORK TIMES July 26, 1986, pg. A10.

[12] W. Pepelko, "Memorandum --Evidence for Carcinogenicity of
1,1 Dimethylhydrazine (DMZ)," (Washington, D.C.: U.S.
Environmental Protection Agency, Carcinogen Assessment Group,
January, 1987).  See also: Eliot Marshall, "A is for apple, Alar,
and... alarmist?" SCIENCE Vol. 254, No. 5028 (October 4, 1991),
pgs. 20-22.

Descriptor terms:  alar; pesticides; apples; nrdc; natural
resources defense council; epa; bans; regulation; alar;
daminozide; udmh; carcinogens; cancer; uniroyal; nci; ntp; iarc;
carcinogen assessment group; cag; intolerable risk: pesticides in
our children's food; ralph nader;

################################################################
                             NOTICE
Environmental Research Foundation provides this electronic
version of RACHEL'S ENVIRONMENT & HEALTH WEEKLY free of charge
even though it costs our organization considerable time and
money to produce it.  We would like to continue to provide this
service free.  You could help by making a tax-deductible
contribution (anything you can afford, whether $5.00 or
$500.00).  Please send your contribution to: Environmental
Research Foundation, P.O. Box 5036, Annapolis, MD 21403-7036.
                                        --Peter Montague, Editor
################################################################