PANUPS: Action Alert -- Bromoxynil
P A N U P S
Pesticide Action Network
May 16, 1997
Action Alert: Bromoxynil Tolerant Cotton
The Environmental Protection Agency (EPA) is in the final
stages of deciding whether to establish a new tolerance for
bromoxynil on bromoxynil-tolerant cotton. The public has one
last opportunity to influence the Agency's decision.
A few weeks ago, the Environmental Defense Fund (EDF) and
Pesticide Action Network North America (PANNA) issued an
action alert asking citizens to write to EPA
concerning the bromoxynil tolerance. At the time, it appeared
the Agency was at the end of its decision-making process.
However, according to the Union of Concerned Scientists
(UCS), public outcry over this question was instrumental in
leading EPA to issue a follow-up Federal Register notice on
May 2, 1997, allowing the public to comment on a new proposed
tolerance for bromoxynil. UCS asks members of the public to
comment once again on this issue by urging the Agency to deny
a tolerance for bromoxynil on cotton. Without a tolerance,
farmers will not be able to apply the herbicide to herbicide-
In 1995, EPA approved a conditional registration for
bromoxynil on transgenic bromoxynil-tolerant cotton under
which the crop was grown commercially in 1995 and 1996. EPA
also established a temporary tolerance -- a maximum permissible
limit for the residues of bromoxynil in or on cottonseed,
which expired April 1, 1997. On May 2, 1997, EPA issued a
proposed rule that would establish a new time-limited
tolerance for bromoxynil in 49 crop and animal commodities
and for bromoxynil and its metabolite, DBHA (3,5-dibromo-4-
hydrobenzoic acid), in cotton hulls, seed, and gin
Tell EPA to deny a tolerance for bromoxynil and its
metabolite DBHA because:
1. Bromoxynil itself is a toxic chemical with numerous known
adverse health and environmental effects.
EPA has classified bromoxynil as a possible human carcinogen
because it causes liver cancer in mice. The herbicide is also
known to be a developmental toxicant, causing birth defects
in mammals. Bromoxynil poses environmental threats, as it is
highly toxic to broadleaf plants and fish.
2. The carcinogenic risk of bromoxynil exceeds the one-in-a-
million standard of the new Food Quality Protection Act.
The Food Quality Protection Act (FQPA) requires EPA to
implement a new safety standard -- a "reasonable certainty of
no harm" for aggregate exposure using dietary residues and
all other reliable exposure information. The legislative
history of the FQPA establishes the reasonable-certainty-of-
no-harm standard for nonthreshold (cancer) effects at a one-
in-a-million risk level, meaning one additional cancer for
each one million people exposed.
EPA's estimate of the carcinogenic risk of bromoxynil in food
sources and drinking water exceeds the one-in-a-million risk
level. The Agency estimates the carcinogenic risk of
bromoxynil from food to be 1.5 in a million and from drinking
water 0.6 in a million for a total carcinogenic risk of 2.1
in a million.
3. The Agency is setting a tolerance without safety data on
the new metabolite produced by genetically engineered cotton.
Bromoxynil-tolerant cotton is able to withstand bromoxynil
because it contains an enzyme that breaks the herbicide down
into a metabolite -- DBHA. The Agency knows that DBHA
accounts for nearly 80% of the residues found in cotton after
bromoxynil application. It expects DBHA residues will be
found in cottonseed oil and meal and in beef, pork, poultry,
and eggs from animals that consume the meal. Though the
Agency and Rhone-Poulenc, the manufacturer of the herbicide,
have known about DBHA for years, Rhone-Poulenc has never
submitted data on its toxicity nor has EPA required those
data as a condition of registration. So, the original
tolerance set by EPA in 1995 covered only bromoxynil.
EPA now recognizes that legally it must set a tolerance for
DBHA as well as bromoxynil in order for the cotton to
continue to be used. In the May 2 notice, EPA proposed a
tolerance that accounts for the residues of DBHA. But the
Agency still has not received the safety data from Rhone-
Poulenc necessary to assess the toxicity of the metabolite.
Not having these data, the Agency has to rely on assumptions.
In this case, it is assuming that DBHA is "toxicologically
equal" to the parent bromoxynil -- that is, a carcinogen with
the same potency as bromoxynil. But what if DBHA is more
potent than bromoxynil or perhaps an endocrine disrupter as
well as a carcinogen? The Agency is willing to approve
bromoxynil without answering these questions.
Rhone-Poulenc could and should have supplied these data on
the unique residue in transgenic cotton long ago. Therefore,
setting the tolerance and effectively approving the
herbicide-tolerant crop without data is an outrageous
concession to Rhone-Poulenc that favors the company's
commercial interests over the public's health.
Given the lack of data on DBHA, the failure to comply with
the FQPA, and bromoxynil's record on birth defects, the
Agency should not establish a tolerance for bromoxynil on
Send comments, identified with Docket Control Number OPP-
300486, to arrive on or before May 26 to:
Public Response and Program Resources Branch Field Operations
Division (7506C) EPA/Office of Pesticide Programs, 401 M St.,
SW, Washington, DC 20460; fax (703) 305-4646; email opp-
firstname.lastname@example.org (submit as ASCII file and do not use
special characters or encryption)
Contact: Jane Rissler, Ph.D., Union of Concerned Scientists,
1616 P St., NW, Washington, DC 20036; phone (202) 332-0900;
fax (202) 332- 0905; email email@example.com.
62 Federal Register 24065-73.
EPA, "PP#3F04233. Extension of conditional registration for
the use of bromoxynil on transgenic cotton," Memo from R.
Griffin et al. to D. Stubbs, Office of Pesticide Programs,
Food Quality Protection Act section 408(b)(2)(A)(ii).
Environmental Working Group and Natural Resources Defense
Council, "Fact sheet: the impact of the new pesticide law,"
Washington, DC, no date.
EPA, "PP#3F04233. Assumptions for estimating bromoxynil
exposure from drinking water," Memo from R. Griffin to D.
Stubbs, Office of Pesticide Programs, 5/6/97.
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