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PANUPS: Action Alert -- Bromoxynil

                         P A N U P S
                   Pesticide Action Network 
                        North America
                       Updates Service

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-
tolerant cotton. 

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 
transgenic cotton. 

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-
docket@epamail.epa.gov (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 jrissler@ucsusa.org.

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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