Bulletin #621
July 18, 2006
Environmentalists are poised to challenge EPA’s decision to license a
fluoride-based soil fumigant pesticide, which they say could draw
attention to the broader issue of whether fluoride standards for
organizations calling on the agency to temporarily ban the use of the
pesticide sulfuryl fluoride, a soil fumigant. Environmentalists are
seeking the ban until the agency addresses their previous calls for an
administrative hearing on EPA’s decision to register, or license,
EPA registered the chemical in 2005 for uses in food processing
facilities, bakeries, rail cars and other storage areas. EPA and
industry sources say the product serves as an alternative for similar
uses of methyl bromide, a pesticide which faces phaseout under an
international treaty because it is thought to deplete stratospheric
Beyond Pesticides charge that allowing any use of the pesticide will
increase fluoride-related human health risks. They argue EPA’s decision
did not meet statutory requirements in the 1996 Food Quality Protection
Act (FQPA) amendments to the Federal Food, Drug & Cosmetic Act (FFDCA),
and threaten legal action if EPA does not open a public hearing on
The law firm Zelle, Hofmann, Voelbel, Mason & Gette filed an
administrative petition with EPA June 1, asking the agency to ban use of
sulfuryl fluoride pending a public hearing on its decision to register
the chemical. The petition states that EPA did not follow statutory
requirements to perform a thorough assessment of exposures and risks
associated with the pesticide. For example, the petition states that EPA
inappropriately used the Office of Water’s Maximum Contaminant Level
Goal (MCLG) as the basis for its risk assessment for sulfuryl flouride.
The MCLG is used to set an enforceable exposure drinking water standard,
or maximum contaminant level (MCL). Both the MCLG and MCL are currently
Under FQPA, the agency is required to consider “aggregate exposure,” or
environmentalists argue that EPA did not appropriately consider fluoride
exposure through drinking water, relying on a faulty water standard for
fully protect children’s health. They argue the agency’s children’s
exposure estimates were too conservative, and that the agency should
consider severe dental fluorosis to be an adverse health effect under
and children, as expressly required in FFCA Section 408(b)(2)(C), EPA
has acted in violation of law and thus there is a substantial likelihood
that objectors will succeed on the merits of this matter,” the petition
The petition calls on EPA to stay its tolerance decisions until the
agency responds to the environmentalists’ concerns. Relevant documents
“As a result of these broad-reaching, staggeringly high fluoride
tolerances, EPA’s own data shows that sulfuryl fluoride will become the
second largest daily source of fluoride in the U.S.,” the petition
states. “The tolerances, therefore, represent a major new source of
fluoride exposure in the U.S. and will — in conjunction with all other
sources of fluoride to which Americans are exposed — contribute to
Both EPA and Dow AgroSciences, the company that manufactures sulfuryl
fluoride, say the agency underwent an extremely detailed risk
assessment, and argue that the exposures resulting from sulfuryl
fluoride use are well below EPA’s reference dose (RfD), or level at
“When all quantified dietary and non-dietary exposure pathways are
combined, risk estimates range from 17 to 43 [percent] of the RfD. These
aggregate risk estimates are below [the Health Effect Division’s] level
of concern for all population subgroups,” according to EPA’s 2004 risk
But environmentalists say their argument is supported by a March report
from the National Academy of Sciences (NAS), which calls on EPA to
revise and tighten its MCLG for naturally occurring fluoride in drinking
water. The NAS report highlights concerns that long-term exposure to
fluoride could result in bone fractures or other bone diseases. NAS did
not recommend a new MCLG, instead asking EPA to perform its own analysis
Environmentalists hope the pesticide issue could influence EPA’s
approach to an MCL, which they argue is based on out-of-date science.
For example, if their petition results in a more detailed fluoride risk
assessment, it could further articulate the need for a more stringent
MCL. Environmentalists could then push for the more stringent standard,
One environmentalist says if EPA denies the petition or the public
hearing, a lawsuit is imminent. “We’re in this all the way to the finish
line,” the source says. “We do not think these tolerances are
Another environmental source says if EPA denies the petition to
temporarily ban the chemical, the groups would ask a federal court to
An industry source says EPA performed a thorough assessment and did not
find any additional risks associated with the sulfuryl fluoride. The
source also points out the value of the chemical as a potential methyl
EPA states in a July 5 Federal Register notice that it is seeking public
comment on the petition due to the complex science and policy issues
surrounding the chemical. “Given that the tolerances as to which the
stay is being sought have been in effect for an extended period and that
the request for a stay raises complex science issues of great public
interest, EPA is . . . requesting comment on the motion,” the document
The industry source says groups are preparing public comments on the
reliance on the NAS report. “The report doesn’t in itself have any
One EPA source says the agency is seeking public comment on the petition
agency wants to give all parties a chance to comment. The source also
notes that limiting sulfuryl fluoride use would likely hamper agency
Public comments on the chemical close August 4. A second EPA source says
the agency will likely issue a decision on the move to ban the
tolerances shortly after the deadline, after the agency reviews the
EPA has also said it is taking NAS’s recommendations into account, and
any changes in drinking water limits would include detail from the
report.







