From: taquilla@erols.com (Tracy Aquilla)
Newsgroups: sci.environment,sci.agriculture
Subject: Re: Is the Delany "anti-carcinogen" clause dead?
Date: Thu, 19 Nov 98 05:41:47 GMT

In Article <72v5qh$6h6$1@news1.epix.net>, Harold Lindaberry
<harlind@epix.net> wrote:
>Michael M Milligan wrote:
>
>> Help! I've lost track of congress. Did our legislators ever eliminate
>> or modify the Delany Clause--the late 50s law mandating zero-tolerance
>> for any known "carcinogenic" chemicals in processed foods, cosmetics,
>> etc??

Hey Mike,
There are actually three Delaney clauses in the FDC Act (the other two apply
to color additives and compounds given to food-producing animals). The
provision you are thinking of applies to food additives, including
pesticides on food (section 409 regulating raw foods, and 408 regulating
processed foods). The clause is applied in a complex scheme to multiple
sections of the code, under both the FDC Act and FIFRA. Our legislators have
not eliminated any of these clauses (but see below).

>> I know that it was written at a time when parts-per-ten-thousand was
>> the norm and became outdated as testing accuracy rose to
>> parts-per-million and beyond.

First conceived in 1954, Delaney introduced it in 1957. The Secretary of HEW
objected almost immediately.

>    Actually in the area of of ppm but not ppb and ppt

Current chemical methods allow for detection below ppb (not sure about ppt).

>> The EPA's response for a long time had been to ignored Delany.
>
>    ?

Basically, but not exactly. EPA applies the Act to pesticides and FDA
enforces it. FDA had control for a long time before EPA came on the scene
and started flexing its muscles (last 20+ years or so). FDA has not really
ignored Delaney, it has just refused to find a compound to be a carcinogen
absent anything short of rigorous scientific proof. Delaney precludes any
analysis of risk and prohibits carcinogens at any level, even if there is no
significant risk. FDA has always been opposed to the Delaney clause because
the rule is un-scientific, and FDA's policies have always been founded on
science.

Delaney resulted in numerous federal litigations in an effort to have it
killed. Since at least 1979, the courts have maintained that the law is
clear on its face and is therefore not subject to judicial construction, and
must be enforced until it is amended by Congress. The FDA has maintained its
position, applying the Delaney clause narrowly, finding only a handful of
true carcinogens that must be prohibited under the Act (EPA however is not
so rigorous). Interestingly, lobbying efforts by both industry and consumer
activists miraculously combined in a most unusual effort to launch the Food
Quality Protection Act (for better or worse).

>> Last I heard (a few years ago) the Supreme
>> Court had ordered it enforced, saying that if the law was no longer
>> sensible, then change it.

Probably thinking of Les v. Reilly (9th Cir. 1992), but the Supremes really
just declined to review the case (essentially confirming it). Since then EPA
has been cancelling a lot of pesticide registrations. Interestingly, EPA
unequivocally states that any risks posed by the pesticide residues are
trivial, and in some cases EPA has revoked or proposed to revoke
registrations based on the mere _possibility_ that a compound might cause
cancer. We most certainly can expect more lawsuits over this arbitrary
application of the law.

>    It wasn't sensible in the first place but good PR for politicians -
>everyone is against sin, death and cancer.

True. Delaney made it known that he had a personal interest as well, since
his wife had been taken by cancer.

>> Did that happen? If so, what took its place?

It is still there, in all three places. What changed was that the FQPA took
pesticides out from under section 409 and modified section 408 to remove
pesticides from the application of Delaney. Instead, the FQPA is based on
risk analysis.

>> Thanks,
>> Mike

Good luck!
Tracy

From: taquilla@erols.com (Tracy Aquilla)
Newsgroups: sci.environment,sci.agriculture
Subject: Re: Is the Delany "anti-carcinogen" clause dead?
Date: Fri, 20 Nov 98 20:57:36 GMT

In Article <734382$18c$1@oak.prod.itd.earthlink.net>,
mmmilligan@earthlink.net (Michael M Milligan) wrote:
>Thanks for the info, Ralph,
>
>Am I mistaken in guessing that the changes to Delaney didn't set well
>with folks worried about pesticides in their food?

Actually, yes, I think you'd be mistaken. The law was heavily lobbied by the
food consumer groups - they wanted this thing as much or more than the
industry, and when it was passed they cheered and patted themselves on the
back. Read some of the articles posted at Charles Benbrook's website. Sorry
I don't have the URL handy.
Tracy

From: taquilla@erols.com (Tracy Aquilla)
Newsgroups: sci.environment,sci.agriculture
Subject: Re: Is the Delany "anti-carcinogen" clause dead?
Date: Sun, 22 Nov 98 00:22:12 GMT

In Article <dmyerson-2011981845560001@207-174-3-228.tnt01.plinet.net>,
dmyerson@plinet.com (Dean Myerson) wrote:
>In article <taquilla.1261983096B@news.erols.com>, taquilla@erols.com
>(Tracy Aquilla) wrote:
>> In Article <734382$18c$1@oak.prod.itd.earthlink.net>,
>> mmmilligan@earthlink.net (Michael M Milligan) wrote:
>> >
>> >Am I mistaken in guessing that the changes to Delaney didn't set well
>> >with folks worried about pesticides in their food?
>>
>> Actually, yes, I think you'd be mistaken. The law was heavily lobbied by the
>> food consumer groups - they wanted this thing as much or more than the
>> industry, and when it was passed they cheered and patted themselves on the
>> back. Read some of the articles posted at Charles Benbrook's website. Sorry
>
>There really wasn't a lot of unity among the people Mike refers to.

True, the anti-pesticide crowd is quite diverse. However, at least some of
the people Mike refers to have made themselves heard publicly on the issue,
and appear to be pleased with the new law.

>Many opposed the weakening of the Delany clause, but it seemed something
>was going to be done.

Well, consumer advocates lobbied heavily in favor of the FQPA. BTW, the
Delaney clause was not weakened, or even changed in any way (see below).

>So some groups negotiated a compromise: a new
>requirement would be added that the setting of exposure limits, must be
>based on the risk to children, who are believeed to be more sensitive and
>more highly exposed.

Not exactly. It would be illogical to base adult tolerances on the risk to
children (particularly if children are more sensitive). I believe there are
actually to be different tolerances set for adults and children, with each
being based on the risks to each respective group.

>So the Delany Clause has been "gutted" in the view of
>many environmentalists,

The Delaney clause (there are actually three of them) was not amended. Its
language remains intact in the federal code, and still applies to food and
feed additives and colorants. It simply does not apply to pesticides
anymore, as it has been superceded in that regard under the FQPA.

>and now they are still waiting for the EPA to
>implement limits based on exposures for children.

There are a lot of pesticides, so yes, it will take a long time to set new
tolerances for all of them. I think ten years is optimistic.

>However, since chemicals
>can't be tested on children, determining what these limits and
>sensitivities are is quite hard.

Pesticides generally cannot be tested on adult humans either. Pesticide
tolerances are based on animal and in vitro testing and various safety
factors, not testing on human subjects.
Tracy

From: taquilla@erols.com (Tracy Aquilla)
Newsgroups: sci.environment,sci.agriculture
Subject: Re: Is the Delany "anti-carcinogen" clause dead?
Date: Sun, 22 Nov 98 15:21:16 GMT

In Article <dmyerson-2111981830260001@207-174-3-198.tnt01.plinet.net>,
dmyerson@plinet.com (Dean Myerson) wrote:
>In article <taquilla.1262081772B@news.erols.com>, taquilla@erols.com
>(Tracy Aquilla) wrote:
>
>> In Article <dmyerson-2011981845560001@207-174-3-228.tnt01.plinet.net>,
>> dmyerson@plinet.com (Dean Myerson) wrote:
>>
>> >So some groups negotiated a compromise: a new
>> >requirement would be added that the setting of exposure limits, must be
>> >based on the risk to children, who are believeed to be more sensitive and
>> >more highly exposed.
>>
>> Not exactly. It would be illogical to base adult tolerances on the risk to
>> children (particularly if children are more sensitive). I believe there are
>> actually to be different tolerances set for adults and children, with each
>> being based on the risks to each respective group.
>
>How can these be applied? If they are applied to foods, they would need
>separate foods for adults and children.

Sorry for the confusion, I did botch that one. I used the word "tolerance"
loosely, when actually I meant to refer to your "exposure limits". The way
'exposure limits' and residue tolerances are set under the Act is rather
complex. Note however, that adults and children do consume different foods
(e.g., infant formula vs. beer), and this fact is taken into consideration.
In fact, the Act requires collection of data on food consumption patterns of
infants and children, and increased sampling of foods most likely consumed
by infants and children. Of course, it is conceivable that certain
tolerances will be influenced by the fact that children are at a lower risk
of exposure than adults from some sources/products.
Tracy

From: taquilla@erols.com (Tracy Aquilla)
Newsgroups: sci.environment,sci.agriculture
Subject: Re: Is the Delany "anti-carcinogen" clause dead?
Date: Mon, 23 Nov 98 15:06:19 GMT

In Article <dmyerson-2211982131120001@207-174-3-122.tnt01.plinet.net>,
dmyerson@plinet.com (Dean Myerson) wrote:
>In article <taquilla.1262135716C@news.erols.com>, taquilla@erols.com
>(Tracy Aquilla) wrote:
>> In Article <dmyerson-2111981830260001@207-174-3-198.tnt01.plinet.net>,
>> dmyerson@plinet.com (Dean Myerson) wrote:
>
>> >> Not exactly. It would be illogical to base adult tolerances on the risk to
>> >> children (particularly if children are more sensitive). I believe there are
>> >> actually to be different tolerances set for adults and children, with each
>> >> being based on the risks to each respective group.
>> >
>> >How can these be applied? If they are applied to foods, they would need
>> >separate foods for adults and children.
>>
>> Sorry for the confusion, I did botch that one. I used the word "tolerance"
>> loosely, when actually I meant to refer to your "exposure limits". The way
>> 'exposure limits' and residue tolerances are set under the Act is rather
>> complex. Note however, that adults and children do consume different foods
>> (e.g., infant formula vs. beer), and this fact is taken into consideration.
>> In fact, the Act requires collection of data on food consumption patterns of
>> infants and children, and increased sampling of foods most likely consumed
>> by infants and children. Of course, it is conceivable that certain
>> tolerances will be influenced by the fact that children are at a lower risk
>> of exposure than adults from some sources/products.
>
>Okay, this makes sense. But beer and infant formula are not the typical
>case. Adults and young children both eat bread. And I hear some adults
>like Frosted Flakes (not me).

Yes, but perhaps adults eat more bread than children do. A child might be
affected by a smaller dose, but they also tend to eat less than adults, so
they may have less exposure.

>It is the conversion of the exposure limits to acceptable levels in the
>produced food that could get complex.

You bet. It is also supposed to be based on scientific data, so we will
probably have to wait while the data are collected.

>I think those enviromentalists who
>assumed that this rule would lead to lower acceptable thresholds may have
>assumed that the lowest level would be adopted (adult vs child).

Furthermore, they may also have assumed that children are at the greatest
risk in all cases, which may not be true.

>example, if adults are more susectable to cancer because their DNA doesn't
>repair as quickly, then the limit would stay the same. If children were
>more sensitive to a different compound because they are still growing,
>that limit would be adopted. The assumption being that most foods are
>eaten by both.

I doubt that assumption will be borne out by the data. We shall see, perhaps
in another 10 years or so.
Tracy