This is a comment that I’ve just submitted to the FDA asking them to enforce their own regulations and conduct appropriate testing, which has not been done to date, to determine whether all current IQOS applications are in compliance with regard to pesticide residues as required by this rule, and then to determine the impact of any discovered pesticide residues on the manufacturer’s many and deceptive “Modified Risk” claims.
You can support a moveon petition to Congress demanding that FDA investigate by clicking on the cute little hummingbird choking on clouds of vaporized pesticides.
(B) ADDITIONAL SPECIAL RULE.—Beginning 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.
FDA Comment Submission
I am concerned that
The presence of pesticide residues in the Tobacco component of IQOS has not been discussed or referenced in any of Philip Morris’s FDA multiple IQOS applications.
While the IQOS applications offer extensively documented comparisons between toxic substances in the IQOS vapor stream and toxic substances in the smoke stream of combusted Tobacco (reference Cigarettes only, not commercial cigarettes), after performing a keyword search through the submitted IQOS documentation I can find no mention of any comparison of pesticide residues in the IQOS vapor stream with those in a reference cigarette smoke stream in support of the IQOS claim of “modified risk”.
The public record does not show that FDA has yet requested that Philip Morris demonstrate compliance with Special Rule 907(a)(1)(B) with regard to any of its IQOS applications.
To grant any application related to IQOS without first establishing that IQOS can and will comply with Special Rule 907(a)(1)(B) would seriously jeopardize public health in that without demonstrated compliance and published results, the public will not have an opportunity to make a fair and complete comparison of the relative risks the pesticide residue contaminants of the IQOS product vs combustible Tobacco products.
To grant any application related to IQOS that claims “harm reduction” without first comparing the relative harm of inhaling the intact pesticide burden in the IQOS vapor stream to the harm of inhaling the partially combusted, altered and degraded pesticides in a conventional Tobacco smoke stream, would not serve the public’s interest in having full and fair disclosure of all relevant risks associated with the use of IQOS.
Discussion
Because the Tobacco materials, along with any pesticide residues, in the Tobacco component of IQOS will be vaporized well below the point of pyrolytic degradation, and none of any pesticide residues contained in the Tobacco component will be destroyed by combustion, therefore it is reasonable to project that a greater proportion of the original pesticide residue burden on the Tobacco component of IQOS will survive and retain bioactivity in the vapor stream compared with the proportion of surviving and bioactive pesticide residues in a smoke stream that would be generated by combusting that same Tobacco component; and
Because in making its case for “modified risk” Philip Morris, by comparing the toxicant properties of an IQOS vapor stream with the toxicant properties of a Reference Cigarette smoke stream, either by oversight or by design fails to address the differences in potential for harm between (1) delivery of the full original pesticide residue burden in the IQOS vapor stream compared with (2) delivery of a reduced portion of the original pesticide residue burden, of which a portion has been destroyed by combustion, and some or all of the remainder of which has been dry-distilled into altered compounds and/or partially degraded by pyrolytic processes; and,
Because Special Rule 907(a)(1)(B) requires that manufacturers “shall not use” tobacco of any origin containing pesticide residues “at a greater level” than “any tolerance” specified under Federal law; and
Because in addition to pesticides registered for use on Tobacco with established tolerance levels, Federal law also specifies certain pesticides that are banned for use on Tobacco; in the context of US Special Rule 907(a)(1)(B) this requires that manufacturers shall not use any Tobacco containing those banned pesticides “at a greater level” than zero; and
Because current Tobacco industry documentation shows that certain pesticides not registered for use on Tobacco in the United States are present in the world Tobacco supply, and certain pesticides banned in the US are also present in the world Tobacco supply (https://www.coresta.org/agrochemical-guidance-residue-levels-grls-29205.html ); and
Because Philip Morris is a large importer of Tobacco stem and waste materials from Brazil, a Tobacco exporter with documented heavy use of pesticides on Tobacco crops; (https://www.zauba.com/Buyers-of-tobacco-stems) and
Because imported Brazilian Tobacco stems and waste that are likely to be contaminated with pesticides residues, some of which may violate the “greater level” condition of Special Rule 907(a)(1)(B), are used in large quantities (millions of kilograms/year) by Philip Morris in its Tobacco product manufacturing in the US and are therefore, in the absence of any statement by the manufacturer to the contrary, likely used in its IQOS manufacturing processes; however, without testing for the presence and concentration of pesticide residues in the IQOS Tobacco component there can be no demonstration of IQOS compliance with Special Rule 907(a)(1)(B) regarding any such “imported tobacco”; and
Because Brazilian Tobacco pesticide use includes the documented use of pesticides for which US EPA and USDA have established that there are no safe levels, and that are either not registered or banned for use on Tobacco in the US ( https://www.hindawi.com/journals/omcl/2018/7017423/); therefore,
I am requesting that FDA suspend further consideration of the Philip Morris MRTP application, and any other Philip Morris application that can result in approval by the FDA for sale of IQOS in the US, until the issues I raise here are addressed under the FDA’s 907(a)(1)(B) authority and any other applicable enabling authorities.
“Dancing around the definition of smoke to avoid indoor-smoking bans is unethical. Principle 1 for implementing article 8 of the World Health Organization convention on tobacco control highlights that we should reject ideas that there is a threshold value for toxic effects from second-hand smoke. Independent studies should further evaluate the health effects of the IQOS. In the meantime, heated tobacco products such as IQOS should fall under the same indoor-smoking bans as for conventional tobacco cigarettes.” Heat Not Burn: Smoke By Any Other Name
This MoveOn.org petition urges Congress to intervene and order the FDA to suspend all IQOS applications while conducting an investigation of a previously-unrecognized public health threat represented by the IQOS system.
After you look over the simple facts revealed below, please click on the happy little hummingbird hovering in all that harmless IQOS vapor, sign the petition, and help stop this sinister fraud.
The Petition Is Simple
“We ask that Congress act with urgency to direct and enable FDA to immediately conduct testing for residues of toxic and banned pesticides on the Tobacco component of IQOS before any further consideration of any of the pending IQOS applications.
And It’s Important
The pesticides in IQOS Tobacco won’t be burned – they’ll be vaporized with full bioactivity intact. There will be much higher concentrations of these toxic substances in Tobacco vapor than in Tobacco smoke.
Teens and younger children whose neurological and reproductive development is still highly vulnerable to the xenobiotic activity of these chemicals will be inhaling a concentrated pesticide vapor, including vapors of pesticides banned for use anywhere in the world.
In its applications for IQOS Philip Morris never mentions pesticides. Accidental oversight or deliberate omission? Philip Morris is well aware of the presence of these toxic substances in the world Tobacco supply yet they appear nowhere in the list of substances being avoided by IQOS users in comparison to smokers.
(B) ADDITIONAL SPECIAL RULE.—Beginning 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.
Congress has to act now, before IQOS can begin vaporizing millions of American lives. And not incidentally, that’s why the 24 countries where IQOS is already vaporizing lives need to investigate and act with even more urgency than the US Congress.
This is a list of pesticide residues from an internal industry document that reveals the 100+ pesticide residues in the world Tobacco supply. That means any or all of these could be in any given Tobacco product in any country. IQOS uses Tobacco to produce its vapor. There is enough authoritative published evidence that these pesticide residues will be present in IQOS Tobacco vapor for Congress to order the FDA to investigate and if necessary act to prevent the chronic exposure of potentially millions of Americans to these 100% avoidable toxic substances.
Why avoidable? Because the industry knows how to produce organic Tobacco products. But they choose not to. That’s an purely financial decision, disregarding the health consequences, that could only be made safely if they believed that the fix was firmly in and working smoothly.
If you want a new way to control the damage that Tobacco products do to your community, then this may interest you.
This post offers credible tobacco industry data showing all of the pesticides that contaminate Tobacco products worldwide. It is published by CORESTA, the tobacco industry’s captive science & research institute. This information alone can empower local initiatives by offering credible evidence that banned toxic substances may be contaminating locally-sold Tobacco products.
If your local health department has regulations that allow it to investigate whether a product being sold in your community is contaminated with banned pesticide residues, then this list will give them probable cause to sample locally-sold Tobacco products and test for the presence of banned pesticide chemicals.
It is important for you to keep in mind, when making such a request, that (1) it doesn’t matter that the products are Tobacco – they are just like pesticide contaminated candles, air fresheners or incense – and (2) these contaminants are present because of negligence by the manufacturer and lack of regulatory oversight by any superior authority, so the local authorities have to act in the interest of public health and safety.
So this is it – the official (but highly confidential) June, 2018 tobacco industry guide to the pesticide chemicals used on tobacco worldwide. It’s an industry list cautioning manufacturers to ‘watch out’ for these chemicals that remain on Tobacco from the fields, which means that it’s a list of what the industry knows is potentially present in any Tobacco product anywhere.
Many of these pesticides are damaging to human health at very low levels of chronic exposure – just like a smoker gets 100-200 times a day, 365 days a year puffing away and inhaling the pesticide residues invisibly contaminating the tobacco in their cigarette. (Except that it isn’t really tobacco, but that’s another post.)
But the really severe public health threat created by pesticides on Tobacco lies in the industry’s attempt to pivot toward vaporizing. Imagine that instead of being at least partially destroyed by combustion and smoking, all those pesticides are now being gently vaporized and delivered full-strength to your lungs as IQOS Tobacco vapor.
While the tobacco industry publishes pesticide standards for its members, it makes clear that nobody actually has to follow this industry guidance. The tobacco companies are safe from accountability because there is no testing of commercial cigarettes in the United States for the presence of any of these chemicals, and what little testing the FDA, EPA and USDA do perform almost seems deliberately designed to shield the tobacco industry from investigation. It’s not as if the FDA doesn’t have the authority to demand that Tobacco companies at least keep the contamination down a little.
907(a)(1)(B) of Section 907 of the Federal Food, Drug, and Cosmetic Act:
(B) ADDITIONAL SPECIAL RULE.—Beginning 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.
Please keep that language in mind as you browse the list below. Chronic low-dose exposure to any one of the pesticides on this list, just by itself, is enough to cause serious damage to human adults, children and babies. The US government, along with the health authorities of every state, seem collectively uninterested in knowing what dozens of these violent chemicals, all being either burned or heated, smoked or vaporized and then inhaled actively or passively are doing to smokers or vapers, their families and everybody else downwind every day of their lives.
One last thing – notice that there are a lot of banned pesticides on the list. That’s because the Tobacco industry recognizes that large stores of these chemicals still exist and farmers still use them for one simple reason – they kill bugs. It might also be that these chemicals are still being made in black factories in India and China.
Whether using banned pesticides or not, most small farmers in the Third World can’t even read the labels, if there are any, so all they care about is killing bugs and fungus. Every pound of tobacco that bugs eat and fungus destroys is one less pound the farmer has to sell to feed his family, which doesn’t mean that the kids just go without a snack for a day or two.
So of course hundreds of thousands of small tobacco farmers worldwide are going to use triple-witching stuff like Endrin, Heptachlor, Aldrin, and Dieldrin whenever they can get it or whenever they are told to use it. Because while manufacturing of these incredibly toxic chemicals is banned almost everywhere, ‘black’ factories in China and India are churning out the oldies but goodies by the ton and selling them in countries where 50% of all pesticides are used on just one crop – tobacco.
But of course regulatory authorities in the ‘advanced’ countries like the US don’t test for these banned pesticides in anything anymore, much less in tobacco products like cigarettes, because “nobody uses them anymore and all the old stores have been used up or destroyed long ago”.
This is not a list of recommended CPAs (Crop Protection Agents) for tobacco. That is a matter for official and/or industry bodies in each country.
GRLs have not yet been set for all CPAs registered for tobacco. Setting GRLs is an ongoing process based on a list of priorities decided by frequency of use and importance to leaf production.
The presence of a compound does not imply endorsement by CORESTA
The entries in the list do not replace MRLs (Maximum Residue Levels) set by the authorities. Compliance with MRLs is a legal requirement for countries that have set them for
No.
CPA
GRL
(ppm)
Residue definition
Notes
1
2,4,5-T
0.05
2,4,5-T
2
2,4-D
0.2
2,4-D
3
Acephate
0.1
Acephate
4
Acetamiprid
3
Acetamiprid
5
Acibenzolar-S-methyl
5
Acibenzolar-S-methyl
6
Alachlor
0.1
Alachlor
7
Aldicarb (S)
0.5
sum of Aldicarb, Aldicarb sulfoxide and Aldicarb sulfone, expressed as Aldicarb
In countries where fungal diseases such as blue mould are a persistent problem in the field throughout the growing season, the use of dithio- carbamates (DTC) fungicides may be an essential part of the season-long disease management strategy and in keeping with GAP as a means of ensuring crop quality and economic viability for the producer. Under high disease pressure residues of dithio- carbamates (DTC) fungicides slightly in excess of the specified GRL may be observed. In countries where there is not a field fungal disease problem the use of fungicides is not necessary, and there should be no residues detected. Consistent with GAP, dithiocarbamates (DTC) fungicides must be used only according to label instructions to combat fungal diseases in the seedbed and in the field.
No.
CPA
GRL
(ppm)
Residue definition
Notes
47
Endosulfans (S)
1
sum of alpha- and beta-isomers and Endosulfan-sulphate expressed as Endosulfan
48
Endrin
0.05
Endrin
49
Ethoprophos
0.1
Ethoprophos
50
Famoxadone
5
Famoxadone
51
Fenamiphos (S)
0.5
sum of Fenamiphos, Fenamiphos sulfoxide and Fenamiphos sulfone expressed as Fenamiphos
52
Fenitrothion
0.1
Fenitrothion
53
Fenthion (S)
0.1
sum of Fenthion, Fenthion sulfoxide and Fenthion sulfone expressed as Fenthion
54
Fenvalerate (S)
1
Fenvalerate (sum of all isomers including Esfenvalerate)
sum of Heptachlor and two Heptachlor epoxides (cis- and trans-) expressed as Heptachlor
62
Hexachlorobenzene
0.02
Hexachlorobenzene
63
Imidacloprid
5
Imidacloprid
64
Indoxacarb (S)
15
Sum of S isomer + R isomer
65
Iprodione (S)
0.5
sum of Iprodione and N-3,5- dichlorophenyl-3-isopropyl-2,4- dioxoimidazolyzin-1-carboxamide expressed as Iprodione
66
Malathion
0.5
Malathion
67
Maleic hydrazide
80
Maleic hydrazide (free and bounded form)
In some instances, where GAP is implemented and label recom- mendations with regard to application rates and timing are strictly adhered to, residue levels may exceed the current GRL of 80 ppm as a result of extreme weather conditions and the current technology available for application. However, as with all CPAs, all efforts should be made to strictly follow label application rates, and use should be no more than necessary to achieve the desired effect.
68
Metalaxyl (S)
2
sum of all isomers including Metalaxyl-M / Mefenoxam
69
Methamidophos
1
Methamidophos
70
Methidathion
0.1
Methidathion
71
Methiocarb (S)
0.2
sum of Methiocarb, Methiocarb sulfoxide, and Methiocarb sulfone expressed as Methiocarb
sum of Dichlorvos, Naled, and Trichlorfon expressed as Dichlorvos
see Dichlorvos
107
Trifluralin
0.1
Trifluralin
Carbendazim is the degradation product of Benomyl and Thiophanate-methyl. In the case the same sample contains residues of both Carbendazim and/or Benomyl/Thiophanate-methyl, the sum of the residues should not exceed 2
Deltamethrin is the degradation product of Tralomethrin. In the case the same sample contains residues of both Deltamethrin and Tralomethrin, the sum of the two residues should not exceed 1
Dichlorvos is the degradation product of Naled and In the case the same sample contains residues of both Dichlorvos and/or Naled/Trichlorfon, the sum of the residues should not exceed 0.1 ppm.
Omethoate is the degradation product of Dimethoate. In the case the same sample contains residues of both Dimethoate and Omethoate, the sum of the two residues should not exceed 0.5
The Dithiocarbamates Group includes the EBDCs: Mancozeb, Maneb, Metiram, Nabam and Zineb – as well as Amobam, Ferbam, Policarbamate, Propineb, Thiram and
Methomyl is the degradation product of Thiodicarb. In the case the same sample contains residues of both Methomyl and Thiodicarb, the sum of the two residues should not exceed 1
Fluopyram added to GRL list June
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This is a comment that I’ve just submitted to the FDA asking them to enforce their own regulations and conduct appropriate testing, which has not been done to date, to determine whether all current IQOS applications are in compliance with regard to pesticide residues as required by this rule, and then to determine the impact of any discovered pesticide residues on the manufacturer’s many and deceptive “Modified Risk” claims. 
