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Please see our supplementary material where you can see the questions
that were asked during the interview. You will note that survey
participants were explicitly advised not to include potatoes when
considering their answers.
Please see our supplementary material where you can see the questions
that were asked during the interview. You will note that survey
participants were explicitly advised not to include potatoes when
considering their answers.
Molter et al. reported the effects of long-term exposure to
particulate matter with aerodynamic diameter <10 micrometer (PM10) and
nitrogen dioxide (NO2) on the prevalence of asthma and wheeze within a
population-based birth cohort (1). They concluded that no significant
association between long-term exposure to PM10 and NO2 and the prevalence
of either asthma or wheeze was found. In contrast, the same authors
report...
Molter et al. reported the effects of long-term exposure to
particulate matter with aerodynamic diameter <10 micrometer (PM10) and
nitrogen dioxide (NO2) on the prevalence of asthma and wheeze within a
population-based birth cohort (1). They concluded that no significant
association between long-term exposure to PM10 and NO2 and the prevalence
of either asthma or wheeze was found. In contrast, the same authors
reported that lifetime exposure to PM10 and NO2 was associated
significantly with reductions in lung volume growth by using the same
cohort (2).
On this point, Gehring et al. conducted meta-analysis with random-
effect model on the effects of air pollution on lung function in children
(3). They concluded that that current levels of NO2, total nitrogen
oxides, and particulate matter with aerodynamic diameter <2.5
micrometer (PM2.5) were significantly associated with the change in forced
expiratory volume in 1 second (FEV1), but PM10 showed no significance. As
the level of statistical significance in studies by Molter et al. or
Gehring et al. was not highly enough, final conclusion cannot be
determined. Relating to these studies, Urman et al. reported health survey
to assess the effects of near-roadway air pollution (NRAP) and regional
pollution on childhood lung function (4). They concluded that the
contribution of regional pollution to adverse lung function, evaluated by
FEV1 and forced vital capacity (FVC), was relatively larger than that of
NRAP, and NO2 contributed little to the decrease in FEV1 and FVC than
other air pollution indicators such as PM2.5 and PM10.
I have some concerns on the study outcomes. First, physiological lung
functions and subjective respiratory complains for dependent variables
would sometimes lead to the different study outcome, and both dependent
factors should be evaluated to know the adverse effect of air pollution on
respiratory organs. As one of the co-authors, I conducted questionnaire
survey for 16,663 pairs of junior high school students and their mothers
in Indonesian cities to measure the effect of air pollution on respiratory
health (5). Nine communities were set and there were inter-class and intra
-class variation of NO2. As a main result, the prevalence rates of the
symptoms of cough, phlegm, persistent cough, wheezing without a cold, and
asthma of the student were significantly correlated with the NO2 emitted
along large roads near their residences.
Second, the superiority of PM2.5 compared with PM10 could not be
confirmed, and the best aerodynamic diameter of particulate matter as an
air pollution indicator should be specified by further studies.
Finally, I recommend for considering indoor air pollution especially
by smoking (6). Anyway, cause-effect relationship would be clarified by
epidemiological cohort studies.
References
1 Molter A, Agius R, de Vocht F, et al. Effects of long-term exposure
to PM10 and NO2 on asthma and wheeze in a prospective birth cohort. J
Epidemiol Community Health 2014;68:21-8.
2 Molter A, Agius RM, de Vocht F, et al. Long-term exposure to PM10
and NO2 in association with lung volume and airway resistance in the MAAS
birth cohort. Environ Health Perspect 2013;121:1232-8.
3 Gehring U, Gruzieva O, Agius RM, et al. Air Pollution Exposure and
Lung Function in Children: The ESCAPE Project. Environ Health Perspect
2013;121:1357-64.
4 Urman R, McConnell R, Islam T, et al. Associations of children's
lung function with ambient air pollution: joint effects of regional and
near-roadway pollutants. Thorax 2013 Nov 19. doi: 10.1136/thoraxjnl-2012-
203159.
5 Duki MI, Sudarmadi S, Suzuki S, et al. Effect of air pollution on
respiratory health in Indonesia and its economic cost. Arch Environ Health
2003;58:135-43.
6 Guerra S, Stern DA, Zhou M, et al. Combined effects of parental and
active smoking on early lung function deficits: a prospective study from
birth to age 26 years. Thorax 2013;68:1021-8.
I may have missed it, but Oyebode et al. do not seem to say exactly
what they mean by a vegetable or what the exact question was. This is
important, because they do refer to a UK Department of Health website,
which states that potatoes, yams, plantain, and casava should not be
included the 5-a-day count, but sweetcorn should. I thought that
sweetcorn was a grain and so would not count it as a vegetable, though I
may b...
I may have missed it, but Oyebode et al. do not seem to say exactly
what they mean by a vegetable or what the exact question was. This is
important, because they do refer to a UK Department of Health website,
which states that potatoes, yams, plantain, and casava should not be
included the 5-a-day count, but sweetcorn should. I thought that
sweetcorn was a grain and so would not count it as a vegetable, though I
may be wrong, but if asked how many portions of vegetables I ate yesterday
would definitely have included potatoes, a staple food in the UK, if I had
eaten them. I think that the authors should clarify this.
Sir, the recent report on "extreme temperatures and paediatric
emergency" is very interesting
[1]. Xu et al. concluded that "children are at particular risk of a
variety of diseases which
might be triggered by extremely high temperatures [1]."Xu et al. also
mentioned for the effect
of climate change. In fact, Xu et al. reported a highly similar
publication in Occup Environ
Med and also noted for the effect of climate chan...
Sir, the recent report on "extreme temperatures and paediatric
emergency" is very interesting
[1]. Xu et al. concluded that "children are at particular risk of a
variety of diseases which
might be triggered by extremely high temperatures [1]."Xu et al. also
mentioned for the effect
of climate change. In fact, Xu et al. reported a highly similar
publication in Occup Environ
Med and also noted for the effect of climate change on childhood illness
with special focus
on asthma [2]. The two works should share the same groups of patients but
the conclusion is
different. In the present report, Xu et al. make a conclusion that
"children aged 10-14 years
were more sensitive to both hot and cold effects [1]" whereas they
proposed that "children
aged 10-14 years were most vulnerable to cold effects [2]." This implies
that there are many
bias in both reports. Hence, it cannot conclude on any effects from hot
and cold temperature
on pediatric illness. In addition, not only temperature but also other
climatic factors can affect
the disease incidence. The good example is the effect of humidity [3],
pollutants [3] and
ozone levels [4].
References
1. Xu Z, Hu W, Su H, Turner LR, Ye X, Wang J, Tong S. Extreme
temperatures and
paediatric emergency department admissions. J Epidemiol Community Health.
2013
Nov 23. doi: 10.1136/jech-2013-202725. [Epub ahead of print]
2. Xu Z, Huang C, Hu W, Turner LR, Su H, Tong S. Extreme temperatures and
emergency department admissions for childhood asthma in Brisbane,
Australia.
Occup Environ Med. 2013 Oct;70(10):730-5.
3. Vandini S, Corvaglia L, Alessandroni R, Aquilano G, Marsico C, Spinelli
M, Lanari
M, Faldella G. Respiratory syncytial virus infection in infants and
correlation with
meteorological factors and air pollutants. Ital J Pediatr. 2013 Jan
11;39(1):1.
4. Jones GN, Sletten C, Mandry C, Brantley PJ. Ozone level effect on
respiratory illness:
an investigation of emergency department visits. South Med J. 1995
Oct;88(10):1049-
56.
Dear Editor,
The published paper by Paananen et al, entitled "Social determinants of
mental health: a Finnish nationwide follow up study on mental disorders"1
was an interesting and rigorous study. Through a longitudinal approach,
all Finnish children who were born in a certain year (1987) were followed
through adolescence in order to examine the development of mental
disorders and assess potential SDH-related risk fact...
Dear Editor,
The published paper by Paananen et al, entitled "Social determinants of
mental health: a Finnish nationwide follow up study on mental disorders"1
was an interesting and rigorous study. Through a longitudinal approach,
all Finnish children who were born in a certain year (1987) were followed
through adolescence in order to examine the development of mental
disorders and assess potential SDH-related risk factors. For this purpose,
the authors created six multivariate models between different groups of
variables and the outcome. In addition, a full model was developed to
include the variables which showed significant associations with the
outcome in at least one of these six models. In Table 2 of that paper, the
determinants of mental disorders according to various models were
demonstrated. Nevertheless, it was not clear for us why parent's highest
educational level, parent's highest SES, parental social assistance,
cohort member's education and cohort member's received social assistance
which showed association with the outcome in models 2, 3 or 5, were not
included in the full model. At the first look, one might speculate that
these variables were included in the full model, but were not shown in
Table 2; as they might not have proved significant. But, this might not be
the correct justification as some non-significant variables e.g. "mother's
age (<20)" and "single mothers" could be found in the full model within
the same table without being significant in the full model. It would be
very kind of the authors to respond to this question and explain whether
it would be a concern in the main findings of the full model or not.
Sincerely Yours,
* Narjes Hazar, MD, Resident in Community Medicine, Department of
Community Medicine, Tehran University of Medical Sciences, Tehran, Iran
* Mojgan Karbakhsh, MD, Associate Professor in Community Medicine,
Department of Community Medicine, Tehran University of Medical Sciences,
Tehran, Iran
Reference:
1. Paananen R, Ristikari T, Merikukka M, Gissler M. Social determinants of
mental health: a Finnish nationwide follow-up study on mental disorders. J
Epidemiol Community Health. 2013 Aug 1. doi:10.1136/jech-2013-202768
________________________________________________________________________
Corresponding author:
Dr Narjes Hazar, MD, Resident in Community Medicine, Department of
Community Medicine, Tehran University of Medical Sciences, Tehran, Iran
Address: Department of Community Medicine, School of Medicine, Tehran
University of Medical Sciences, PoorSina St, Qods St, Enqelab Av, Tehran,
Iran
Email: n-hazar@razi.tums.ac.ir
Tel/Fax: +9821 88962357
This is a great contribution to the literature on fuel poverty, cold
housing, and health.
The authors call for a review of qualitative and intervention
research
related to this topic. It may be useful for readers to be made aware of
a recently updated version of a systematic review of the health and
socio-economic impacts of housing improvement published by the Campbell
and Cochrane Collaborations 1. In this revi...
This is a great contribution to the literature on fuel poverty, cold
housing, and health.
The authors call for a review of qualitative and intervention
research
related to this topic. It may be useful for readers to be made aware of
a recently updated version of a systematic review of the health and
socio-economic impacts of housing improvement published by the Campbell
and Cochrane Collaborations 1. In this review we looked at physical
improvements to housing infrastructure and this included a group of 15
quantitative (including five RCTs) and seven qualitative studies of
warmth & energy efficiency improvements. We did not include studies
which only looked at financial help with fuel bills, for example the
winter fuel allowance distributed to the elderly in the UK.
1. Thomson H, Thomas S, Sellstrom E, Petticrew M. Housing
improvements
for health and associated socio-economic outcomes. Cochrane Database of
Systematic Reviews 2013;2:Art. No.: CD008657 DOI:
10.1002/14651858.CD008657.pub2.
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008657.pub2/pdf/standard
Pesticide Action Network Europe
It cannot be denied that TTC (Threshold of Toxicological Concern) was
originally proposed in the U.S., as Dr Harris states in her commentary on
our article,[1] but her industry-sponsored organisation, the International
Life Sciences Institute (ILSI) played a major role in developing it
further to the form in which it was accepted by European Food Safety
Authority (EFSA).
This process took p...
Pesticide Action Network Europe
It cannot be denied that TTC (Threshold of Toxicological Concern) was
originally proposed in the U.S., as Dr Harris states in her commentary on
our article,[1] but her industry-sponsored organisation, the International
Life Sciences Institute (ILSI) played a major role in developing it
further to the form in which it was accepted by European Food Safety
Authority (EFSA).
This process took place in an EFSA working group, in which ten out of 13
members had previously developed and promoted the tool with ILSI.[2] While
EFSA communicators have attempted damage control in their online Q&A, the
biased work on TTC raised such concerns in the European Parliament that
EFSA was forced to ban ILSI-linked people from being members of expert
panels and working groups. Any link with ILSI now has to be cut in order
to qualify as an EFSA expert.
Apart from this industry infiltration of EFSA, the tool as delivered by
ILSI is far from being "scientifically supported", as Dr Harris suggests.
The database underpinning the TTC for non-genotoxic substances[3] is
entirely made up of (potentially biased) industry studies. Many of these
studies are 40-60 years old and non-retrievable (cannot be accessed),
meaning that their quality cannot be assessed. In addition, the old
protocols used means that current scientific knowledge will not be taken
into account in calculating TTCs. In utero exposure is generally missing
and important risks will be overlooked because of the limited endpoints
considered at that time. The grouping of chemicals for TTC is artificial
and is based on the Cramer classification,[4] which relies on expert
judgement only and is subjective. ILSI has also manipulated the genotoxin
database to get to an apparently desired outcome. For example, it has
removed aflatoxin-like, azo- and N-nitroso- substances.[5] Another
unscientific shortcoming of TTC is its disregard of cumulative effects.
The TTC is derived by arbitrarily removing from the calculation the most
toxic effects found in the database of NOELs (no adverse effect levels).
The TTC sets the 'level of no concern' at the 5th percentile, resulting in
a 1 in 20 chance that a random substance in any one group of chemicals is
toxic at this exposure level. Thus 5% of the chemicals in the group are
more toxic than the 'level of no concern' that is set for any one group of
chemicals.
TTC is promoted as a screening tool while in practice it is already being
used as a cut-off criterion (safe level) for pesticide metabolites.[6]
Industry is now trying to extend TTC to other fields such as any chemical
found in food,[7] outcomes of developmental testing,[8] drinking water,[9]
and inhaled chemicals.[10] In many cases, and not coincidentally,
advocates of TTC are pursuing these aims through opinions published in
Regulatory Toxicology and Pharmacology, the controversial
chemical/pharmaceutical industry-sponsored journal. The journal was one of
several entities that were investigated by a US Congressional Committee in
2008 over their role in the Food and Drug Administration (FDA) decision
allowing bisphenol A in infant formula and other foods.[11-13]
Analysing the TTC tool and the background of its development can only lead
to the conclusion that industry has invested massively in a tool that does
not safeguard human health, as Dr Harris misleadingly claims, but exactly
the opposite. The tool serves industry's agenda of fast-tracking chemicals
to the market and avoids the costs of testing. The tool undermines
European legislation and policy. It aims to replace the existing EU policy
of 'no safe level' for genotoxic substances with claimed 'safe levels'
arrived at through the TTC. It also aims to replace the EU policy that
health of citizens should be protected by adequate testing and the
precautionary principle with a tool that enables avoidance of testing for
chemicals, metabolites and impurities.
The tool, which serves industry's agenda but places public health at risk,
has been introduced into European agencies by people who have served as
members of expert panels while maintaining conflicts of interest with
industry. Dr Harris's reference to the Danish study[14] as a balanced
review of TTC is a case in point. Its author, John Christian Larsen,
worked in ILSI scientific bodies from 2002 till 2008[15] and has published
studies with ILSI-affiliated people who have promoted TTC.[16] TTC has
made its way into the regulatory policy of the food safety authority EFSA
because of industry's massive resources and a lack of awareness on the
part of EFSA's staff, not for reasons of sound science.
References
1. Robinson C, Holland N, Leloup D, et al. Conflicts of interest at
the European Food Safety Authority erode public confidence. J Epidemiol
Community Health Published Online First: 8 March 2013. doi:10.1136/jech-
2012-202185
2. Muilerman H, Tweedale T. A toxic mixture? Industry bias found in
EFSA working group on risk assessment for toxic chemicals, Pesticide
Action Network Europe 2011.
3. EFSA Scientific Committee. Scientific opinion on exploring options
for providing advice about possible human health risks based on the
concept of Threshold of Toxicological Concern (TTC). EFSA Journal 2012;10:
2750.
4. Cramer GM, Ford RA, Hall RL. Estimation of toxic hazard - a
decision tree approach. Food Cosmet Toxicol 1978;16: 255-276.
5. Kroes R, Renwick AG, Cheeseman M, et al. Structure-based
thresholds of toxicological concern (TTC): guidance for application to
substances present at low levels in the diet. Food Chem Toxicol 2004; 42:
65-83.
6. European Commission Health and Consumer Protection Directorate-
General (DG SANCO). Guidance document on the assessment of the relevance
of metabolites in groundwater of substances regulated under Council
Directive 91/414/EEC: Sanco/221/2000-rev.10-final. 25 February 2003.
7. Koster S, Boobis AR, Cubberley R, et al. Application of the TTC
concept to unknown substances found in analysis of foods, Food and
Chemical Toxicology 2011; 49: 1643-1660.
8. Van Ravenzwaay B, Dammann M, Buesen R, et al. The threshold of
toxicological concern for prenatal developmental toxicity. Regulatory
Toxicology and Pharmacology 2011;59: 81-90.
9. Melching-Kollmuss S, Dekant W, Kalberlah F. Application of the
''threshold of toxicological concern" to derive tolerable concentrations
of ''non-relevant metabolites" formed from plant protection products in
ground and drinking water. Regulatory Toxicology and Pharmacology 2010;
56: 126-134.
10. Escher SE, Tluczkiewicz I, Batke M, et al. Evaluation of
inhalation TTC values with the database RepDose. Regulatory Toxicology and
Pharmacology 2010; 58: 259-274.
11. Michaels, D. Doubt Is Their Product: How Industry's Assault on
Science Threatens Your Health. Oxford University Press. 2008: 53-54.
12. Layton L. Studies on chemical in plastics questioned. Washington
Post 27 April 2008.
13. Dingell JD. Letter to Jack N Gerard, president and CEO, American
Chemistry Council. 2 April 2008. http://bit.ly/ZWMbi6 (accessed 15 April
2013).
14. Nielsen E, Larsen JC. The Threshold of Toxicological Concern
(TTC) concept: Development and regulatory applications. Danish Ministry of
the Environment, Environmental Protection Agency. Environmental Project
No. 1359. 2011. http://www2.mst.dk/udgiv/publications/2011/03/978-87-92708
-86-1.pdf (accessed 15 April 2013).
15. European Food Safety Authority (EFSA). Declarations of interests
(DoIs). http://www.efsa.europa.eu/en/efsawho/doi.htm (accessed 15 April
2013).
16. Pratt I, Barlow S, Kleiner J, et al. The influence of thresholds
on the risk assessment of carcinogens in food. Mutation Research 2009;
678: 113-117.
Conflict of Interest:
Hans Muilerman is employed at Pesticide Action Network Europe, which receives funding from trusts and foundations, including the European Endocrine Health Initiative.
It cannot be denied that TTC (Threshold of Toxicological Concern) was
originally proposed in the U.S., as Dr Harris states in her commentary on
our article,[1] but her industry-sponsored organisation, the International
Life Sciences Institute (ILSI) played a major role in developing it
further to the form in which it was accepted by European Food Safety
Authority (EFSA).
It cannot be denied that TTC (Threshold of Toxicological Concern) was
originally proposed in the U.S., as Dr Harris states in her commentary on
our article,[1] but her industry-sponsored organisation, the International
Life Sciences Institute (ILSI) played a major role in developing it
further to the form in which it was accepted by European Food Safety
Authority (EFSA).
This process took place in an EFSA working group, in which ten out of
13 members had previously developed and promoted the tool with ILSI.[2]
While EFSA communicators have attempted damage control in their online
Q&A, the biased work on TTC raised such concerns in the European
Parliament that EFSA was forced to ban ILSI-linked people from being
members of expert panels and working groups. Any link with ILSI now has to
be cut in order to qualify as an EFSA expert.
Apart from this industry infiltration of EFSA, the tool as delivered
by ILSI is far from being "scientifically supported", as Dr Harris
suggests. The database underpinning the TTC for non-genotoxic
substances[3] is entirely made up of (potentially biased) industry
studies. Many of these studies are 40-60 years old and non-retrievable
(cannot be accessed), meaning that their quality cannot be assessed. In
addition, the old protocols used means that current scientific knowledge
will not be taken into account in calculating TTCs. In utero exposure is
generally missing and important risks will be overlooked because of the
limited endpoints considered at that time. The grouping of chemicals for
TTC is artificial and is based on the Cramer classification,[4] which
relies on expert judgement only and is subjective. ILSI has also
manipulated the genotoxin database to get to an apparently desired
outcome. For example, it has removed aflatoxin-like, azo- and N-nitroso-
substances.[5] Another unscientific shortcoming of TTC is its disregard
of cumulative effects.
The TTC is derived by arbitrarily removing from the calculation the
most toxic effects found in the database of NOELs (no adverse effect
levels). The TTC sets the 'level of no concern' at the 5th percentile,
resulting in a 1 in 20 chance that a random substance in any one group of
chemicals is toxic at this exposure level. Thus 5% of the chemicals in the
group are more toxic than the 'level of no concern' that is set for any
one group of chemicals.
TTC is promoted as a screening tool while in practice it is already
being used as a cut-off criterion (safe level) for pesticide
metabolites.[6] Industry is now trying to extend TTC to other fields such
as any chemical found in food,[7] outcomes of developmental testing,[8]
drinking water,[9] and inhaled chemicals.[10] In many cases, and not
coincidentally, advocates of TTC are pursuing these aims through opinions
published in Regulatory Toxicology and Pharmacology, the controversial
chemical/pharmaceutical industry-sponsored journal. The journal was one of
several entities that were investigated by a US Congressional Committee in
2008 over their role in the Food and Drug Administration (FDA) decision
allowing bisphenol A in infant formula and other foods.[11-13]
Analysing the TTC tool and the background of its development can only
lead to the conclusion that industry has invested massively in a tool that
does not safeguard human health, as Dr Harris misleadingly claims, but
exactly the opposite. The tool serves industry's agenda of fast-tracking
chemicals to the market and avoids the costs of testing. The tool
undermines European legislation and policy. It aims to replace the
existing EU policy of 'no safe level' for genotoxic substances with
claimed 'safe levels' arrived at through the TTC. It also aims to replace
the EU policy that health of citizens should be protected by adequate
testing and the precautionary principle with a tool that enables avoidance
of testing for chemicals, metabolites and impurities.
The tool, which serves industry's agenda but places public health at
risk, has been introduced into European agencies by people who have served
as members of expert panels while maintaining conflicts of interest with
industry. Dr Harris's reference to the Danish study[14] as a balanced
review of TTC is a case in point. Its author, John Christian Larsen,
worked in ILSI scientific bodies from 2002 till 2008[15] and has published
studies with ILSI-affiliated people who have promoted TTC.[16] TTC has
made its way into the regulatory policy of the food safety authority EFSA
because of industry's massive resources and a lack of awareness on the
part of EFSA's staff, not for reasons of sound science.
References
1. Robinson C, Holland N, Leloup D, et al. Conflicts of interest at
the European Food Safety Authority erode public confidence. J Epidemiol
Community Health Published Online First: 8 March 2013.
doi:10.1136/jech-2012-202185
2. Muilerman H, Tweedale T. A toxic mixture? Industry bias found in
EFSA working group on risk assessment for toxic chemicals, Pesticide
Action Network Europe 2011.
3. EFSA Scientific Committee. Scientific opinion on exploring options
for providing advice about
possible human health risks based on the concept of Threshold of
Toxicological Concern (TTC). EFSA Journal 2012;10: 2750.
4. Cramer GM, Ford RA, Hall RL. Estimation of toxic hazard - a
decision tree approach. Food Cosmet Toxicol 1978;16: 255-276.
5. Kroes R, Renwick AG, Cheeseman M, et al. Structure-based
thresholds of toxicological concern (TTC): guidance for application to
substances present at low levels in the diet. Food Chem Toxicol 2004; 42:
65-83.
6. European Commission Health and Consumer Protection Directorate-
General (DG SANCO). Guidance document on the assessment of the relevance
of metabolites in groundwater of substances regulated under Council
Directive 91/414/EEC: Sanco/221/2000-rev.10-final. 25 February 2003.
7. Koster S, Boobis AR, Cubberley R, et al. Application of the TTC
concept to unknown substances found in analysis of foods, Food and
Chemical Toxicology 2011; 49: 1643-1660.
8. Van Ravenzwaay B, Dammann M, Buesen R, et al. The threshold of
toxicological concern for prenatal developmental toxicity. Regulatory
Toxicology and Pharmacology 2011;59: 81-90.
9. Melching-Kollmuss S, Dekant W, Kalberlah F. Application of the
''threshold of toxicological concern" to derive tolerable concentrations
of ''non-relevant metabolites" formed from plant protection products in
ground and drinking water. Regulatory Toxicology and Pharmacology 2010;
56: 126-134.
10. Escher SE, Tluczkiewicz I, Batke M, et al. Evaluation of
inhalation TTC values with the database RepDose. Regulatory Toxicology and
Pharmacology 2010; 58: 259-274.
11. Michaels, D. Doubt Is Their Product: How Industry's Assault on
Science Threatens Your Health. Oxford University Press. 2008: 53-54.
12. Layton L. Studies on chemical in plastics questioned. Washington
Post 27 April 2008.
13. Dingell JD. Letter to Jack N Gerard, president and CEO, American
Chemistry Council. 2 April 2008.
http://bit.ly/ZWMbi6 (accessed 15 April 2013).
14. Nielsen E, Larsen JC. The Threshold of Toxicological Concern
(TTC) concept: Development and regulatory applications. Danish Ministry of
the Environment, Environmental Protection Agency. Environmental Project
No. 1359. 2011. http://www2.mst.dk/udgiv/publications/2011/03/978-87-92708
-86-1.pdf (accessed 15 April 2013).
15. European Food Safety Authority (EFSA). Declarations of interests
(DoIs). http://www.efsa.europa.eu/en/efsawho/doi.htm (accessed 15 April
2013).
16. Pratt I, Barlow S, Kleiner J, et al. The influence of thresholds
on the risk assessment of carcinogens in food. Mutation Research 2009;
678: 113-117.
Conflict of Interest:
Hans Muilerman is employed at Pesticide Action Network Europe, which receives funding from trusts and foundations, including the European Endocrine Health Initiative.
I am responding on behalf of the International Life Sciences
Institute (ILSI) to the Commentary published on Online First on 8 March
2013: "Conflicts of interest at the European Food Safety Authority erode
public confidence" by Robinson et al.
In their Commentary, the authors raise questions about practical
scientific tools being studied by a variety of private and public sector
groups, including the European F...
I am responding on behalf of the International Life Sciences
Institute (ILSI) to the Commentary published on Online First on 8 March
2013: "Conflicts of interest at the European Food Safety Authority erode
public confidence" by Robinson et al.
In their Commentary, the authors raise questions about practical
scientific tools being studied by a variety of private and public sector
groups, including the European Food Safety Authority (EFSA). EFSA has
previously and thoroughly responded to the questions posed by the authors
on plant biotechnology; the Threshold of Toxicological Concern (TTC)
concept; and scientific integrity.(1) My goal is to address the specific
section of the Commentary under the heading "EFSA Promotes Industry
Concept to Assess Chemicals Risk" by providing additional context on TTC
as a risk assessment tool.
The concept underlying TTC was initially proposed in 1967(2) and
formally articulated by the US Food and Drug Administration in 1986(3). It
was developed to identify, characterize, and prioritize risk when data on
substances of concern were extremely limited or nonexistent. As the
authors state, ILSI has supported a number of activities designed to test
the validity of the TTC approach since then, and we have worked with
industry and public partners to hone the tool as more data becomes
available.
We encourage JECH readers to learn more about the TTC concept by
reading the report "The Threshold of Toxicological Concern (TTC) concept:
Development and regulatory applications."(4) This document, produced by
the Danish Ministry of the Environment, Environmental Protection Agency
and available in English, provides an extremely comprehensive, detailed,
and readable review of the TTC concept's scientific principles; its
development over the years; its current uses; and its strengths and
weaknesses.
ILSI's actions on TTC have been with the primary goal to help improve
response to safety assessment needs in situations when it is analytically
difficult to identify a substance or when an assessment is needed urgently
and existing data are insufficient. We fully recognize TTC is not a
blanket solution and our own publications describe its limitations.(5)
However, to diminish well-studied, scientifically supported tools that can
be used to safeguard human health is both inappropriate and irresponsible.
2 Frawley JP (1967). Scientific evidence and common sense as a basis
for food packaging regulations. Fd Cosmet Toxicol 5, 293-308.
3 Rulis AM (1986). De minimis and the threshold of regulation. In:
Felix CW (Ed.) Food Protection Technology. Lewis Publishers Inc., Chelsea,
Michigan, 29-37.
4 Nielsen E and Larsen JC (2011). The Threshold of Toxicological
Concern (TTC) concept: Development and regulatory applications. Danish
Ministry of the Environment, Environmental Protection Agency.
Environmental Project No. 1359 2011. This report can be downloaded at
http://www2.mst.dk/udgiv/publications/2011/03/978-87-92708-86-1.pdf
online.]
5 Koster S et al. (2011). Application of the TTC concept to unknown
substances found in analysis of foods . Food Chem. Toxicol. 1643 - 1660.
Conflict of Interest:
I am employed by the International Life Sciences Institute, which is primarily funded by the food, drug, and agriculture industries.
Hamer et al. conducted a 13-year longitudinal study on the predictive
ability of self-reported physical activity on physical activity measured
by accelerometers (1). Participants were 394 healthy men and women aged 54
years on average. They concluded that the habits of physical activity in
adulthood are partly tracked into older age. About their attractive
report, I have several concerns on their statistical outcomes....
Hamer et al. conducted a 13-year longitudinal study on the predictive
ability of self-reported physical activity on physical activity measured
by accelerometers (1). Participants were 394 healthy men and women aged 54
years on average. They concluded that the habits of physical activity in
adulthood are partly tracked into older age. About their attractive
report, I have several concerns on their statistical outcomes.
First, Hamer et al. categorized self-reported physical activity into
four groups, and analysis of variance on accelerometer-derived physical
activities was made by adjusting several confounders. They adopted general
linear models as multivariate analysis in combination with correlation
coefficient (CC). Although they concluded their outcome from that
statistical significance, the level of association presented by CC was
weak and there was no presentation of explanation rate to predict
accelerometer-derived physical activities from multivariate analysis.
Second, I appreciate their long term follow-up of the target
participants, but their analysis was the trend analysis, presenting that
groups who declared high levels of self-reported physical activity
subsequently showed high objective physical activity on average. On this
point, individual agreement of physical activity over 13 years should be
presented such as intra-class CC, concordance CC and the Bland-Altman
plot, which would improve the quality of study.
Third, I understand that the self-reported physical activity and
objective physical activity by accelerometers have different meaning on
activity monitoring (2). If the authors assume the physical activity by
accelerometers as a gold standard, please present validation data for the
accelerometer around the waist to monitor physical activity. Relating to
the selection of indicators on physical activity, predictive ability of
self-reported physical activity for the same indicator after 13 years is
also a simple and understandable for their study. In this case, (weighted)
kappa statistics would become useful statistical indicator for the
agreement.
Anyway, caution should be paid on the validity of accelerometer as a
monitoring tool for physical activity or sedentary behaviour from mid-life
to early old age (3).
References
1. Hamer M, Kivimaki M, Steptoe A. Longitudinal patterns in physical
activity and sedentary behaviour from mid-life to early old age: a
substudy of the Whitehall II cohort. J Epidemiol Community Health
2012;66:1110-5.
2. Martinez-Gomez D, Gomez-Martinez S, Ruiz JR, et al. Objectively-
measured and self-reported physical activity and fitness in relation to
inflammatory markers in European adolescents: the HELENA Study.
Atherosclerosis 2012;221:260-7.
3. Evenson KR, Buchner DM, Morland KB. Objective measurement of
physical activity and sedentary behavior among US adults aged 60 years or
older. Prev Chronic Dis 2012;9:E26.
Dear Prof. Bland,
Please see our supplementary material where you can see the questions that were asked during the interview. You will note that survey participants were explicitly advised not to include potatoes when considering their answers.
http://jech.bmj.com/content/suppl/2014/03/04/jech-2013- 203500.DC1/jech-2013-203500supp1.pdf
Conflict of Interest:
N...
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Pesticide Action Network Europe It cannot be denied that TTC (Threshold of Toxicological Concern) was originally proposed in the U.S., as Dr Harris states in her commentary on our article,[1] but her industry-sponsored organisation, the International Life Sciences Institute (ILSI) played a major role in developing it further to the form in which it was accepted by European Food Safety Authority (EFSA). This process took p...
It cannot be denied that TTC (Threshold of Toxicological Concern) was originally proposed in the U.S., as Dr Harris states in her commentary on our article,[1] but her industry-sponsored organisation, the International Life Sciences Institute (ILSI) played a major role in developing it further to the form in which it was accepted by European Food Safety Authority (EFSA).
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Hamer et al. conducted a 13-year longitudinal study on the predictive ability of self-reported physical activity on physical activity measured by accelerometers (1). Participants were 394 healthy men and women aged 54 years on average. They concluded that the habits of physical activity in adulthood are partly tracked into older age. About their attractive report, I have several concerns on their statistical outcomes....
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