This is my Citizen’s Petition that has just been accepted by FDA in which I request that FDA investigate and confirm the widespread presence of DDT in Swisher Sweets and, if this is confirmed, to declare a nationwide Public Health Emergency. Note that this request is on the basis of just the globally-banned DDT in Swisher Sweets, without reference to other equally hazardous pesticides including Carbendazim and Cypermethrin.
The DDT in Swisher Sweets that my research has identified potentially impacts tens of thousands of unborn babies of smoking mothers, largely in marginalized communities of color. Based on solid scientific evidence and hard data, presented throughout the petition below, I am requesting FDA to follow its own regulations to investigate, confirm and then and immediately seize and destroy all stocks of contaminated Swisher Sweets tobacco products to protect the health of thousands of unborn children.
The petition has been accepted and it is under consideration and available for public comment. Here’s the link:
https://www.fda.gov/tobacco-products/products-guidance-regulations/tobacco-products-related-citizen-petitions
Citizen Petition
Date: October 2, 2023
A. Action Requested
The undersigned submits this petition requesting immediate action by the Secretary under the provisions of 21 U.S.C. § 387g (Tobacco Product Standards) and 42 U.S. Code § 247d (Public Health Emergencies), and any other applicable regulatory and legal authorities.
I am requesting that the Secretary act with urgency to initiate a Health Hazard Evaluation of the Swisher Sweets brand of little cigars, looking for possible widespread contamination of this brand with DDT, as potentially indicated by initial recent private small-sample testing (see Statement of Grounds) and,
IF testing conducted by FDA confirms the widespread presence of DDT in this brand, occurring in concentrations sufficient to transfer to the placental blood serum of a pregnant smoker in potentially hazardous concentrations, as delineated by a rapidly growing body of published research on the impact of in-utero DDT exposure (see also Statement of Grounds),
Petitioner THEN requests the Secretary to declare a nationwide Public Health Emergency with an immediate and enforceable ban on all sales of Swisher Sweets tobacco products and a mandatory total recall, and/or an immediate and enforceable order for an open-ended or a mass seizure and destruction of all commercial inventories or stocks of Swisher Sweets brand little cigars, wherever located, as a legal and justifiable emergency action to protect the neurological and endocrinological development of prenatal children of pregnant female smokers of Swisher Sweets brand little cigars who are likely to be gravely endangered by DDT contamination of their mother’s tobacco product.
B. Statement of Grounds
I am requesting that FDA take immediate action; first, to confirm privately-funded 2018/19 research data (see below) showing the presence of potentially hazardous concentrations of DDT (0.816 mg/kg) in a single sample of the Swisher Sweets Tobacco product, and secondly, if such significantly high DDT concentrations are confirmed to be widespread in currently available (10/23) Swisher Sweets products, to immediately take all necessary steps to prevent any further DDT exposure of the developing children of pregnant women who smoke Swisher Sweets and/or who use them as wrappers for Cannabis Blunts, either before or during pregnancy.
DDT is a teratogenic pesticide that transfers in proportion to its concentration in the tobacco product into the contaminated tobacco product’s smoke stream, from which it is absorbed into the smoker’s blood stream, from where it is transported to the umbilical and placental blood streams. (See Section B-4) This means that a significant portion of 0.816 ppm of DDT in the smoke stream would be absorbed into a pregnant smoker’s blood stream after inhalation, at levels that are known to be severely hazardous to an in-utero child. (See Section B-4) DDT is also known to bio-accumulate so even if young female smokers of a DDT-contaminated brand stop smoking while pregnant, their blood serum can still potentially transfer hazardous concentrations of DDT to their developing child. (See Section B-4)
PETITIONER ASSERTS THAT FDA HAS AUTHORITY AND RESPONSIBILITY
The authority to address this appalling but clearly preventable hazard to the lifelong health of large numbers of unborn children currently at risk who will be born to smoking pregnant women lies within the provisions of the law (21 U.S.C. § 387g) and (42 U.S. Code § 247d), which I believe empower the Secretary to revise tobacco product standards as needed to protect public health, and to seize and destroy any Tobacco products whose consumption would create exposure to significant levels of DDT, and/or any other similarly hazardous pesticides, in Swisher Sweets at levels that are recognized by a significant body of published research to represent a clear potential danger to the unborn children of pregnant smokers of any such products.(See Section B-5)
Petitioner cites as further supporting authority for the requested action:
https://www.fda.gov/tobacco-products/tobacco-science-research/tobacco-product-problem-reports
“FDA may conduct focused product sample testing as part of a coordinated probe of a national public health threat.”
Realizing that neither DDT nor any pesticide chemical is currently designated as an HPHC (Harmful and Potentially Harmful Constituent) in tobacco product smoke, nevertheless, in support of the requested action, Petitioner further cites FDA’s regulatory actions in 91 instances of identified Harmful and Potentially Harmful Constituents based on the principle that exposure to the identified HPHC would “cause or could cause harm”:
“The Food, Drug and Cosmetic Act (FD&C Act) requires tobacco manufacturers and importers to report the levels of harmful and potentially harmful constituents (HPHCs) found in their tobacco products and tobacco smoke. HPHCs are chemicals or chemical compounds in tobacco products or tobacco smoke that cause or could cause harm to smokers or nonsmokers. FDA must publish HPHC quantities in each brand and subbrand of tobacco product, in a way that people find understandable and not misleading.”
The requested action is also supported by the Precautionary Principle, as expressed in the precautionary “that cause or could cause ” language of the FDA/HPHC quote above, and which FDA has rightly and fairly applied in other regulatory decisions and actions not involving pesticides.
“The Precautionary Principle”
https://pubmed.ncbi.nlm.nih.gov/15968832/
“The Precautionary Principle in its simplest form states: “When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause-and-effect relationships are not fully established scientifically”.
“The Precautionary Principle has been used in the environmental decision-making process and in regulating drugs and other consumer products in the United States.”
Additionally, the requested action is supported by “Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed” wherein FDA sets Action Levels for DDT in all widely consumed foods including foods that may be consumed by pregnant women and therefore must be kept safe for the unborn children of any pregnant women who consume these foods. These Action Levels are based on a scientific assessment of hazard and risk that occurs at or above a specific level of DDT exposure in consumable food products. However, in addition to not including pesticides in its classification of HPHCs (Harmful and Potentially Harmful Constituents) in tobacco product smoke, FDA has also not set tobacco product DDT Action Levels that are an equivalent with food product risk level/hazard from DDT (or any other pesticides), although CDC data shows that ” one in 14 women who gave birth in the United States in 2016 reported that they had smoked cigarettes during pregnancy.” (See also Section B-3 below)
https://www.cdc.gov/nchs/products/databriefs/db305.htm
Petitioner’s request is also mirrored in science-based recommendations made directly to FDA with reference to Little Cigars as a class – recommendations for FDA action even without reference to pesticide residues as shown in the 2018 and 2022 data and in published scientific literature presented in Sections B-1 b through B-5 below.
Cigarillo and Little Cigar Mainstream Smoke Constituents from Replicated Human Smoking
https://pubs.acs.org/doi/10.1021/acs.chemrestox.7b00312#
“Little cigar and cigarillo smoking is increasing in popularity in the U.S., but little is known about the topography and mainstream smoke (MSS) constituents of these types of cigar products. This report describes the quantity of selected MSS toxicants generated from puff-by-puff replication of human laboratory smoking.”
“Cigarillos and little cigars, like cigarettes, deliver nicotine and other toxicants known to be harmful to health; their regulation by the FDA is appropriate for their public health risk.”
SECTION B-1: PRESENCE OF DDT IN SWISHER SWEETS BRAND OF LITTLE CIGAR.
Pesticide residues on tobacco do not occur naturally. The presence of pesticide residues in Tobacco products is exclusively the result of production, manufacturing, and financial decisions, rather than a necessary or unavoidable outcome of Tobacco and Tobacco product production and manufacturing.
In 2018 Petitioner commissioned Columbia Labs in Portland, Oregon to do a scientifically valid random selection of Tobacco products from area minimarts and to then subject them to testing for the presence of pesticide residues.
Columbia Labs is a US subsidiary of the German company Tentamus Group, which has in depth experience in testing for pesticide residues on tobacco substrate including raw tobacco and finished tobacco products (cigarettes). Limited in scope by Petitioner’s financial constraints, the lab chose 6 tobacco products using random selection techniques, including 4 brands of cigarettes, one brand of little cigar, and one snus.
In the Swisher Sweets brand little cigar, Columbia Labs found 0.816 mg/kg DDT. Because this level of DDT was unexpected, they repeated the testing several times, and confirmed the initial 0.816 mg/kg DDT number.
Here are the results of this 2018 testing (red indicates unique to Swisher Sweets):
SECTION B-2: DEMOGRAPHICS OF POTENTIAL DDT EXPOSURE THROUGH LITTLE CIGARS
COMMENT: Swisher Sweets are a brand of tobacco product that is heavily marketed to young African American women and men of reproductive age.
Neighborhood Disparities in the Availability, Advertising, Promotion, and Youth Appeal of Little Cigars and Cigarillos, United States, 2015
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7733061/
“Nearly 90% of retailers sold LCCs, 83.0% sold flavored LCCs, and 30.9% had youth marketing. Controlling for retailer type and other neighborhood characteristics, neighborhoods with the highest proportion of black residents had significantly higher odds of flavored LCC availability (adjusted odds ratio [AOR] = 2.24, 95% confidence interval [CI] = 1.52, 3.30); exterior advertisements (AOR = 2.84, 95% CI = 1.94, 4.16); price promotions (AOR = 1.62; 95% CI = 1.07–2.45), and youth appeal (AOR = 1.49, 95% CI 1.08–2.08) compared to the lowest. Disparities in flavored LCC availability, exterior advertising, and youth appeal were also present for lower income neighborhoods.”
COMMENT: As can be seen in the data in this article, Swisher Sweets brand little cigars dominated the convenience store market and was the best-selling brand from 2009-2020. The article quote cited is from the end of the article, and points to a goal of more effective regulation of tobacco products that Petitioner shares.
Cigar Sales in Convenience Stores in the US, 2009-2020
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8693219/
“In 2021, the FDA proposed a ban on flavored cigars, but policy implementation may take years and face substantial delays due to industry litigation. Policies that restrict the availability of flavored and inexpensive cigars should be considered at the local and state levels.”
“The Impact of Influencers on Cigar Promotions: A Content Analysis of Large Cigar and Swisher Sweets Videos on TikTok”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9222503/
“…Swisher Sweets videos were also more likely to feature females, Black individuals, and younger individuals.”
Prevalence of current large cigar versus little cigar/cigarillo smoking among U.S. adults, 2018–2019
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8683982/
“Prevalence of currently smoking LCCs varied greatly by age and race/ethnicity, with the highest prevalence of current LCC smoking being among 18–30-year-old non-Hispanic Black adults. Cigar smoking prevention and cessation efforts should prioritize non-Hispanic Black young adults who are most at risk for cigar smoking health effects.”
COMMENT: This 2020 study of urban Black women looked for DDT and 3 other organochlorine pesticide levels and found that plasma pesticide concentrations were significantly higher in smokers. Brands weren’t specified in this study, nor was pregnancy status investigated, but smoking & health data shows strong preferences among urban Black women for sweet, fruity little cigars and menthol cigarettes.
“Correlates of organochlorine pesticide plasma concentrations among reproductive-aged black women”
https://pubmed.ncbi.nlm.nih.gov/32182481/
“Current smoking was associated with 10-19% higher plasma concentrations of all four OCPs, and was highest for current smokers of ≥10 cigarettes/day (% differences ranged from 22 to 29%).”
SECTION B-3: PUBLISHED DATA ON WOMEN SMOKING DURING PREGNANCY
COMMENT: A significant percentage of pregnant women smoke before and during pregnancy, inhaling any pesticide residues present in the tobacco product they smoke.
The fertility rate in the United States in 2020 was 56.0 per 1,000 women ages 15-44, in a population of 64 million women, or 3,584,000 pregnancies. In 2020, 7% of pregnant women smoked during pregnancy. This implies that in 2023 +/- 250,000 unborn children of smoking mothers in the US are being directly exposed to multiple pesticides throughout their in-utero development and continuing after birth.
“Cigarette Smoking During Pregnancy: Do Complete Abstinence and Low-Level Cigarette Smoking Have Similar Impact on Birth Weight?”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092690/
“Among US women who smoked at conception only 23% self-reported having quit smoking during pregnancy. In 2011, 11.5 % of mothers were smoking in the 3 months before pregnancy and in 2013, 8.5 % of pregnant US women smoked any time during their pregnancy (8.3% in the first trimester, 7.1% in the second, and 6.7% in the third). With an absolute number of births of around 4 million in the United States in 2013, 340 000 fetuses were directly exposed to tobacco in utero.”
“Declines in Cigarette Smoking During Pregnancy in the United States, 2016–2021”
https://www.cdc.gov/nchs/products/databriefs/db458.htm
“Although differences in the prevalence of smoking during pregnancy narrowed across age and race and Hispanic-origin groups and among the U.S. states between 2016 and 2021, mothers under age 30, non-Hispanic American Indian or Alaska Native mothers, non-Hispanic White mothers, and mothers in 10 states (Arkansas, Kentucky, Maine, Missouri, Montana, Ohio, South Dakota, Vermont, West Virginia, and Wyoming) continued to have the highest smoking prevalence in both years.”
“About 1 in 30 middle and high school kids said they smoke the compact, sweet-flavored cigars. The percentages rise as kids get older, to nearly 1 in 12 high school seniors, the Centers for Disease Control and Prevention reported.”
COMMENT: In 2021 in the US there were 11.2 million males and 10.54 million females ages 15-19. 1 in 12, or roughly 8% of 21.74 million teenagers would be 1,739,200 smokers ages 15-19 of these “compact, sweet-flavored cigars.”
“Cigar and Marijuana Blunt Use Among Pregnant and Nonpregnant Women of Reproductive Age in the United States, 2006–2016”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6050836/
“Tobacco smoking during pregnancy is the leading preventable cause of poor pregnancy outcomes in the United States and a major public health issue.1Research on smoking during pregnancy focuses primarily on cigarette smoking, with little emphasis on cigars or blunts (partially or entirely hollowed out cigar wrappers containing marijuana). The examination of cigar smoking during pregnancy is increasingly important, because cigar sales have increased by 51% between 2008 and 2015,2 prompting some to regard it as an ignored public health threat.3 Similarly, the use of marijuana is increasing, especially among reproductive-aged women.4 Increases in cigar smoking and in smoking of blunts (i.e., smoking both tobacco and marijuana) could potentially affect maternal and child health.”
COMMENT: While smoking during pregnancy is known to be associated with multiple lifetime health issues with the child, the independent and potentially quantifiable impact of the pesticides contaminating the tobacco products being smoked has not been investigated or identified.
“Smoking during pregnancy and harm reduction in birth weight: a cross-sectional study”
https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-018-1694-4#
“The prevalence of smoking during pregnancy was 13.4% in the study population. In full-term infants, birth weight decreased as the category of cigarette number per day increased, with a significant weight reduction as of the category 6 to 10 cigarettes per day. Compared with infants born to non-smoking mothers, mean birth weight was 320 g lower in infants whose mothers smoked 6 to 10 cigarettes per day and 435 g lower in infants whose mothers smoked 11 to 40 cigarettes per day during pregnancy.”
COMMENT: Inhaled DDT is known to be bio-accumulative, so any history of smoking DDT-contaminated tobacco products prior to pregnancy increases the level of risk of DDT-induced damage to any subsequent developing child.
“Djordjevic et al. (1995) assessed the chlorinated pesticide residues in U.S. and foreign cigarettes manufactured from the 1960s to the 1990s. Since 1970, the concentration of DDT analogues decreased by >98%.”
Concentration ranges of DDT-related compounds in samples of cigarettes manufactured between 1961 and 1979 and between 1983 and 1994 were:
p,p’-DDD,
(1961–1979 levels) 1,540–30,100 ng/g
(Ed. note: 30,100 ng/g equals approximately 30.1 ppm.)
(1983–1994 levels) 12.6–99.7 ng/g;
o,p’-DDD,
(1961–1979 levels) 396–7,150 ng/g,
(1983–1994 levels) ND-19.0 ng/g;
p,p’-DDT,
(1961–1979 levels) 720–13,390 ng/g,
(Ed. note: 13,390 ng/g equals approximately 13.4 ppm)
(1983–1994 levels) 19.7–145 ng/g; (approximately 0.145 ppm)
o,p’-DDT,
(1961–1979 levels) 105–1,940 ng/g;
(1983–1994 levels) ND-88 ng/g;
p,p’-DDE,
(1961–1979 levels) 58– 959 ng/g,
(1983–1994 levels) 6.6–15.8 ng/g;
p,p’-DDMU (1-chloro-2,2-bis(p-chlorophenyl)ethylene),
(1961–1979 levels) 92.7–2,110 ng/g,
(1983–1994 levels) ND–27.5 ng/g.
“Until 1970, tobacco smoke contributed significantly to the intake of DDT by humans, but since then, the amount of DDT in tobacco has dropped markedly and today, cigarette smoke is a minor source of human exposure (Djordjevic et al. 1995).” (p 385)”
COMMENT: The 1995 Djordjevic statement above, quoted by USPHS in 2022, that “today, cigarette smoke is a minor source of human exposure” clearly was not accurate in 2022. (Reference Section B-1)
SECTION B-4: PUBLISHED DATA ON THE TRANSFER RATE OF DDT IN TOBACCO PRODUCT SMOKE
COMMENT: DDT residues in Tobacco product smoke are known to transfer in significant proportions into the blood of smokers. Based on these data on DDT transfer rates, pregnant women in the US smoking this popular brand would absorb approximately 20% of a level of 0.816 PPM DDT into their blood, or 0.204 PPM DDT. DDT is known to pass through the placental wall and infuse the blood circulation and developing neurological and endocrinological tissues of the unborn human child.
The 0.816 /0.204 PPM exposure risk from inhaling the smoke of the Swisher Sweets Tobacco product is more than 1000 times the 0.0002 PPM exposure level reported by FDA as the mean for 162 food samples in the Total Diet Study of 2017.
“The transfer rate from tobacco into mainstream smoke amounts to 22% for DDD, 19% for DDT, and 27% for DDE.”
(Quoted from p. 332 in “Agency for Toxic Substances and Disease Registry (ATSDR). 2022. Toxicological Profile for DDT, DDE, DDD . Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service“. Toxicological Profile for DDT, DDE, and DDD
Comment: The transfer rate of DDT and the other organochlorine pesticides have been studied for over 50 years, so there can be no doubt that there is substantial transfer of any residues of these pesticides in a tobacco product into the smoke stream inhaled by smokers.
Chlorinated Insecticide Residues in The University Of Kentucky
Reference And Alkaloid Series Cigarettes (1976)
“The transfer of DDT-TDE residues to mainstream smoke has been the subject of several investigations. Generally, 12 to 18% of the p,p’-DDT and p,p’-TDE residues on cigarettes are transferred intact to the mainstream smoke. In addition, p,p’-TDEE has been found at levels amounting to 13 to 46% of the identified chlorinated hydrocarbon residues in smoke condensate. From this study, as well as others, it may be assumed that 15% to 30% of the DDT-TDE residues present on the tobacco will be carried over to the mainstream smoke.”
Placental transfer of pesticides studied in human placental perfusion
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7689789/
“This study demonstrates the potential of pesticides to be transferred across placenta into the foetal circulation, and the ability of the placenta to produce metabolites, exposing the mother and foetus to both parent compounds and their metabolites.”
Placental transfer of DDT in mother-infant pairs from Northern Thailand
https://www.tandfonline.com/doi/abs/10.1080/03601230802174615
p,p′-DDE (1,1-dichloro-2,2-bis(p-chlorophenyl)ethylene) was the major component and detected in every cord and maternal serum samples with geometric means of 1,255 and 1,793 n g−1 lipids, respectively.
p,p′-DDT (1,1,1-trichloro-2,2-bis(p-chlorophenyl)ethane) was detected at 89.8 and 100% of cord and maternal serum samples, respectively.
The second and third highest levels detected were p,p′-DDD (1,1-dichloro-2,2-bis(p-chlorophenyl)ethane) and p,p′-DDT, respectively.
The ratios between cord and maternal sera for p,p′-DDE, p,p′-DDT, and p,p′-DDD that were less than 1 had high correlation coefficients (ratio = 0.70, r = 0.82 for p,p′-DDE, ratio = 0.62, r = 0.66 for p,p′-DDT, and ratio = 0.79, r = 0.78 for p,p′-DDD).
Transfer of DDT used in malaria control to infants via breast milk.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2393309/
“Organochlorines were therefore largely transferred to the infant from the mother, with DDT in the environment playing a secondary role.”
SECTION B-5: ADDITIONAL SUPPORTING PUBLISHED RESEARCH
COMMENT: The requested action is supported by a growing consensus among experts in many fields regarding the urgent need to protect developing pre-natal children from exposure to pesticides, with DDT frequently cited in the literature.
Many experts in the field of pre-natal pesticide exposure agree that there is sufficient basis for regulatory action to protect children from known sources of preventable in-utero pesticide exposure, with special concern focused on prenatal DDT exposure.
Given what is known regarding the epigenetic impact of maternal DDT exposure, any significant exposure of the prenatal children of today’s generations must be treated as the ongoing Public Health Emergency it is.
“Protecting children from known pesticides exposures: our collective duty to provide primary prevention.”
https://www.nature.com/articles/s41390-018-0210-x
“While additional research is always supported and necessary, those of us in the advocacy arena wonder how much additional science will be needed for action to occur?”
“Pesticide Exposure in Children”
https://doi.org/10.1542%2Fpeds.2012-2758
“Evidence is increasingly emerging about chronic health implications from both acute and chronic exposure. A growing body of epidemiological evidence demonstrates associations between parental use of pesticides, particularly insecticides, with acute lymphocytic leukemia and brain tumors. Prenatal, household, and occupational exposures (maternal and paternal) appear to be the largest risks.”
“Prospective cohort studies link early-life exposure to organophosphates and organochlorine pesticides (primarily DDT) with adverse effects on neurodevelopment and behavior. Among the findings associated with increased pesticide levels are poorer mental development by using the Bayley index and increased scores on measures assessing pervasive developmental disorder, inattention, and attention-deficit/hyperactivity disorder. Related animal toxicology studies provide supportive biological plausibility for these findings.”
“Additional data suggest that there may also be an association between parental pesticide use and adverse birth outcomes including physical birth defects, low birth weight, and fetal death, although the data are less robust than for cancer and neurodevelopmental effects.”
“Children’s exposures to pesticides should be limited as much as possible.”
“Epigenetic Inheritance: Intergenerational Effects of Pesticides and Other Endocrine Disruptors on Cancer Development”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9102839/
“Studies in both animal models and human cohorts have linked exposure to pesticides and other environmental toxicants to defects in the parental germline.”
“For instance, in utero exposure to DDE, a DDT metabolite, impairs male fertility and causes epigenetic alterations in the male germline in rats. Other pesticides have similar effects: prenatal dioxin induces sperm epimutations and disease in subsequent generations.”
“Studies in human cohorts support the findings in animal models and report an association between pesticide exposure, including DDT, and sperm quality.”
“The female germline and reproductive health have also been shown to be sensitive to the endocrine disrupting action of pesticides, with long-term adverse effects to offspring.”
“In Utero human life is known to be vulnerable to pesticides in unique ways that require unique forms of protection.”
“DDT exposure during pregnancy and DNA methylation alterations in female offspring in the Child Health and Development Study”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6710160/
“In summary:
- “Prenatal DDTs exposure is associated with DNA methylation in key genes that are potentially important to breast cancer.”
- “Differentially methylated regions (DMRs) in CCDC85A, CYP1A1 and ZFPM2 are associated with markers of DDT.”
- “Higher methylation in genes that are involved in growth and development and breast cancer susceptibility are associated with higher in utero DDT exposure.”
- “Prenatal DDT exposure may have life-long consequence through alteration in genes relevant to breast cancer.”
“Effects of exposure to pesticides during pregnancy on placental maturity and weight of newborns”
https://pubmed.ncbi.nlm.nih.gov/19744971/
“It is known that pesticides cross the placental barrier and can cause alterations in the development of placental structures resulting in adverse effects in reproduction.”
“In utero exposure to DDT at critical moments in development is known or strongly suspected to cause serious childhood diseases and disabilities including diabetes, asthma, autism, obesity, birth defects, and cancers including breast cancer and ALL.”
The Synapse as a Central Target for Neurodevelopmental Susceptibility to Pesticides
https://www.mdpi.com/2305-6304/4/3/18
“OCs bioaccumulate due to their lipophilicity and are known to cross the placenta and excrete in breastmilk. Perhaps most well-known is DDT, whose manufacture and use was banned in the US in 1972 but is still in use for malaria control internationally. DDT slowly metabolizes, primarily into 1,1-dichloro-2,2-bis(p-chlorophenyl) ethylene (DDE), dichlorodiphenyldichloroethane (DDD), and dichlorodiphenylacetic acid (DDA) metabolites. The DDE metabolite is lipophilic and stores in adipose tissue, and is often used as a biomarker of exposure to DDT. While DDT has a variety of effects on neuronal targets it is most effective at holding sodium (Na+) channels in the axonal membrane open, which then leads to prolonged depolarization of the neuron.”
“Prenatal p,p´-DDE exposure and neurodevelopment among children 3.5-5 years of age”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3569679/
“Our findings support the hypothesis that DDE prenatal exposure is negatively associated with child neurodevelopment at 3.5–5 years of age. Additional follow up is needed to determine if GCI, quantitative, verbal, and memory associations with prenatal DDE exposure is a key determinant of poor further academic performance, considering that DDT is still being used in some countries.”
“Consequences of DDT Exposure Could Last Generations”
https://www.scientificamerican.com/article/consequences-of-ddt-exposure-could-last-generations/
“Using more than 200 mother-daughter-granddaughter triads, Cohn’s team found that the granddaughters of those in the top third of DDT exposure during pregnancy had 2.6 times the odds of developing an unhealthy BMI. They were also more than twice as likely to have started their periods before age 11. Both factors, Cohn says, are known to raise the risk of later developing breast cancer and cardiovascular disease. These results, published in Cancer Epidemiology, Biomarkers, and Prevention, mark the first human evidence that DDT’s health threats span three generations.”
The Pine River Statement: Human Health Consequences of DDT Use
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2737010/
“In the U.S. Collaborative Perinatal Project (CPP), where the median maternal serum DDE level was 24.5 μg/L, high DDE concentrations (45–59 vs. < 15 μg/L) were associated with an increased risk of fetal loss in previous pregnancies.”
“DDT and its primary breakdown product, dichlorodiphenyldichloro-ethylene (DDE), are highly lipophilic, persist in the environment, and bioaccumulate in humans because of their long half-lives (6 years and possibly up to 10 years, respectively) (Longnecker 2005; Wolff et al. 2000).”
Cumulative Chemical Exposures During Pregnancy and Early Development
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4626367/
“Dichlorodiphenyldichloroethylene (DDE), hexachlorobenzene (HCB), and trans-nonachlor are typically detected in over 90% of samples across matrices, including maternal serum, breast milk. OCs are able to cross the placenta and are detected in cord serum, meconium, placenta and amniotic fluid. Using wet weights, OC levels are higher in maternal than cord blood, though the difference is slight for some compounds. Using lipid-adjusted measures, OC levels are typically slightly higher in cord than maternal serum, though the levels are not different enough to imply fetal accumulation. Additionally, levels of DDE and dichlorodiphenyltrichloroethane (DDT) in maternal serum do not differ across trimesters of pregnancy.
DDT Exposure in Utero and Breast Cancer
https://academic.oup.com/jcem/article/100/8/2865/2836085
Results:
“Maternal o,p′-DDT predicted daughters’ breast cancer (odds ratio fourth quartile vs first = 3.7, 95% confidence interval 1.5–9.0). Mothers’ lipids, weight, race, age, and breast cancer history did not explain the findings.
Conclusions:
This prospective human study links measured DDT exposure in utero to risk of breast cancer. Experimental studies are essential to confirm results and discover causal mechanisms. Findings support classification of DDT as an endocrine disruptor, a predictor of breast cancer, and a marker of high risk.”
“Neurobehavioural effects of developmental toxicity”
https://pubmed.ncbi.nlm.nih.gov/24556010/
“The developing human brain is uniquely vulnerable to toxic chemical exposures, and major windows of developmental vulnerability occur in utero and during infancy and early childhood. During these sensitive life stages, chemicals can cause permanent brain injury at low levels of exposure that would have little or no adverse effect in an adult.”
“Assessment of Nonoccupational Exposure to DDT in the Tropics and the North: Relevance of Uptake via Inhalation from Indoor Residual Spraying”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3094425/
“A growing body of evidence indicates that exposure to DDT and its metabolites may be associated with adverse human health outcomes, particularly in children (Bouwman and Kylin 2009; Eskenazi et al. 2009).”
“Association between prenatal exposure to organochlorine pesticides and the mental and psychomotor development of infants at ages 6 and 18 months: The Hokkaido Study on Environment and Children’s Health”
https://www.sciencedirect.com/science/article/abs/pii/S0161813X17302346
” After controlling for confounders, we found an inverse association between prenatal exposure to cis-heptachlor epoxide and the Mental Developmental Index at 18 months of age. Furthermore, infants born to mothers with prenatal concentrations of cis-heptachlor epoxide in the highest quartile had Mental Developmental Index scores −9.8 (95% confidence interval: −16.4, −3.1) lower than that recorded for infants born to mothers with concentrations of cis-heptachlor epoxide in the first quartile (p for trend <0.01). These results support the hypothesis that prenatal exposure to OCPs, especially cis-heptachlor epoxide, may have an adverse effect on the neurodevelopment of infants at specific ages, even at low levels.”
“Grandmaternal Perinatal Serum DDT in Relation to Granddaughter Early Menarche and Adult Obesity: Three Generations in the Child Health and Development Studies Cohort”
Results:
“F0 o,p’-DDT was associated with F2 obesity [Odds ratio (OR), 2.6; 95% confidence interval (CI), 1.3–6.7; tertile 3 vs. 1), among normal weight F0 (70%), but not among overweight and obese F0 (Pinteraction = 0.03), independent of other DDTs.”
“F0 o,p’-DDT was also associated with F2 early menarche (OR, 2.1; 95% CI, 1.1–3.9, tertile 3 vs. 1) and this association was not modified by F0 BMI.”
Conclusions:
“Ancestral exposure to environmental chemicals, banned decades ago, may influence the development of earlier menarche and obesity, which are established risk factors for breast cancer and cardiometabolic diseases.”
“Ancestral dichlorodiphenyltrichloroethane (DDT) exposure promotes epigenetic transgenerational inheritance of obesity”
https://pubmed.ncbi.nlm.nih.gov/24228800/
“Observations indicate ancestral exposure to DDT can promote obesity and associated disease transgenerationally. The etiology of disease such as obesity may be in part due to environmentally induced epigenetic transgenerational inheritance.”
Association between maternal exposure to the pesticide dichlorodiphenyltrichloroethane (DDT) and risk of obesity in middle age
https://www.nature.com/articles/s41366-020-0586-7
“These data indicate maternal DDT exposure is significantly associated with increased obesity risk among middle-aged women independent of the obesity definition, confounding, and obesity risk factors.”
Preconception Serum DDT and Pregnancy Loss: A Prospective Study Using a Biomarker of Pregnancy
https://academic.oup.com/aje/article/162/8/709/122451
“The relative odds of early pregnancy losses associated with a 10-ng/g increase in serum total DDT were 1.17 (95% CI: 1.05, 1.29).”
“In this population, there was a positive, monotonic, exposure-response association between preconception serum total DDT and the risk of subsequent early pregnancy losses.”
SECTION B-6: Research on The Synergistic Effects of Multiple Pesticide Exposure
Comment: Petitioner further requests that in considering the requested action based on DDT contamination of Swisher Sweets products, the Secretary also consider that there is a substantial and growing body of scientific evidence that there is a meaningful increased toxic synergy when exposure to multiple pesticides occurs as is the case when Swisher Sweets tobacco products are combusted and inhaled by a pregnant smoker.
Synergistic Effects of Heavy Metals and Pesticides in Living Systems
https://www.frontiersin.org/articles/10.3389/fchem.2017.00070/full
“The information retrieved from the extensive literature survey indicates that the combinations of pesticides with pesticides, pesticide with heavy metal, and heavy metal to heavy metal acts synergistically and exhibit more toxicity than a single molecule alone. The studies relating heavy metals (Cd and Pb) are also reported to be displaying accelerated toxicological, hematological and immunological indices.
In case of humans, the combined exposure of these xenobiotic substances acts in two different ways: firstly, the toxic hazard of a single component could be modified in combined exposures, which can lead to unexpected adverse health consequences.
Studies demonstrated that a variety of chemicals may contribute to behavioral disabilities, developmental, and learning impairment. Humans are generally exposed by not only the oral route but also by dermal contact, inhalation, as well as ingestion.
Secondly, the delectability of the toxic effects, including immunotoxic effects of a single compound can be changed by the interactions with one or more with other heavy metal or other xenobiotics. Thus, the synergistic interactions between pesticides and heavy metals may lead to several health consequences which needed further investigations.”
SECTION B-7: SUPPORTING PUBLISHED DATA ON WORLDWIDE DDT CONTAMINATION OF TOBACCO
COMMENT: Industry data indicates that at least some of the tobacco used to manufacture Swisher Sweets products is imported from countries where DDT is actively applied to growing Tobacco, and where raw Tobacco and Tobacco products are known to be contaminated with DDT and other organochlorine pesticides.
https://www.floridatobaccoshop.com/Swisher-Sweets-Cigars_c_565.html
” Nearly one-third of all the cigars sold in the country are Swisher Sweets.”
“The blend inside most of the commonly available (Swisher Sweet) cigars is made from a combination of four different tobaccos originating in separate countries.”
COMMENT: Regarding the possible origins of DDT in US tobacco products, DDT is currently (2023) produced only in India, China, and North Korea. Coincidentally, China and India are #1 and #2 in global tobacco production and export, and we have multiple indications that DDT is currently being used on tobacco in India and China. Nicaragua, Honduras and Dominican Republic are major importers of DDT and major exporters of tobacco to the US. Petitioner cannot identify any published research on DDT use in tobacco production in these countries, but DDT is a commonly found contaminant of other agricultural products exported to the US from Nicaragua, Honduras and Dominican Republic, and is a heavy residual contaminant in the soils and water of all three countries.
COMMENT: This 2019 study identified DDT and other organochlorines as contaminants of tobacco products worldwide.
An unnoticed issue: Organochlorine pesticides in tobacco products around the world
https://pubmed.ncbi.nlm.nih.gov/30529853/
“In 11 of the 14 samples DDTs were the dominant compounds, with maximum concentrations of ppʹ-DDT in Morocco cigarettes (9 ng g−1) and of ppʹ-DDE in Italian cigars (13 ng g−1).”
“DDT also belongs to the 98 tobacco smoke components for which risk assessment authorities have established a human inhalation risk value for cancer (Talhout et al., 2011).”
COMMENT: A 2022 study by the Saudi Ministry of Health showed significant concentrations of pesticides along with significant concentrations of heavy metals.
Analyzing pesticides and metal(loid)s in imported tobacco to Saudi Arabia and risk assessment of inhalation exposure to certain metals.
https://doi.org/10.1080/08958378.2022.2037791
Case study of tobacco cultivation and alternate crops in India
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2801202
“India and China both export DDT to countries in Africa, either as technical product or as a formulation, for the purpose of vector control. DDT is being formulated in Ethiopia and South Africa with ingredients imported from China. South Africa exports some of its formulated product to other countries in Africa.”
In one of the few references to the current use of DDT on tobacco in India, the 2009 article mentions almost in passing that “A study in Karnataka by CMDR found that the frequent and unabated use of chemicals was adversely affecting the health of the farmers, causing respiratory ailments, skin irritation and allergies. There is also evidence to indicate that pesticide residues on tobacco leaf adversely affect those who consume semi-processed tobacco products, due to residual pesticides such as endosulphan and DDT (which are banned, but still being used surreptitiously).”
C. Environmental Impact
Published data detailing the environmental impact of pesticide use in tobacco farming is available, as are comparative studies on the reduced environmental impact of organic farming vs. conventional agriculture using pesticides.
D. Economic Impact
Published data is available on the economic and social costs of birth defects and chronic childhood disease in children of mothers who smoke tobacco products.
Petitioner asserts that the tobacco industry would not suffer long-term economic damage from the elimination of pesticides in tobacco production. Published data demonstrates that it is both feasible and profitable to produce Tobacco products that are USDA Organic, meaning among other things that they are free from residues of pesticides known to be hazardous or potentially hazardous. An example is USDA certified organic American Spirit cigarettes, a highly profitable and successful brand that provides a replicable, scalable model for pesticide-free tobacco production.
E. Certification
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
(Signature)
(Name of petitioner)’
Bill Drake
panaceachronicles 