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U.S. Department of State

Diplomacy in Action

The Government of Colombia's Procedures for Handling Claims of Colombian Citizens That Their Health Was Harmed or Their Licit Agricultural Crops Were Damaged by Aerial Eradication


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Summary:

Since the inception of the aerial illicit crop eradication program, the Government of Colombia has had a process by which Colombian citizens might seek compensation for claims of harm to legal crops or human health. The process was recently updated to make it more efficient and well-publicized.

With Embassy support, the process of investigating harm to legal crops has recently been improved to provide for faster investigation and resolution of complaints. If sufficient evidence is presented to identify the site, date, and details of the incident that allegedly caused harm, farmers who have suffered damage to legal crops will be compensated for the market value of the lost crops.

To ensure that local citizens are aware of their rights under the new process, Embassy Bogot�, working with the National Directorate of Dangerous Drugs (DNE), has placed a series of newspaper and radio announcements informing citizens of their rights. These also air and/or are published in major municipalities in each spray zone before and during each spraying operation.

The Embassy, DNE, and Colombian National Police are engaged in this new process. Complaints are being received, logged, investigated, verified, and compensation is being allocated to cases with merit.

With respect to complaints of harm to individuals' health, Embassy Bogot� will continue to investigate serious complaints for which sufficient identifying information is provided, as it has done in the past.

Background:

The Government of Colombia has long had a process under which Colombian citizens could seek compensation for claims of harm to legal crops or human health. Over the years in which the aerial eradication program has operated, there have been fairly regular complaints by citizens who claimed their legal crops were damaged by spraying, and scattered complaints of harm to individuals' health. Most are ruled out by an initial check of flight records establishing that spraying did not take place near the site of the claimed harm.

Process for complaints of legal crops sprayed in error:

On October 4, 2001, the GOC formally instituted a new process for compensation for legal crops sprayed in error. The GOC directs the process with funds provided by the United States Government.

Under this new system, complaints are routed through municipal representatives ("Personeros") who record them on standardized forms, then immediately refer them to the Colombian Farming and Livestock Institute (ICA) and the Municipal Offices of Technical Agricultural Assistance (UMATA) for preliminary field verification. Within two days of a field visit, the Personero will submit the complaint and a record of preliminary verification to the Antinarcotics Police (DIRAN) and the National Directorate of Dangerous Drugs (DNE). Within five days of receipt of these materials, the DIRAN certifies whether or not it had sprayed in the area where the alleged damage took place. If not, the complaint is dismissed, and the DNE sends a letter notifying the claimant of the outcome. If so, a field visit is made within ten days to determine whether spraying in fact caused the alleged damage and, if so, the amount of compensation to be paid. The evidence must "clearly establish" that any harm was due to spraying. Required proof includes certification from DIRAN that there was spraying in the area; copies of flight logs; reports on the field visits; and "other relevant evidence."

The Director of the DNE has informed Embassy Bogot� that for each spray operation (i.e., each period of spraying in a given location) the DNE will schedule and publicize a specific period for the receipt of complaints, and that all complaints received in that period will be investigated and adjudicated within sixty days from the first day scheduled for receipt of complaints. To ensure that local citizens are aware of their rights under the new process, Embassy Bogot�, working with the DNE has placed a series of newspaper and radio announcements informing citizens of their rights. These also air and/or are published in major municipalities in each spray zone before and during each spraying operation.

DNE has certified to Embassy Bogot� that the new complaints process is functioning. Embassy officials have accompanied representatives from the DNE and the DIRAN on verification missions in Putumayo, Nari�o, and Cesar and have seen first-hand a commitment to having a process that works.

As of the end of August 2002, the DNE has received over 1,000 complaints through the streamlined complaint resolution procedure. Of these, close to 800 have been closed on paper after further investigation that showed that spraying did not take place in the complainant's vicinity during the date of the complaint. Some 220 complaints require field verification and are in the pipeline for in situ verification. Fourteen sites have been physically verified (11 in Putumayo, 2 in Nari�o and one in Cesar) and in one of these cases, the DNE has agreed to pay damages that are currently being estimated. Although security and safety factors sometimes delay verification missions, the Embassy, the DNE, and the DIRAN are committed to this process.

Process for complaints of harm to human health:

Embassy Bogot� and INL have taken great care to seek and evaluate scientific evidence on the health effects of the spray mix and its component ingredients, and are convinced that the mix poses no serious risk to human health. Glyphosate - the only active ingredient in the spray herbicide we use - is one of the most common weed killers in the world. It is widely used in the United States in commercial agriculture. The glyphosate applied in the coca and opium eradication program constitutes only about one eighth of all the glyphosate applied throughout Colombia. Glyphosate has been registered by the United States Environmental Protection Agency (USEPA) since the 1970's. USEPA says it is of low toxicity, non-carcinogenic, and does not cause mutations or birth defects. The World Health Organization and the International Programme on Chemical Safety report similar findings.

The glyphosate formulation we use consists of glyphosate, water, and a surfactant. This formulation is further mixed with water and a Colombian-manufactured and approved surfactant called Cosmo-Flux 411F. The surfactants help the herbicide penetrate the waxy surface of the leaves of the coca or opium plants. Although Cosmo-Flux 411F is not registered in the United States, the USEPA has certified that its ingredients are within accepted tolerances for use on food crops. The application rate we use for our spray mixture is within the limits prescribed by the manufacturers.

Because of their wide use, glyphosate-based formulations have been the subject of numerous health studies over a period of more than 25 years. These have consistently concluded that these formulations can, at most, cause short-term and completely reversible irritation of eyes, nose, mouth, and skin, but do not pose a serious health risk to human beings exposed as bystanders, for example to spray drift. This body of literature was reviewed in a recent comprehensive article published in a peer-reviewed journal. Williams, Kroes, and Munro, Safety Evaluation and Risk Assessment of the Herbicide Roundup and its Active Ingredient, Glyphosate, for Humans, Regulatory Toxicology and Pharmacology 31, 117-165 (2000).

In addition, Embassy Bogot� has contracted Colombian medical experts to investigate every allegation of serious health harm brought to its attention. None has been substantiated. The reports of two of the four major investigations undertaken to date in San Bernardo (Nari�o department) and Argelia (Putumayo) are attached. The two reports that investigate health-related complaints allegedly caused by spraying in Aponte (Nari�o) and Orito, San Miguel and Valle de Guamuez (Putumayo) have been widely distributed previously and not included here due to their size (they are posted on the Embassy's website).

In contrast, to date, there is no equally credible scientific or field evidence to support the proposition that the spray mix ingredients can cause health harm other than the minor mucous membrane irritation described above. Such harm is not, however, subject to the same claims procedure as for claims of damage to legal crops. It can be very difficult to establish causation in health-related cases. That is especially so in the context of rural Colombia - where a claimant would be hard pressed to establish that an alleged health harm was caused by spraying and not by poverty, unsanitary living conditions, poor access to health care, lifestyle, or use of dangerous chemicals for coca cultivation and processing.

Colombian law provides that citizens may claim that their health was harmed by aerial eradication, and they may seek compensation if their claims are meritorious. Citizens may do so either by the legal action known as "tutela" or by a direct action against the appropriate Government of Colombia entity. An action for "tutela" seeks to enforce a right guaranteed under the Colombian Constitution. It is available for citizens who have no other means under the law of avoiding an "irrevocable injustice." A citizen may also bring a direct action against the responsible government entity. The Government of Colombia does not enjoy immunity from prosecution in such suits.

Embassy Bogot� shall continue to investigate all claims of spray-related health epidemics or serious harm for which sufficient detail is provided. In addition, the Embassy is participating in two other health-related projects. First, it has instituted a Medical Civic Action Program ("MEDCAP"), in cooperation with the Colombian Army, in which Army medics will offer to all citizens living in spray zones vitamins, immunizations, and medical treatment for the health problems most commonly suffered by rural Colombians. The medics' training has been completed, and MEDCAP's will be scheduled in each spray zone when operational and security needs permit. Since these actions will take place in the spray zones concurrently with spraying, they will provide an effective means of immediately assessing conditions that might be attributed to spraying. Secondly, the Interamerican Drug Abuse Control Commission (CICAD) of the Organization of American States will design and lead an independent, scientific study of the health effects of the spray program on people, fauna/flora and the environment; the Embassy is prepared to fully cooperate with this project.

To summarize, a large body of scientific evidence holds that exposure to the spray mix may cause minor and short-term mucous membrane irritation but not serious health effects. There is no equally credible evidence that spray products cause other types of harm. Embassy Bogot� investigates all claims of serious harm brought to its attention and none has yet been substantiated. CICAD will complete a scientific study to monitor effects of the spray program, within one year. And the Colombian Army has initiated a new program in which its military medics will treat citizens in spray zones for common rural ailments and assess spray-related conditions.


REPUBLIC OF COLOMBIA

THE NATIONAL DRUG COUNCIL RESOLUTION NO. 0017 OF 2001

[Seal] October 4, 2001

"For adoption of a procedure to address complaints of damage presumably derived from aerial spraying with the herbicide glyphosate by the Illicit Crop Eradication Program"

THE NATIONAL DRUG COUNCIL

In exercise of its legal faculties and pursuant to Article 91, sub-sections a, b, c and particularly sub-section g, and Article 92 of Law 30 /1986

WHEREAS Law 30 of 1986 establishes an illicit crop eradication procedure and designates the National Drug Council, in particular, to arrange for the eradication of marijuana, coca and other crops from which addictive substances may be extracted, using the means most appropriate for this purpose and with the concurrence of the agencies commissioned to safeguard public health and guarantee preservation and stability of the nation's ecosystem (Sub-section g, Article 91);

WHEREAS Resolution No. 0001 of February 11, 1994 was amended by the National Drug Council under Resolution No. 0005 of 2000 to reinforce control, follow-up and monitoring mechanisms aimed at evaluating the impact of the Illicit Crop Eradication Program on the environment, agriculture and health, and to establish specific criteria for its implementation;

WHEREAS the National Narcotics Office (DNE), pursuant to Resolution No. 0005 of 2000, is the agency responsible for coordinating the Illicit Crop Eradication Program, and the Counter-narcotics Office is responsible for planning the program from an operational standpoint;

WHEREAS the Single Convention Governing Narcotic Drugs, 1961, amended by the 1972 Protocol Amending the Single Convention Governing Narcotic Drugs, 1961, ratified by Colombia under Law 13 of 1974, considered that effective measures against abuse of narcotic drugs require coordinated and universal action, that such action calls for international cooperation guided by the same principals and aimed at common objectives, and desired to provide for continuous international cooperation and control for the achievement of the aims and objectives set forth in said Convention;

WHEREAS a Letter of Agreement on Cooperation to Prevent and Control the Drug Problem was signed on September 7, 1999 by the government of Colombia, represented by the Director of the National Narcotics Office, and the government of the United States, represented by the Director of the Narcotics Affairs Section at the American Embassy;

WHEREAS the parties to said agreement promised to supply the resources and to undertake all action specified therein, including, as outlined in Point II - Project Description, a build-up in the technical and logistic capacity and equipment of the National Narcotics Office to implement, coordinate, monitor and evaluate the National Plan for the War on Drugs.

WHEREAS the Narcotics Supply Reduction strategy outlined in the National Plan for the War on Drugs contains Objective No. 2, which calls for Goal No. 1 - Technical and Controlled Illicit Crop Eradication.

WHEREAS eradication of illicit crops through aerial spraying with the herbicide glyphosate might produce collateral effects with an impact on legal crops in the vicinity;

WHEREAS the Illicit Crop Eradication Program has new systems and advanced satellite information technology for illegal crop detection, including medium- resolution satellite images, high-resolution color and panchromatic aerial photographs and satellite location systems aboard the aircraft used for spraying, all of which facilitate more and better protection for the rights of individuals in areas where the Illicit Crop Eradication Program operates;

WHEREAS complaints from citizens in several regions of the country have increased due to presumed damage to agriculture from aerial spraying with the herbicide glyphosate, making it necessary to issue regulations to ensure these complaints are addressed promptly and effectively;

IT HAS AGREED AS FOLLOWS:

CHAPTER ONE

PROCEDURE

ARTICLE ONE. OBJECTIVE. The purpose of this resolution is to help guarantee the protection of fundamental rights pursuant to the terms of the Colombian constitution by adopting a simple procedure for due attention to complaints from individuals presumably affected by aerial spraying with the herbicide glyphosate as part of the Illicit Crop Eradication Program.

ARTICLE TWO. RESPONSIBLE AUTHORITIES. The National Narcotics Office and the Antinarcotics Directorate of the National Police are the authorities responsible for handling complaints from people presumably affected by the herbicide glyphosate used in Illicit Crop Eradication Program, with due consideration for speed, effectiveness, transparency, good faith and promptness, in addition to all other principles provided for by law.

ARTICLE THREE. RECEIPT OF COMPLAINTS. Complaints related to illicit crop eradication through aerial spraying with the herbicide glyphosate shall be received by the municipal representatives, in their capacity as the Attorney General's representatives in towns throughout the country.

ARTICLE FOUR. FILING A COMPLAINT. Complaints may be filed verbally or in writing and shall include the following required information:

  1. Full name and identification of the person filing the complaint
  2. Name and location of the presumably affected property, as stipulated in the paragraph of this article.

  3. A copy of the deed to the property in question or a statement of the title under which the presumably affected property is being used.

  4. The economic activity now developed on the property in question

  5. A list of damages, indicating the quality and quantity of affected goods or property

  6. Date and time of spraying

  7. The objective of the petition

  8. A list of all documents and evidence attached to the complaint

  9. Home address or place where a reply may be sent

  10. Signature of the petitioner and the official with whom the complaint is filed.

PARAGRAPH: For added clarity and quicker verification of the facts related to the complaint, a form shall be adopted with the foregoing items and with an attached map of the municipality. It shall be filled out in the presence of the municipal representative, who shall identify the presumably affected property or properties on the map attached to the form.

ARTICLE FIVE. PRELIMINARY VERIFICATION OF THE FACTS CONNECTED WITH THE COMPLAINT. Once the municipal representative receives the complaint, he shall immediately ask the local ICA and/or UMATA official to visit the site indicated in the complaint for preliminary verification of the facts in question. A record of this field visit shall be drawn up and attached to the complaint for delivery to the National Narcotics Office.

PARAGRAPH: A guide or format for verifying the information shall be adopted to this end. It shall be filled out by the ICA and/or UMATA official and by the municipal representative, and is to be accompanied by full identification of the presumably affected property on the map provided for this purpose.

ARTICLE SIX. DELIVERY OF THE COMPLAINT TO THE NATIONAL NARCOTICS OFFICE. Within two (2) days subsequent to preliminary verification, the municipal representative shall send the complaint and a record of preliminary verification to the Counter-narcotics Office of the National Police, with a copy of the complaint to the National Narcotics Office (DNE). This shall be done simultaneously, and the municipal representative shall inform the petitioner accordingly.

ARTICLE SEVEN. PRIOR REPORT. Within five (5) days after receipt of the complaint, the Counter-narcotics Office of the National Police (DIRAN) shall certify whether or not the zone in question was sprayed. This certification shall be based on satellite location flight reports, copies of spraying records and polygrams, and reports from illicit crop detection and monitoring systems used by the Illicit Crop Eradication Program in the municipality or area related to the complaint.

If it is concluded, on the basis of the foregoing certification, that no aerial spraying was conducted in the area connected with the complaint, DIRAN shall immediately inform the municipal representative and the DNE to this effect.

ARTICLE EIGHT. FIELD VISIT AND REPLY. If DIRAN certification indicates the area in question was sprayed by the Illicit Crop Eradication Program, the complaint group created for this purpose shall conduct a field visit within ten (10) days thereafter to:

  1. Verify the basis for the complaint
  2. Determine existence of the damage and its relation to aerial spraying with the herbicide glyphosate as part of the Illicit Crop Eradication Program.

If the conclusion, based on this verification, is that damage was done and is the result of aerial spraying, the complaint group shall estimate its amount and sign a damage recognition certificate.

However, should the complaint group conclude that no damage was inflicted, it shall advise the municipal representative accordingly within two (2) days after the visit, explaining the reasons for this decision.

PARAGRAPH: The field visit mentioned in this article shall be ruled out in cases where public unrest prevents an inspection of this type. Such unrest is to be certified by the National Police.

CHAPTER TWO

CROP REPLACEMENT

ARTICLE NINE. CROP REPLACEMENT. The complaint group shall reimburse only those whose legal crops are affected as a direct consequence of aerial spraying with the herbicide glyphosate by the Illicit Crop Eradication Program, provided they have not taken prelegal or legal action.

ARTICLE TEN. DEADLINE FOR PRESENTING A COMPLAINT. Complaints filed sixty (60) days after the date of aerial spraying with the herbicide glyphosate by the Illicit Crop Eradication Program shall not be processed.

ARTICLE ELEVEN. CROP CLASSIFICATION AND REPLACEMENT CRITERIA. To replace legal crops that have been damaged, these shall be classified as permanent or temporary.

Permanent crops have a vegetation period of more than one year and are harvested more once during that time.

Temporary crops, for genetic or technical reasons, yield only one harvest during their vegetation period, which is one year or less.

Permanent crop replacement shall include:

  1. Investment in installation

  2. The market value of the impaired harvest, based on CORABASTOS prices.

  3. The cost of reinstalling the crop

  4. The value of future harvests, calculated up to the time the new plantation becomes fully productive.

Temporary crop replacement shall include only:

  1. The value of the impaired harvest, based on CORABASTOS prices.

ARTICLE TWELVE. CALCULATING REPLACEMENT. The complaint group shall estimate the replacement cost of the probable harvest according to the number of plants affected, with maximum possible production calculated on this basis and in accordance with the tables established for this purpose by the Colombian Agricultural Institute.

ARTICLE THIRTEEN. REQUIRED EVIDENCE. To proceed with crop replacement, the crop in question must be certified as being legal and the damage as being a direct result of aerial spraying with the herbicide glyphosate used in the Illicit Crop Eradication Program.

For the above, the following evidence of damage is required:

  1. National Police - Counter-Narcotics Office (DIRAN) certification of aerial spraying in the zone connected with the complaint.

  2. Copy of satellite location flight reports

  3. Copies of spraying records and polygrams

  4. Copy of the report from the illicit crop detection and monitoring system of the Illicit Crop Eradication Program in the municipality or area connected with the complaint.

  5. Copy of the field visit report

  6. Other evidence that may be considered relevant or appropriate.

ARTICLE FOURTEEN PAYMENT. To acknowledge the replacement of affected crops and to proceed with payment, the complaint group coordinator and the beneficiary shall sign a damage recognition certificate.

If the beneficiary is not available at the time of this procedure, the damage recognition certificate duly signed by the complaint group coordinator shall be deposited at the office of the municipal representative for subsequent signature by the beneficiary.

Once this procedure is complete, the certificate in question shall be sent to the National Narcotics Office and, as of that moment, steps shall be taken to effect payment in the most suitable way.

CHAPTER THREE

GENERAL PROVISIONS

ARTICLE FIFTEEN. FORMATION OF THE COMPLAINT GROUP: The National Narcotics Office and the Counter-Narcotics Office of the National Police shall form an interdisciplinary group to address the complaints referred to in this resolution.

ARTICLE SIXTEEN. CASE FILE. A case file shall be established at the National Narcotics Office and at the Counter-Narcotics Office of the National Police with copies of all action to which this resolution refers. Said file shall constitute a documentary report and evidence of how complaints have been addressed.

ARTICLE SEVENTEEN. VALIDITY. The regulations contained in this resolution apply as of the date of its publication. Failure to observe them on the part of officials from the proper agencies or bureaus shall constitute inappropriate conduct and be cause for pertinent disciplinary action.

Let it be published, made known and observed.

Issued in the city of Bogota on October 4, 2001.

[Signature] R�mulo Gonz�lez Trujillo, Chairman

[Signature] Mercedes Vasquez de Gomez, Executive Secretary


Publicity for new GOC Compensation Process

Radio Announcements:

Colombian citizens living in areas where aerial spraying of illicit coca and opium poppy crops is taking place should know they have a right to seek compensation from their government if their legal crops are mistakenly sprayed. The Government of Colombia will reimburse citizens for losses in such cases. If your legal crops have been damaged by aerial spraying, please contact your Municipal Representative, who will ask you to provide basic information about your claim and will turn it over to national government authorities for a decision. Please make your claims as soon as possible, as there are time limits for doing so.

This announcement is sponsored by the Direcci�n Nacional de Estupefacientes.

Newspaper Announcements:

IMPORTANT NOTICE

ATTENTION CITIZENS WHOSE LEGAL CROPS WERE SPRAYED

Colombian citizens living in areas where aerial spraying of illicit coca and opium poppy crops is taking place should know they have a right to seek compensation from their government if their legal crops are mistakenly sprayed. The Government of Colombia will reimburse citizens for losses in such cases. If your legal crops have been damaged by aerial spraying, please contact your Municipal Representative, who will ask you to provide basic information about your claim and will turn it over to national government authorities for a decision. Please make your claims as soon as possible, as there are time limits for doing so.

This announcement is sponsored by the Direcci�n Nacional de Estupefacientes.


A REPORT ON TWO DEATHS IN THE VILLAGE OF LA ARGELIA, MUNICIPALITY OF LA HORMIGA, VALLE DEL GUAMU�Z, By: Jorge Hern�n Botero Tob�n, M.D., Chemical Risk, Toxicology and Human Health Consultant, Bogot�, Colombia, January 2002

1. BACKGROUND

On November 27, 2001, the 24th Colombian Army Brigade Intelligence Division received a report of two deaths at the Sacred Heart of Jesus Hospital in La Hormiga, a state institution.1The first was an 11-month-old boy. When interviewed by the hospital staff and the investigating officer, his mother said the child was in the patio of his home when spray aircraft flew over. He reportedly developed acute diarrhea and vomiting immediately thereafter, which led to severe dehydration and death within 24 hours. She indicated the boy's father and cousin experienced diarrhea and vomiting as well.

1Report on two deaths in La Argelia (La Hormiga, Valle del Guamu�z) allegedly caused by glyphosate. 24th Army Brigade Intelligence Division, November 25, 2001.

According to the same report, another child in La Argelia experienced diarrhea, which improved initially then worsened, accompanied by respiratory failure. He died the next day at the same hospital.

The family of the 11-month old deceased child and the municipal representative attributed his illness and death to aerial spaying of coca in La Argelia township, La Hormiga Municipality, where he resided with his family. The family of the 4-year-old did not, but the hospital apparently reported both cases to the Army at the same time.

The author of this report was retained by the U.S. Embassy, Narcotics Affairs Section, to investigate the deaths. He traveled to La Hormiga by plane on Wednesday, December 5, departing at 09:00 hours and arriving at 10:30 hours. There, he met with the municipal representative, Mr. Leandro Antonio Romo-Pantoja, and the Director of the Sacred Heart of Jesus Hospital, Dr. Jos� Victor P�rez (both of whom had been in contact with the families of the deceased) and reviewed the children's medical records.

According to the municipal representative, both cases were preceded by the death of fish and chickens in the villages of El Tigre, El Para�so and Maraveles, at about the time of aerial spraying on November 13, 2001.

2. THE HERBICIDE USED IN AERIAL SPRAYING

The commercial formulation of glyphosate used in the illicit crop eradication program consists of glyphosate, water, and a surfactant. This formulation is mixed with water and a Colombian-manufactured and approved surfactant, Cosmo-Flux 411F. A surfactant, which is like a soap, helps the herbicide penetrate the leaves of a plant.

The dose used in the aerial eradication program for coca spraying contains 10.4 liters (2.75 gallons) of the commercial glyphosate formulation per hectare. The dose of the active ingredient, glyphosate, is 3.74 kilograms (acid equivalent) per hectare. This is equivalent to 374.4 mg of glyphosate per square meter.2

There is a large body of scientific literature indicating that glyphosate is of low toxicity for humans, animals and the environment.3

3. CASE REVIEW

3.1 CASE 1: Edwin Xavier Daza Fern�ndez

3.1.1 Clinical History

During the interviews with the officials mentioned above, the complaint filed with the municipal representative by the child's relatives was reviewed, as was his clinical history. It says, in summary, that a nursing child 11 months old was admitted to the hospital in a state of shock, and that his relatives had reported that his symptoms initiated 24 hours earlier, characterized initially by diarrhea and vomiting on multiple occasions and instability after exposure to spraying for fumigation. According to the municipal representative, these symptoms were preceded by nasal and ocular itching, inability to maintain posture and ocular deviation. However, this information is not included in the hospital's emergency care record, according to which " the symptoms worsened and his condition at the time of admission to the hospital did not respond to treatment." 4

2Parra, L.E., (Consultant to Narcotics Affairs Section, US Embassy, "Overview of Risks of Exposure to Glyphosate," July 2000.
3Environmental Health Criteria No. 159, Glyphosate, International Programme on Chemical Safety, World Health Organization, Gen�ve, 1994; Williams, G.M., Kroes, R., Munro, I.C., "Safety Evaluation and Risk Assessment of the Herbicide Glyphosate," J Regulatory Toxicology and Pharmacology, 31: 117-165, Academic Press, 2000; Giesy, J.P., Dobson, S., Solomon, K., "Ecotoxicological Risk Assessment for Glyphosate Herbicide," Rev. Environ Contam Toxicol, (Sic) 167: 32-120, Springer Verlag, 2000.
4Record of emergency care, Sacred Heart of Jesus Hospital, La Hormiga, Putumayo.

The child was not transferred to La Hormiga until the following day, when he was taken to the hospital at 18:00 hours. Transportation and movement in the region are difficult because the Revolutionary Armed Forces of Colombia (FARC) and the Colombian Self-defense Forces (AUC) are fighting for control of the area. According to the hospital record, a physical examination revealed the child was "in a state of shock" and exhibited obvious signs of severe dehydration, such as a depressed fontanel [note: this is the "soft spot" on the top of a baby's skull], sunken and dull eyes, dry mucus, mucocutaneous pallor, intercostal retraction, crackles in the bases of the lungs, lowered tone rhythmic cardiac noises and cardiac frequency, a depressed abdomen with no intestinal noise, rigid extremities and a profoundly depressed state of consciousness. (Here, the record refers to "Glasgow 4/5," a reference to a neurological classification of one's state of consciousness. However, this is probably not appropriate, because this illness does not appear to have been a traumatic or neurological disease.) Treatment was initiated with a saline solution administered intravenously, ampicillin, and gentamicin. Admission was at 19:30 hours and the patient died 45 minutes later.

An autopsy was performed and samples were taken of the liver, lungs and brain. They were sent to the Institute of Forensic Medicine in Bogota for analysis. As yet there have been no results.

According to the medical director of the hospital, the child's grandfather and four-year-old brother were treated as well: the grandfather for exacerbation of chronic symptoms of severe epigastralgy (a painful burning sensation in the upper abdomen) and the brother for diarrhea and vomiting.

Although not noted in the child's medical records, Dr. P�rez indicated the local water supply is extremely poor. Because sewage from rural homes is dumped directly into surface flows, most water sources are polluted with solid waste.

3 .1.2 Discussion of the Findings

In this case, the mother apparently believes there may have been direct exposure to the sprayed mixture ("an airplane flew over") prior to appearance of the symptoms.

However, computerized spray flight records indicate that on November 14, the date of the alleged exposure, spraying took place in the townships of El Tigre, La Chorrosa, El Diamante, Campoalegre, El Venado, San Francisco and Guadualito.5 Guadualito is three miles south of Argelia; the other townships are further away. Although there may be slight drift of the spray mix at times, it is highly unlikely that the spray could not have drifted that far.

Even if the child were directly exposed to spraying, however, there is no indication that his illness was related to such an exposure. Even full-body exposure would have been minimal in comparison to harmful doses. Considering the dose used in aerial eradication, and assuming a conservative body weight of nine kilograms (actual weight is not on record), a corporal surface of 0,44 m26 and total exposure to spraying, the dose on the cutaneous surface would be:

5Flight data from aerial eradication records, 2001.
6Corporal surface of an 11-month-old child weighing nine kilograms, according to the Boyd & West modified nomogram (a graphic representation of several lines marked to scale and arranged so that by using a straightedge to connect known values, an unknown value can be read at the point of intersection), Nelson's Textbook of Pediatrics, 12th Edition, McGraw-Hill, 1993.

  •  0. 44 m2 x 374.4 mg/m2 of glyphosate (dose/ m2) = 164.73 mg
  •  For 9 kg body weight, the total dose received would be :
  • 164. 73 mg 9 kg = 18.30 mg/Kg
  • Assuming a conservative absorption rate equal to 15% of the applied dose, the absorbed or "effective" dose would be:
  • 164.73 mg x 0.15 = 24.71 mg or 2.74 mg/kg. This is 1,824 times less than the measured lethal dose7 for laboratory animals (5,000 mg/kg) and one and a half times less than the "Allowable Daily Intake" (ADI).8 Thus, the total amount of glyphosate to which the child would have been exposed even had his entire body surface been sprayed (164.73 mg) would be equivalent to 0.48 mL of the commercial glyphosate formula. Even if administered orally, this amount would be insufficient to produce the aforementioned effects.

Moreover, a review of existing literature shows no fatalities from cutaneous exposure. Mortality associated with glyphosate exposure has been observed only with the ingestion of large quantities of the commercial formula (80 to 250 mL, 184 mL on average).9

7"Lethal Dose 50," or "LD50," is a universally-applied marker for evaluating toxicity. The LD50 of a chemical is that single dose which will, on the average, result in death of 50% of a given population of experimental animals. Normally, this is a standardized test species. The oral LD50 of glyphosate is over 4,320 milligrams per kilogram of body weight, meaning that ingestion of more than 4,320 milligrams of glyphosate per kilogram of body weight would be necessary to prove lethal to the test species, in this case, rats.
8The "ADI" is a standard risk assessment indicator established by the World Health Organization International Programme on Chemical Safety and the U.S. Environmental Protection Agency (EPA). It indicates the maximum allowable amount of a toxic substance that can be ingested daily over a lifetime without a probability of suffering an adverse affect. Environmental Health Criteria No. 6, Risk Assessment of Chemical Substances, International Programme on Chemical Safety, World Health Organization, Gen�ve, 1984.
9Talbot et al. (1991), Sawada & Nagai (1992), Tominack et al. (1993) in Environmental Health Criteria No. 159 , Glyphosate, International Programme on Chemical Safety, World Health Organization, 1994.

The child's symptoms correspond to the unspecified signs of acute diarrhea with severe dehydration. However, those the mother reported to the municipal representative; namely, conjugated deviation of the eye and corporal instability, also suggest the presence of a major hydroelectrolytic imbalance, toxicity of a neurotoxic pesticide (a property of other pesticides, not glyphosate) or the clinical manifestations preceding incipient meningitis.

The grandfather and brother experienced similar discomforts, but no source indicates they were exposed to spraying. This could denote an infectious-contagious disease or one of toxic-food origin.

The toxic potential of glyphosate is minimal and the level of exposure does not coincide with the symptoms observed in this case. However, exposure to a more potent chemical neurotoxic agent, such as one of the organophosphate or carbamate pesticides used to protect coca (which are widely used without safety precautions both in legal and illegal agriculture in the rural regions of Colombia), could conceivably have been the cause. 10

In conclusion, a toxic etiology of the disease responsible for death cannot be identified. However, even if the child had been exposed to aerial spraying with glyphosate, the dose would not have been significant. Exposure by the cutaneous pathway is inefficient for absorption, which some authors say is around 2 percent.11 The action of glyphosate is not known to produce severe diarrhea,12 and the region's epidemiological patterns point to the high likelihood of an infectious cause. Finally, there are no reported cases of glyphosate being responsible for human death, except in cases involving intentional ingestion of significant quantities of the undiluted commercial product. (See references on intentional exposure in footnotes 2, 3 and 10).

The samples taken during the autopsy are being analyzed at the Institute of Forensic Medicine in Bogota.

4.2 CASE 2: Diomedes Niasa Villa

4.2.1 Clinical History

On November 22 at 19:00 hours, the second child, a four-year-old boy and neighbor of the first child, was treated at the hospital for fever and diarrhea, which began the afternoon of November 21, 2001. The patient was feverish upon admission (39�C temperature and a cardiac frequency of 150 beats per minute). A blood test showed leukocytosis (an increase of white blood cells) with neutrophilia (the condition that results when neutrophilic cells predominate to an abnormal degree). At 06:00 hours, the patient registered "confusional syndrome, labial cyanosis, coldness, periungual cyanosis without diuresis" then "cardiorespiratory arrest. It was managed with endotracheal intubation, cardiac massage, adrenaline, atropine but without effect and was followed by death.

The final diagnosis was noted as "acute diarrhea, hydroelectrolytic imbalance and possible paraquat intoxication".13 According to the medical director of the hospital, the autopsy showed a massive amount of parasites migrating from the respiratory tract to the digestive tract.

10"Retrospective Study of Reported Human Health Effects From Glyphosate Exposure in Putumyo", Uribe, C. et al., June 2001.
11Williams, G.M., Kroes, R., Munro, I.C., Safety Evaluation and Risk Assessment of the Herbicide Glyphosate, J Regulatory Toxicology and Pharmacology, 31: 117-165, Academic Press, 2000.
12Reigart, J. R., Roberts, J.R., Recognition and Management of Pesticide Poisonings, 5th Edition, See information on human exposure in notes 2 and 3.
13Emergency Care Record No. 49729, Sacred Heart of Jesus Hospital, La Hormiga, Putumayo.

4 .2.2 Discussion of the Findings

There was no spraying at La Hormiga on November 21, which was the first day of the acute illness observed in the second case. On November 22, the other date of possible exposure in this case, spraying took place in Brisas del Placer, Arauca, La Paloma, El Palmar, and Brisas del Guamu�z. However, only two of these locations (Palmar and Brisas del Guamu�z) are in the municipality of La Hormiga. The closest, Palmar, is located 20 miles west of La Argelia. As in the first case discussed above, this is too far for exposure to spray drift to have been a reasonable possibility.

As to the medical findings, the second child was also a case of severe diarrhea. He was ultimately found to have a definite history of massive intestinal parasite infestation and symptoms of infection (fever + leukocytosis). However, the child's parents did not claim that he had been exposed to spraying, nor was there any other evidence of exposure to aerial spraying. In fact, it is not clear why this case was brought to the attention of the Army, since it appears neither the parents nor the municipal representative made a complaint. Most likely, the hospital mentioned this case to the Army because it occurred close in time to the death of the first case discussed above (which was attributed to spraying) and in a region where aerial spraying was thought to have occurred.

As to the child's illness and cause of death, a review of the patient's treatment at the hospital shows the quantity and infusion rate and the sodium content of the liquids administered intravenously were insufficient to replace losses incurred earlier through diarrhea and vomiting, or to restore diuresis within a period of at least three hours and to initiate the administration of potassium, which probably was reduced substantially by diarrhea, at least during the previous 24 hours. In the end, death was the result of a severe hydroelectrolytic deficit, hypokalemia and subsequent multisystemic failure, which could not be reversed through resuscitation.

In this case, infestation with Ascaris lumbricoides, a very common intestinal parasite, is, in addition to Stongyloides stercolaris infestation, one of the most common causes of diarrhea.14 This alone could explain the origin of the disease responsible for death. Additionally, the notes of the treating physicians suggest that exposure to paraquat, a highly toxic agricultural chemical commonly used in coca cultivation in Colombia, was a possibility, although no tests for that substance were apparently conducted.

14
Plata Rueda et al., El Pediatra Eficiente, Chapter 8 "Diarreas," Salvat, 1986; Nelson's Textbook of Pediatrics, 12th Edition, McGraw-Hill, 1993.

The presence of fever accompanied by leukocytosis is the clinical event that suggests infection was responsible for the diarrhea that led to dehydration, which was the ultimate cause of death. This was aggravated by an insufficient supply of liquids and electrolytes during treatment. It is quite possible that migration of parasites to the respiratory tract and symptoms of asphyxia were contributing factors as well.

5. EPIDEMIOLOGICAL ANALYSIS

An epidemiological analysis of the cause of an outbreak of diarrhea or gastrointestinal disease must consider the time, form and place, in addition to the factors that could be responsible and the extent and intensity of exposure to them.

These infectious factors (bacterial, parasital, viral), the most common in the environment, and the toxins that produce the symptoms characteristic of diarrhea and gastrointestinal disease, as in the case of certain pesticides, must be considered when assessing the possible cause of death.

With diarrhea, the most probable cause in patients with no previous illness is infection. The risk situation in La Hormiga (described below) points to infection as a highly probable cause. Toxic agents such as organophosphate and carbamate pesticides are far more likely to cause diarrhea with fatal dehydration than is glyphosate (See footnote 13).

As to the two cases in question, the most important environmental event is water pollution resulting from solid waste disposal. This is a predominant risk factor for the people of La Hormiga and is an effective means of dissemination and exposure to infectious diarrhea.

According to health statistics, acute diarrhea (ADD) is the leading cause of death in La Hormiga.

TABLE 1. Morbidity per Outpatient
La Hormiga, Department of Putumayo
1992 - 1996

Municipality

Diagnosis

1992
No. Cases

1993
No. Cases

1994
No. Cases

1995
No. Cases

1996
No. Cases

La Hormiga
(Dept. of Putumayo)

ADD
(Acute diarhhea)

113

72

98

102

51

 

ARI
(Acute respiratory infection)

88

63

81

103

71

 

Dermatopathy

49

49

42

65

51

 

Conjunctivitis

5

5

2

4

8

 

Cephalea

28

22

9

51

41

Source: Figures on the Department of Putumayo were supplied by the National Health Institute and originate with the National Health Policy Analysis and Planning Office. SIS103, Ministry of Health.

Notes:

Due to the social and political situation in Colombia and because departmental health officials are slow about reporting data to the National Health Institute (INS), these figures could be incomplete and should be regarded with caution. Figures from recent years are not consolidated and, in some cases, none have been reported. The system was changed in 1997 and departmental officials only report when notification is mandatory, as is the case with diseases transmitted by vectors, those preventable through vaccination and sexually transmitted diseases.

All infectious skin diseases are grouped as dermatopathies, even though WHO differentiates between specific diseases such as dermatophytosis, eczemas, pruritus, allergic dermatitis, other types of dermatitis, etc. According to the INS, this change in procedure is not fully understood, especially at municipal level. As a result, there are problems with records on morbidity.

In addition, the risk of morbidity associated with water and sanitation is 57.67 percent in La Hormiga. This is one of the highest rates in the country and is near 60 points, which is the health unfeasibility limit for a community or region.15

The intensive and uncontrolled use of pesticides to protect coca crops and the potential for environmental transport of these substances after application are also factors to consider. A wide variety of highly toxic products are used in rural Colombia to protect coca against pests and blight. In most instances, for obvious reasons, these substances are not applied properly or in the correct dose, nor are they stored, handled or mixed according to safety standards. Disposal of empty containers and similar waste is usually inadequate. At some point, they could result in significant exposure to humans. Those who are most vulnerable, such as children and the elderly, would be affected first, as would certain types of wildlife. This could have been the case.16

15"Segunda Fase de Actualizaci�n del Inventario Nacional de la Calidad del Agua," Colombian Ministry of Health, 1998.
16op. cit. in Note 11.

The following table shows the products used most often, their toxicity and their measured lethal dose.

TABLE 2.3. Main Insecticides and Fungicides Used on Illicit Crops (10)

Trade Name

Active Ingredient

Toxicity Category in Colombia

Toxicity Category according to the EPA

LD 50
Oral              Dermal
(Rats)           (Rabbits)
(mg/k)           (mg/k)

INSECTICIDES

Tamaron

Metamidophos

I

I

21-16

118

Sevin

Carbaryl

II

I

250-850

>2,000

Metavin

Metomil

I

I

30

>2,000

Furadan/Liquid/
Granulated

Carbofuran

I

I

5

885

Curacr�n

Prophenophos

II

II

630

143.4

Thionil

Endosulfan

I

I

18-220

200-359

Parathi�n

Methyl parathion

I

I

4.5-24

6

Matador

Lambda-cyhalothrine

III

II

56-79

632

Thiodan

Endosulfan

I

I

18-220

200-359

Malathi�n

Malation

III

III or IV

480-10,700

>2,000

Nuvacron

Monocrotophos

I

I

17

354

Lorsban: Liquid/
Granulated

Chlorpiriphos

II

II

82-270

1,000-2,000

Convoy

Cypermetrine and diazinon

III

III

2.75-450

-

Politrin

Cypermetrine

II

II

 

>2,000

FUNGICIDE

Manzate

Mancozeb

III

III

4,500-11,200

5,000-15,000

Copper Oxychloride

Copper oxychloride

III

-

-

-

Bavistin

Carbendazim

III

-

-

-

Source: "Retrospective Study of Reported Human Health Effects From Glyphosate Exposure in Putumyo", Uribe, C. et al., June 2001.

CONCLUSION

There is no evidence in the two cases discussed above of either exposure to aerial spraying or of glyphosate as a causal agent in the deaths of the two children in La Hormiga.

APPENDICES

CLINICAL HISTORY NO. 1

CLINICAL HISTORY NO. 2

LETTER: NATIONAL INSTITUTE OF LEGAL MEDICINE AND FORENSIC SCIENCES


REPORT:  ASSESSMENT OF A PATIENT IN THE TOWN OF SAN BERNARDO (NARI�O, COLOMBIA), Bogota, September 21, 2001

TABLE OF CONTENTS

Timeline of Activities

Medical History                                                        

Differential Diagnoses

Medical Opinion and Conclusions

Bibliography

Figure 1 and Photos [not available]


 TIMELINE OF ACTIVITIES

I visited the town of San Bernadino on September 1 and 2 of this year.  I had originally started my trip on August 31, but due to the strong winds in the city of Pasto, my flight was forced to return to Bogota.  On September 1, I left Bogota at 7:00 a.m. for Pasto, where I arrived at 8:30 a.m. I took ground transportation from the airport to the bus terminal and then took public transportation to the town of San Bernadino, where I arrived at 1:00 p.m. I made my way to the Mayor's Office and was received by the municipal spokesperson and the Mayor, Mr. Paulino Erazo-Imbachi.

The minor Yeison Aurelio Bola�os-Castillo, a two-year-old boy, was waiting with his parents at the Mayor's Office, and I proceeded with my assessment, taking down his medical history as part of the assessment process.  I finished at 3:30 p.m. and once again traveled to the city of Pasto, where I spent the night, returning to Bogota on September 2.

On September 3 and 5, Dr. Camilo Uribe-Granja evaluated the case and conducted a review of the relevant literature.  From September 6 to 9, the case was presented to and analyzed with Dr. Carlos Mart�n Restrepo, Head of the Genetics Unit of the Rosario University Medical School.  On September 10, the report with the final diagnosis was put together.

MEDICAL HISTORY

NAME: Yeison Aurelio Bola�os-Castillo.
AGE: Two (2) years old.
SEX: Male.
DOB: May 15, 1999.
DATE OF ASSESSMENT: September 1, 2001.
TIME: 1:45 pm
HISTORY OF THE ILLNESS:

This patient displayed birth defects involving the reduction of his four (4) extremities, hydrocephalus and delayed neural development. He was evaluated for the purpose of determining and diagnosing the possible cause of his congenital abnormalities.

PERSONAL BACKGROUND:

The patient was the product of a first full-term gestation with no prenatal medical check-ups, and he is one of two (2) siblings. Gestation took place in the months from September 1998 to May 1999, dates which are inconsistent with fetal exposure to Phosphonomethylglycine (a substance also known as Glyphosate). There were no aerial eradication operations until August 14, 1999, three (3) months after the child's birth. This was a vaginal delivery at home, and the somatometry at birth is unknown, nor was any mention made of this in the documents presented by the Municipal Health Center.  The closest data that we have at present are: Weight: 4 Kg; Length: 42 cm; and Cephalic Perimeter: 52 cm at five (5) months of age. The child underwent a ventricular-peritoneal valve derivation at one (1) year of age at the San Pedro Hospital in Pasto, due to hydrocephalus. Five (5) months ago he suffered convulsions, apparently a secondary episode to hypothermia due to acute respiratory infection. His vaccinations are up to date for his age. Respiratory infections are repeatedly mentioned, and there is documentation of delayed psychomotor development.

FAMILY BACKGROUND:

The patient's parents are 22 years old and come from the Pindal countryside, an area with a population of approximately 2,000 that belongs to the greater San Bernardo municipal area, in the Department (i.e., Province) of Nari�o with an estimated population of 10,000 inhabitants.

The parents are healthy and are not related to each other (non-consanguineous). Both have been employed in manufacturing hemp (natural rope fiber), for the last seven (7) years. As a couple, they have started three (3) gestations, G3P2V2, and they are currently in the eighth month of gestation of their third child, and have been without obstetrical check-ups. The children of this couple are the patient and another son, who is referred to as healthy and who was not brought to the appointment. There is no history of other anomalies similar to those found in the patient, nor of any heredopathy on either side of the patient's family.

PHYSICAL EXAMINATION OF THE PATIENT:

VS: CF: 98 per minute, RF: 21 per minute, Weight: It was not possible to weigh the patient.  The last weight reported was at 15 months of age in which he weighed 8 kg and his height was 52 cm. Cephalic perimeter: 54.5 cm.

The patient was microsomic with apparent macrocephaly, open and normotensive fontanel. The neurological exam showed isochoric pupils with normal reaction to light. He cannot hold up his head and has difficulty with decubital changes (changing the horizontal position of his body, i.e., rolling over). Normal deglutition. The patient apparently conserves sensitivity, and there is no evidence of fascia or hemangomia. Normal eyes, normal mouth, normal buccal cavity. Normal external ear canopies and lobes. Symmetrical neck. Normal hair and normal follicular implantation on neck. Symmetrical thorax. Cardiopulmonary assessment showed sight raling (noisy accessory breathing) at the base of the lungs. Heart beat with systolic murmur in the fourth intercostal space to the left of the sternum. The patient displayed a soft abdomen with no abnormally large organs (organomegaly). Intestinal noise was present. The patient's extremities show severe defects and reduction, consistent with the absence of the middle and distal segments, though remnants can be seen in the proximal region. The lower extremities are totally absent, with cutaneous fossas in the areas where the missing extremities would be inserted (see photos 1 and 2).

DIAGNOSIS:

1. Amelia / Hypomelia Complex
2. Congenital Hydrocephalus
3. Delayed psychomotor development

Adriana Zamora-Su�rez, M.D.
Toxicologist & Medical Physician
Med. License 01-1532/98

DIFFERENTIAL DIAGNOSES

Possible etiological diagnoses considered for this patient were Roberts Syndrome, TAR Syndrome and Odontotrichomelic Syndrome.

Roberts Syndrome (RS) is also known as Pseudothalidomide or CS Syndrome, because of its similar phenotype to the clinical manifestations of fetal exposure to Thalidomide. It was described for the first time by Roberts in 1919, and is not a very common syndrome, with probably fewer than one (1) case in every 100,000 births. Nevertheless, in Colombia, over 60 cases have been documented in the Cundinamarca-Boyaca high plateau region. It is a hereditary recessive autosomal disorder, frequently associated with consanguinity of the parents, and accompanied by a characteristic chromosomal defect that is consistent with the premature separation of the heterochromatin during the metaphase. The principal characteristics are tetraphocomelia (the severe reduction of the extremities with no absence of the relevant proximal, medial and distal structures, accompanied by medial-line facial malformations such as cleft lip or cleft palate, variable mental retardation and other alterations, such as scarce, thin and gray hair, facial hemangiomas, cryptorchidism, microcephaly, hydrocephalus, microphtalmia, cataracts, corneal opacity, various cardiac and renal abnormalities, thromocytopenia and hypospadias.  Those suffering from the syndrome normally show an average lifespan of 10 years, and the parents are at 25% risk of having another child with the disorder in each subsequent pregnancy (see Figure 1).

TAR Syndrome, or Radial Aplasia-Thrombocytopenia Syndrome, was discovered in 1956, and is also an inherited autosomal recessive disorder. Those suffering from the syndrome have thrombocytopenia with an absence or hypoplasia of the megacaryocytes; it can also be accompanied by eosinophilia in 53% of patients and granulocytosis in 62%. There is an absence or hypoplasia of the radius, usually bilaterally. It can manifest itself as occasional abnormalities, such as shortness, kidney problems, spina bifida, syndactyly and shortened humerus. In terms of the prognosis, close to 40% of all patients die due to hemorrhaging during childhood.

The Odontotrychomelic Syndrome (OTMS) is another inherited recessive autosomal disorder. The most important clinical findings are extensive deficiencies in the development of the extremities, tetra amelia, hypotrichosis, abnormal dentition and deformity of the ear canopies and lobes. This syndrome has been reported with greater frequency in Caucasian Italian and Brazilian families. The prognosis for lifespan is better than in the case of RS and STAR.

There was no aerial eradication in Nari�o until August 14, 1999, three (3) full months after the child's birth. Consequently, any connection with aerial eradication exercises can be discarded based simply on these dates.

Even if this were not the case, however, there is no report in the body of medical literature of fetal teratogenic syndrome in connection with phosphonomethylglycine. A review of the literature shows that reproductive and development studies of rats and rabbits by researchers, such as Schroeder in 1981 and Yusef in 1995, show no reproductive disturbances. Other studies of teratogenicity carried out on pregnant rats with phosphonomethylglycine doses of up to 3,500 mg/kg/day administered from days 6-9 of gestation produced the following effects: increased softer fecal depositions, reduced activity, delayed growth, and fewer implanted fetuses. With doses below 1,000 or even 2,000 mg/kg/day, no effects were observed. In rabbits, doses of 350 mg/kg/day administered from days 6-27 of gestation once again showed a higher number of fecal depositions and reduced activity. With doses of 175 mg/kg/day, these effects were no longer present. In both animals, there have been no reported general or appendicular skeletal defects, which once again confirms that the experimental administration of glyphosate is not linked to teratogenic effects.

MEDICAL OPINION AND CONCLUSIONS

In summary, the patient has a combination of symmetrical hypomelia in his upper extremities and amelia in his lower ones, accompanied by hydrocephalus and delayed psychomotor development, probably secondary to hydrocephalus. Possibly, the cause of his malady is the primary absence of development of the extremities for an unknown cause. Nevertheless, from a clinical point of view, the three (3) Syndromes mentioned earlier, RS, STAR and OTMS, are discarded since the anatomical or family-history findings are not consistent.

Phosphonomethylglycine is also discarded as a cause, not only by the fact that the spraying dates do not coincide with those of the pregnancy, but also because the scientific literature shows no teratogenic potential for the glyphosate molecule.

Furthermore, the three (3) hereditary entities that were considered show discrepancies between the findings that characterize them and what was observed in the patient.

The risk of recurrence of this entity in another sibling of Yeison's is probably very low (less than 1%). Despite this, Level III Ultrasound follow-up is recommended for the unborn sibling of the patient.

Carlos Mart�n Restrepo-Fern�ndez, MD, MSc.
Head of the Genetics Unit, ICB
Medical School
Rosario University

Camilo Uribe-Granja, MD
Toxicologist and Medical Physician
Scientific Director
Uribe-Cualla Toxicology Clinic

Adriana Zamora-Su�rez, MD
Toxicologist and Medical Physician
Uribe-Cualla Toxicology Clinic

BIBLIOGRAPHY

Buyse ML. Birth Defect Encyclopedia.  First Edition. U.S.A: Blackwell Scientific Publications; 1990.

Milunsky A. Genetic Disorders and The Fetus. Diagnosis, Prevention and Treatment.  Third Edition. U.S.A: The Johns University Press; 1992.

Jones KL. Smith�s Recognizable Patterns of Human Malformation. Fourth Edition. U.S.A: W.B. Saunders Company; 1988.

Thompson MW, McInnes RR, Willard HF. Genetics In Medicine. Fifth Edition. U.S.A: W.B. Saunders Company; 1991.

Emery AE. Mueller RF. Principios de Gen�tica M�dica (Principles of Medical Genetics). Seventh Edition. Spain: Churchill Livingstone; 1992.

Benzacken B. Savary JB. Manouvriers S, et al.  Prenatal Diagnosis of Roberts Syndrome: Two New Cases. Prenatal Diagnosis 1996; 16: 125-130.

Temtamy SA. McKusick UA. The Genetics of Hand Malformations. Vol XIV, Number 3. First Edition. New York: Alan R. Liss. INC; 1978.

Shepard TH. Catalog of Teratogenic Agents. Sixth Edition. U.S.A: The Johns University Press; 1989.

International Programme on Chemical Safety (IPCS). Environmental Health Criteria 159,    Glyphosate. World Health Organization. Finland, 1994.

Environmental Protection Agency of the United States (EPA). Diagnosis and Treatment of Cases of Pesticide Poisoning. Fourth Edition, September 1995.

Bronstein A.C., and J. B. Sullivan. Herbicides, fungicides, biocides, and pyrethrines.  Hazardous Materials Toxicology, Clinical Principles of Environmental Health.  J. B. Sullivan, Jr., and G.R. Krieger (editors).  Baltimore, Maryland:  Williams and Wilkins. Pp. 1063-77, 1992.

Canadian Centre for occupational Health and Safety.  Glyphosate.  Hamilton, Ontario.  Chemical safety information Sheet.  Herbicide.  Toxicity irritation of respiratory tract, skin and eyes, 1990.

Flaherty D.K, Gross C. J., McGarity K. L., Winzenburger P. P., and Wratten S. J.  The effect of agricultural herbicides on the function of human immunocompetente cells.  Effect on natural killer cell and cytotoxic T cel function.  In Vitro Toxicology.  A Journal of Molecular and Cellular Toxicology 4,  no. 2:145-60, 1991.

Williams G, Kroes R, Munro I. Evaluaci�n de la Seguridad y el Riesgo para Humanos del Herbicida Roundup y su ingrediente Activo, Glifosato (Human Safety & Risk Assessment of the Herbicie Roundup and its Active Ingredient: Glyphosate). Canada. 1999.

FIGURE 1 AND PHOTOS

[not available]



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