Vol. 10 No. 3 July 1990

Table of Contents

I. Society of Toxicology President's Message, Curtis D. Klaassen, Ph.D
II. Clinical Spectrum of Eosinophilia-Myalgia Syndrome -- California
III. Eosinophilia-Myalgia Syndrome Update
IV. Transmission of Plasmodium vivax Malaria - San Diego County, California, 1988 and 1989
V. Moth-Associated Dermatitis -- Cozumel, Mexico
VI. Excerpts from "Should You Jog in the Smog?"
VII. Mercury Exposure from Interior Latex Paint - Michigan
VIII.Elemental Mercury Poisoning in a Household - Ohio, 1989
IX. Household Hazardous Waste Series #1: Batteries
X. Regulatory Requirements for Spray Mixes
XI. UC Exemptions from Pesticide Permit Regulations
XII. Veterinarians and the Manufacturing of Drugs
XIII.USDA Reports Problems with Sulfa, Gentamicin Residues in Dairy Cows
XIV. USDA Reports on Residues in Imported Meat
XV. Tidbits


This issue of the Environmental Toxicology Newsletter begins with a message taken from the Society of Toxicology Newsletter about toxicologists' responsibility to be involved in public communication. Also included is the latest update on EMS associated with ingestion of L-tryptophan supplements. A short article about malaria in San Diego County is included as a reminder that this disease is still present in the United States. For our natural toxicant fans I included an article about dermatitis induced by moths, which seems right since certain caterpillars are know to cause dermatitis. As promised in the last issue, we present the answer to the question about jogging in the smog, by Dr. Bernard Goldstein. Two articles about mercury poisoning from unusual sources are also included and reinforce the premise put forth in our last issue that heavy metal poisoning is not a thing of the past. Mike Stimmann has contributed two articles that will be of particular interest to UC employees that use pesticides as part of their work, and Allison Beale has contributed information about batteries as thefirst of a series on household hazardous waste (we will carry more in the future). Lastly under Veterinary Notes are two short articles about residues of drugs in domestic and foreign animal products, and a longer article about veterinarians and drug manufacture. Our last offering is a new section in which we will present "tidbits" of information that may be of interest. As mentioned previously, we welcome our readers to submit articles or "tidbits" for inclusion, and of course welcome suggestions. Thank you.

I. Society of Toxicology President's Message, Curtis D. Klaassen, Ph.D.

As we all know, there is a political revolution occurring in Eastern Europe at the present time. There is also occurring in toxicology a revolution in Western Europe and America. Many citizens want to make decisions of which chemicals and how much of each chemical they should be exposed to. Some citizens feel that the safety of chemicals can be determined without using animals.

The bottom line to these problems is that we live in a scientifically illiterate society. However, part of the blame has to be put on us scientists, as we have not expended sufficient energies in educating the lay people. For example, when is the last time you talked to the Boy Scouts, Rotary, Elks, etc. about toxicological principles? The Animals in Research Committee as well as the Public Communications Committee have been working diligently and making progress in these areas the last few years. However, a major increase in emphasis in educating lay people about basic toxicology principles has to be a major priority of this Society. We have to teach the concept of the dose response to lay people, as well as other scientists. However, no one or two committees can accomplish this task; this has to be a grass-roots project. Possibly the Public Communications Committee can provide prepared information as well as ideas on how to educate lay people. Maybe the Regional Chapters can play an active role in their respective communities in disseminating this information to the lay people.

During the last year and a half the ad hoc Tox 90s Educational Issues Task Force has expended a large amount of energy in preparing posters, flyers, a resource guide to careers in toxicology as well as summer internships as ways to inform undergraduate students of the possibility of selecting a career in toxicology. We are beginning to see the benefits of this program. However, many of these undergraduate programs would like to see a real live toxicologist. Would you as a member be willing to visit various undergraduate science programs if appropriate information was provided to you by the Society? Again, much like lay education, neither a small committee or even academia can fulfill these potential requests. We need grass root activities, possibly coordinated by the regional chapters.

If you would like to have a "real, live toxicologist" for a presentation sometime, please contact our office. The Northern California Society of Toxicology has many members with expertise in many areas of toxicology, and many of our members have expressed a desire to be involved with public education programs. We will do our best to find someone to suit your needs.

Reference: Society of Toxicology Newsletter, May/June 1990.

II. Clinical Spectrum of Eosinophilia-Myalgia Syndrome -- California

As of January 12, 1990, 210 eosinophilia-myalgia syndrome (EMS) cases had been reported to the California Department of Health Services (CDHS); three patients have died. This report summarizes clinical features and laboratory findings in 118 EMS patients for whom completed case-report forms are available.

One hundred five (89%) of the 118 patients were female; 94% were non-Hispanic white, 2% were Hispanic, <1% were black, and <1% were Asian (for 3%, race was unknown). Patients ranged in age from 29 to 73 years (median: 48 years). One hundred three (87%) patients became ill during or after July 1989. All patients reported use of L-tryptophan (LT) supplements before onset of illness; the time from onset of LT use to onset of symptoms varied from <2 weeks to >15 years (median: 152 days). Hospitalization was reported for 34 (29%) patients.

The most commonly reported symptoms were myalgia (muscle pain) (100%) and arthralgia (joint pain) (69%), followed by dyspnea (difficulty breathing) or cough (64%) and rash (64%). Edema (swelling) occurred in 51% of patients, and fever was reported by 47%. Scleroderma-like skin changes (e.g., skin thickening) and increased hair loss were each reported in 18% of patients.

Neuropathy (nerve disorder) was diagnosed by physical examination or electrophysiologic testing in 16 (14%) cases. At least three patients have developed a progressive polyneuropathy; electromyographic testing detected axonal loss (actual destruction of nerve connections) in all these patients. All deaths occurred 2-3 months after onset of illness.

In addition to the cases described above, CDHS has received reports of five persons who used LT and had eosinophilia and dyspnea but no myalgia. In addition, an infant with unexplained eosinophilia, fever, rash, and vomiting was born to a woman who took LT daily during the last 4 months of pregnancy; the mother is asymptomatic. CDHS is investigating an additional death associated with EMS reported after January 12.

Editorial Note: The clinical manifestations of some EMS patients in California also parallel those in victims of toxic-oil syndrome (TOS). Particularly severe features of TOS, also seen in some California EMS patients, include progressive polyneuropathy leading to pulmonary hypertension, vasculitis (inflammation of blood vessels), embolic (clots blocking blood vessels) phenomena, and death. Clinicians should be aware of the multisystemic nature of EMS and the potential for severe, long- term sequelae in some EMS patients.

Reference: MMWR, Vol. 39/No. 6, February 16, 1990.

III. Eosinophilia-Myalgia Syndrome Update

As of June 1990, 1517 EMS cases have been reported to CDC from state and territorial health departments in the United States. A total of 27 persons who had been taking LT before their illness have died.

The following information is taken from 4 issues of Food Chemical News scanning from mid June to late July. Recent epidemiologic investigations have found that the L-tryptophan associated with EMS syndrome was produced by a single Japanese manufacturer. In-depth studies showed that the disease is associated with consumption of high levels of certain lots of L- tryptophan produced by this manufacturer. At a recent conference, investigators presented evidence that the lots of L- tryptophan associated with producing EMS when analyzed showed a distinctive peak on high-performance liquid chromatography not associated with batches that did not cause EMS. The investigators hinted that this peak may be a compound related to L-tryptophan known as 3-methyl-indole. 3-methyl-indole is a compound definitively known to cause toxicity in ruminants, however it causes a completely different spectrum of clinical effects and its toxicity is directly to the lung.

The studies that are being made on the etiology of EMS are classical examples of the use of epidemiology, analytical chemistry, and toxicology to unravel a mystery. At this point it is much to early to say that the unknown peak identified in the chromatogram is actually the chemical responsible for producing EMS. As pointed out in some of the articles, the presence of an unidentified peak in the sample known to cause the disease does not necessarily mean that unidentified peak is responsible for production of the disease. It is also possible that another compound, as yet unidentified, may be masked in other portions of the chromatogram. Therefore, considerable more work needs to be done in order to determine the actual chemical involved. One of the difficulties with actually finding the chemical responsible is the lack of a suitable animal model with which to test chemicals that are isolated and hypothesized to be responsible for the disease. Without this, it may not be possible to ever definitively know which chemical has caused EMS. Future issues of the Environmental Toxicology Newsletter will include updates as they develop.

IV. Transmission of Plasmodium vivax Malaria -- San Diego County, California, 1988 and 1989

Malaria transmission in the United States occurs infrequently; since 1950, 21 outbreaks of introduced malaria, all caused by Plasmodium vivax, have been identified. However, 14 of these occurred in California (seven during 1986, 1988, and 1989). Four outbreaks -- one each in 1986 and 1988 and two in 1989 -- occurred in San Diego County. This report describes the out breaks in San Diego County in 1988 and 1989.

August 1988

On August 2, 1988, a migrant worker who lived in a canyon near the Lake Hodges reservoir (25 miles north of San Diego) was diagnosed with P. vivax infection. Twelve other workers who lived in the same area and had symptoms suggestive of malaria were referred by a public health nurse for diagnosis; on August 3, P. vivax parasitemia was confirmed in all 12 workers.

July 1989

On July 7, a migrant worker who lived in an open field in Rancho Penasquitos (20 miles northeast of San Diego) had onset of chills and fever; P. vivax infection was diagnosed. A second migrant worker from this area became ill on July 30; P. vivax parasites were detected in a blood smear. On August 22, a permanent resident of this area became ill; P. vivax parasites were identified. This resident had no history of foreign travel, IV-drug use, or blood transfusions. Twelve light traps placed in the open field in Rancho Penasquitos on July 26 caught six An. hermsi mosquitoes. On August 31, 36 An. hermsi mosquitoes were caught in eight light traps placed near the resident's house. Control measures included treating infected persons and applying larvicides and adulticides. No further cases were reported fromthis area.

August 1989

On August 6, a San Diego resident who lived north of the San Dieguito River became ill with confirmed P. vivax infection. He had no history of foreign travel, IV-drug use, or blood transfusions. On August 10, a migrant worker who resided in a camp at the San Dieguito River (1 mile from the resident's house) became ill, and P. vivax infection was diagnosed. On August 11, P. vivax infections were diagnosed in three of 40 migrant workers living in the area around the camp. On August 10, 27 An. hermsi mosquitoes were caught in five light traps in the area. Control measures included the application of larvicides and adulticides and the administration of chloroquine chemoprophylaxis to migrant workers in the area. No further cases were reported from this area.

Editorial Note: Common features of the 1986 outbreak and later instances of malaria transmission in San Diego County were 1) the limited access to medical care for migrant workers with malaria, resulting in delays in identification and treatment of parasitemic persons and in institution of control measures; 2) the lack of sanitary water and waste water disposal facilities and adequate shelter for the workers; and 3) the presence of an effective Anopheles mosquito vector and a susceptible population. Specific sources of infection for the mosquitoes could not be identified. However, in all of these outbreaks, agricultural workers from countries with endemic malaria had been present in the affected areas.

Reduction of the risk for malaria in migrant workers requires improved access to medical care and early detection of malaria cases. For workers living in remote areas, disease surveillance, health education, and early recognition and medical evaluation of illness are needed to reduce the risk for malaria transmission.

Reference: MMWR, Vol. 39/No.6, February 16, 1990.

V. Moth-Associated Dermatitis -- Cozumel, Mexico

On December 5, 1989, the Mexican Field Epidemiology Training Program (FETP), Directorate of Epidemiology, Secretariat of Health, was notified of an outbreak of dermatitis among employees of the 17 tourist hotels in Cozumel in October and November.

Because scabies (a parasite that causes intense itching) was initially suspected, a case was defined as a person who had onset since July 1 of a rash that itched continually and lasted >1 week. Of the 417 employees, 19 (4.6%) met the case definition. However, 91 (21.8%) reported nonspecific dermatitis of <1 weeks' duration since July 1.

During the survey, several persons anecdotally suggested that onset of symptoms followed skin contact with a moth. Moths were noticeably present in Cozumel during October and November but had disappeared by December. The FETP concluded that the outbreak was not scabies and was probably moth-associated. Because all cases had resolved and the likely source was no longer present, no further action was taken.

On January 8, 1990, the FETP was notified of a second outbreak of acute dermatitis among hotel employees and in the general population of Cozumel since January 1. At approximately the same time, thousands of moths had reappeared throughout the island. To assess the effect of direct contact exposure of skin to moths, the body and wings of a live moth were rubbed on the forearms of six volunteers from the Cozumel health center. Within 5 minutes, five of the six developed an intense pruritis (itching), followed by an erythematous (red) rash. Symptoms lasted 3 days. An entomologic study classified the insect as belonging to the family Saturnidae, genus Hylesia, species alinda Druce, which has a 3-month generational cycle.

Suggested control measures included replacing the clear light bulbs of the hotels with yellow insect-repelling bulbs, installing electric insect traps on the grounds of the hotels, and spraying insecticide around the borders of the hotels. Because a third outbreak is expected in association with the next generation of moths, community vector control is being planned. Entomologists suggest that the natural parasites of this moth likely will return within a year, causing a natural decline in the population of Hylesia moths. Active epidemiologic and entomologic surveillance is in place.

Editorial Note: Dermatitis from skin contact with certain species of moths belonging to the genus Hylesia was first reported in the United States in 1901. In 1907, the mechanism of the dermatitis was attributed to a chemical substance present within the nettling hairs of the moth. Recent studies indicate that histamine participates in the production of Hylesia- associated dermatitis. However, because antihistamine therapy generally has not been effective, other mechanisms of pathogenesis may be involved.

Outbreaks of dermatitis produced by Hylesia moths have been reported from Venezuela and Peru. The first reported outbreak in Mexico followed the eruption of the Chichonal volcano in 1982, which diminished the natural parasites of H. frigida and resulted in a large increase in the population of this species. A similar population increase in Hylesia moths in Cozumel followed the passage of Hurricane Gilbert in September 1988, with a new crop of adult moths appearing every 3 months.

Reference: MMWR, Vol. 39/No. 13, April 6, 1990.

VI. Excerpts from "Should You Jog in the Smog?"
by Bernard Goldstein, MD

Dr. Bernard Goldstein is a medical toxicologist in New Jersey and serves as a member of the Society of Toxicology Public Communications Committee. He recently sent me a reprint of this article and I thought the information would be useful to most of us.

"Even during the summer there is a simple way to avoid most ozone pollution: exercise early in the day. The photochemical process needs a few hours of sunlight before it can start to make new ozone from the precursors. When the sun goes down new ozone formation stops. On bad days ozone already in the atmosphere at nightfall may last a few hours. By sunrise the next morning ozone levels will be down to lower levels, leaving a few hours for activity with less exposure to pollutants.

If your schedule does not allow you to exercise early in the day, you can avoid smog by exercising indoors. Ozone is a very reactive chemical which tends to react with any surface it hits, and breaks down to ordinary oxygen in the process.

In many locations local news shows will provide forecasts of air pollution. A good rule-of-thumb is that a smoggy day will be followed by one as bad, or worse, unless there is either a break in the weather or a decrease in traffic.

So in general, continue to run and exercise outdoors. When there is a smog alert in your area, remember that ozone and other pollutants have a negative effect on exercise performance. Avoid high concentrations by exercising early in the morning. Try to avoid exercising during rush hours, especially in the afternoon. The highest pollution levels are close to highways, so take your workout as far away as possible from traffic. Parks and areas with trees are particularly recommended."

Reference: Running and FitNews, Volume 7, Number 8, pp. 4-5.

VII. Mercury Exposure from Interior Latex Paint - Michigan

In August 1989, a previously healthy 4-year-old boy in Michigan was diagnosed with acrodynia, a rare manifestation of childhood mercury poisoning. Symptoms and signs included leg cramps; rash; itching; excessive perspiration; rapid heartbeat; intermittent low-grade fevers; irritability; marked personality change; insomnia; headaches; hypertension; swelling; redness and peeling of the hands, feet, and nose; weakness of the pectoral and pelvic girdles; and nerve dysfunction in the lower extremities. A urine mercury level of 65 mg/L was measured on a 24-hour urine collection. Treatment with intensive chelation therapy increased his urine mercury excretion 20-fold. Examination of his mother and two siblings found urine mercury levels greater than or approximately equal to his; his father had elevated, although lower, levels. Parents and siblings were asymptomatic, although electromyographic (measurements of muscle electrical activity) abnormalities were detected in one sibling.

The Michigan Department of Public Health (MDPH) identified inhalation of mercury-containing vapors from phenylmercuric acetate contained in latex paint as the probable route of mercury exposure for the family; 17 gallons of paint had been applied to the inside of the family's home during the first week of July. Samples of the paint contained 930-955 ppm mercury; the Environmental Protection Agency (EPA) limit for mercury as a preservative in interior paint is 300 ppm. During July, the house was air-conditioned, and the windows were not opened.

Following 4 months of hospitalization with repeated courses of chelation therapy and intensive rehabilitation, the patient's symptoms abated except for residual lower extremity weakness. Although electroneuromyographic abnormalities persist, he is able to walk and continues to improve.

Editorial Note: Phenylmercuric acetate is routinely added by some paint manufacturers to interior latex (water-based) paint as a fungicide and bactericide to prolong the paint's shelf-life. EPA permits interior latex paint to contain <300 ppm elemental mercury and exterior latex paint to contain <2000 ppm. However, neither the presence nor the concentration of mercury in the paint is required to be labeled on the paint can. Mercury may not lawfully be used in oil-based paint.

In adults, chronic exposure to mercury vapors can cause nerve- conduction delays, tremor, insomnia, loss of appetite, and irritability. In 1965, mercury vapor exposure from paint may have been the cause of a cluster of neuromyasthenia cases (with symptoms including headache, weakness, tremor, unsteady gait, and depression) in workers in an electronics factory. However, the long-term health effects in clinically asymptomatic persons with elevated urine mercury levels and the potential adverse health effects to children and fetuses have not been well established.

Because alternative paint preservatives are available, EPA is determining the distribution of mercury-containing paints and is reviewing the use of mercury as a paint preservative. To prevent mercury exposure from paint, proper ventilation should be assured both during and after painting. Cases of mercury poisoning considered to be associated with interior latex paint should be reported through state health departments to the Health Studies Branch, Division of Environmental Hazards and Health Effects, Center for Environmental Health and Injury Control, CDC; telephone (404) 488-4682.

Reference: MMWR, Vol. 39/No. 8, March 2, 1990.

VIII. Elemental Mercury Poisoning in a Household - Ohio, 1989

On November 22, 1989, a 15-year-old male who had been hospitalized in Columbus, Ohio, was diagnosed with acrodynia, a form of mercury poisoning.

In early November, following an acute illness, the patient was diagnosed with measles. He was subsequently referred for psychiatric evaluation because of his declining performance in school and nonspecific complaints (e.g., aches, irritability, and inability to think clearly) that were presumed to be psyc hosomatic. On November 17, he was admitted to the hospital after his blood pressure measured 142 mm Hg systolic and 106 mm Hg diastolic. Additional manifestations noted at that time included rash, sweating, cold intolerance, tremor, irritability, insomnia, and anorexia. When analysis of a 24-hour urine collection detected a mercury level of 840 ug/L, acrodynia was diagnosed. On December 1, the patient's 11-year-old sister was hospitalized with hypertension, mild acrodynia, irritability, and mild generalized muscle weakness. Her 24-hour urine mercury level was 1500 ug/L. Although both parents were asymptomatic, their 24-hour urine mercury levels were 820 ug/L and 1250 ug/L. (Elevated considerably above 20 ug/L "normal".)

On November 29, the CHD (Columbus Health Department) investigated the apartment where the family had lived since August 26, 1989. Neighbors reported that the previous tenant had spilled a large jar of elemental mercury within the apartment. Although this tenant could not be located for confirmation, mercury vapor concentrations in seven rooms ranged from 50-400 ug/m3 (the Agency for Toxic Substances and Disease Registry's acceptable residential indoor air mercury concentration is <0.5 ug/m3). The apartment was sealed, pending decontamination efforts which are ongoing. In three other apartments in the same building, air mercury concentrations were less than the measuring instrument's detection limit of 10 ug/m3.

After both patients were diagnosed as having acrodynia with neuropsychiatric impairment, they were treated with oral 2,3- dimercaptosuccinic acid (DMSA). Except for a persistent mild tremor, acrodynia and other neurologic symptoms resolved following two 21-day courses of DMSA therapy.

Editorial Note: Although nonoccupational elemental mercury poisoning occurs less frequently than occupational mercury poisoning, cases of elemental mercury exposure and toxicity in children have been reported. Because mercury vapors are dense and tend to settle, children playing near the floor may be exposed to mercury if it is present. Moreover, children may be physiologically more susceptible to the health hazards of mercury exposure than adults.

Elemental mercury (also termed metallic mercury or quicksilver) is volatile at room temperature, and its rate of vaporization is a function of both temperature and surface area. Mercury enters the bloodstream after it is inhaled; because of its lipid solubility, mercury crosses both the blood brain barrier and the placenta. Elemental mercury is excreted in the urine and has an elimination half-life of approximately 60 days.

Manifestations of mercury poisoning include intention tremor, memory loss, insomnia, timidity, gingivitis, diarrhea, anorexia, weight loss, and, in severe cases, delirium. Mercury is used in some school laboratories; in such settings, its ambient concentrations (and the safeguarding of mercury supplies) should be carefully monitored. Additionally, mercury is added into many household products, such as latex paints, adhesives, joint compounds, acoustical plates, and cleaning solutions. Because not all products that contain mercury are labeled as such, adequate ventilation must be ensured when using potentially toxic household chemicals.

Reference: MMWR, Vol. 39/No. 25, June 29, 1990.

IX. Household Hazardous Waste Series #1: Batteries
Allison Beale

According to the Waste Watch Center (WWC), of Andover, MA, over two (2) billion household batteries are sold annually in the United States. On the average, 1.7 pounds of these batteries are disposed of every year by each American (US) family.

The concern over the volume of batteries in the waste stream centers around the metals that allow batteries to function. Lead, nickel, cadmium, mercury, silver and lithium all pose environmental and health hazards, although there is a lack of agreement among experts as to the extent metals from batteries contribute to any demonstrable problem.

Studies by the Environmental Protection Agency (EPA) testing ash from Municipal Solid Waste (MSW) incinerators has shown that lead and cadmium typically exceed permissible levels. Further studies contracted out by EPA to track down and quantify the waste products contributing lead and cadmium have shown that batteries are the primary source. Lead-acid batteries, the type used in automobiles, accounted for 65% (138,043 tons) of the lead in MSW of 1986. Rechargeable nickel-cadmium batteries, which are often incorporated into small appliances, account for 52% (930 tons) of the cadmium discharges.

Similar studies in Sweden of incinerator ash prompted that government to both initiate collection of household batteries and to ban the use of mercury in batteries by 1990. Japan, on the other hand, found no reason for concern over batteries containing mercury entering the MSW stream.

The National Electrical Manufacturer's Association (NEMA) cites six international studies indicating that household batteries are not a threat in MSW regardless of whether they are incinerated or placed in a landfill. None-the-less, the industry as a whole is tending to decrease the use of the more toxic metals (like mercury) and increase the usable lifespan of batteries. Industry usage of mercury has dropped from 778.1 tons in 1984 to 130 tons in 1989. Polaroid has developed mercury-free camera (button) batteries and there is a trend to make rechargeable batteries in appliances accessible for removal and recycling.

Many Household Hazardous Waste Management (HHWM) programs separate batteries for recycling. Usually a recyclist will pay for the mercury and silver button batteries and charge for taking the nickel-cadmium batteries. The Mercury Refining Company, Latham, NY, processes mercury and silver containing batteries while exporting nickel-cadmium batteries to Europe for recycling. The Quick Silver Company of Brisbane, CA, also recycles mercury and silver. The Environmental Pacific Corporation of Lake Osego, OR, accepts all batteries.

If asked, where to go from here, many activists in the area of HHWM will identify the following as needing attention or continued development: continued improvements by industry in reducing toxic constituents in batteries; risk assessment of batteries in the MSW stream; labeling of batteries with disposal instructions; research and development of recycling technology; and the further establishment of battery collection and recycling projects.

This article was summarized from HHWM News 1(1) and 1(2), 1989.

X. Regulatory Requirements for Spray Mixes
M.W. Stimmann

In response to a recent question concerning the use of table sugar and molasses as adjuvants in a pesticide tank mix, Rex Magee, Associate Director, California Department of Food and Agriculture, provided us with the following interpretation of the regulations.

"Growers cannot legally add sugar or molasses to pesticide mixes to enhance efficacy. Anything that is added to a pesticide spray tank to enhance the efficacy of the pesticide is a spray adjuvant under Section 12758 of the California Food and Agricultural Code, and must be registered.

Fortunately, there are five spray adjuvants that are sugar- or molasses-based which are registered for use like the one you describe. All of them can be used on the site (citrus groves) you are concerned about. The labels of these products do not specifically mention thrips, but under Section 2(ee) of the Federal Insecticide, Fungicide, and Rodenticide Act, and under Section 6000 of the California Code of Regulations, thrips would be treatable as an unnamed pest.

The Veratran D label has rates from 10-20 pounds per acre, and does not prohibit the use of feeding attractants as spray adjuvants. The Veratran D product began as a Section 24(c) registration several years ago, and has since been converted to a Section 3 registration by the registrant. The 24(c) registration is now inactive. The attached Veratran D label is the valid, correct, and current registration.

If the growers still would rather use sugar or molasses or some other natural or food grade material as an additive to pesticide sprays, they are free to pursue spray adjuvant registration with the Department for the uses they desire. The registration and distribution of the product could be made through a grower group or other interested party."

XI. UC Exemptions from Pesticide Permit Regulations
M.W. Stimmann

CDFA issued a formal notice, 90-14 on June 29, 1990 amending and adding to the Research Authorization provisions of the California Code of Regulations. Under Section 6268 UC employees are exempt from the Authorization for Research requirement

"...if they are operating according to the current established policy of the college or university which covers pesticide use and experimentation."

A new section has been added:

"Section 6414. Permit Exemptions (d). No permit shall be required for restricted materials used only for experimental or research purposes when possessed or used, by or under the supervision of, research personnel from colleges and universities provided they are operating according to the current established policy of the college or university which covers pesticide use and experimentation."

The second section clarifies an occasional problem: over the years we have had questions concerning the need for restricted materials permits for research use of pesticides. In some cases the County Agricultural Commissioners have required the permits. In other cases they ignored the issue. Now CDFA has clarified the issue; we are not required to have permits for research uses.

Since 1984 our policy has been Policy Communication 18. That policy is being revised to incorporate these changes, and will be included in Section 261 etc. of the Administrative Handbook. Communication 18 will be replaced when the new Administrative Handbook is officially adopted by the Division of Agriculture and Natural Resources.

Note: Restricted materials permits are still required for any ordinary pest control operations on UC or private lands regardless of whether or not the pesticide is being used in an experimental plot. Ordinary pest control refers to pesticides applied to control pests, not to measure efficacy, residues and so on. For example applying an insecticide to control insects in an herbicide trial would be ordinary pest control. If the insecticide were restricted a permit would be required.


Veterinarians and the Manufacturing of Drugs Letter from Joe S. Gloyd, DVM (4-4-90) American Veterinary Medical Association

Veterinary practitioners in your state may not be aware of the multitude of regulations surrounding the veterinary practice, and if so knowledgeable, they may not be aware of the conditions that are considered to be drug manufacturing, which is subject to regulation by FDA.

Manufacturing, as defined by FDA-CVM, includes the combining or repackaging of drugs outside the context of a valid veterinarian-client-patient relationship and, therefore, is subject to regulatory action. According to Dr. Richard Teske, deputy director of FDA's Center for Veterinary Medicine, veterinarians who combine approved drug products, whether they are OTC or prescription products, would not ordinarily be subject to regulatory action so long as the drugs are dispensed at the point of sale under a valid veterinarian-client-patient relationship and there are no drug residues found in the animals at slaughter. Dr. Teske further emphasized that the mixing of drug products should be done at the point of sale, not made in batches for storage at drug distribution sites or in the veterinarian's front office.

According to Dr. Teske, "It is often a poor medical practice to combine drugs." He further explained that these drugs are carefully formulated and mixing could result in an incompatible combination. Although the FDA-CVM does not regulate the practice of veterinary medicine, it does regulate the drugs, devices, and medicated feeds which may be used by veterinarians and, to an extent, regulates the manner in which those drugs can be used.

Dr. Teske states that "The repackaging of gentamicin, for example, into smaller dose forms for baby pigs would not ordinarily be subject to regulatory action so long as the repackaging took place under a valid veterinarian-client-patient relationship, the dispensing package was properly labeled, and no violative drug residues were present in the animals at slaughter." He added, however, that anytime a veterinarian uses an unapproved product or alters an approved product, he or she takes on additional risks and responsibilities.

Practicing within the confines of a strict veterinarian- client-patient relationship is the best way to stay out of the regulatory web. A veterinarian-client-patient relationship means that a veterinarian in the practice has seen the animals to be treated, is familiar with the premises and management system, and has established a tentative diagnosis for the condition to be treated. If a veterinarian is in doubt about an FDA regulation and its application in the course of practice, he is best advised to contact Dr. John Augsburg at the FDA's Center for Veterinary Medicine at 301-443-3450 or write to him at 5600 Fishers Lane, Rockville, MD 20857.

XIII. USDA Reports Problems with Sulfa, Gentamicin Residues in Dairy Cows

Domestic Monitoring Program Shows 0.3% Violation Rate

The agency's 41,505-sample domestic monitoring program showed a 0.3% violation rate in 1989, FSIS Assistant Deputy Administrator Dr. Richard L. Carnevale reported. "Statistically, that means less than 1 out of each 100 animals marketed contained illegal residues, and perhaps as few as 1 in 1,000 animals."

The monitoring program is statistically designed to flag 95% of the residue problems affecting 1% or more of the 121 million head of livestock and nearly 6 billion birds slaughtered annually.

For livestock, 31,992 monitoring samples yielded 115 violations, as follows:

8 of 5,439 cattle samples; 40 of 8,700 calf samples; 7 of 2,420 sheep samples; 5 of 1,451 goat samples; 51 of 12,470 swine samples; and 4 of 1,512 horse samples.

FSIS reported 10 violations in 9,463 poultry monitoring samples, with three or less violations found in: 3,042 young chicken samples; 2,489 young turkey samples; 738 mature turkey samples; 1,434 duck samples; and 275 goose samples. No violations were found in 1,485 mature chicken samples.

Reference: Food Chemical News, June 4, 1990.


XIV. USDA Reports on Residues in Imported Meat

In a report to Congress concerning the 1989 fiscal year, the USDA-FSIS reported 15 residue violations in imported meat, chiefly sulfamethazine residues in Canadian pork. The FSIS said that it tested 16,500 samples of products from 30 eligible exporting countries for residues of 17 compounds, at a cost of $903,000.

Of 377 samples of Canadian pork tested by the agency for sulfamethazine, 11 were found to contain violative levels ranging from 0.11 ppm to 1.71 ppm, both in fresh pork samples.

Also in fiscal year 1989, two of 55 Australian pork samples were violative for sulfamethazine at levels of 0.14 ppm and 0.34 ppm.

The remaining import residue violations involved sulfamethazine in cured pork from Ireland. Of 38 samples, two were violative at 0.17 ppm and 0.52 ppm.

USDA's Agricultural Marketing Service reported on its testing of imported egg products for residues. The AMS said it tested 38 samples of egg products from Canada and The Netherlands--the only two countries eligible for export to the United States--for 53 organochlorine and organophosphate compounds at a cost of under $5,000 without finding any violations.

Reference: JAVMA, Vol. 196, No. 12, June 15, 1990.


Science and Public Policy

The Washington Aquafarm Letter reports that at a recent meeting, Dr. John Augsburg, Special Assistant to the Director of FDA's Center for Veterinary Medicine, discussed drug developments for aquaculture. In this light, he made quite an interesting statement concerning the role of public opinion in the development of public policy related to regulation of aquaculture medicine. A quote in the Aquafarm Newsletter of Dr. Augsburg's comments is as follows: "Consumer perceptions about a health issue whether scientifically correct or not have an influence on regulatory policy. Such perceptions influence the behavior of consumers and that behavior effects public policy."

Bovine Somatotropin (BST)

A panel appointed by the American Medical Association to look at bovine somatotropin (BST) and its potential to cause human health effects found the following:

"Bovine somatotropin exhibits only low level bonding affinity for the human somatotropin receptor and does not induce metabolic activity. The finding that bovine somatotropin had no effect when injected into children suffering from growth hormone deficiencies supports this conclusion. Because recombinant BST is a protein, enzymes in the digestive tract will cleave the protein into many fragments. ...(E)ven if the recombinant BST or digestive fragments were able to reach the circulation following ingestion of the milk, the recombinant protein fragments would not be expected to exhibit any deleterious activity. The potential immunogenicity of the peptide fragments remains to be determined."

In concluding its report, the AMA Council made the following recommendations:

(1) Endorse or implement programs that will convince the public and government officials that genetic manipulation is not inherently hazardous; and that the health and economic benefits of recombinant DNA technology greatly exceed any risk posed to society.

(2) Where necessary, urge Congress and federal regulatory agencies to develop appropriate guidelines which will not impede the progress of agricultural biotechnology, yet will ensure that adequate safety precautions are enforced.

(3) Encourage and assist State medical societies to coordinate programs which will educate physicians in recombinant DNA technology as it applies to public health, such that the physician may respond to patient query and concern.

(4) Encourage physicians, through their State medical societies, to be public spokespersons for those agricultural biotechnologies that will benefit public health.

(5) Actively participate in the development of national programs to educate the public about the benefits of agricultural biotechnology.

Safety and Food Costs

At a recent conference, Deputy Agriculture Secretary Jack Parnell stated, "If we react carelessly without science in response to imagined risks and thereby needlessly increase food costs, the poor will be the first to notice reduced buying power and higher nutrition costs." The secretary stated that already 30 million people in America spend over 50% of their income on food and these people are not always thought of when the debate on food safety begins. Parnell also presented evidence recently reported by FDA scientist Dr. Robert Scheuplein, to the effect that the majority of dietary risk is from natural carcinogens. In addition, Parnell spoke and made a request for the elimination of the Delaney Clause (this clause allows zero residues of carcinogenic food additives in foods) and at the end stated "It must be said again, science, not fear is the answer."


Art Craigmill
Extension Toxicologist
UC Davis

Mike Stimmann
Statewide Pesticide Coordinator
UC Davis

Carl Winter
Extension Toxicologist
U.C. Riverside

Allison Beale
Environmental Toxicology and Water
UC Riverside Advisor