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PubMed1994

Processing of samples.

The Good Laboratory Practice (GLP) Processing Program at Texas A&M University provides a service that encompasses research and pilot scale processing of raw agricultural commodities while conforming to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 40 CFR, Part 160. A general overview of a typical processing study is presented to include preliminary discussions with the study director, sample and protocol receipt, sample processing, fraction shipment, and processing report disposition. Atypical situations are also introduced to stress the need for improved communication and organization within the agrochemical industry. Examples of processed fractions are presented to clarify better the role of the processor in the chemical registration process. To describe the versatility required within this segment of the registration process, a new processing procedure is introduced.

Agrochemicals↗
PubMed1994

Worker exposure studies.

The first federal pesticide law was enacted in 1910 and was replaced by a more expansive Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) in 1947. In 1972 the Federal Environmental Pesticide Control Act amended the FIFRA from primarily a consumer protection law to a risk/benefit regulation with primary emphases on human and environmental health. "Modern" pesticides were beginning to be developed during World War II. Early attempts to assess human exposure to pesticides seemed to coincide with the development of the organophosphate pesticides in the early to mid 1950s. A continually expanding base of toxicological knowledge has forced increased efforts to refine exposure assessments. Early "patch" dosimeters have evolved to numerous and more refined methods of dosimetry. In addition to studying worker exposure, modern students of pesticide application must also deal with a myriad of situations ranging from field or site reentry to bystander and/or residential exposures. Efforts to standardize pesticide exposure assessments resulted in the 1987 issuance of U.S. EPA Pesticide Assessment Guidelines--Subdivision U--Applicator Exposure Monitoring. In October, 1989 (40 CFR Part 160), the Agency directed that studies initiated on or after that date and submitted in support of pesticide regulation must be conducted under the standards of Good Laboratory Practices. All of these and related factors culminate in the continued development and refinement of methodologies for pesticide exposure assessment.

Agriculture↗
PubMed1994

Fat and oil inhibit phosphine release from aluminium phosphide--its clinical implication.

Poisoning by suicidal or accidental ingestion of aluminium phosphide (AlP) is a frequent medical emergency seen all over the world. AlP, a grain fumigant and rodenticide, on exposure to moisture, liberates highly toxic gas, phosphine. The rapidly inhibits mitochondrial respiration and has cytotoxic action. No specific antidote is known against it till date and prognosis depends much on dose and time lag between AlP ingestion and the stomach wash in the hospital (critical period). Physicochemical properties of AlP and nonmiscibility of fat and water promoted us to study the effect of different fats and oils as possible antidotes to inhibit phosphine liberation. In vitro experiments revealed that vegetable oils and liquid paraffin were much more effective than butter and ghee in inhibiting release of phosphine from AlP. These findings may have significant clinical implication.

Aluminum Compounds↗
PubMedDate not supplied

Quality assurance responsibilities as defined by the EPA Good Automated Laboratory Practices (GALPs).

In December 1990, the Environmental Protection Agency's (EPA) Office of Information Resources Management (OIRM) issued a draft of the Good Automated Laboratory Practices (GALP). The GALPs developed from a union of existing Federal and EPA regulations and policies, including: the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) & Toxic Substance Control Act (TSCA), Good Laboratory Practices (GLP), the EPA Information Resources Management Policy (IRMP), and the Computer Security Act of 1987. The GALPs consolidate the regulations and policies to provide a single source of reference, and sever as an extension of the GLP standards (40 CFR 160 & 792). Whereas the GLPs describe acceptable laboratory management practices, the GALPs describe acceptable automated data management practices, and give guidance for standardizing and implementing procedures to ensure the quality and integrity of automated data collection and storage. The GALPs have been formatted to parallel the structure of the GLPs. Just as the GLPs define the responsibilities of the Quality Assurance Unit (QAU) in maintaining good laboratory practices, the GALPs define the responsibilities of the QAU in maintaining good automated data practices. The QAU is charged with (i) maintaining copies of written procedures for the automated data collection system, (ii) performing inspections of laboratory operations utilizing the automated data collection system and reporting findings, (iii) ensuring authorization and documentation of deviations from written procedures, (iv) auditing data and reports from the automated data collection system to ensure they accurately represent the raw data, and (v) maintaining records of the above-defined QAU functions.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Laboratory Information Systems↗
PubMed1993

A review of thallium toxicity.

Thallium (Tl) is one of the most toxic of the heavy metals. Its continued use as a rodenticide in many developing countries and its increasing use in an expanding number of new technologies raise concerns about exposure risk to animals and humans. Because Tl and potassium (K) have the same charge and similar ionic radii, Tl follows K distribution pathways and alters and number of K-dependent processes. Possible toxic mechanisms of Tl include ligand formation with protein sulfhydryl groups, inhibition of cellular respiration, interaction with riboflavin and riboflavin-based cofactors, and disruption of calcium homeostasis. The principal clinical features of thallotoxicosis are gastroenteritis, peripheral neuropathy of unknown etiology, and alopecia. The presence of elevated Tl levels in the urine or other biologic materials confirms the diagnosis of Tl poisoning. Treatment with prussian blue (or activated charcoal) will interrupt the enterohepatic cycling of Tl, thus enhancing fecal elimination of the metal. Forced diuresis with potassium loading will increase the renal clearance of Tl, but should be used cautiously because neurologic and cardiovascular symptom may be exacerbated. If recognized and treated early, Tl poisoning carries a favorable prognosis for full recovery.

Animals↗
PubMed1995

U.S. EPA challenges and review--highlights of the Fiscal Year 1994 Inspection Program and EPA's laboratory accreditation considerations.

The reorganization and consolidation of the United States Environmental Protection Agency's (EPA's) Headquarters Enforcement and Compliance programs into a new Office of Enforcement and Compliance Assurance (OECA) is now complete. The Good Laboratory Practice (GLP) inspection program is now part of the Office of Compliance, one of the principal offices in this new organization. The role of the Office of Compliance and the implications of these changes for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA) GLP programs are addressed. Highlights of the fiscal year 1994 inspection program are reviewed. The status of the Agency's consideration of laboratory accreditation is discussed.

Accreditation↗
PubMed1996

Sarcocystis singaporensis: studies on host specificity, pathogenicity, and potential use as a biocontrol agent of wild rats.

Host specificity and pathogenicity of Sarcocystis singaporensis were investigated as a prerequisite to a subsequent application of the parasite as a biocontrol agent of wild rats in Egypt. After inoculation of 7 snake species comprising the families Elapidae, Viperidae, Colubridae, and Boidae with sarcocysts, sporocyst development was only observed in a reticulated python. Among amphibians, reptiles, and rodents that orally received various sporocyst doses in the laboratory, 2 x 10(4) sporocysts or more were lethal to roof rats Rattus rattus frugivorous, brown rats Rattus norvegicus, and bandicoot rats Nesokia indica. Sarcocysts developed in Rattus spp. and Nile grass rats Arvicanthis niloticus. Subsequently, the pathogenicity of S. singaporensis was tested under natural control situations offering bait pellets containing high amounts of sporocysts to a free-living population of roof rats, which was monitored by indirect census baiting commonly used in rodenticide evaluation. Ten days after consumption of the bait pellets, the infected population collapsed, leading to a control success of 73%. A negative control population, which received a placebo, remained stable. These data demonstrate for the first time that S. singaporensis can be used as a biocontrol agent of wild rats. However, an immunization experiment with roof rats in the laboratory showed that these are capable of mounting a rapid specific immune response resulting in survival of acute sarcocystosis.

Amphibians↗
PubMedDate not supplied

Thallium loading in owls and other birds of prey in Denmark.

Due to previous findings of increased concentrations of the rodenticid, thallium, in free-living Danish carnivores, thallium analysis has been carried out on material from 77 owls and birds of prey. Thallium was found in 2/3 of the birds and in 10% the concentration was so high that the load of thallium may have caused the death of the birds. The load of thallium in birds of prey was lower than concentrations found in carnivores, probably because poisoning caused by direct intake of thallium baits placed for rodent control does not seem to occur among birds of prey. From the investigation of this limited number of birds, it is not possible to tell if thallium did have any influence on the maintenance of a healthy population of birds of prey, but the large number of thallium loaded birds also justify the restrictions in the sue of thallium which were given from the 1st of July, 1975.

Animals↗
PubMed1995

Standard operating procedures (SOPs): reason for, types of, adequacy, approval, and deviations from and revisions to.

Standard Operating Procedures (SOPs) are required in order to comply with the Good Laboratory Practice Standards (GLPS) as promulgated in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) 40 CFR Part 160. Paragraph 160.81 (a) states: "A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study." Types of SOPs include administrative and personnel, analyses, substances, quality assurance and records, test system, equipment, and field related. All SOPs must be adequate in scope to describe the function in sufficient detail such that the study data are reproducible. All SOPs must be approved by a management level as described in a corporate organization chart. Signatures for SOP responsibility, authorship, and Quality Assurance review adds strength and accountability to the SOP. In the event a procedure or method is performed differently from what is stated in the SOP, an SOP deviation is necessary. As methods and procedures are improved, SOP revisions are necessary to maintain SOP adequacy and applicability. The replaced SOP is put into a historical SOP file and all copies of the replaced SOPs are destroyed.

Facility Regulation and Control↗
PubMed1997

Telephone toxicological information service on pesticide poisonings.

The problem of pesticide poisonings has been discussed with reference to the records of the toxicological information provided in 1993-1995 by the staff of the National Poison Information Centre and the physicians of the Clinic of Acute Poisonings in Lódź. Based on those data, pesticide poisonings occupy second place among the categories of chemical most frequently responsible for acute poisonings, while the first place is occupied by drugs. In the pesticide category, most of the information related to poisonings with pyrethroids, followed by organophosphorous compounds, coumarine derivatives, carbamates. Pesticide poisonings in children continue to be a serious problem. Coumarine derivatives and zinc phosphide found in rodenticides constitute the most frequent source of pesticide poisoning among children. Considering the circumstances of pesticide poisoning, accidental poisonings are the most frequent. The high incidence of pesticide poisoning shows that it is a serious problem and the steps should be taken to prevent poisonings with pesticides.

Adolescent↗
PubMedDate not supplied

FIFRA-88, GLP, and QA: pesticide registration.

The 1988 amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA-88) has decreased the number of pesticide registrations in the United States. Subsequent implementation of the U.S. Environmental Protection Agency (EPA) Good Laboratory Practice (GLP) and quality assurance (QA) standards has increased costs of maintaining these registrations. The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) maintains approximately 30 Section 3 (federal) or Section 24c (state) vertebrate pesticide registrations for the Wildlife Services (WS) program to control wild mammals and birds that damage crops, impact endangered species, or pose human health risks. Under FIFRA-88, APHIS summarized, performed, and submitted or gained waivers for > 500 studies requested by the U.S. EPA to assess potential hazards/effects of these pesticides. A summary of FIFRA-88 milestones for registration of 3-chloro-p-toluidine hydrochloride (CPTH), the active ingredient (AI) in a "low-volume, minor-use" avicide (DRC-1339, Starlicide), is used to illustrate GLP/QA/animal welfare issues involved in this process. Trends in the development of new pesticides and veterinary drugs are compared to provide some perspectives on future career paths for QA professionals.

Animal Welfare↗
PubMedDate not supplied

Food Quality Protection Act: its impact on the pesticide industry.

Enacted into law by Congress in August 1996, the Food Quality Protection Act (FQPA) is the most significant piece of federal pesticide legislation since the 1988 amendments to the Federal Insecticide, Fungicide and Rodenticide Act. FQPA was hastily drafted and approved towards the end of the 1996 Congressional session. The new law was advertised as resolving some long-standing problems; however, it is clear now that it has also created some new ones. Since the FQPA's passage, the U.S. Environmental Protection Agency has issued numerous rules and regulations that are being used to evaluate and judge the safety of pesticide use on foods. This article discusses some of the major provisions of the new law and their impact to the U.S. pesticide industry.

Child↗
PubMed1999

Effect of aluminum phosphide on blood glucose level.

Aluminum phosphide (AlP), a poison extensively used as a grain fumigant and rodenticide, can cause an increase or decrease in blood glucose levels Both hypo- and hyper-glycemic effects of AlP can be attributed to the wide variety of changes in magnesium, calcium, phosphate, citrate and cortisol levels. These biochemical changes can act as active stimulatory or inhibitory modulators to enzymes and hormones that catalyze and regulate glucose metabolism. According to the type of biochemical changes, AlP can cause either elevation, decrease or no change in blood glucose levels. A case of AlP-caused death is reported.

Adolescent↗