Applying the Good Laboratory Practice regulations to studies involving genetically modified plants.

How can the Environmental Protection Agency's Good Laboratory Practice (GLP) regulations, originally written primarily for mammalian toxicology studies, be applied to regulatory studies conducted for genetically modified plants? Do they fit? Can they be applied and still make sense? How is a Quality Assurance Unit (QAU) to interpret the requirements in this new area of biotechnology? The answers to these questions are discussed in this brief presentation of how one team within the Monsanto QAU, along with the researchers, developed am effective and comprehensive compliance program by applying the "traditional approach" to the GLP regulations to a new and important scientific field in regulatory compliance. Topics discussed will address the differences in the approach between traditional toxicity testing and the newer technology and how the differences were resolved, new and innovative definitions of particular phases and other aspects of regulatory studies, and how the draft regulations for pesticidal plants will help this area of technology in the future.

The health of the very aged.

Little information is available on the health status of persons 85 years or over. Recent United States data indicate that 20% of individuals 85 years of age or over reside in nursing and personal care homes and that among these institutional residents 31% are bedfast, 11% are chairfast and 71% manifest evidence of senility. An investigation into the health of persons 85 years of age or over in two Ontario counties revealed that 39% resided in long-stay institutions, and that one of the main differences between old people living independently in the community and those in institutions was the higher proportion of the latter needing help with the activities of daily living and showing mental disorientation. Of those individuals 85 years of age or over in institutions for 1 year, 26% acknowledged often feeling depressed and 18% acknowledged often wishing they were dead, but these tendencies were not more frequent in those 85 years of age or over than in those 65 to 84 years of age. These findings have implications for service and research needs and attitudes towards death.

Elderly applicants to long-term care institutions. II. The application process; placement and care needs.

As part of a study of long-term institutional care of the elderly, this report presents salient data concerning 193 elderly applicants. Physicians play an important role in decisions to apply for such care. More than half of the applicants and about 80% of their family members approved of the proposed move. The number applying to homes for the aged vs. other institutions seemed much greater than appropriate; many of these applicants appeared more elibible for placement in foster homes and specialized facilities for the demented, or for remaining in their own homes. About a fifth of the applicants could have continued living independently if they had received a reasonable amount of community assistance. Action implications include: 1) expansion and more informed use of community services, 2) more programs of supervised foster homes for the elderly, 3) construction of specialized institutions for the demented, and 4) a greater effort by institutions to satisfy the desire of many new residents to be involved there in useful tasks.

Elderly applicants to long-term care institutions. I. Their characteristics, health problems and state of mind.

As part of a study of long-term institutional care of the elderly, this report presents a comparison of the characteristics, health problems, and state of mind of 193 elderly applicants for such care (Group A) with those of 141 elderly persons living independently in the community (Group I). Group A members were older, living with a spouse less often, and had low incomes. They showed much more cerebrovascular disease, incontinence, recent loss of independence in the activities of daily living, dementia, recent hospitalization, loneliness, and depression. They had had much less recent involvement in social and recreational activities, although most had not been socially isolated. They had received more extensive help from relatives and friends, and it seemed unlikely that additional help from these sources would keep many more of these elderly persons out of institutions. Community agencies and services had been used by a relatively low proportion of Group A, and hardly at all by Group I.