FPIN NEWS

 The Year in Review

The end of the year is a good time to reflect on the events and progress of the past twelve months.

2002 has been a year that measurable progress has been made in efforts to educate and increase awareness regarding health and environmental concerns related to fragrance.

Betty Bridges, Editor

In This Issue

Highlights of 2002
Article Review: Generally Recognized as Safe
Current Science
Action Items
Links of Interest

 

 

Highlights of 2002

The end of the year is a good time to reflect on the events and progress of the past twelve months. 2002 has been a year that measurable progress has been made in efforts to educate and increase awareness regarding health and environmental concerns related to fragrance.

February - MSNBC feature article Scents and sensitivities by Francisca Lyman points out that the gift of fragrance may not be the healthiest choice. http://www.msnbc.com/news/702445.asp

June - The fragrance chemical Iso E Super is nominated for National Toxicology Program studies. http://ntp-server.niehs.nih.gov/NomPage/2002Noms.html

July - "Not Too Pretty Campaign" raises concerns related to phthalates in perfume and other cosmetics. A full page ad appears in the New York Times http://www.nottoopretty.org/

September - Flavours and Fragrance journal contains the article Fragrance: emerging health and environmental concerns, the first comprehensive review of concerns related to fragrance. http://www3.interscience.wiley.com/cgi-bin/abstract/93514043/START

October - MSNBC features the article Scents and sensitivities by Francisca Lyman again. http://www.msnbc.com/news/702445.asp

October - The American Lung Association’s The Breathe Easy / Asthma Digest features PERFUMES MAY BE COMPROMISING LUNG HEALTH, ESPECIALLY FOR PEOPLE WITH ASTHMA

November - Cosmetics including fragrance tested in Europe contain phthalates that are associated with reproductive concerns. The European Commission bans the use of two of these phthalates. http://www.nottoopretty.org/pr_new_11_13_02.htm

November - Flavours and Fragrance journal contains the article Fragrances: are they safe? Viewpoint from the industry on the safety of fragrance. http://www3.interscience.wiley.com/cgi-bin/abstract/99520468/START

December - Study suggests diethyl phthalate, which is commonly used in fragrance is linked to sperm damage. http://www.nottoopretty.org/pa_12_09_02.htm

ARTICLE REVIEW

Editor's note: A preprint version of Fragrance emerging health and environmental concerns can be accessed at: http://www.fpinva.org/FragranceReview.htm

Generally Recognized
As Safe?

Review of "Fragrance: Emerging Health and Environmental Concerns" Flavour and Fragrance Journal 2002; 17; 361-371 By Betty Bridges Fragranced Products Information Network.

Review by Prof. I.L. Feitshans JD and ScM   ilf2@cornell.edu  Author BRINGING HEALTH TO WORK; Author DESIGNING AN EFFECTIVE OSHA COMPLIANCE PROGRAM, Legal Advisor WHO/RAMS Committee of Experts on Reproductive Health at Work

Since the 1980’s when I served as a Legal Intern at the Directorate of Health Standards for OSHA, the concept that flavor or fragrance additives to foods, cosmetics and a variety of household items ranging from harsh cleansers to candles might require regulatory inquire has been a complex, uncharted area of toxic and hazardous substance regulation. In those days, the regulatory theory was founded upon the notion that few, if any, people had sufficient exposure to large quantities of the components of these substances to present any clearly negative health effects or long-term harms. The notion that only small quantities of these substances were ever in contact with users in the general public had, in the decades before, led to the creation of a Food and Drug Administration list of otherwise potentially harmful substances whose quantity of use was considered so low to be too small to be measured, the so-called GRAS list, (Generally Recognized As Safe).

 In the 1980’s two things happened at the same time that changed these assumptions: 1. Technology made it possible to study and in turn regulate potentially harmful substances in smaller and smaller quantities; and 2. The regulatory climate changed in response to popular outrage at pollution from industry effluents and occupational deaths from illness that was associated with carcinogens and other toxins. As a result, an intergovernmental memo of understanding in the 1980’s between FDA and OSHA allowed for some study of flavors and fragrances at the level of potential harm from occupational exposure, even though the listed substances themselves were still, under law, Generally Recognized As Safe. When the Occupational Safety and Health Administration (OSHA) finally did complete its long-litigated OSHA Hazard Communication Standard, 29 CFR 1910.1200 et seq, disclosure of the potential harmful health effects from individual worker exposure to industrial use of some of these substances became mandated and subject to OSHA penalties, even though those substances never lost their label of "safe" under FDA law.

After 1985, for example, the large quantities of a fragrance component in a particular workplace mixture must be disclosed on the Material Safety Data Sheet (MSDS); its harmful effects described during safety training as mandated by the OSHA Hazard Communication Standard 29 CFR 1910.1200 et seq; protective gear or clothing must be issued to workers who use it with instructions how such protective equipment are to be used; exposures must be monitored and not exceed OSHA regulatory standards; and the failure to follow these steps is, of course, subject to fines and other penalties under OSHA laws. After a protracted litigation in the 1980’s also, the Court of Appeals for the Third Circuit found that OSHA could, in such instances, require disclosure of the components of such mixtures without impinging on proprietary trade secrets, because the MSDS was structured in such a manner that it would not be possible to engage in reverse engineering and that the risk of such industrial concern for secrets could not outweigh the potential harm to America’s working men and women. Thus, even though many people might not think to examine workplace exposures to flavor or fragrance components that are potentially toxic, under OSHA standards there is a great deal of available information to those who face comparative large doses of exposure to such substances. Such exposures of course occur in the industrial use of mixtures or chemicals that have been purchased by employers for internal cleaning use, for example, in addition to the actual manufacture of products such as candles, cosmetics and perfumes. Under OSHA regulations, the Material Safety Data Sheet (MSDS) listing the potential harmful health effects of such substances must travel with the substance until it reaches the end user. Effective scrutiny of these issues has caused many people, such as the excellent research team at the Yale University Medical School clinic, to look very closely at issues of so-called "chemical sensitivity". This area of occupational medicine practice has been the subject of OSHA guidelines regarding Indoor Air Quality and can be the basis for workers’ compensation in a small number of jurisdictions.

 In her article, "Fragrance: Emerging health and Environmental Concerns": Flavour and Fragrance Journal, 2002; 17-361-371, Betty Bridges makes an excellent case for bringing the world of consumer product and food and drug and cosmetic regulation into line with the current OSHA practices.

 Although she does not precisely define fragrances or scents, and she also does not distinguish between artificial fragrances, (which presumably can be controlled) compared to naturally occurring fragrances which are perhaps more difficult to control, Ms. Bridges in her article, makes several valid points. First of all in the world outside the workplace, as Ms. Bridges notes, there is a strong scientific basis for expecting that a host of regulatory agencies in the USA that could effectively revisit the presumption under law that certain substances are "Generally Recognized As Safe".

 For example, by the turn of the 21st century, industrial hygienists, acting as full-time expert employees within governments and other experts hired by federal, state and local governments can measure substances at the parts per trillion level, and toxicologists can study them. Toxicologists can find both short-term and long-term effects from a variety of substances or the confluence of several substances that were not understood before. The association between some chemical components of artificial fragrances, for example, and their ability to mimic estrogens has become the subject of international scientific scrutiny concerning so-called "endocrine disruptors". See: DECLARATION_POSITION STATEMENT AND PROPOSED PLAN OF ACTION FOR PERIOD UP TO 2000 AND IN 21st CENTURY: ON WORKERS’ REPRODUCTIVE HEALTH PROTECTION) Thus, the very characteristic of some perfumes that makes the user sexually attractive may create a set of undesirable biological reactions in that user, leading to long term harms, (See: Texas Journal of Women and the Law, Fall 1998, IS THERE A HUMAN RIGHT TO REPRODUCTIVE HEALTH? Ilise L. Feitshans)

Several United Nations agencies, such as the World Health Organization, (WHO) the International Agency for Research on Cancer (IARC) and the US Environmental Protection Agency’s interagency Task Force on Endocrine Disruptors are among several bodies who have expressed their concern for the possible association between these exposures in the ambient environment and reproductive dysfunction, including the alarming increase of breast cancer in the USA. (See Brian Price, Workplace Reproductive Hazards for Men and Women, in Conference Papers: Safety and Health at Work, London, March 4-6, 1997 (citing Introduction, in Theo Colburn et al., Our Stolen Future: Are We Threatening Our Fertility, Intelligence & Survival?--A Scientific Detective Story v-vii (1996). Price notes that "endocrine effects are not usually investigated when a new chemical is tested prior to use, so the possibility exists that familiar materials may be influencing human reproductive functions. The situation is complicated by the chance of interactions between different materials which may magnify or counteract the effects of each other." )

  These concepts, however, have not been tied together in a fully coherent regulatory analysis of consumer exposure to fragrances (however defined) because of the many types of environmental factors, including the unknown but suspected synergistic reaction between several different exposures to harmful substances at the same time. The need for a consumer-oriented approach to these issues is the next layer of regulation required in order to fully implement protections of public health under these laws. Ms. Bridges has done a great job of setting forth a blueprint for raising such concerns at public fora, in layperson’s terms.

In summary, Fragrance: Emerging health and Environmental Concerns": Flavour and Fragrance Journal, 2002; 17-361-371 reminds the general public of a more precise, and potentially urgent, need for corporate accountability in the ill-defined area of fragrance use. International resources and USA laws governing occupational health and safety provide an important backdrop against which the scope and efficacy of the other national laws can be measured, and hopefully future articles by the author will examine these important differences in regulatory scheme under different health and safety protective laws more closely. Occupational health exposure regulations and related laws provide more than a yardstick for measuring compliance, however; these laws underscore the fundamental character of such vital health protections as human rights. The universal need for such rules of law promotes and ensures the work, health and survival of civilized society. Ms. Bridges’ article wisely concludes that there is no dearth responsibility to be accepted for the potential harms to which all populations are presently exposed. Rather, there is a universal need for health professionals to urge the necessity and importance of  revisiting outdated research and then implementing sensible policies, in order for the health protections of all populations, not simply the workforce, to be achieved. 

I hereby grant permission for you to use the review, "Generally Recognized As Safe?" in full or in part, so long as credit is duly given to the author, specifically. Ilise L. Feitshans JD and ScM. This permission extends to web-based publication and printed media.

Editor’s note: The author has graciously given her permission for use as long as proper credit is given. Additional background information mentioned in the review is at the end of the newsletter

  

Current Science

There are obvious concerns related to fragrance regarding women’s reproductive health as well as the health of the developing fetus and breast-feeding infant. Research indicates there are also concerns related to male reproductive health.

Musk ambrette is a synthetic nitromusk that has been in use since the early 1900s. In the 1980s it was recommended that it not be used in fragrance as it had neurotoxic, phototoxic, and allergenic properties. In addition animal studies had found it caused atrophy of the testicles. In spite of the recommendation that the material not be used, it is still available for sale.

Citral is a common raw fragrance material. It causes enlargement of the prostate tissue in animal studies and has estrogenic effects. It tends to affect older male animals more than it does younger males. Research indicates it has estrogenic effects. The impact on the human male reproductive system has not been explored.

Research just published indicates there is an association between sperm damage and diethyl phthalate. Diethyl phthalate is the most common phthalate used in scented products. Previous research had not tested diethyl phthalate for its effects on sperm.

While this study does not prove that diethyl phthalate is the cause of the damage to the sperm, it does indicate much more research needs to be done and that present testing of materials used in fragrance is not adequate. Safety of fragrance materials needs to be assessed for male as well as female reproductive effects.

More information can be found at:

http://www.nottoopretty.org/pa_12_09_02.htm

http://ehpnet1.niehs.nih.gov/docs/2003/5756/abstract.pdf

 

ACTION ITEMS

  1. Support FDA Petition #99P-1340

    The Environmental Health Network of
    California asks that labeling laws which
    requires a warning for products whose safety
    has not be substantiated to be enforced.
    Send comments to

    Dockets Management Branch,
    Food and Drug Administration (FDA)
    Room 1061, 5630 Fishers Lane,
    Rockville, MD 20852.

    FAX: 301-827-6870

    E-mail: mailto:fdadockets@oc.fda.gov

    More information at: http://users.lmi.net/
    ~wilkworks/FDApetition/bkgrinfo.htm

  2. Support the Not Too Pretty Campaign, which calls from the removal of phthalates from cosmetics.

http://www.nottoopretty.org/index.htm

http://www.nottoopretty.org/action.html

Links of Interest

Environmental Health Perspectives - The journal is a forum for the discussion of the effect of the environment on human health http://ehp.niehs.nih.gov/

US Patent Office - Access US patents which are a source of technical and scientific information http://www.uspto.gov/

Find Articles - Search to find full text articles from a number of publications. www.findarticles.com

The WWW Virtual Library - http://www.vlib.org/

 

About FPIN News

FPIN News is the latest addition to the Fragranced Products Information Network site. The FPIN site and FPIN NEWS are owned, maintained, and financed by Betty Bridges.

The newsletter is freely accessible on the site and may be printed out and distributed in its entirety.

If you wish to use specific sections rather than the whole newsletter, please give proper credit including FPIN’s website address. Permission is given for use as long as the integrity of the material is not compromised.

If you have a question, suggestion, or comment for FPIN News please submit it to fpinva@fpinva.org

Please keep in mind that this newsletter is freely copied and distributed so do not include any information that you do not wish to be made public.

If you would like to contribute information for inclusion please send to: fpinva@fpinva.org

Future issues of FPIN NEWS will include a question and answer section. If you have a question, please submit it to: fpinva@fpinva.org

 

 

 

Additional background information provided by Ilise L. Feitshans JD and ScM

 

DECLARATION_POSITION STATEMENT AND PROPOSED PLAN OF ACTION FOR PERIOD UP TO 2000 AND IN 21st CENTURY: ON WORKERS’ REPRODUCTIVE HEALTH PROTECTION

(Adopted by the International Conference _ Medical and Ecological Problems of Workers Reproductive Health, 9_10 December 1998, Moscow, and refined by the Informal International Consulting Meeting of Experts on Reproductive Health Protection, 11th December 1998, Moscow, Russian Federation)

To insure optimum reproductive health protection worldwide, the Members of the International conference and Informal meeting of experts believe that there is an urgent need for elaboration of international consensus statements as well as the Plan of Action.

BACKGROUND INFORMATION: As satellite venture to the Conference on 11 December 1998 the Informal International Consulting Meeting of Experts on Reproductive Health Protection was held organized by the Initiative group (Dr. O.Sivochalova, Dr. E.Denisov, Prof. I. Figa_Talamanca, Dr. T.Vergieva, and Prof. I. Feitshans as Member and Legal Advisor). In the Consulting Meeting 21 specialists have participated from Belarus, Kazakhstan, Poland, Russia, Tadzhikistan, USA as Attending experts and 4 specialists from Bulgaria, Canada, Italy and Ukraine as Ex Officio experts (contributing by fax and e_mail correspondence). Chairpersons of the Meeting were Prof N. Izmerov, Director of the RAMS Institute of occupational health and Dr. O.Sivochalova, Head of the Centre of Medical and Ecological Problems of Workers, Reproductive Health of this Institute .Declaration_Position Statement and Proposed Plan of Action for Period up to 2000 and in 21st Century on Workers' Reproductive Health Protection have been unanimously adopted by the Committee of Experts.

 INTRODUCTION As recently called for by His Excellence, Mr. Kofi Annan, Secretary_General of the United Nations, the International Organizations, such as the ILO and the WHO and the national governments throughout the world should give occupational health and safety higher priority of their agendas. This would be necessary to respond effectively to the health and safety needs of working people and thereby promoting the overall socioeconomic development and well_being of countries and people. Dr. Gro Harlem Brundtland, Director_General Elect of the World Health Organization in her speech to the Fifty_first World Health Assembly (Geneva, 13 May 1998) emphasized: 2WHO can and must change. It must become more effective, more accountable, more transparent and more receptive to a changing world.

Recognizing the urgent need for improved primary care, protection of mothers, working parents and their children for the benefit of the family and the urgency attached to the problem of understanding the interaction between workplace exposures, environmental factors and preventing worker exposures that jeopardize familial health and human reproductive health, the Committee of Experts hereby calls upon the Director_General of WHO to use her good offices to foster further understanding, research and international co-operation in the following areas to prevent and reduce known or expected hazards to reproductive health AND

RECOGNIZING THAT many conventions that suggest there is an international need and obligation to address these issues, but no single comprehensive internaitonal instrument about reproductive health in the workplace addresses these issues directly nor does any such instrument adequately ensure access to information and risk communication for all people who confront reproductive health hazards at work;

The following proposals are based on updated principles and practices and should be considered as background for better reproductive health protection for every worker.

2. GENERAL STATEMENTS

According to the UN definition, "Reproductive health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity, in all matters relating to the reproductive system and its functions and processes... reproductive health care is defined as the constellation of methods, techniques and services that contribute to reproductive health and well-being by preventing and solving reproductive health problems..." (Cairo, 1994).

The Committee of Experts,

HAVING REGARD TO THE Aims and Principles of United Nations Charter, Universal Declaration of Human Rights, International Convention on the Elimination of All Forms of Discrimination Against Women, International Convention on Child Rights, UN Conference on Environment and Development (Rio De Janeiro, 1992), on Population and Development (Cairo, 1994), on Women (Beijing, 1995), WHO Constitution, Alma Ata Declaration (1978) and Health for All 2000", WHO Global Strategy for Occupational Health for All (1996), WHO revised policy document Health for All in the 21st Century (to be issued later), ILO Conventions and Recommendations on women workers, specifically but not limited to: C.103 Convention Concerning Maternity Protection (1952), C.165 Convention Concerning Employment Protection and Protection Against Unemployment; C. 156 Convention Concerning Equal Opportunities and Equal Treatment for Men and Women: Workers With Family Responsibilities", and C. 155 Convention Concerning Occupational Safety and Health, Related regional and national directives and recommendations namely Council Directive 92/85/ on safety and health of pregnant workers and

RECOGNIZING First that preserving any and every wage-earner's health and ability to enjoy reproductive health is essential to family life; to preserving the family; and protecting the next generation for posterity and

RECALLING the WHO view that health is tied to the prevention of impairments and the ability to participate in all life activities, and that the WHO should endorse a Plan of Action in this Declaration to address this urgent problem the Committee of Experts hereby FINDS AND DECLARES:

At present experts in many countries express serious anxiety about unsatisfactory health status of population especially of reproductive health as well as of children’s health due to influence of hazardous occupational and environmental factors (physical, chemical, biological agents, physic loads and nervous stresses[i][xii]). In some countries on the background of social and economical problems a critical situation in population reproduction have formed which threatens their sustainable development, especially for countries with transitional economies. Many pregnant workers have been denied access to primary care in occupational health services or in the health care delivery systems of the different nations and this grave situation causes further deterioration of maternal and child health and the well being of all society. 

The International Conference on Population and Development (Cairo, 1994) and the Fourth World Conference on Women (Beijing, 1995) have together focused on the need for all countries to examine policies and practices related to broader health concerns, bringing in both a human rights and a gender perspective. According to modern approach adopted ILO and WHO reproductive health of both genders (men and women) should be protected and promoted as part of general health. Women in some periods of reproductive life (women of fertile age, pregnant, recently delivered and breast-feeding) as well as children and adolescents should be considered as vulnerable groups i.e. high risk groups and need supplementary protection. In fundamental medical sciences by mutual efforts of professional community the concept of reproductive health is emerging as topic of the highest medical and social priority. The Meeting of Experts was an extension of other actions in the field namely Expert meeting AWomen at work@, 10_12 November 1997, Helsinki, Finland where it was suggested to develop an International legal document on the health protection of women at work, including pregnant women.

 3.ISSUES 3.1. Priorities in research and for primary health care system and occupational safety and health service Notwithstanding the progress in maternal and child health and in reproductive pathologies, some problems persist, and are even in the increase. A high proportion of conceptuses is lost prematurely, manifested as sub-fecundity and infertility, the rate of spontaneous abortion seems unchanged, congenital defects are a continuous problem, while childhood cancers are increasing. According to some, but not all studies, fertility and sperm quality are decreasing.

Although research efforts have considerably increased in this area in recent years, there are still many open questions. Some examples are the following:

-Is there a differential susceptibility of the female versus the male organism to exposures of chemical and physical agents in the work environment,

-How justifiable are differential standards and limits of exposure for the two genders, are present day work exposure limits sufficiently low to protect the reproductive health of men and women,

-Is there a true reduction in human fertility (and sperm quality), in the industrialized countries, and what may be the risk factors involved,

-How do factors previously neglected such as stress, shift work, work with new technologies, affect reproductive health,

-Are the known reproductive risks under control, and how can this be accomplished ?

Particular attention must be paid to the health of working women, a subject that has been neglected in both developed and developing countries. To fill this gap, it is important that the following steps be undertaken by governments and international organizations:

- Studies in the production sectors which employ predominantly female workers. These include both paid and unpaid (invisible) work in agriculture, in domestic labor, in garment, textile and food industry, in the health care sector.

-Identify reproductive risks for both men and women in these settings, and prevent exposures of those more vulnerable.

-Take account in studies of the double load of women workers, and of family and other stresses.

- Most reproductive hazards are dangerous to both males and females. Research should examine both. Selective overprotection of women may compromise employment opportunities of women, condemning them to poverty.

-Document the many forms of exploitation and illicit labor in developing countries, especially among adolescent girls and child laborers. These phenomena, although macroscopic are not sufficiently documented, and are often tolerated by local authorities.

-Document the deprivation and reproductive risks of migrant workers, who seek employment and survival in western countries. For them too, documentation and intervention programs are deplorably scarce.

3.2.Considerations for the need of specific approach in studying reproductive health at work

A number of chemicals are with a short half-life in the organism and a certain endpoint (as for example a birth defect) might arise only after exposure in the respective sensitive period of gestation, the necessity of studying a range of endpoints including sensitive ones and subtle changes as minor birth defects and postnatal functional deficits.

-Investigation directed to reveal dose-effect and dose-response relationship for proven and/or suspected reproductive and developmental hazards.

-Examination of additional and eventually new endpoints for reproductive toxicity.

-Studies on contribution of combined exposures.

-Exploration of potential reproductive hazards of new technologies, for newly introduced occupational chemicals and other agents as well as in branches of industry which have not been considered yet.

-Development of study protocols and statistical approach to deal with the problem of small numbers of employees in specific occupational settings and being exposed to specific hazards.

-Implementation of models for monitoring reproductive health of workers and subsequent use of these data for epidemiological studies. Further refinement of the protocols with inclusion of individual exposure data relevant for the respective endpoint period in case-control studies nested in a follow-up cohort.

-Encouraging occupational health services in reporting eventual clusters of mis-events in reproductive health and with the help of other specialists organizing at spot of follow-up studies.

3.3 Proposed Action to fill the gaps in existing international and state laws Regarding the role of workplace exposures in shaping reproductive health outcomes:.

The Committee of Experts Notes that there are many conventions that suggest there is an international need and obligation to address these issues, but

No single comprehensive international instrument about reproductive health in the workplace addresses these issues directly nor does any such instrument adequately ensure access to information and risk communication for all people who confront reproductive health hazards at work

An initial survey of international laws demonstrates that many of the treaties and conventions and international human rights instruments that provide jurisdiction for the protection of reproductive health are important but inadequate; they form only a patchwork of indirect efforts to protect people from reproductive health hazards in their workplace.

Further international legal research is needed in this area, comparing and harmonizing local, national and international laws and codes of practices from corporations regarding reproductive health hazards from occupational exposures.

In addition to further legal research harmonizing international and state laws and analyzing the jurisprudence of pregnancy and of related health laws and laws governing the delivery of primary care at local, national regional and international levels,

The Committee of Experts strongly urges the development of an international instrument (Such as an ILO Convention, WHO Recommendation, ISO Standard, treaty or other multilateral document) that will directly address these problems,

 Combined with a strong legislative awareness effort that will educate legislators, members of the international governmental community, regulators, scientists and the general public regarding the urgency and the visible means of preventing foreseeable reproductive health hazards in the workplace and preventing their adverse consequences.

4. PROPOSED PLAN OF ACTION

4.1. Request for Urgent Priority to this matter from the Director-General of the WHO and of the ILO and related International Organizations.

4.2. Implementation of international consensus statements on reproductive health protection (UN Task Force on Reproductive Health, WHO, ICOH, ILO, Council of Europe=s CDEG etc).

4.3. Development of agreed terminology on reproductive hazards and reproductive health risks as well as standard definitions for describing and monitoring legislation, policies, services provision and use and reproductive health outcomes (UN Task Force on Reproductive Health, WHO, ICOH, ILO, Council of Europe=s CDEG, WHO Collaborating centers on Occupational Health) for the purposes of the implementation of an enabling International Instrument.

4.4. Elaboration of the Guide (or Code of practice) Risk assessment and risk management for pregnant female workers and health monitoring (WHO, ILO, ICOH,).

4.5. International Co-ordination of efforts and exchange of experience gained between National centers on reproductive health protection of WHO Collaborating centers on Occupational Health (coordinating meeting with participation of WHO and ILO) and methodological support of the WHO Safe Motherhood Campaign up to 2000 (WHO Collaborating centers on Occupational Health) regarding risk assessment, management and communication, research regarding the interaction of occupational exposures and environmental factors, and related matters of reproductive health of workers.

4.6. Preparation of an International Instrument (e.g. ILO Convention supplemented by WHO/ILO-Joint Committee activity or the specialized branches of WHO; or criteria such other documentation as appropriate) on safe motherhood, reproductive health protection for mothers, fathers, and the next generation whose reproductive health may be impaired by the harms we study today, but who will not experience the effects of those harms until they also reach reproductive age; and health promotion of female workers (ad-hoc group).

RECOMMENDATION

Therefore the Committee of Experts on Reproductive Health in the Workplace Meeting in Moscow December 11, 1998 hereby Declares and recommends that definitions of occupational health, reproductive health and environmental health impacting on the vitality of the family and the next generation include but are not limited to the effects of dangerous or potentially dangerous exposures to adults in any workplace and shall be considered as a fundamental component of assessing each individual's health status and well-being .

Therefore this Committee further Recommends that there shall be an international meeting to follow-up this meeting on regular basis, under the auspices of WHO and related international governmental organizations, and that the results of such meetings shall be the production and adoption of an International Instrument for the protection of reproductive health of people at work.

6.A. REFERENCES (official)

Annan K.A. Occupational health: a high priority on the global, international and national agenda.-Asian-Pacific Newsletter on Occupational health and safety -1997; 4(3):59

Brundtland Gro Harlem. Speech following election as Director-General of the WHO 13 May 1998. 55th World Healh Assembly.

Implementation of the WHO Global strategy for occupational health for all. Plan of action covering specific period 1996-2001//Int. J. Occup. Med. Environ. Hlth.-1997._v. 10, N 2._ P.113_139

UN, Commission on Population and Development, Concise report on world population monitoring, 1996, reproductive rights and reproductive health, E/CN.9/1996/2, 15, January 1996

WHO Global strategy on occupational health for all. The way to health at work._WHO/OCH/95.1._Geneva: WHO, 1995._ 68 pp.

WHO revised policy document Health for All in 21st Century* (to be issued later)

6.B. REFERENCES (scientific)

1.Abeytunga P.K. and Tennassee M. Occupational and environmental exposure data: Information sources and linkage potential to adverse reproductive outcomes data in Canada, in: Understanding infertility: risk factors affecting fertility. Volume 7 of the Research Studies, Royal Commission on New Reproductive Technologies, Ottawa Canada 1993

2.Feitshans I.L. Occupational health as a human right._In: Encyclopaedia of occupational health and safety._Geneva: ILO, 1998._P.23.21_23.27. Also: BRINGING HEALTH TO WORK, Emalyn Press, Haddonfield USA 1997

3.Effects of occupational health hazards on reproductive functions. Eds. M.A. El Batawi, V. Fomenko, K. Hemminki, M. Sorsa, T. Vergieva. WHO/OCH/87.2. Geneva, WHO, 1987. _ 60

4.Langard S. Partitioning of causal weights of work and environment related diseases based on epidemiologic results ( Norwegian, abstr in English)/Nor. J. Epidemiol._1994._v.4,N 1._P. 26 31

5.Medical and ecological problems of workersÆ reproductive health. û Abstracts of the International Conference, 9_10 December 1998, Moscow. RAMS Institute of Occupational Health, Moscow, 1998. 126 pp.

6.Proposed national strategy for the prevention of disorders of reproduction._ DHHS (NIOSH) Publication N 89_133, 1988._29 pp.

7.Rantanen J., Fedotov I.A. Standards, principles and approaches in occupational health services. In: Encyclopedia of occupational health and safety. ûGeneva: ILO, 1998. ûP.23.14_23.21.

8.Reproductive toxicity. Volume 1. Summary review of the scientific evidence (for 30 chemicals). û EUR 14991 EN 1993.

9.Sanotsky I.V., Fomenko V.N. Long_term effects of chemicals on the organism. û UNEP, IRPTC, Centre of international projects, GKNT. Moscow, 1986. û 206 pp.

10.Sivochalova O.V., Kozhin A.A. Protecting the reproductive health of the family.//Reproductive Toxicology._1994._Vol. 8, N 1._ P.5_9.

11.Vergieva T. Adverse effects of environmental chemicals on the outcome of human pregnancy. In: Reproductive Toxicology, Ed. M. Richardson, VCH, Weinheim_New York_Basel_Cambridge_Tokyo,1993, 73_97.

12.Women at Work. Proceedings of the International Expert Meeting 10_12 November 1997. û People and work. Research reports 20._Finnish Institute of Occupational Health, Helsinki,1998._214 pp.

List of Participating Experts

Chairpersons of the Meeting:

Izmerov Nikolai F., MD, Dr Sc, Prof,

Director, RAMS Institute of Occupational Health, Russian Federation

Sivochalova Olga V., MD, Dr Sc,

Head, Centre of Medical and Ecological Problems of Workers Reproductive Health,

RAMS Institute of Occupational Health, Russian Federation

Legal Advisor

Feitshans, Ilise L. JD and ScM

Cornell University N

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FPIN NEWS

 The Year in Review

The end of the year is a good time to reflect on the events and progress of the past twelve months.

2002 has been a year that measurable progress has been made in efforts to educate and increase awareness regarding health and environmental concerns related to fragrance.

Betty Bridges, Editor

In This Issue

Highlights of 2002
Article Review: Generally Recognized as Safe
Current Science
Action Items
Links of Interest

 

 

Highlights of 2002

The end of the year is a good time to reflect on the events and progress of the past twelve months. 2002 has been a year that measurable progress has been made in efforts to educate and increase awareness regarding health and environmental concerns related to fragrance.

February - MSNBC feature article Scents and sensitivities by Francisca Lyman points out that the gift of fragrance may not be the healthiest choice. http://www.msnbc.com/news/702445.asp

June - The fragrance chemical Iso E Super is nominated for National Toxicology Program studies. http://ntp-server.niehs.nih.gov/NomPage/2002Noms.html

July - "Not Too Pretty Campaign" raises concerns related to phthalates in perfume and other cosmetics. A full page ad appears in the New York Times http://www.nottoopretty.org/

September - Flavours and Fragrance journal contains the article Fragrance: emerging health and environmental concerns, the first comprehensive review of concerns related to fragrance. http://www3.interscience.wiley.com/cgi-bin/abstract/93514043/START

October - MSNBC features the article Scents and sensitivities by Francisca Lyman again. http://www.msnbc.com/news/702445.asp

October - The American Lung Association’s The Breathe Easy / Asthma Digest features PERFUMES MAY BE COMPROMISING LUNG HEALTH, ESPECIALLY FOR PEOPLE WITH ASTHMA

November - Cosmetics including fragrance tested in Europe contain phthalates that are associated with reproductive concerns. The European Commission bans the use of two of these phthalates. http://www.nottoopretty.org/pr_new_11_13_02.htm

November - Flavours and Fragrance journal contains the article Fragrances: are they safe? Viewpoint from the industry on the safety of fragrance. http://www3.interscience.wiley.com/cgi-bin/abstract/99520468/START

December - Study suggests diethyl phthalate, which is commonly used in fragrance is linked to sperm damage. http://www.nottoopretty.org/pa_12_09_02.htm

ARTICLE REVIEW

Editor's note: A preprint version of Fragrance emerging health and environmental concerns can be accessed at: http://www.fpinva.org/FragranceReview.htm

Generally Recognized
As Safe?

Review of "Fragrance: Emerging Health and Environmental Concerns" Flavour and Fragrance Journal 2002; 17; 361-371 By Betty Bridges Fragranced Products Information Network.

Review by Prof. I.L. Feitshans JD and ScM   ilf2@cornell.edu  Author BRINGING HEALTH TO WORK; Author DESIGNING AN EFFECTIVE OSHA COMPLIANCE PROGRAM, Legal Advisor WHO/RAMS Committee of Experts on Reproductive Health at Work

Since the 1980’s when I served as a Legal Intern at the Directorate of Health Standards for OSHA, the concept that flavor or fragrance additives to foods, cosmetics and a variety of household items ranging from harsh cleansers to candles might require regulatory inquire has been a complex, uncharted area of toxic and hazardous substance regulation. In those days, the regulatory theory was founded upon the notion that few, if any, people had sufficient exposure to large quantities of the components of these substances to present any clearly negative health effects or long-term harms. The notion that only small quantities of these substances were ever in contact with users in the general public had, in the decades before, led to the creation of a Food and Drug Administration list of otherwise potentially harmful substances whose quantity of use was considered so low to be too small to be measured, the so-called GRAS list, (Generally Recognized As Safe).

 In the 1980’s two things happened at the same time that changed these assumptions: 1. Technology made it possible to study and in turn regulate potentially harmful substances in smaller and smaller quantities; and 2. The regulatory climate changed in response to popular outrage at pollution from industry effluents and occupational deaths from illness that was associated with carcinogens and other toxins. As a result, an intergovernmental memo of understanding in the 1980’s between FDA and OSHA allowed for some study of flavors and fragrances at the level of potential harm from occupational exposure, even though the listed substances themselves were still, under law, Generally Recognized As Safe. When the Occupational Safety and Health Administration (OSHA) finally did complete its long-litigated OSHA Hazard Communication Standard, 29 CFR 1910.1200 et seq, disclosure of the potential harmful health effects from individual worker exposure to industrial use of some of these substances became mandated and subject to OSHA penalties, even though those substances never lost their label of "safe" under FDA law.

After 1985, for example, the large quantities of a fragrance component in a particular workplace mixture must be disclosed on the Material Safety Data Sheet (MSDS); its harmful effects described during safety training as mandated by the OSHA Hazard Communication Standard 29 CFR 1910.1200 et seq; protective gear or clothing must be issued to workers who use it with instructions how such protective equipment are to be used; exposures must be monitored and not exceed OSHA regulatory standards; and the failure to follow these steps is, of course, subject to fines and other penalties under OSHA laws. After a protracted litigation in the 1980’s also, the Court of Appeals for the Third Circuit found that OSHA could, in such instances, require disclosure of the components of such mixtures without impinging on proprietary trade secrets, because the MSDS was structured in such a manner that it would not be possible to engage in reverse engineering and that the risk of such industrial concern for secrets could not outweigh the potential harm to America’s working men and women. Thus, even though many people might not think to examine workplace exposures to flavor or fragrance components that are potentially toxic, under OSHA standards there is a great deal of available information to those who face comparative large doses of exposure to such substances. Such exposures of course occur in the industrial use of mixtures or chemicals that have been purchased by employers for internal cleaning use, for example, in addition to the actual manufacture of products such as candles, cosmetics and perfumes. Under OSHA regulations, the Material Safety Data Sheet (MSDS) listing the potential harmful health effects of such substances must travel with the substance until it reaches the end user. Effective scrutiny of these issues has caused many people, such as the excellent research team at the Yale University Medical School clinic, to look very closely at issues of so-called "chemical sensitivity". This area of occupational medicine practice has been the subject of OSHA guidelines regarding Indoor Air Quality and can be the basis for workers’ compensation in a small number of jurisdictions.

 In her article, "Fragrance: Emerging health and Environmental Concerns": Flavour and Fragrance Journal, 2002; 17-361-371, Betty Bridges makes an excellent case for bringing the world of consumer product and food and drug and cosmetic regulation into line with the current OSHA practices.

 Although she does not precisely define fragrances or scents, and she also does not distinguish between artificial fragrances, (which presumably can be controlled) compared to naturally occurring fragrances which are perhaps more difficult to control, Ms. Bridges in her article, makes several valid points. First of all in the world outside the workplace, as Ms. Bridges notes, there is a strong scientific basis for expecting that a host of regulatory agencies in the USA that could effectively revisit the presumption under law that certain substances are "Generally Recognized As Safe".

 For example, by the turn of the 21st century, industrial hygienists, acting as full-time expert employees within governments and other experts hired by federal, state and local governments can measure substances at the parts per trillion level, and toxicologists can study them. Toxicologists can find both short-term and long-term effects from a variety of substances or the confluence of several substances that were not understood before. The association between some chemical components of artificial fragrances, for example, and their ability to mimic estrogens has become the subject of international scientific scrutiny concerning so-called "endocrine disruptors". See: DECLARATION_POSITION STATEMENT AND PROPOSED PLAN OF ACTION FOR PERIOD UP TO 2000 AND IN 21st CENTURY: ON WORKERS’ REPRODUCTIVE HEALTH PROTECTION) Thus, the very characteristic of some perfumes that makes the user sexually attractive may create a set of undesirable biological reactions in that user, leading to long term harms, (See: Texas Journal of Women and the Law, Fall 1998, IS THERE A HUMAN RIGHT TO REPRODUCTIVE HEALTH? Ilise L. Feitshans)

Several United Nations agencies, such as the World Health Organization, (WHO) the International Agency for Research on Cancer (IARC) and the US Environmental Protection Agency’s interagency Task Force on Endocrine Disruptors are among several bodies who have expressed their concern for the possible association between these exposures in the ambient environment and reproductive dysfunction, including the alarming increase of breast cancer in the USA. (See Brian Price, Workplace Reproductive Hazards for Men and Women, in Conference Papers: Safety and Health at Work, London, March 4-6, 1997 (citing Introduction, in Theo Colburn et al., Our Stolen Future: Are We Threatening Our Fertility, Intelligence & Survival?--A Scientific Detective Story v-vii (1996). Price notes that "endocrine effects are not usually investigated when a new chemical is tested prior to use, so the possibility exists that familiar materials may be influencing human reproductive functions. The situation is complicated by the chance of interactions between different materials which may magnify or counteract the effects of each other." )

  These concepts, however, have not been tied together in a fully coherent regulatory analysis of consumer exposure to fragrances (however defined) because of the many types of environmental factors, including the unknown but suspected synergistic reaction between several different exposures to harmful substances at the same time. The need for a consumer-oriented approach to these issues is the next layer of regulation required in order to fully implement protections of public health under these laws. Ms. Bridges has done a great job of setting forth a blueprint for raising such concerns at public fora, in layperson’s terms.

In summary, Fragrance: Emerging health and Environmental Concerns": Flavour and Fragrance Journal, 2002; 17-361-371 reminds the general public of a more precise, and potentially urgent, need for corporate accountability in the ill-defined area of fragrance use. International resources and USA laws governing occupational health and safety provide an important backdrop against which the scope and efficacy of the other national laws can be measured, and hopefully future articles by the author will examine these important differences in regulatory scheme under different health and safety protective laws more closely. Occupational health exposure regulations and related laws provide more than a yardstick for measuring compliance, however; these laws underscore the fundamental character of such vital health protections as human rights. The universal need for such rules of law promotes and ensures the work, health and survival of civilized society. Ms. Bridges’ article wisely concludes that there is no dearth responsibility to be accepted for the potential harms to which all populations are presently exposed. Rather, there is a universal need for health professionals to urge the necessity and importance of  revisiting outdated research and then implementing sensible policies, in order for the health protections of all populations, not simply the workforce, to be achieved. 

I hereby grant permission for you to use the review, "Generally Recognized As Safe?" in full or in part, so long as credit is duly given to the author, specifically. Ilise L. Feitshans JD and ScM. This permission extends to web-based publication and printed media.

Editor’s note: The author has graciously given her permission for use as long as proper credit is given. Additional background information mentioned in the review is at the end of the newsletter

  

Current Science

There are obvious concerns related to fragrance regarding women’s reproductive health as well as the health of the developing fetus and breast-feeding infant. Research indicates there are also concerns related to male reproductive health.

Musk ambrette is a synthetic nitromusk that has been in use since the early 1900s. In the 1980s it was recommended that it not be used in fragrance as it had neurotoxic, phototoxic, and allergenic properties. In addition animal studies had found it caused atrophy of the testicles. In spite of the recommendation that the material not be used, it is still available for sale.

Citral is a common raw fragrance material. It causes enlargement of the prostate tissue in animal studies and has estrogenic effects. It tends to affect older male animals more than it does younger males. Research indicates it has estrogenic effects. The impact on the human male reproductive system has not been explored.

Research just published indicates there is an association between sperm damage and diethyl phthalate. Diethyl phthalate is the most common phthalate used in scented products. Previous research had not tested diethyl phthalate for its effects on sperm.

While this study does not prove that diethyl phthalate is the cause of the damage to the sperm, it does indicate much more research needs to be done and that present testing of materials used in fragrance is not adequate. Safety of fragrance materials needs to be assessed for male as well as female reproductive effects.

More information can be found at:

http://www.nottoopretty.org/pa_12_09_02.htm

http://ehpnet1.niehs.nih.gov/docs/2003/5756/abstract.pdf

 

ACTION ITEMS

  1. Support FDA Petition #99P-1340

    The Environmental Health Network of
    California asks that labeling laws which
    requires a warning for products whose safety
    has not be substantiated to be enforced.
    Send comments to

    Dockets Management Branch,
    Food and Drug Administration (FDA)
    Room 1061, 5630 Fishers Lane,
    Rockville, MD 20852.

    FAX: 301-827-6870

    E-mail: mailto:fdadockets@oc.fda.gov

    More information at: http://users.lmi.net/
    ~wilkworks/FDApetition/bkgrinfo.htm

  2. Support the Not Too Pretty Campaign, which calls from the removal of phthalates from cosmetics.

http://www.nottoopretty.org/index.htm

http://www.nottoopretty.org/action.html

Links of Interest

Environmental Health Perspectives - The journal is a forum for the discussion of the effect of the environment on human health http://ehp.niehs.nih.gov/

US Patent Office - Access US patents which are a source of technical and scientific information http://www.uspto.gov/

Find Articles - Search to find full text articles from a number of publications. www.findarticles.com

The WWW Virtual Library - http://www.vlib.org/

 

About FPIN News

FPIN News is the latest addition to the Fragranced Products Information Network site. The FPIN site and FPIN NEWS are owned, maintained, and financed by Betty Bridges.

The newsletter is freely accessible on the site and may be printed out and distributed in its entirety.

If you wish to use specific sections rather than the whole newsletter, please give proper credit including FPIN’s website address. Permission is given for use as long as the integrity of the material is not compromised.

If you have a question, suggestion, or comment for FPIN News please submit it to fpinva@fpinva.org

Please keep in mind that this newsletter is freely copied and distributed so do not include any information that you do not wish to be made public.

If you would like to contribute information for inclusion please send to: fpinva@fpinva.org

Future issues of FPIN NEWS will include a question and answer section. If you have a question, please submit it to: fpinva@fpinva.org

 

 

 

Additional background information provided by Ilise L. Feitshans JD and ScM

 

DECLARATION_POSITION STATEMENT AND PROPOSED PLAN OF ACTION FOR PERIOD UP TO 2000 AND IN 21st CENTURY: ON WORKERS’ REPRODUCTIVE HEALTH PROTECTION

(Adopted by the International Conference _ Medical and Ecological Problems of Workers Reproductive Health, 9_10 December 1998, Moscow, and refined by the Informal International Consulting Meeting of Experts on Reproductive Health Protection, 11th December 1998, Moscow, Russian Federation)

To insure optimum reproductive health protection worldwide, the Members of the International conference and Informal meeting of experts believe that there is an urgent need for elaboration of international consensus statements as well as the Plan of Action.

BACKGROUND INFORMATION: As satellite venture to the Conference on 11 December 1998 the Informal International Consulting Meeting of Experts on Reproductive Health Protection was held organized by the Initiative group (Dr. O.Sivochalova, Dr. E.Denisov, Prof. I. Figa_Talamanca, Dr. T.Vergieva, and Prof. I. Feitshans as Member and Legal Advisor). In the Consulting Meeting 21 specialists have participated from Belarus, Kazakhstan, Poland, Russia, Tadzhikistan, USA as Attending experts and 4 specialists from Bulgaria, Canada, Italy and Ukraine as Ex Officio experts (contributing by fax and e_mail correspondence). Chairpersons of the Meeting were Prof N. Izmerov, Director of the RAMS Institute of occupational health and Dr. O.Sivochalova, Head of the Centre of Medical and Ecological Problems of Workers, Reproductive Health of this Institute .Declaration_Position Statement and Proposed Plan of Action for Period up to 2000 and in 21st Century on Workers' Reproductive Health Protection have been unanimously adopted by the Committee of Experts.

 INTRODUCTION As recently called for by His Excellence, Mr. Kofi Annan, Secretary_General of the United Nations, the International Organizations, such as the ILO and the WHO and the national governments throughout the world should give occupational health and safety higher priority of their agendas. This would be necessary to respond effectively to the health and safety needs of working people and thereby promoting the overall socioeconomic development and well_being of countries and people. Dr. Gro Harlem Brundtland, Director_General Elect of the World Health Organization in her speech to the Fifty_first World Health Assembly (Geneva, 13 May 1998) emphasized: 2WHO can and must change. It must become more effective, more accountable, more transparent and more receptive to a changing world.

Recognizing the urgent need for improved primary care, protection of mothers, working parents and their children for the benefit of the family and the urgency attached to the problem of understanding the interaction between workplace exposures, environmental factors and preventing worker exposures that jeopardize familial health and human reproductive health, the Committee of Experts hereby calls upon the Director_General of WHO to use her good offices to foster further understanding, research and international co-operation in the following areas to prevent and reduce known or expected hazards to reproductive health AND

RECOGNIZING THAT many conventions that suggest there is an international need and obligation to address these issues, but no single comprehensive internaitonal instrument about reproductive health in the workplace addresses these issues directly nor does any such instrument adequately ensure access to information and risk communication for all people who confront reproductive health hazards at work;

The following proposals are based on updated principles and practices and should be considered as background for better reproductive health protection for every worker.

2. GENERAL STATEMENTS

According to the UN definition, "Reproductive health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity, in all matters relating to the reproductive system and its functions and processes... reproductive health care is defined as the constellation of methods, techniques and services that contribute to reproductive health and well-being by preventing and solving reproductive health problems..." (Cairo, 1994).

The Committee of Experts,

HAVING REGARD TO THE Aims and Principles of United Nations Charter, Universal Declaration of Human Rights, International Convention on the Elimination of All Forms of Discrimination Against Women, International Convention on Child Rights, UN Conference on Environment and Development (Rio De Janeiro, 1992), on Population and Development (Cairo, 1994), on Women (Beijing, 1995), WHO Constitution, Alma Ata Declaration (1978) and Health for All 2000", WHO Global Strategy for Occupational Health for All (1996), WHO revised policy document Health for All in the 21st Century (to be issued later), ILO Conventions and Recommendations on women workers, specifically but not limited to: C.103 Convention Concerning Maternity Protection (1952), C.165 Convention Concerning Employment Protection and Protection Against Unemployment; C. 156 Convention Concerning Equal Opportunities and Equal Treatment for Men and Women: Workers With Family Responsibilities", and C. 155 Convention Concerning Occupational Safety and Health, Related regional and national directives and recommendations namely Council Directive 92/85/ on safety and health of pregnant workers and

RECOGNIZING First that preserving any and every wage-earner's health and ability to enjoy reproductive health is essential to family life; to preserving the family; and protecting the next generation for posterity and

RECALLING the WHO view that health is tied to the prevention of impairments and the ability to participate in all life activities, and that the WHO should endorse a Plan of Action in this Declaration to address this urgent problem the Committee of Experts hereby FINDS AND DECLARES:

At present experts in many countries express serious anxiety about unsatisfactory health status of population especially of reproductive health as well as of children’s health due to influence of hazardous occupational and environmental factors (physical, chemical, biological agents, physic loads and nervous stresses[i][xii]). In some countries on the background of social and economical problems a critical situation in population reproduction have formed which threatens their sustainable development, especially for countries with transitional economies. Many pregnant workers have been denied access to primary care in occupational health services or in the health care delivery systems of the different nations and this grave situation causes further deterioration of maternal and child health and the well being of all society. 

The International Conference on Population and Development (Cairo, 1994) and the Fourth World Conference on Women (Beijing, 1995) have together focused on the need for all countries to examine policies and practices related to broader health concerns, bringing in both a human rights and a gender perspective. According to modern approach adopted ILO and WHO reproductive health of both genders (men and women) should be protected and promoted as part of general health. Women in some periods of reproductive life (women of fertile age, pregnant, recently delivered and breast-feeding) as well as children and adolescents should be considered as vulnerable groups i.e. high risk groups and need supplementary protection. In fundamental medical sciences by mutual efforts of professional community the concept of reproductive health is emerging as topic of the highest medical and social priority. The Meeting of Experts was an extension of other actions in the field namely Expert meeting AWomen at work@, 10_12 November 1997, Helsinki, Finland where it was suggested to develop an International legal document on the health protection of women at work, including pregnant women.

 3.ISSUES 3.1. Priorities in research and for primary health care system and occupational safety and health service Notwithstanding the progress in maternal and child health and in reproductive pathologies, some problems persist, and are even in the increase. A high proportion of conceptuses is lost prematurely, manifested as sub-fecundity and infertility, the rate of spontaneous abortion seems unchanged, congenital defects are a continuous problem, while childhood cancers are increasing. According to some, but not all studies, fertility and sperm quality are decreasing.

Although research efforts have considerably increased in this area in recent years, there are still many open questions. Some examples are the following:

-Is there a differential susceptibility of the female versus the male organism to exposures of chemical and physical agents in the work environment,

-How justifiable are differential standards and limits of exposure for the two genders, are present day work exposure limits sufficiently low to protect the reproductive health of men and women,

-Is there a true reduction in human fertility (and sperm quality), in the industrialized countries, and what may be the risk factors involved,

-How do factors previously neglected such as stress, shift work, work with new technologies, affect reproductive health,

-Are the known reproductive risks under control, and how can this be accomplished ?

Particular attention must be paid to the health of working women, a subject that has been neglected in both developed and developing countries. To fill this gap, it is important that the following steps be undertaken by governments and international organizations:

- Studies in the production sectors which employ predominantly female workers. These include both paid and unpaid (invisible) work in agriculture, in domestic labor, in garment, textile and food industry, in the health care sector.

-Identify reproductive risks for both men and women in these settings, and prevent exposures of those more vulnerable.

-Take account in studies of the double load of women workers, and of family and other stresses.

- Most reproductive hazards are dangerous to both males and females. Research should examine both. Selective overprotection of women may compromise employment opportunities of women, condemning them to poverty.

-Document the many forms of exploitation and illicit labor in developing countries, especially among adolescent girls and child laborers. These phenomena, although macroscopic are not sufficiently documented, and are often tolerated by local authorities.

-Document the deprivation and reproductive risks of migrant workers, who seek employment and survival in western countries. For them too, documentation and intervention programs are deplorably scarce.

3.2.Considerations for the need of specific approach in studying reproductive health at work

A number of chemicals are with a short half-life in the organism and a certain endpoint (as for example a birth defect) might arise only after exposure in the respective sensitive period of gestation, the necessity of studying a range of endpoints including sensitive ones and subtle changes as minor birth defects and postnatal functional deficits.

-Investigation directed to reveal dose-effect and dose-response relationship for proven and/or suspected reproductive and developmental hazards.

-Examination of additional and eventually new endpoints for reproductive toxicity.

-Studies on contribution of combined exposures.

-Exploration of potential reproductive hazards of new technologies, for newly introduced occupational chemicals and other agents as well as in branches of industry which have not been considered yet.

-Development of study protocols and statistical approach to deal with the problem of small numbers of employees in specific occupational settings and being exposed to specific hazards.

-Implementation of models for monitoring reproductive health of workers and subsequent use of these data for epidemiological studies. Further refinement of the protocols with inclusion of individual exposure data relevant for the respective endpoint period in case-control studies nested in a follow-up cohort.

-Encouraging occupational health services in reporting eventual clusters of mis-events in reproductive health and with the help of other specialists organizing at spot of follow-up studies.

3.3 Proposed Action to fill the gaps in existing international and state laws Regarding the role of workplace exposures in shaping reproductive health outcomes:.

The Committee of Experts Notes that there are many conventions that suggest there is an international need and obligation to address these issues, but

No single comprehensive international instrument about reproductive health in the workplace addresses these issues directly nor does any such instrument adequately ensure access to information and risk communication for all people who confront reproductive health hazards at work

An initial survey of international laws demonstrates that many of the treaties and conventions and international human rights instruments that provide jurisdiction for the protection of reproductive health are important but inadequate; they form only a patchwork of indirect efforts to protect people from reproductive health hazards in their workplace.

Further international legal research is needed in this area, comparing and harmonizing local, national and international laws and codes of practices from corporations regarding reproductive health hazards from occupational exposures.

In addition to further legal research harmonizing international and state laws and analyzing the jurisprudence of pregnancy and of related health laws and laws governing the delivery of primary care at local, national regional and international levels,

The Committee of Experts strongly urges the development of an international instrument (Such as an ILO Convention, WHO Recommendation, ISO Standard, treaty or other multilateral document) that will directly address these problems,

 Combined with a strong legislative awareness effort that will educate legislators, members of the international governmental community, regulators, scientists and the general public regarding the urgency and the visible means of preventing foreseeable reproductive health hazards in the workplace and preventing their adverse consequences.

4. PROPOSED PLAN OF ACTION

4.1. Request for Urgent Priority to this matter from the Director-General of the WHO and of the ILO and related International Organizations.

4.2. Implementation of international consensus statements on reproductive health protection (UN Task Force on Reproductive Health, WHO, ICOH, ILO, Council of Europe=s CDEG etc).

4.3. Development of agreed terminology on reproductive hazards and reproductive health risks as well as standard definitions for describing and monitoring legislation, policies, services provision and use and reproductive health outcomes (UN Task Force on Reproductive Health, WHO, ICOH, ILO, Council of Europe=s CDEG, WHO Collaborating centers on Occupational Health) for the purposes of the implementation of an enabling International Instrument.

4.4. Elaboration of the Guide (or Code of practice) Risk assessment and risk management for pregnant female workers and health monitoring (WHO, ILO, ICOH,).

4.5. International Co-ordination of efforts and exchange of experience gained between National centers on reproductive health protection of WHO Collaborating centers on Occupational Health (coordinating meeting with participation of WHO and ILO) and methodological support of the WHO Safe Motherhood Campaign up to 2000 (WHO Collaborating centers on Occupational Health) regarding risk assessment, management and communication, research regarding the interaction of occupational exposures and environmental factors, and related matters of reproductive health of workers.

4.6. Preparation of an International Instrument (e.g. ILO Convention supplemented by WHO/ILO-Joint Committee activity or the specialized branches of WHO; or criteria such other documentation as appropriate) on safe motherhood, reproductive health protection for mothers, fathers, and the next generation whose reproductive health may be impaired by the harms we study today, but who will not experience the effects of those harms until they also reach reproductive age; and health promotion of female workers (ad-hoc group).

RECOMMENDATION

Therefore the Committee of Experts on Reproductive Health in the Workplace Meeting in Moscow December 11, 1998 hereby Declares and recommends that definitions of occupational health, reproductive health and environmental health impacting on the vitality of the family and the next generation include but are not limited to the effects of dangerous or potentially dangerous exposures to adults in any workplace and shall be considered as a fundamental component of assessing each individual's health status and well-being .

Therefore this Committee further Recommends that there shall be an international meeting to follow-up this meeting on regular basis, under the auspices of WHO and related international governmental organizations, and that the results of such meetings shall be the production and adoption of an International Instrument for the protection of reproductive health of people at work.

6.A. REFERENCES (official)

Annan K.A. Occupational health: a high priority on the global, international and national agenda.-Asian-Pacific Newsletter on Occupational health and safety -1997; 4(3):59

Brundtland Gro Harlem. Speech following election as Director-General of the WHO 13 May 1998. 55th World Healh Assembly.

Implementation of the WHO Global strategy for occupational health for all. Plan of action covering specific period 1996-2001//Int. J. Occup. Med. Environ. Hlth.-1997._v. 10, N 2._ P.113_139

UN, Commission on Population and Development, Concise report on world population monitoring, 1996, reproductive rights and reproductive health, E/CN.9/1996/2, 15, January 1996

WHO Global strategy on occupational health for all. The way to health at work._WHO/OCH/95.1._Geneva: WHO, 1995._ 68 pp.

WHO revised policy document Health for All in 21st Century* (to be issued later)

6.B. REFERENCES (scientific)

1.Abeytunga P.K. and Tennassee M. Occupational and environmental exposure data: Information sources and linkage potential to adverse reproductive outcomes data in Canada, in: Understanding infertility: risk factors affecting fertility. Volume 7 of the Research Studies, Royal Commission on New Reproductive Technologies, Ottawa Canada 1993

2.Feitshans I.L. Occupational health as a human right._In: Encyclopaedia of occupational health and safety._Geneva: ILO, 1998._P.23.21_23.27. Also: BRINGING HEALTH TO WORK, Emalyn Press, Haddonfield USA 1997

3.Effects of occupational health hazards on reproductive functions. Eds. M.A. El Batawi, V. Fomenko, K. Hemminki, M. Sorsa, T. Vergieva. WHO/OCH/87.2. Geneva, WHO, 1987. _ 60

4.Langard S. Partitioning of causal weights of work and environment related diseases based on epidemiologic results ( Norwegian, abstr in English)/Nor. J. Epidemiol._1994._v.4,N 1._P. 26 31

5.Medical and ecological problems of workersÆ reproductive health. û Abstracts of the International Conference, 9_10 December 1998, Moscow. RAMS Institute of Occupational Health, Moscow, 1998. 126 pp.

6.Proposed national strategy for the prevention of disorders of reproduction._ DHHS (NIOSH) Publication N 89_133, 1988._29 pp.

7.Rantanen J., Fedotov I.A. Standards, principles and approaches in occupational health services. In: Encyclopedia of occupational health and safety. ûGeneva: ILO, 1998. ûP.23.14_23.21.

8.Reproductive toxicity. Volume 1. Summary review of the scientific evidence (for 30 chemicals). û EUR 14991 EN 1993.

9.Sanotsky I.V., Fomenko V.N. Long_term effects of chemicals on the organism. û UNEP, IRPTC, Centre of international projects, GKNT. Moscow, 1986. û 206 pp.

10.Sivochalova O.V., Kozhin A.A. Protecting the reproductive health of the family.//Reproductive Toxicology._1994._Vol. 8, N 1._ P.5_9.

11.Vergieva T. Adverse effects of environmental chemicals on the outcome of human pregnancy. In: Reproductive Toxicology, Ed. M. Richardson, VCH, Weinheim_New York_Basel_Cambridge_Tokyo,1993, 73_97.

12.Women at Work. Proceedings of the International Expert Meeting 10_12 November 1997. û People and work. Research reports 20._Finnish Institute of Occupational Health, Helsinki,1998._214 pp.

List of Participating Experts

Chairpersons of the Meeting:

Izmerov Nikolai F., MD, Dr Sc, Prof,

Director, RAMS Institute of Occupational Health, Russian Federation

Sivochalova Olga V., MD, Dr Sc,

Head, Centre of Medical and Ecological Problems of Workers Reproductive Health,

RAMS Institute of Occupational Health, Russian Federation

Legal Advisor

Feitshans, Ilise L. JD and ScM

Cornell University N

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FPIN NEWS

 The Year in Review

The end of the year is a good time to reflect on the events and progress of the past twelve months.

2002 has been a year that measurable progress has been made in efforts to educate and increase awareness regarding health and environmental concerns related to fragrance.

Betty Bridges, Editor

In This Issue

Highlights of 2002
Article Review: Generally Recognized as Safe
Current Science
Action Items
Links of Interest

 

 

Highlights of 2002

The end of the year is a good time to reflect on the events and progress of the past twelve months. 2002 has been a year that measurable progress has been made in efforts to educate and increase awareness regarding health and environmental concerns related to fragrance.

February - MSNBC feature article Scents and sensitivities by Francisca Lyman points out that the gift of fragrance may not be the healthiest choice. http://www.msnbc.com/news/702445.asp

June - The fragrance chemical Iso E Super is nominated for National Toxicology Program studies. http://ntp-server.niehs.nih.gov/NomPage/2002Noms.html

July - "Not Too Pretty Campaign" raises concerns related to phthalates in perfume and other cosmetics. A full page ad appears in the New York Times http://www.nottoopretty.org/

September - Flavours and Fragrance journal contains the article Fragrance: emerging health and environmental concerns, the first comprehensive review of concerns related to fragrance. http://www3.interscience.wiley.com/cgi-bin/abstract/93514043/START

October - MSNBC features the article Scents and sensitivities by Francisca Lyman again. http://www.msnbc.com/news/702445.asp

October - The American Lung Association’s The Breathe Easy / Asthma Digest features PERFUMES MAY BE COMPROMISING LUNG HEALTH, ESPECIALLY FOR PEOPLE WITH ASTHMA

November - Cosmetics including fragrance tested in Europe contain phthalates that are associated with reproductive concerns. The European Commission bans the use of two of these phthalates. http://www.nottoopretty.org/pr_new_11_13_02.htm

November - Flavours and Fragrance journal contains the article Fragrances: are they safe? Viewpoint from the industry on the safety of fragrance. http://www3.interscience.wiley.com/cgi-bin/abstract/99520468/START

December - Study suggests diethyl phthalate, which is commonly used in fragrance is linked to sperm damage. http://www.nottoopretty.org/pa_12_09_02.htm

ARTICLE REVIEW

Editor's note: A preprint version of Fragrance emerging health and environmental concerns can be accessed at: http://www.fpinva.org/FragranceReview.htm

Generally Recognized
As Safe?

Review of "Fragrance: Emerging Health and Environmental Concerns" Flavour and Fragrance Journal 2002; 17; 361-371 By Betty Bridges Fragranced Products Information Network.

Review by Prof. I.L. Feitshans JD and ScM   ilf2@cornell.edu  Author BRINGING HEALTH TO WORK; Author DESIGNING AN EFFECTIVE OSHA COMPLIANCE PROGRAM, Legal Advisor WHO/RAMS Committee of Experts on Reproductive Health at Work

Since the 1980’s when I served as a Legal Intern at the Directorate of Health Standards for OSHA, the concept that flavor or fragrance additives to foods, cosmetics and a variety of household items ranging from harsh cleansers to candles might require regulatory inquire has been a complex, uncharted area of toxic and hazardous substance regulation. In those days, the regulatory theory was founded upon the notion that few, if any, people had sufficient exposure to large quantities of the components of these substances to present any clearly negative health effects or long-term harms. The notion that only small quantities of these substances were ever in contact with users in the general public had, in the decades before, led to the creation of a Food and Drug Administration list of otherwise potentially harmful substances whose quantity of use was considered so low to be too small to be measured, the so-called GRAS list, (Generally Recognized As Safe).

 In the 1980’s two things happened at the same time that changed these assumptions: 1. Technology made it possible to study and in turn regulate potentially harmful substances in smaller and smaller quantities; and 2. The regulatory climate changed in response to popular outrage at pollution from industry effluents and occupational deaths from illness that was associated with carcinogens and other toxins. As a result, an intergovernmental memo of understanding in the 1980’s between FDA and OSHA allowed for some study of flavors and fragrances at the level of potential harm from occupational exposure, even though the listed substances themselves were still, under law, Generally Recognized As Safe. When the Occupational Safety and Health Administration (OSHA) finally did complete its long-litigated OSHA Hazard Communication Standard, 29 CFR 1910.1200 et seq, disclosure of the potential harmful health effects from individual worker exposure to industrial use of some of these substances became mandated and subject to OSHA penalties, even though those substances never lost their label of "safe" under FDA law.

After 1985, for example, the large quantities of a fragrance component in a particular workplace mixture must be disclosed on the Material Safety Data Sheet (MSDS); its harmful effects described during safety training as mandated by the OSHA Hazard Communication Standard 29 CFR 1910.1200 et seq; protective gear or clothing must be issued to workers who use it with instructions how such protective equipment are to be used; exposures must be monitored and not exceed OSHA regulatory standards; and the failure to follow these steps is, of course, subject to fines and other penalties under OSHA laws. After a protracted litigation in the 1980’s also, the Court of Appeals for the Third Circuit found that OSHA could, in such instances, require disclosure of the components of such mixtures without impinging on proprietary trade secrets, because the MSDS was structured in such a manner that it would not be possible to engage in reverse engineering and that the risk of such industrial concern for secrets could not outweigh the potential harm to America’s working men and women. Thus, even though many people might not think to examine workplace exposures to flavor or fragrance components that are potentially toxic, under OSHA standards there is a great deal of available information to those who face comparative large doses of exposure to such substances. Such exposures of course occur in the industrial use of mixtures or chemicals that have been purchased by employers for internal cleaning use, for example, in addition to the actual manufacture of products such as candles, cosmetics and perfumes. Under OSHA regulations, the Material Safety Data Sheet (MSDS) listing the potential harmful health effects of such substances must travel with the substance until it reaches the end user. Effective scrutiny of these issues has caused many people, such as the excellent research team at the Yale University Medical School clinic, to look very closely at issues of so-called "chemical sensitivity". This area of occupational medicine practice has been the subject of OSHA guidelines regarding Indoor Air Quality and can be the basis for workers’ compensation in a small number of jurisdictions.

 In her article, "Fragrance: Emerging health and Environmental Concerns": Flavour and Fragrance Journal, 2002; 17-361-371, Betty Bridges makes an excellent case for bringing the world of consumer product and food and drug and cosmetic regulation into line with the current OSHA practices.

 Although she does not precisely define fragrances or scents, and she also does not distinguish between artificial fragrances, (which presumably can be controlled) compared to naturally occurring fragrances which are perhaps more difficult to control, Ms. Bridges in her article, makes several valid points. First of all in the world outside the workplace, as Ms. Bridges notes, there is a strong scientific basis for expecting that a host of regulatory agencies in the USA that could effectively revisit the presumption under law that certain substances are "Generally Recognized As Safe".

 For example, by the turn of the 21st century, industrial hygienists, acting as full-time expert employees within governments and other experts hired by federal, state and local governments can measure substances at the parts per trillion level, and toxicologists can study them. Toxicologists can find both short-term and long-term effects from a variety of substances or the confluence of several substances that were not understood before. The association between some chemical components of artificial fragrances, for example, and their ability to mimic estrogens has become the subject of international scientific scrutiny concerning so-called "endocrine disruptors". See: DECLARATION_POSITION STATEMENT AND PROPOSED PLAN OF ACTION FOR PERIOD UP TO 2000 AND IN 21st CENTURY: ON WORKERS’ REPRODUCTIVE HEALTH PROTECTION) Thus, the very characteristic of some perfumes that makes the user sexually attractive may create a set of undesirable biological reactions in that user, leading to long term harms, (See: Texas Journal of Women and the Law, Fall 1998, IS THERE A HUMAN RIGHT TO REPRODUCTIVE HEALTH? Ilise L. Feitshans)

Several United Nations agencies, such as the World Health Organization, (WHO) the International Agency for Research on Cancer (IARC) and the US Environmental Protection Agency’s interagency Task Force on Endocrine Disruptors are among several bodies who have expressed their concern for the possible association between these exposures in the ambient environment and reproductive dysfunction, including the alarming increase of breast cancer in the USA. (See Brian Price, Workplace Reproductive Hazards for Men and Women, in Conference Papers: Safety and Health at Work, London, March 4-6, 1997 (citing Introduction, in Theo Colburn et al., Our Stolen Future: Are We Threatening Our Fertility, Intelligence & Survival?--A Scientific Detective Story v-vii (1996). Price notes that "endocrine effects are not usually investigated when a new chemical is tested prior to use, so the possibility exists that familiar materials may be influencing human reproductive functions. The situation is complicated by the chance of interactions between different materials which may magnify or counteract the effects of each other." )

  These concepts, however, have not been tied together in a fully coherent regulatory analysis of consumer exposure to fragrances (however defined) because of the many types of environmental factors, including the unknown but suspected synergistic reaction between several different exposures to harmful substances at the same time. The need for a consumer-oriented approach to these issues is the next layer of regulation required in order to fully implement protections of public health under these laws. Ms. Bridges has done a great job of setting forth a blueprint for raising such concerns at public fora, in layperson’s terms.

In summary, Fragrance: Emerging health and Environmental Concerns": Flavour and Fragrance Journal, 2002; 17-361-371 reminds the general public of a more precise, and potentially urgent, need for corporate accountability in the ill-defined area of fragrance use. International resources and USA laws governing occupational health and safety provide an important backdrop against which the scope and efficacy of the other national laws can be measured, and hopefully future articles by the author will examine these important differences in regulatory scheme under different health and safety protective laws more closely. Occupational health exposure regulations and related laws provide more than a yardstick for measuring compliance, however; these laws underscore the fundamental character of such vital health protections as human rights. The universal need for such rules of law promotes and ensures the work, health and survival of civilized society. Ms. Bridges’ article wisely concludes that there is no dearth responsibility to be accepted for the potential harms to which all populations are presently exposed. Rather, there is a universal need for health professionals to urge the necessity and importance of  revisiting outdated research and then implementing sensible policies, in order for the health protections of all populations, not simply the workforce, to be achieved. 

I hereby grant permission for you to use the review, "Generally Recognized As Safe?" in full or in part, so long as credit is duly given to the author, specifically. Ilise L. Feitshans JD and ScM. This permission extends to web-based publication and printed media.

Editor’s note: The author has graciously given her permission for use as long as proper credit is given. Additional background information mentioned in the review is at the end of the newsletter

  

Current Science

There are obvious concerns related to fragrance regarding women’s reproductive health as well as the health of the developing fetus and breast-feeding infant. Research indicates there are also concerns related to male reproductive health.

Musk ambrette is a synthetic nitromusk that has been in use since the early 1900s. In the 1980s it was recommended that it not be used in fragrance as it had neurotoxic, phototoxic, and allergenic properties. In addition animal studies had found it caused atrophy of the testicles. In spite of the recommendation that the material not be used, it is still available for sale.

Citral is a common raw fragrance material. It causes enlargement of the prostate tissue in animal studies and has estrogenic effects. It tends to affect older male animals more than it does younger males. Research indicates it has estrogenic effects. The impact on the human male reproductive system has not been explored.

Research just published indicates there is an association between sperm damage and diethyl phthalate. Diethyl phthalate is the most common phthalate used in scented products. Previous research had not tested diethyl phthalate for its effects on sperm.

While this study does not prove that diethyl phthalate is the cause of the damage to the sperm, it does indicate much more research needs to be done and that present testing of materials used in fragrance is not adequate. Safety of fragrance materials needs to be assessed for male as well as female reproductive effects.

More information can be found at:

http://www.nottoopretty.org/pa_12_09_02.htm

http://ehpnet1.niehs.nih.gov/docs/2003/5756/abstract.pdf

 

ACTION ITEMS

  1. Support FDA Petition #99P-1340

    The Environmental Health Network of
    California asks that labeling laws which
    requires a warning for products whose safety
    has not be substantiated to be enforced.
    Send comments to

    Dockets Management Branch,
    Food and Drug Administration (FDA)
    Room 1061, 5630 Fishers Lane,
    Rockville, MD 20852.

    FAX: 301-827-6870

    E-mail: mailto:fdadockets@oc.fda.gov

    More information at: http://users.lmi.net/
    ~wilkworks/FDApetition/bkgrinfo.htm

  2. Support the Not Too Pretty Campaign, which calls from the removal of phthalates from cosmetics.

http://www.nottoopretty.org/index.htm

http://www.nottoopretty.org/action.html

Links of Interest

Environmental Health Perspectives - The journal is a forum for the discussion of the effect of the environment on human health http://ehp.niehs.nih.gov/

US Patent Office - Access US patents which are a source of technical and scientific information http://www.uspto.gov/

Find Articles - Search to find full text articles from a number of publications. www.findarticles.com

The WWW Virtual Library - http://www.vlib.org/

 

About FPIN News

FPIN News is the latest addition to the Fragranced Products Information Network site. The FPIN site and FPIN NEWS are owned, maintained, and financed by Betty Bridges.

The newsletter is freely accessible on the site and may be printed out and distributed in its entirety.

If you wish to use specific sections rather than the whole newsletter, please give proper credit including FPIN’s website address. Permission is given for use as long as the integrity of the material is not compromised.

If you have a question, suggestion, or comment for FPIN News please submit it to fpinva@fpinva.org

Please keep in mind that this newsletter is freely copied and distributed so do not include any information that you do not wish to be made public.

If you would like to contribute information for inclusion please send to: fpinva@fpinva.org

Future issues of FPIN NEWS will include a question and answer section. If you have a question, please submit it to: fpinva@fpinva.org

 

 

 

Additional background information provided by Ilise L. Feitshans JD and ScM

 

DECLARATION_POSITION STATEMENT AND PROPOSED PLAN OF ACTION FOR PERIOD UP TO 2000 AND IN 21st CENTURY: ON WORKERS’ REPRODUCTIVE HEALTH PROTECTION

(Adopted by the International Conference _ Medical and Ecological Problems of Workers Reproductive Health, 9_10 December 1998, Moscow, and refined by the Informal International Consulting Meeting of Experts on Reproductive Health Protection, 11th December 1998, Moscow, Russian Federation)

To insure optimum reproductive health protection worldwide, the Members of the International conference and Informal meeting of experts believe that there is an urgent need for elaboration of international consensus statements as well as the Plan of Action.

BACKGROUND INFORMATION: As satellite venture to the Conference on 11 December 1998 the Informal International Consulting Meeting of Experts on Reproductive Health Protection was held organized by the Initiative group (Dr. O.Sivochalova, Dr. E.Denisov, Prof. I. Figa_Talamanca, Dr. T.Vergieva, and Prof. I. Feitshans as Member and Legal Advisor). In the Consulting Meeting 21 specialists have participated from Belarus, Kazakhstan, Poland, Russia, Tadzhikistan, USA as Attending experts and 4 specialists from Bulgaria, Canada, Italy and Ukraine as Ex Officio experts (contributing by fax and e_mail correspondence). Chairpersons of the Meeting were Prof N. Izmerov, Director of the RAMS Institute of occupational health and Dr. O.Sivochalova, Head of the Centre of Medical and Ecological Problems of Workers, Reproductive Health of this Institute .Declaration_Position Statement and Proposed Plan of Action for Period up to 2000 and in 21st Century on Workers' Reproductive Health Protection have been unanimously adopted by the Committee of Experts.

 INTRODUCTION As recently called for by His Excellence, Mr. Kofi Annan, Secretary_General of the United Nations, the International Organizations, such as the ILO and the WHO and the national governments throughout the world should give occupational health and safety higher priority of their agendas. This would be necessary to respond effectively to the health and safety needs of working people and thereby promoting the overall socioeconomic development and well_being of countries and people. Dr. Gro Harlem Brundtland, Director_General Elect of the World Health Organization in her speech to the Fifty_first World Health Assembly (Geneva, 13 May 1998) emphasized: 2WHO can and must change. It must become more effective, more accountable, more transparent and more receptive to a changing world.

Recognizing the urgent need for improved primary care, protection of mothers, working parents and their children for the benefit of the family and the urgency attached to the problem of understanding the interaction between workplace exposures, environmental factors and preventing worker exposures that jeopardize familial health and human reproductive health, the Committee of Experts hereby calls upon the Director_General of WHO to use her good offices to foster further understanding, research and international co-operation in the following areas to prevent and reduce known or expected hazards to reproductive health AND

RECOGNIZING THAT many conventions that suggest there is an international need and obligation to address these issues, but no single comprehensive internaitonal instrument about reproductive health in the workplace addresses these issues directly nor does any such instrument adequately ensure access to information and risk communication for all people who confront reproductive health hazards at work;

The following proposals are based on updated principles and practices and should be considered as background for better reproductive health protection for every worker.

2. GENERAL STATEMENTS

According to the UN definition, "Reproductive health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity, in all matters relating to the reproductive system and its functions and processes... reproductive health care is defined as the constellation of methods, techniques and services that contribute to reproductive health and well-being by preventing and solving reproductive health problems..." (Cairo, 1994).

The Committee of Experts,

HAVING REGARD TO THE Aims and Principles of United Nations Charter, Universal Declaration of Human Rights, International Convention on the Elimination of All Forms of Discrimination Against Women, International Convention on Child Rights, UN Conference on Environment and Development (Rio De Janeiro, 1992), on Population and Development (Cairo, 1994), on Women (Beijing, 1995), WHO Constitution, Alma Ata Declaration (1978) and Health for All 2000", WHO Global Strategy for Occupational Health for All (1996), WHO revised policy document Health for All in the 21st Century (to be issued later), ILO Conventions and Recommendations on women workers, specifically but not limited to: C.103 Convention Concerning Maternity Protection (1952), C.165 Convention Concerning Employment Protection and Protection Against Unemployment; C. 156 Convention Concerning Equal Opportunities and Equal Treatment for Men and Women: Workers With Family Responsibilities", and C. 155 Convention Concerning Occupational Safety and Health, Related regional and national directives and recommendations namely Council Directive 92/85/ on safety and health of pregnant workers and

RECOGNIZING First that preserving any and every wage-earner's health and ability to enjoy reproductive health is essential to family life; to preserving the family; and protecting the next generation for posterity and

RECALLING the WHO view that health is tied to the prevention of impairments and the ability to participate in all life activities, and that the WHO should endorse a Plan of Action in this Declaration to address this urgent problem the Committee of Experts hereby FINDS AND DECLARES:

At present experts in many countries express serious anxiety about unsatisfactory health status of population especially of reproductive health as well as of children’s health due to influence of hazardous occupational and environmental factors (physical, chemical, biological agents, physic loads and nervous stresses[i][xii]). In some countries on the background of social and economical problems a critical situation in population reproduction have formed which threatens their sustainable development, especially for countries with transitional economies. Many pregnant workers have been denied access to primary care in occupational health services or in the health care delivery systems of the different nations and this grave situation causes further deterioration of maternal and child health and the well being of all society. 

The International Conference on Population and Development (Cairo, 1994) and the Fourth World Conference on Women (Beijing, 1995) have together focused on the need for all countries to examine policies and practices related to broader health concerns, bringing in both a human rights and a gender perspective. According to modern approach adopted ILO and WHO reproductive health of both genders (men and women) should be protected and promoted as part of general health. Women in some periods of reproductive life (women of fertile age, pregnant, recently delivered and breast-feeding) as well as children and adolescents should be considered as vulnerable groups i.e. high risk groups and need supplementary protection. In fundamental medical sciences by mutual efforts of professional community the concept of reproductive health is emerging as topic of the highest medical and social priority. The Meeting of Experts was an extension of other actions in the field namely Expert meeting AWomen at work@, 10_12 November 1997, Helsinki, Finland where it was suggested to develop an International legal document on the health protection of women at work, including pregnant women.

 3.ISSUES 3.1. Priorities in research and for primary health care system and occupational safety and health service Notwithstanding the progress in maternal and child health and in reproductive pathologies, some problems persist, and are even in the increase. A high proportion of conceptuses is lost prematurely, manifested as sub-fecundity and infertility, the rate of spontaneous abortion seems unchanged, congenital defects are a continuous problem, while childhood cancers are increasing. According to some, but not all studies, fertility and sperm quality are decreasing.

Although research efforts have considerably increased in this area in recent years, there are still many open questions. Some examples are the following:

-Is there a differential susceptibility of the female versus the male organism to exposures of chemical and physical agents in the work environment,

-How justifiable are differential standards and limits of exposure for the two genders, are present day work exposure limits sufficiently low to protect the reproductive health of men and women,

-Is there a true reduction in human fertility (and sperm quality), in the industrialized countries, and what may be the risk factors involved,

-How do factors previously neglected such as stress, shift work, work with new technologies, affect reproductive health,

-Are the known reproductive risks under control, and how can this be accomplished ?

Particular attention must be paid to the health of working women, a subject that has been neglected in both developed and developing countries. To fill this gap, it is important that the following steps be undertaken by governments and international organizations:

- Studies in the production sectors which employ predominantly female workers. These include both paid and unpaid (invisible) work in agriculture, in domestic labor, in garment, textile and food industry, in the health care sector.

-Identify reproductive risks for both men and women in these settings, and prevent exposures of those more vulnerable.

-Take account in studies of the double load of women workers, and of family and other stresses.

- Most reproductive hazards are dangerous to both males and females. Research should examine both. Selective overprotection of women may compromise employment opportunities of women, condemning them to poverty.

-Document the many forms of exploitation and illicit labor in developing countries, especially among adolescent girls and child laborers. These phenomena, although macroscopic are not sufficiently documented, and are often tolerated by local authorities.

-Document the deprivation and reproductive risks of migrant workers, who seek employment and survival in western countries. For them too, documentation and intervention programs are deplorably scarce.

3.2.Considerations for the need of specific approach in studying reproductive health at work

A number of chemicals are with a short half-life in the organism and a certain endpoint (as for example a birth defect) might arise only after exposure in the respective sensitive period of gestation, the necessity of studying a range of endpoints including sensitive ones and subtle changes as minor birth defects and postnatal functional deficits.

-Investigation directed to reveal dose-effect and dose-response relationship for proven and/or suspected reproductive and developmental hazards.

-Examination of additional and eventually new endpoints for reproductive toxicity.

-Studies on contribution of combined exposures.

-Exploration of potential reproductive hazards of new technologies, for newly introduced occupational chemicals and other agents as well as in branches of industry which have not been considered yet.

-Development of study protocols and statistical approach to deal with the problem of small numbers of employees in specific occupational settings and being exposed to specific hazards.

-Implementation of models for monitoring reproductive health of workers and subsequent use of these data for epidemiological studies. Further refinement of the protocols with inclusion of individual exposure data relevant for the respective endpoint period in case-control studies nested in a follow-up cohort.

-Encouraging occupational health services in reporting eventual clusters of mis-events in reproductive health and with the help of other specialists organizing at spot of follow-up studies.

3.3 Proposed Action to fill the gaps in existing international and state laws Regarding the role of workplace exposures in shaping reproductive health outcomes:.

The Committee of Experts Notes that there are many conventions that suggest there is an international need and obligation to address these issues, but

No single comprehensive international instrument about reproductive health in the workplace addresses these issues directly nor does any such instrument adequately ensure access to information and risk communication for all people who confront reproductive health hazards at work

An initial survey of international laws demonstrates that many of the treaties and conventions and international human rights instruments that provide jurisdiction for the protection of reproductive health are important but inadequate; they form only a patchwork of indirect efforts to protect people from reproductive health hazards in their workplace.

Further international legal research is needed in this area, comparing and harmonizing local, national and international laws and codes of practices from corporations regarding reproductive health hazards from occupational exposures