Exposure to certain agricultural pesticides may be associated with an increased risk of prostate cancer among pesticide applicators, according to a large study looking at the causes of cancer and other diseases in the farming community. The study, part of a long-term study of pesticide applicators and their spouses known as the Agricultural Health Study (AHS), appears in the May 1, 2003, issue of the American Journal of Epidemiology. The AHS is a collaborative effort involving the National Cancer Institute (NCI), the National Institute of Environmental Health Sciences, and the Environmental Protection Agency.
The latest report from the AHS evaluated the role of 45 pesticides and found that only a few of them showed evidence of a possible association with prostate cancer among pesticide applicators. Methyl bromide was linked to the risk of prostate cancer in the entire group, while exposure to six other pesticides was associated with an increased risk of prostate cancer only among men with a family history of the disease.
"Associations between pesticide use and prostate cancer risk among the farm population have been seen in previous studies; farming is the most consistent occupational risk factor for prostate cancer," said Michael Alavanja, Dr.P.H., from NCI's Division of Cancer Epidemiology and Genetics in Bethesda, Md., and principal investigator of the AHS.
The AHS, which began in 1993, is following nearly 90,000 participants from North Carolina and Iowa over time to evaluate the role of a variety of agricultural and lifestyle exposures on health. The participants are either farmers, wives of farmers, or workers who use pesticides on a regular basis.
The current study included 55,332 men who are classified as either "private pesticide applicators" (92 percent) or "commercial pesticide applicators" (8 percent). Private applicators are farmers or nursery-workers. Commercial applicators work for pest control companies or for businesses such as warehouses or grain mills that use pesticides regularly. Between 1993 and 1999, 566 new prostate cancers developed among all applicators, compared to 495 that were predicted from the incidence rates in the two states. This means that the risk of developing prostate cancer was 14 percent greater for the pesticide applicators compared to the general population. The men in this study were followed for about 4.3 years.
Methyl bromide is a fumigant gas used nationally to protect crops from pests in the soil and to fumigate grain bins and other agricultural storage areas. The scientists found that among both North Carolina and Iowa pesticide applicators, the risk of prostate cancer rose with increasing frequency of use of methyl bromide and with longer lifetime exposure to this pesticide. Elevated risks were seen only at the two highest levels of exposure (out of five possible levels). Risks were two to four times higher than among men who were not exposed to methyl bromide. Based on animal studies, the National Institute for Occupational Safety and Health (NIOSH) lists methyl bromide as a potential occupational carcinogen.
"We cannot rule out the possibility that our observation occurred by chance alone," cautioned Aaron Blair, Ph.D. M.P.H., chief of the Occupational and Environmental Epidemiology Branch in NCI's Division of Cancer Epidemiology and Genetics, and an author of the current study. "Clearly, these findings need to be replicated. But, the internal consistency of our findings does not allow us to dismiss these results."
The researchers found another link between pesticides and prostate cancer: among men with a family history of prostate cancer, exposure to six pesticides -- chlorpyrifos, coumaphos, fonofos, phorate, permethrin, and butylate -- was associated with an increased risk of prostate cancer. This effect was not seen among those without a family history. This type of finding, i.e., something appearing in only a subgroup of the entire study population, is particularly difficult to interpret, since it could result from chance or from differences between subgroups other than their use of pesticides. However, four of these pesticides, chlorpyrifos, coumaphos, fonofos, and phorate, are thiophosphates and share a common chemical structure. These findings suggest that certain pesticides may interact with a particular form of one or more genes shared by men with a family history of prostate cancer, making them more susceptible to developing the disease.
The most consistent risk factors associated with prostate cancer are age, family history, and African-American ethnicity. Hormonal factors and high levels of animal fat and red meat in the diet are also suspected risk factors. Several previous occupational studies have linked farming to prostate cancer risk. However, the variety of environmental exposures in the farming community such as pesticides, engine exhausts, solvents, dusts, animal viruses, fertilizers, fuels, and specific microbes, have made it difficult for researchers in previous studies to sort out which of these factors is linked to specific diseases. Because of the large size of the AHS population, and the detailed information on specific exposures and risk factors collected by the AHS researchers, it is possible to evaluate the risks associated with a number of specific chemical exposures.
As the study continues and participants age, many new cases of cancer and other diseases will develop. With time, the researchers will be able to confirm or refute the current findings, assess additional relationships between exposures and diseases, and search for possible genetic links to the variety of environmental exposures in the farming community.
FDA Issues Final Two Proposed Food Safety Regulations
The Food and Drug Administration (FDA) today publication of the final two food safety proposed regulations required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("The Act"), which gave FDA new authority to protect the nation's food supply.
The proposals are two of four proposed regulations that the Act calls upon FDA to develop regarding food safety. These two proposals deal with establishing and maintaining records among food firms, and the administrative detention of foods that may pose a risk to public health. The other two proposals, concerning the registration of food facilities and prior notice of imported foods, were published in January 2003.
The recordkeeping proposal is designed to help FDA track foods implicated in future emergencies, such as terrorism-related contamination. Under the proposed rule, manufacturers, processors, packers, distributors, receivers, holders and importers of food would be required to keep records identifying the immediate source from which they received the food, as well as, the immediate subsequent recipient, to whom they sent it. This requirement would apply to almost all foreign and domestic food sources and almost all recipients of food destined for consumption in the United States. It would assist FDA in addressing credible threats of serious adverse health consequences or death to humans or animals.
To minimize the economic burden on food companies affected by the proposal, FDA's proposals would allow companies to keep the required information in any form that they prefer. Records may be kept in any format, paper or electronic, provided they contain all the required information. The proposed rule also states that existing records can be used to satisfy the requirements of the regulations if these records contain all the required information.
For persons other than transporters the proposed rule would require the records to contain the following information for each article of food:
- The firm's name, and the responsible individual representative of the firm that was the immediate previous source or the immediate subsequent recipient of the food
- The address, telephone and fax numbers, and e-mail address of that person, if available
- The type of food, including brand name and specific variety
- The date received or released
- Lot number or other identifier number, if available
- The quantity and type of packaging
- The name, address, telephone number -- and, if available, fax number and e-mail address -- of the transporter who transported the food
With respect to the immediate previous source, the specific source of each ingredient that was used to make every lot of finished food product would have to be identified if this information is reasonably available. What is reasonably available may vary from case to case.
If an article of food is reasonably believed to be adulterated and presenting a threat of serious adverse health consequence or death to humans or animals firms would be required to provide these and other records to FDA within four hours during certain business hours, or eight hours at other times.
Transporters (e.g., trucking companies, private delivery carriers, railroads and airlines) would also be required to keep similar documentation-including information about all the means of transportation used.
The proposed rule would require records to be established at the time the covered activity occurs. FDA is proposing that required records for perishable foods not intended for processing into non-perishable foods, and required records for animal food including pet food, be retained for one year from the date they were created. Records for all other foods would have to be retained for two years after the date they were created.
Farms, restaurants, (including all operations that prepare food for, or serve food directly to consumers), fishing vessels not engaged in processing, and firms regulated exclusively by the U.S. Department of Agriculture, would be exempted from the new recordkeeping requirements. With some exceptions, foreign facilities would be excluded if their food products undergo further manufacturing/processing, including packaging, by another facility outside the United States.
Retail food operations would be exempted from maintaining records on immediate subsequent recipients of foods sold directly to consumers.
This proposed regulation provides that a final rule would become effective six months from the date of publication of the final rule in the Federal Register. For small businesses (fewer than 500 but more than ten full-time equivalent employees) a final regulation would become effective 12 months from that date, and for very small businesses (ten or fewer full-time equivalent employees), the effective date would be 18 months from publication of the final regulation.
FDA intends to publish a final rule no later than December 12, 2003, in accordance with the deadline set forth in the Act. Given this statutory deadline, FDA will not be able to extend the comment period on this proposed rule.
The other proposed regulation on administrative detention implements FDA's new authority to detain any article of food for which there is credible evidence that the article poses a threat of serious adverse health consequences or death.
The administrative detention authority granted to FDA under the Act is self-executing and currently in effect, and provides an added measure to ensure the safety of the nation's food supply. As required by the Act, FDA is issuing this proposed rule that includes expedited procedures for instituting certain enforcement actions against perishable foods. The proposed rule also includes procedures describing how FDA will detain an article of food and the process for appealing a detention order.
Specifically, the proposed rule would require a detention order to be approved by the FDA District Director of the district where the detained article of food is located or a more senior official. A copy of the detention order would be given to the owner, operator, and/or agent in charge of the place where the article of food is located, and to the owner of the food if different than those listed above. If FDA issues a detention order for an article of food located in a vehicle or other carrier used to transport the detained article of food, FDA also would have to provide a copy of the detention order to the shipper of record.
The detention order would provide the following information:
- The detention order number
- The hour and date of the order
- The identification of the detained article of food
- The detention period
- A statement that the food identified in the order is detained for the period shown
- A brief, general statement of the reasons for the detention
- The address and location where the article of food is to be detained and the appropriate storage and transportation conditions.
The proposed rule would require a detained article of food to be held in a secure location, as determined by FDA. Detained food may not be delivered to another entity, such as its importer, owner, or consignee. Detained food also may not be transferred from the place where it has been ordered detained, or from the place to which it has been removed, until FDA releases the article or the detention period expires. The detention may not exceed 30 days. Violation of a detention order is a prohibited act.
Any person who is entitled to claim the detained article of food may appeal the detention order. For perishable food, the proposed rule would require an appeal to be filed within two calendar days of receipt of the detention order. For non-perishable food, a notice of intent to appeal would have to be filed within four calendar days, and the appeal would have to be filed within ten calendar days of receipt of a detention order. FDA is required to issue a decision within five calendar days after an appeal is filed, after providing an opportunity for an informal hearing. The decision rendered on appeal is considered final agency action that may be challenged in court.
The definition of food used in the proposed rule references the definition of food in section 201(f) of the Federal Food, Drug, and Cosmetic Act and would include food intended for consumption both in the U.S. and elsewhere. Food under the exclusive jurisdiction of USDA (i.e., meat products, poultry products and egg products) is not be covered by the administrative detention proposed regulation.
A comment period of 60 days will be provided on these proposals. Written comments can be submitted to FDA at: Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. It is important to include docket number 02N-0277 for the recordkeeping proposal and docket number 02N-0275 for the administrative detention proposal when providing comments.
OSHA Reopens Manhattan Area Office
OSHA officially re-opened its Manhattan Area Office, a year and a half after it was destroyed in the terrorist attacks on New York City on Sept. 11, 2001. John L. Henshaw, Assistant Secretary of Labor for Occupational Safety and Health, inaugurated the new office, located at 201 Varick Street.
"Although OSHA's Manhattan Area Office was destroyed on September 11, 2001, its employees stepped up to the challenge and continued their work undaunted," said Henshaw. "With the opening of this new facility, OSHA's Manhattan Area Office has a permanent home from which it will continue its important work of protecting the workers it serves so well."
OSHA's original office, located in Building Six of the World Trade Center complex, was destroyed by the terrorist attack. Staff from that office safely evacuated, regrouped, and soon returned to service at the site of their former office. There, joined by over one thousand other OSHA professionals, they worked around the clock for 10 months to protect the safety and health of workers at the site.
During the operation, OSHA workers fitted more than 6,100 workers for respirators, including 2,700 New York fire department employees; distributed on-site more than 130,000 respirators; collected more than 6,000 samples of hazardous substances; and most importantly, ensured that no more lives were lost at the site.
OSHA Receives First Set of Work Plans from National Advisory Committee on Ergonomics
The National Advisory Committee on Ergonomics (NACE) presented their first set of work plans to OSHA to assist the agency in its goal of reducing musculoskeletal disorders in the workplace. The committee wrapped up its second meeting in Washington following two days of work group sessions highlighting guidelines, outreach and assistance, and research.
"We challenged you in January to use your collective expertise to help us achieve our goal of reducing musculoskeletal injuries in the workplace," Henshaw told the 15-member committee, lauding the productivity of the work groups. "In only two meetings, you're already given us much to consider and I look forward to your continued best recommendations on some tough issues that ultimately will help us achieve our goal of reducing musculoskeletal injuries in the workplace."
The committee's efforts focused on three work groups: guidelines, outreach and assistance, and research. The guidelines work group discussed factors that OSHA should use to determine specific industries for which guidelines should be developed, including injury/illness rates, population impacted, willingness of specific industry stakeholders, and taking into consideration existing successful program models. The group also suggested various types of data OSHA should consider that help demonstrate that ergonomics makes good financial sense, such as savings in a lower worker turnover rate, lower workers compensation costs, and increased productivity and worker morale.
The breakout group on outreach and assistance has already begun reviewing current OSHA outreach efforts, and will review the agency's website and links to other resources. The group will also be identifying industries and organizations willing to share ergonomic best practices, success stories and their own outreach materials, and others willing to join OSHA in conducting ergonomics seminars and roundtables throughout the country.
Based upon a recommendation of the research discussion group, NACE is recommending a symposium for published researchers on work-related musculoskeletal disorders to examine in detail their studies and the methodologies used. The research group also recommended that future presentations to the full committee include a neurologist to discuss diagnostics as a key to effective research, and a presentation on research reports from the National Academy of Sciences.
The National Advisory Committee on Ergonomics was selected by Secretary of Labor Elaine L. Chao last December and is tasked with advising her and the Assistant Secretary of Labor for OSHA on ergonomic guidelines, outreach and assistance, and research. Chartered for two years, the committee is scheduled to meet again in September.
OSHA Invites Comments on Draft Ergonomics Guidelines For Retail Grocery Stores
The draft guidelines will be published in the May 9, 2003 Federal Register.
"In developing these guidelines, OSHA reviewed existing ergonomic practices and programs in the retail grocery industry, and visited grocery stores to observe programs in action," said John L. Henshaw, Assistant Secretary of Labor for Occupational Safety and Health. "The agency also considered the available scientific data, and conducted one-on-one meetings with stakeholder groups to gather the best information available on successful practices, programs and processes in the retail grocery store industry."
The draft guidelines consist of an introduction and two main sections. The introduction provides an overview of musculoskeletal disorders in retail grocery stores and explains the role of ergonomics in reducing these injuries. The first section describes how to develop and implement a strategy for analyzing the workplace, implementing ergonomic solutions, training employees, addressing injury reports, and evaluating progress. The second section gives examples of solutions that may be used by retail grocery stores to control exposure to ergonomic risk factors in their workplaces, including recommendations geared to specific departments like stocking, bakery, produce, meat, and checkout, bagging and carryout. The draft guidelines conclude with a list of helpful references and resources.
"Many grocery stores have implemented injury prevention efforts," continued Henshaw. "The grocery store industry has reduced occupational injuries by a third over the last 10 years, from 12.5 per 100 full-time workers in 1992 to 8.1 in 2001. But workers are still injured in this industry, and we hope these guidelines will help employers reduce the injury and illness rate still further."
The guidelines are intended to provide practical solutions for reducing ergonomic-related injuries and illnesses in retail grocery stores. They do not address warehouses, convenience stores, or business operations that may be located within grocery stores, such as banks, post offices or coffee shops, although they may be useful to employers and workers in those workplaces. They will not be used for enforcement purposes. OSHA is also working on guidelines for the poultry processing and shipyard industries, and will make drafts available for comment.
Interested parties must submit written comments on the draft retail grocery store ergonomics guidelines to the OSHA Docket Office by July 8, 2003. After the conclusion of the comment period, there will be a stakeholder meeting in the Washington, DC metropolitan area to discuss the draft guidelines. Individuals are required to submit their intent to participate in this one-day stakeholder meeting by July 8, 2003. Location and date will be announced at a later date. Copies of the guidelines can be downloaded from the OSHA Webpage and also are available by calling OSHA toll-free at (800) 321-OSHA (6742) or faxing a request to (202) 693-2498. Additional information on submitting comments is available by calling the OSHA Docket Office at (202) 693-2350 (TTY (877) 889-5627), or in the May 9, 2003 Federal Register.
