This report presents the status of the chronic health effects studies required by the Birth Defect Prevention Act (the Act) for the priority 200 active ingredients. DPR identified these active ingredients in 1985 as having the most significant data gaps, widespread use, and which were suspected of being hazardous to people. For the priority 200 active ingredients, the required health effects studies were due to the Department of Pesticide Regulation (DPR) by March 30, 1996. If pesticide registrants failed to submit the required studies, data gaps exist. A "data gap" means that DPR lacks adequate health effects studies in the following areas: chronic toxicity, mutagenicity, neurotoxicity, oncogenicity, reproductive effects, and teratology. Pesticide registrants are in compliance with the Act when DPR receives final reports for all required studies, unless later evaluation determines that any study is not adequate.

This is DPR's annual report to the Legislature on the data gaps that remain for the priority 200 active ingredients, as required by 1991 legislation (SB 550) amending the Act.

BACKGROUND:

The Act required DPR to acquire certain toxicological data for registered pesticide active ingredients in order to make a scientific determination that their continued uses will not cause significant adverse health effects. If the use of an active ingredient presents potential significant adverse effects, the Act requires DPR to suspend or cancel the registration of pesticide products containing those active ingredients.

In January 1986, DPR notified each registrant of pesticide products containing any of the priority 200 active ingredients of the data required to fill the data gaps. DPR found that much of the data submitted in response to the data call-in notice were from studies that did not meet the U.S. Environmental Protection Agency guidelines for conducting such studies. Because these studies had been performed some years ago, many registrants were unable to obtain additional data from the laboratories which conducted the original studies; thus, the studies could not be upgraded. Then registrants contracted with laboratories to begin new studies; however, most registrants failed to complete and submit new chronic health effects studies within the time frames in the law.

AMENDMENTS:

The Act was amended in 1991 and 1996. In 1991, amendments strengthened the Director's authority to suspend product registrations. They required the Director to initiate a suspension process for products containing active ingredients for which data gaps existed after December 31, 1991. These amendments provided that under certain conditions, registrants and others could petition for additional time to submit the data. However, the law clearly states that no pesticide product shall remain registered if it contains any of the priority 200 active ingredients for which data gaps exist after March 30, 1996. In March 1996, another amendment to the Act allowed continued registration of products containing two active ingredients while studies are being completed. For methyl bromide and pentachlorophenol, the studies are due by December 31, 1997.

REPORT SUMMARY:

Of the priority 200 active ingredients, 147 remain registered. Of the 53 active ingredients that are no longer registered in California, DPR suspended product registrations for six active ingredients before registrants chose not to renew them. For the active ingredients that remain registered, the report identifies study categories with adequate data, data being developed for methyl bromide and pentachlorophenol, the data at DPR pending evaluation, and inadequate data. Product registrations are suspended if data for any active ingredient cannot be upgraded with the submission of additional information. DPR determined that pesticide registrants filled the data gaps for 125 active ingredients. DPR also determined that sufficient data exist in the public literature to assess potential adverse health effects for nine active ingredients in lieu of submission of additional data. For eight active ingredients, DPR is evaluating submitted data. Data gaps exist for five active ingredients. DPR suspended registrations of products containing three of these active ingredients, and studies are in progress for two active ingredients, methyl bromide and pentachlorophenol. These studies are due to DPR by December 31, 1997.

The following table summarizes the June 1997 annual report.

                      BIRTH DEFECT PREVENTION ACT
                             REPORT SUMMARY
                               JUNE 1997

Status summary of the priority 200 pesticide active ingredients identified
according to Food and Agricultural Code Section 13127(a).

 I.   53 active ingredients are no longer registered
          a.  Registrations were not renewed by registrants       47
          b.  Registrations were suspended before the
                   products were not renewed by registrants        6
                    Cyhexatin
                    Coumaphos
                    Dimethylphthalate
                    Ferbam
                    Naphthalene
                    Parathion                          
                                                                                                    
II.  147 active ingredients are currently registered
          a.  A set of adequate data is on file                   125
                1 active ingredient exempted from data requirements 
                  for three years under FAC section 13127 (e)(2):
                         Diclofop-methyl
          b.  Data are not required at this time
               (adequate data exist in public literature to 
                 assess potential adverse health effects)           9
          c.  All data submitted (one or more studies
               pending review and/or data are upgradable)           8           
          d.  Active ingredients with data gaps                     5
               1.  2 active ingredients with one or more 
                    studies in progress.  Deadline extended 
                    to 12/31/97 in FAC section 13127.32 for:
                      Methyl Bromide
                      PCP (Pentachlorophenol)
               2.  3 active ingredients have products suspended:
                      Bendiocarb
                      Chloroneb*
                      Petroleum Distillates, Aromatic
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                                                                   200

* One Chlorneb product was suspended; one product was granted an exemption
from the data requirements; one product is being evaluated for exemption
from data requirements.