To: Angela Hofmann, EPA
Brett Hauber, OMB
From: Kevin Bromberg, SBA
Subject: Comments Regarding FIFRA Section 6(a)(2) Draft Final Rule
The SBA Office of Advocacy is forwarding these comments regarding the draft final rule that accompanied the Information Collection Request recently submitted to OMB. We have the following suggestions for revisions under the Paperwork Reduction Act, and pursuant to the OMB rule review process.
Under section 6(a)(2) of FIFRA, registrants are required to report to the agency allegations of "unreasonable adverse effects" in order to assure that the pesticide is being used without unreasonable adverse effects to human health or the environment. EPA's current reporting requirements under section 6(a)(2) of FIFRA are outlined in a 1979 Federal Register notice. EPA's assumption of only 7700 annual reported incidents seems extremely low under the draft final rule which dramatically expands the current requirements, by including incidents involving minor effects and adverse effects that may occur in the future.
Under the current version of the draft final rule, we doubt that EPA can appropriately certify this rule as having an insignificant economic impact. It states only a "fraction" of 2,500 registrants are small entities. This statement is misleading. However, the ICR states that the "other 90% of pesticide registrants are often small businesses." It is our belief that well over 90% of these entities qualify under the SBA definition of small entities (under 500 employees). I understand that EPA is revising this language regarding the certification, and am asking EPA to send the revised language to SBA for our review and comment on this important issue.
This draft rule adds paperwork requirements that are unreasonably burdensome (items A, B, C and D below) and lack "practical utility" (items B, C below) under the Paperwork Reduction Act. Furthermore, EPA has failed to utilize regulatory alternatives that would have lessened small business burdens under the Regulatory Flexibility Act. Specifically, EPA should examine exempting small businesses from the potentially costly "look back" review.
A. Definition of Registrant
Under the draft final rule, a registrant would include all "employees or agents," with some limited exceptions. Clearly this requirement goes far beyond the current policy, and could include consultants, lawyers, and many employees who have little to do with receiving such information, but "may be expected" to receive this information. EPA's preamble suggests that employees in such activities as food services, maintenance, and personnel would be excluded. This description does not comport with the agency's estimate that, on average, only seven employees per registrant would require training. In order to limit this requirement to match EPA's seven person average, which appears to be an appropriate target, we suggest that the covered employees and agents should be limited to those whose assigned functions include receiving and reviewing such complaints.
B. May Suffer An Adverse Effect
Currently, an incident is reported only if there is an effect allegedly due to pesticide exposure. The new draft rule expands this to "may suffer" a "toxic or adverse effect." It is difficult to imagine how this requirement can be interpreted or enforced. One can imagine that anyone who uses or is in contact with a pesticide "may suffer [an] adverse effect" sometime in the future. This open-ended type of requirement is unreasonably burdensome and lacks "practical utility" under the PRA. Perhaps this provision should be limited to nonacute effects that would not be cause symptoms in the short term. Also, the registrant should be allowed the option to exercise its judgment that no adverse effects can reasonably be expected.
C. Exemption for Minor Effects Warned Of on the Label
EPA requires incident reporting, except for minor eye or skin irritation warned of on the label in a residential setting. The current policy exempts such reporting in all settings, including institutional, industrial and agricultural settings. It is of limited utility to receive reports describing hundreds or thousands of persons receiving minor effects already described on the label - this is to be expected. Why should registrants of bug spray send incident reports of minor itching from workers to EPA? Should the agency receive a report about every agricultural worker who has splashed insecticide on his skin? CMA has estimated that this provision alone would increase incident reports by up to 900 percent. The current policy makes more sense. When the product is up for reregistration, then the experience of these minor effects can be reexamined in a more cost-effective manner, to examine whether packaging or other labeling changes are warranted.
At a minimum, the requirement to send incident reports involving minor warned of effects should sunset at the end of the three year period, unless the agency can affirmatively show the value of this reporting based on its actual experience with this provision. Also, EPA should exclude minor effects that do not require warnings by regulation. We suggest, in addition, that the agency should include an exemption for all minor effects in the current subsection (d)(3) which allows quarterly reporting of minor effects.
D. Retroactive Examination of Incident Reports
EPA's draft final rule requires a retrospective examination of all reports over the last five years. This provision is potentially the most expensive provision of the entire rule. CMA provides substantial evidence about the size of this burden being much greater than EPA's estimate. We would tend to believe CMA's figures, as they are based on actual experience examining analogous issues under the Toxic Substances Control Act. Unless small firms are exempted from this retroactive review requirement, it could impose a major financial burden on smaller registrants. Many registrants, particularly small registrants, maintain files by registration, rather than by severity of the adverse effects. EPA should carefully consider exempting small registrants from the "look back" requirement. Serious effects, if any, can be considered during the reregistration for such products, which will occur in the near term.
More importantly, I believe that any new reports under the "look back" requirement would provide evidence of violations of the current 6(a)(2) policy to report unreasonable adverse effects. In that event, companies submitting new reports would subject themselves and their employees to possible criminal and civil liabilities for failure to report. If these liabilities are real, EPA should be simultaneously issuing an enforcement policy providing for an amnesty period for the look back requirements.
E. Regulatory Flexibility
Based on the above, we would estimate that hundreds of small business registrants could have costs well in excess of $20,000 in the first year, given the number of incidents to report, and the scope of the retroactive review. This would subject the rule to the RFA requirements. As stated above, we look forward to EPA's revised certification language, in order to examine this issue further.