Document ID: EPA-HQ-OPP-2010-0305-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-12-31T05:00Z

Cost and Small Business Analysis of 
                 Proposed Revisions to Minimum Risk Exemption
                               November 9, 2012 
                                       
Background
      Under FIFRA 25(b)(2), EPA may exempt from the requirements of FIFRA any pesticide that is "of a character unnecessary to be subject to [FIFRA]". Pursuant to this authority, in March 1996, EPA promulgated 40 CFR 152.25(g), which exempted from FIFRA any pesticide products consisting solely of specified ingredients that EPA judged to pose minimum risk to humans and the environment (61 FR 8876, March 6, 1996).  This provision was later redesignated as §152.25(f) (66 FR 64759, December 14, 2001).  
      
      Unlike producers of registered pesticides, producers of products exempted under 152.25(f) do not register their products with EPA, pay registration fees, or report production to EPA.  Exempt products are required to provide certain information on their labels, including the names of both the active and inert ingredients.  However, the names found on labels are often the technical names, which are not known to consumers, may not be known to all inspectors, which can lead to confusion and delays in enforcement.
      
      EPA is modifying the label requirements in the exemption to require the use of specific common chemical names in lists of ingredients on minimum risk pesticide product labels, which will facilitate enforcement, and to require producer contact information on the label. EPA is also proposing to more clearly specify the active and inert ingredients permitted in products eligible for the exemption from regulation for minimum risk pesticides (40 CFR 152.25(f)).  EPA is reorganizing these lists and adding specific chemical identifiers to make it clearer to manufacturers; the public; and Federal, state, and tribal inspectors the specific ingredients that are permitted in minimum risk pesticide products.  
      
      The purpose of this analysis is to estimate the cost of label changes as proposed, as separate and distinct from (i.e., incremental to) routine label changes that producers already undertake and assess the impacts on small entities.  The document is organized as follows.  In section 2, the profile of affected industry is described, including the total number of minimum risk pesticide products currently on the market and the firms that produce these products.  In section 3, the anticipated costs of the proposed rule are estimated for three implementation periods: immediate, two years, and three years.  The cost per label change and the total number of label changes anticipated from the proposed rule are estimated, from which the industry cost is derived.  Using the cost estimates of section 3, the impacts on small businesses are analyzed in section 4.  Based on this analysis, EPA concludes that there will not be a significant impact on substantial number of small entities.
Profile of Affected Industry
      In this section, the minimum risk pesticide industry that would be affected by the proposed rule, once final, is delineated.  Minimum risk pesticide products are identified in subsection 2.1 and the firms that produce these products are described in subsection 2.2.
Minimum Risk Pesticide Products
      Table 1 shows the number and types of minimum risk pesticide products.  The information in Table 1 is derived primarily from lists of products registered in 14 states (EPA, 2010).  Although minimum risk products are exempt from registration by EPA, approximately 37states require registration of these pesticide products.  Many of these states provide their pesticide registration lists (including for minimum risk pesticides) online, and available to the public.  In addition to the states' registration lists, the list of personal insect repellent products is also derived from the retail store scanner data (Nielsen, 2008) and on-line searches.  

                        Table 1.  Minimum Risk Products
Type of Product
                                    Number
Antimicrobial
                                       2
Deodorizer
                                       1
Fungicide
                                       9
Fungicide & Herbicide
                                       2
Herbicide
                                      62
Herbicide & Fertilizer
                                      32
Rodenticide
                                       6
Insecticide
                                      149
Insecticide/Repellent
                                       2
Repellent, Animals
                                      141
Repellent, Insect for Animals
                                      31
Repellent, Insect for Pets
                                      20
Repellent, Insect
                                      218
Repellent, Insect, Skin-applied
                                      74
Unknown
                                       8
Total
                                      757
                             Sources: State minimum risk product registrations (2010)
             	   and AC Nielsen (2008).

      Only the products that comply with 40 CFR 152.25(f) would be subject to the rule.  Based on the Agency's enforcement experience and review of minimum risk insect repellent labels, some products marketed under the minimum risk exemption are not in full compliance.  They may, for example, include inert ingredients that have not been approved for these products.  When identified, these products must be registered with EPA or reformulated to comply with 40 CFR 152.25(f).  
      
      Since EPA may have incomplete information regarding the number of products out of compliance, we assume that all 757 products in Table 1 are subject to the rule, which would result in an overestimation of the cost of the rule.  On the other hand, since exempt products are not registered, Table 1 may not include all of the minimum risk pesticide products on the market, leading to an underestimate of the cost of the rule.  The net effect of these two opposing factors cannot be determined due to the lack of data. 
       
Firms Producing Minimum Risk Products
      Table 2 summarizes the number of firms producing the minimum risk pesticide products identified by EPA.  A total of 216 firms were identified. Some of these firms (23) produce both skin-applied insect repellents and other minimum risk pesticide products.
                                       
    Table 2. Number of Minimum Risk Pesticide Product Firms by Product Type
Firms Producing
                                Number of Firms
                                   Products
Skin-Applied Insect Repellents
                                      34
                                      74
Other Products
                                      205
                                      683
Both of the Above
                                      23
                                       
All Products
                                      216
                                      757
         	   Sources: State minimum risk product registrations (2010) and AC Nielsen (2008).  
      
      For the purpose of cost analysis, the firm data is needed for the highest level of multi-layered corporate organizations, called the parent firm.  EPA used the Dun & Bradstreet (D&B) Market Spectrum database to obtain firm size and financial data, and to determine the parent firms (Dun & Bradstreet, 2009).  D&B is a comprehensive source of financial information on entities, including firm locations, sales, and primary business classifications under North American Industrial Classification System code (NAICS).  Based on a review of this data, 192 parent companies were identified (Table 3).  Not all parent companies could be determined from the D&B database.  Together, the 192 parent companies account for 541 minimum risk products, or about 79 percent of those identified by EPA.
                 
      Table 3 shows the distribution of firms by NAICS code.  Most firms in the minimum risk pesticide industry belong to Chemical Manufacturing (NAICS code 325) and Merchant Wholesalers, Nondurable Goods (NAICS code 424).  Forty-two firms are divided among 31 NAICS codes, including NAICS codes 311, 332, and 333, each with four firms), NAICS codes 335 with 3 firms, NAICS codes 112, 115, 445, 453, 525, each with two firms, and 17 NAICS codes with one firm in each.  

                Table 3.  Producers of Minimum Risk Pesticides
                              3-digit NAICS Code
                            NAICS Code Description
                            Number of parent firms 
                                      325
Chemical Manufacturing
                                      72
                                      339
Miscellaneous Manufacturing
                                       8
                                      423
Merchant Wholesalers, Durable Goods
                                      11
                                      424
Merchant Wholesalers, Nondurable Goods
                                      32
                                      444
Building Material and Garden Equipment and Supplies Dealers
                                       7
                                      541
Professional, Scientific, and Technical Services
                                       7
                                      561
Administrative and Support Services
                                      13
                                    Others
 
                                      42
                                       
Total with classification 
                                      192
Sources:  State product registrations (2010), AC Nielsen retail store scanner data (2008).

Cost of Label Changes
      In this section, the cost of the proposed rule, once final, is estimated.  The cost of the rule consists of a one-time change in the design of the label to comply with the proposed requirements.  The incremental cost of the proposed rule depends on the extent to which the change is separate and distinct from the routine label changes firms undertake on regular basis.  The section is organized as follows: The methodology for estimating the cost per label change is presented in subsection 3.1.  In subsection 3.2, the total industry cost is estimated by multiplying the cost per label change by the total number of label changes that result from the proposed rule.  
Cost per Label Change Methodology
     In general, the cost of a label change depends on the size and type of packages for products, which determine types of graphics and printing methods.  Also, the firm size can influence the cost of labeling as smaller firms may choose setups that are less expensive (e.g., graphic designs with fewer colors).  It is noted that firms change their labels on a routine basis to update or "refresh" their product labels even if not required by government regulation and this is an important factor that determines the magnitude of the cost of the rule.  The proposed rule, once final, will impose some cost to redesign the label to accommodate new EPA requirements.  The expected cost of the label change will depend on the duration of the rule implementation period, which will determine the extent to which the EPA's requirements can be incorporated into firm's routine relabeling operations.  
     
     To estimate the cost of the rule, EPA uses the Food and Drug Administration's (FDA) labeling cost model (FDA, 2003) developed for estimating the labeling cost for food products.  This is a reasonable model for minimum risk pesticide products because the package sizes and shapes of exempt pesticide products are similar to the packaging for many food products.  According to this model, firm's labeling cost consists of:
      1. Setup costs
            a. Administrative costs
            b. Graphic design
            c. Printing setup  -  prepress and engraving
      2. Printing cost

     Administrative costs include working with outside vendors to supply graphic design, prepress and engraving, market testing of redesigned graphics, and meeting EPA requirements (e.g., searching the common chemical names for the ingredients).  Firms often work with a graphic design company to redesign their label graphics.  Depending on the type of graphic designs (e.g., number of colors), costs vary.  Prepress operations convert the design created by the designer into the film or files that are used to engrave or etch the printing plates or cylinders (FDA, 2003).  Estimates for these setup costs are described in the next subsection (Table 4). 
     
     Because firms have to print labels anyway, printing cost is not a cost of this rule unless firms would have to print labels before they used up their stock of printed labels.  Because firms will be allowed two years to change labels and will know in advance of two years that label changes will be required, we assume that firms will be able to plan in advance and not have any unused packaged product and label stock.

     The cost of a firm's routine label change is considered as the baseline in estimating the incremental cost of the proposed rule, because the routine re-labeling cost is part of the normal business operations in the absence of the rule.  
     
     In the next subsection the setup costs per label change are described.
Setup Costs per Label Change  -  Baseline
     In order to successfully market their product, producers label their product with the information that they want the public to know about the product.  Thus, producers create labels, and update labels as a routine cost of doing business.  
     
     Table 4 below summarizes the setup costs per label change.  Many products have more than one size or type of package.  Each is referred to as a stock keeping unit (SKU) (FDA, 2003).  Each SKU would have to be relabeled to comply with the new requirements.  For each type of a label change (e.g. 1-color), FDA has a low, medium, and high estimate.  Table 4 shows the low estimate for a 1-color change, the medium estimate for a 2-color change, and the high estimate for a full redesign with 6 colors, thus covering the range of cost estimates from the lowest to the highest.  The last column shows the simple average of all nine of FDA's estimates.   EPA assumes that these average costs will apply to the industry as whole (both large and small firms).  The average setup costs to re-label range from $1,282 to $14,762.
   
Table 4.  Setup Cost to Re-label per SKU (Stock Keeping Unit): Baseline
 
                                 1-color, low
                                2-color, medium
                            Full redesign, high[b]
                                  Average[c]
Administrative
                                                                          $134 
                                                                          $504 
                                                                          $986 
                                                                          $504 
Graphic design
                                                                          $336 
                                                                        $1,512 
                                                                        $3,360 
                                                                        $1,512 
Prepress a
                                                                          $353 
                                                                          $765 
                                                                        $3,920 
                                                                        $1,389 
Engraving a
                                                                          $459 
                                                                        $1,374 
                                                                        $6,496 
                                                                        $2,229 
Total
                                                                        $1,282 
                                                                        $4,155 
                                                                       $14,762 
                                                                        $5,634 
Source: FDA Labeling Cost Model (FDA, 2003) adjusted for inflation using Producer Price Index for printing of 1.12
[a] Average of flexography, offset lithograph, and rotogravure
[b] With 6 colors
c Average of all 9 of FDA estimates:  3 each of 1-color, 2-color, and full redesign.

	  Estimates in Table 4 represent the baseline costs of label change the firms routinely conduct as part of normal business operation.  In the next subsection, the costs of the proposed rule under different compliance periods are estimated.
Cost of the Proposed Rule
      The proposed rule, once final, will impose some cost to redesign the label to accommodate new EPA requirements.  The expected cost of the label change will depend on the length of the rule implementation period, which will determine the extent to which the new EPA requirements can be incorporated as part of firm's routine relabeling operations.  In a previous analysis (EPA, 2005), EPA determined that many pesticide labels routinely undergo changes every 1 to 3 years.  Based on this information, for the current cost analysis, EPA assumes that firms will routinely re-label every three years, although some firms may re-label more or less frequently.
      
      Also, the 2005 EPA analysis assumed that if the changes occurred during a routine label update, then one-third of the artwork cost would be due to EPA's mandate.  Applying the same assumption, EPA assumes that if the firm's routine re-labeling operation falls within the rule compliance period (that is, if the rule requirements can be fully coordinated with the firm's routine labeling change), the cost of the rule would amount to one-third of the baseline administrative and graphic design costs only.  This incremental cost is associated with complying with EPA requirements (adding common chemical names and company contact information, etc).  This is the only cost of the label change due to the rule because the rest of relabeling costs will be incurred as part of firm's normal business operations.  In Table 5, the cost estimates for this scenario range from $157 to $1,449.
      
      If the firm's routine relabeling cycle falls outside the rule compliance period (that is, if the rule requirements cannot be incorporated into the firm's routine labeling change), then the firm must incur the full cost of label change estimated in the previous subsection (see Table 4) plus administrative and graphic design costs would be one-third larger due to EPA's mandate.  In the first row of Table 5, the cost estimates for this scenario range from $1,439 to $16,210.  These costs are calculated by adding the one-third extra administrative and design costs to the baseline costs of a routine label change from Table 4.   This extra cost is shown in the last row of Table 5 because EPA assumes that all labels would have been routinely changed within three years without the rule.
      
      If the firm's routine relabeling cycle overlaps with the rule implementation period, the cost of the rule would lie between the two cases described above.  For example, if the rule implementation period is two years, two-thirds of the labels are likely to be relabeled during the rule implementation period, while one-third of the labels are likely to be relabeled ahead of their routine label change schedule because of the rule mandate (FDA, 2003).  In this case, the average cost per label is estimated to range from $584 to $6,369 (Table 5).  For example, the weighted average cost for a 1-color change is computed as $1,439*(1/3) + $157*(2/3) = $584.  
      
      The estimated costs of the rule under different rule compliance periods are shown in Table 5.   
      
Table 5.  Relabeling Cost per SKU (Stock Keeping Unit) under Three Rule Implementation Periods
 
                                 1-color, low
                                2-color, medium
                              Full redesign, high
                                   Average[1]
Immediate relabeling[2]
                                                                        $1,439 
                                                                        $4,827 
                                                                       $16,210 
                                                                        $6,306 
2-year implementation
                                                                          $584 
                                                                        $2,057 
                                                                        $6,369 
                                                                        $2,550 
3-year implementation[3]
                                                                          $157 
                                                                          $672 
                                                                        $1,449 
                                                                          $672 
Source:  EPA calculations.
[1]Average of all 9 of FDA estimates:  3 each of 1-color, 2-color, and full redesign.
[2] Does not include additional printing costs due to discarding of label stocks.
[3]Since 3 years sufficient time for  routine label changes, this row represents the cost attributable to rule if the firm would have relabeled anyway, which is 1/3 of administrative and design costs.

      
     If firms are required to re-label their products, additional costs could be incurred in terms of unused packaged product and label stocks that have to be discarded requiring additional printing costs to replace discarded label stocks.   However, EPA assumes that firms will be able to plan in advance and not have any unused inventory stocks, thus avoiding this cost with two or more years to comply with the label change requirements.  While these costs would occur with immediate relabeling, we have no information to estimate additional printing costs due to discarding of label stocks.  For the above reasons, we did not include this cost in our estimates.
Industry Cost    
     To estimate the cost to industry of the proposed rule, the average label setup cost per SKU is multiplied by the anticipated number of label changes (the total number of SKUs).  For the industry consisting of large and small firms, we use the average re-label cost in the right hand column of Table 5.  The total number of label changes is based on the number of exempt pesticide products in the industry and the average number of SKUs per product, which depends on the number of package sizes and types per product.  Since there is no data regarding the number of SKUs per product for the minimum risk pesticide industry, EPA uses 1.53 SKUs per product from the FDA's sunscreen rule (FDA, 2011).  EPA believes that skin-applied insect repellents (approximately 10% of the total number of minimum risk products identified in this study, see Table 1) are probably similar to sunscreen products in terms of multiple packaging since both are dermal application products for humans and thus, 1.53 SKUs per product may be a reasonable estimate for these products.  However, for the other products affected by the rule there are no data regarding the number of SKUs per product, and this is a source of uncertainty in the estimation of the cost of the proposed rule.  Any information during the public comment period on the number of SKUs per product would be useful since the cost of this rule is proportional to this number.

      Using the average cost estimates from the last column of Table 5 EPA estimates the industry cost under three different rule implementation periods, assuming firms are on a three-year relabeling cycle: immediate relabeling, two years, and three years.  To estimate the cost of the rule under each implementation period, the number of SKUs per product (1.53) is multiplied by the total number of minimum risk pesticide products (757 from Table 1) to obtain the total number of SKUs (1,158), which is in turn multiplied by the average cost per SKU from the last column of Table 5.  The results are displayed in Table 6.  
      
Table 6: Industry Cost Under Three Rule Implementation Periods
 
                                   Immediate
                                    2 years
                                    3 years
Total number of SKUs[a]
                                     1,158
                                     1,158
                                     1,158
Average cost per SKU label change (last column of Table 5)
                                    $6,306
                                    $2,550
                                     $672
Total cost to industry[b]
                                  $7,300,282
                                  $2,952,097
                                   $778,005
Source:  (FDA, 2003 and 2011)
[a] The total number of SKUs is equal to the SKUs per product (1.53) times the number of products (757).
[b] The total cost to industry is equal to the total number of SKUs times the average cost per SKU.

Under an implementation period of two years, the estimated industry cost is about $3 million.  As shown in Table 6, with a three-year compliance period, the cost of the rule is reduced to about $780,000.  
Small Firm Impact Analysis
     The Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, requires regulators to assess the effects of regulations on small entities, including businesses, non-profit organizations, and governments.  In some instances when significant economic impacts on a substantial number of small entities are expected, agencies are also required to examine regulatory alternatives that may reduce adverse economic effects on significantly impacted small entities.

      The RFA does not define the terms "significant" or "substantial" with regards to the extent of the economic impact and number of small entities affected.  EPA has previously characterized annual incremental compliance costs of one percent of annual sales as not significant.  If costs are likely to be greater than one percent of annual sales, EPA considers both the number of affected firms and their proportion of all small firms to determine if a substantially higher number of firms will be impacted.  If costs are likely to be greater than three percent of annual sales, a smaller number and proportion of affected firms is considered substantial.  
Profile of Small Businesses
      Firms are classified as small or large by the Small Business Administration (SBA).  SBA uses either the number of employees or annual gross revenue as a threshold to classify a company as small or large.  For example, the firms in the NAICS code 325: Chemical Manufacturing, the most common code for the firms producing minimum risk pesticide products are classified as small if the number of employees is less than 500, 750, or 1,000, depending on the more refined classification scheme (that is, the 6-digit NAICS code) (see Table 3).  The firms in the next most common NAICS code  -  424: Merchant Wholesalers, Nondurable Goods  -  are classified as small if the number of employees is less than 100.  The revenue threshold is used for only a few firms in the industry.  Using such SBA thresholds, it is determined that for the minimum risk pesticide industry, there are 97 small firms (out of the total 192, see Table 3), accounting for approximately 51% of the industry.  They employ on average approximately 30 employees, with average annual revenue of approximately $2.8 million. Base on this information, EPA certifies that there will not be a significant impact on a substantial number of small entities (SISNOSE).  This conclusion is based on our finding that the following criteria are met:  Fewer than 25 small businesses are likely to experience an economic impact of 1% or more of gross sales, and less than 25% of the small businesses are likely to experience an economic impact of 1% or more of gross sales.  If costs are likely to be greater than or equal to 3% of annual sales, fewer than 10 small firms, and less than 10% of the small firms are likely to experience an economic impact of such magnitude.
Estimation of Impacts on Small Businesses
      As noted above, EPA evaluates the impact of a rule on a small firm by comparing the cost to the firm with the firm's annual sales.  We first examine the likely impact to small firms on average before refining the analysis to consider those firms that may face higher than average impacts.
      
      The average cost to a small firm is simply the average cost of a label change multiplied by the number of labels the average firm would have to modify.  The number of labels that must be changed is estimated as the average number of products a firm markets times the average number of SKU per product.
      
      The average relabeling cost per SKU was estimated in the previous section and presented in the last column of Table 5.  The average cost may overestimate costs to small firms in the industry as smaller firms may be more likely than large firms to use simpler labels with one or two colors.  The 97 small firms identified in Section 4.1 market, on average, 3.8 products.  The average number of products is multiplied by the estimate of 1.53 SKUs per product (see the discussion in Section 3.2 above) to obtain the expected number of labels that the average small firm would change as a result of the rule: 5.75 labels per firm.  Table 7 presents the estimated impact, given average revenues of $2.8 million/year, under different rule implementation periods.  The impacts of the proposed rule on small firms are measured as the cost of the rule as a percent of the average small business annual revenue ($2.8 million).  Thus, the impacts are approximately 1.3%, 0.5%, and 0.1% of the average gross revenue of small firms, under each rule implementation period.  This means that under a two-year implementation period, for example, an average small firm is likely to experience the impact that is approximately 0.5% of average gross revenue.  A similar interpretation is given for the other two implementation periods.
      
Table 7. Small Business Impacts
                          Rule implementation period
                             Average cost per SKU
                           Average cost per firm[a]
                        Impact (% of gross revenue)[b]
                                                                      Immediate
                                                                        $6,306 
                                                                       $36,189 
                                                                           1.3%
                                                  With 2 years to change labels
                                                                        $2,550 
                                                                       $14,634 
                                                                           0.5%
                                                  With 3 years to change labels
                                                                          $672 
                                                                        $3,857 
                                                                           0.1%
a Cost per SKU times 5.75   SKUs per firm (3.8 products  per firm x 1.53 SKUs per product).
b Given average revenue per small firm of $2.8 million.
      
      Thus, for the two-year and three-year implementation periods, EPA concludes that the average small firm would not face significant impacts, based on the criteria above.  The immediate label change scenario might be a borderline case, but this scenario is very unlikely to be implemented.  
      
      To better understand the distribution of impacts across firms, in the next section, the small business impacts are analyzed in more detail by further delineating the SBA-defined small firms into "small" and "very small" firms.
Refined Analysis
      The size of the company may influence the cost of label change.  In general, small firms might choose setup costs that are less expensive, compared to the large companies with more resources.  Thus, EPA assumes that small firms would choose either 1-color or 2-color label change schemes, and are unlikely to do a full color design of their labels.  Inspection of firm revenue data indicates that there are several small firms with very small annual revenue.  To investigate the impacts of the proposed rule on these firms more closely EPA further classified the SBA-defined small firms into "small" and "very small" firms as follows.  Since the medium cost for a 2-color label change is estimated to be $4,155 (see Table 4), which is approximately 1% of the gross revenue of a firm with gross revenue of $500,000, EPA assumes that small firms with annual revenues of $500,000 or more would, on average, choose the medium 2-color setup for their labels.  EPA also assumes that "very small" firms of less than $500,000 sales revenue would choose the low 1-color setup for their labels.  
      
      Since the data on the number of products for each small firm is available, using the estimate of 1.53 SKUs per product for all small firms, EPA was able to estimate the total number of SKUs for each small firm.  Then, EPA computed the cost of the rule for each small firm by multiplying the appropriate (i.e., the 1-color low estimate for "very "small" and 2-color medium estimate for "small" firms) average relabeling cost per SKU from Table 5 by the total number of SKUs for each firm.  These firm-specific costs, as a percent of each firm's annual revenue, are used as a measure of the impact of the proposed rule on small businesses.    

      The impacts of the proposed rule on small businesses are reported in Table 8.  With a two-year compliance period as currently proposed, 26 small firms (or 27% of all small firms) are likely to experience an economic impact of 1% or more of gross sales, and nine small firms (9% of all small firms) may incur impacts greater than or equal to 3% of gross sales.  Therefore, based on the criteria described above, EPA concludes that there will be no significant impact on a substantial number of small entities (SISNOSE)
      
      Because many of the firms are very small, even the modest setup cost (Table 4) can result in a large impact on small firms.  However, by allowing firms sufficient time to comply with the re-label requirements the impact on small firms can be reduced.  For example, from Table 8, if given three years to comply, the impact on small businesses can be greatly reduced.
      
Table 8. Small Business Impacts  -  Refined Analysis
Rule implementation period
                     Impact (% of annual gross revenue)[a]

                                    >= 1%
                                    >= 3%
Immediate
                                   64% (62)
                                   21% (21)
With 2 years to change labels
                                   27% (26)
                                    9% (9)
With 3 years to change labels
                                    7% (7)
                                    0% (0)
[a] The estimates are the percent of the small firms impacted out of 97 small firms and the 
numbers in parentheses represent the number of firms impacted. 
 References 
Comments submitted by small businesses.  Docket EPA-HQ-OPP-2010-0305

Dun and Bradstreet, 2009. Market Spectrum Analysis.

EPA, 2005.  "Economic Analysis of the Bulk Pesticide Container Design and Residue Removal Standards." Docket EPA-HQ-OPP-2005-0327. Document ID:  EPA-HQ-OPP-2005-0327-0024 

EPA, 2010.  State registration lists:  AL, AK, AZ, CO, IO, LA, MS, NH, NC, OK, RI, SC, SD, and WA.  Docket EPA-HQ-OPP-2010-0305

FDA, 2003.  FDA Labeling Cost Model.  Research Triangle Institute.

FDA, 2011.  Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use, Final Rule, June 17, 2011.  Docket ID FDA-1978-N-0018 (formerly 1978N-0038).

Nielsen Company. Scanner data on skin-applied insect repellent products. 2008.  Docket EPA-HQ-OPP-2010-0305

EPA.  State minimum risk product registrations. 2010.  Docket EPA-HQ-OPP-2010-0305