*** Public Review Draft ***

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## Cost **and Small Business Analysis of**  **Proposed Revisions to Minimum Risk Exemption**

**November 9 , 2012** 
**1 Back** **ground** 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 con sisting solel y 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 bo th 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 delay s 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 p roposing to more clearl y specif y 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, includi ng the total number of minimum risk pesticide products currently on the market and the firms that produce these products. In section 3, the anticipated cost s 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 s ection 4. Based on this anal ys is, EPA concludes that there will not be a significant impact on substantial number of small entities.*** Public Review Draft ***

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### 2 **Profile of Affected Industry** In this section, the minimum risk pesticide industry that would be affected by the proposed rul e, 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. 

### 2.1 **Minimum Risk Pesticide Products** Table 1 shows the number and ty pes of minimum risk pesticide products. The information in Table 1 is derived primaril y from lists of products registered in 14 states (EPA, 2010) . A lthough minimum risk products are exempt from registration by EPA, approximately 37 states 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,*** Public Review Draft ***

Page **3** of **11** 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 n ot 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.


### 2.2 **Firms Producing Minimum Risk Products** Table 2 summarizes the number of firms producing the minimum risk pesticide products identified b y 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 Minim um 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 analy sis, 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 Sy stem 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 f irms by NAI CS code

. Most firms in the minimum risk pesticide industry belong to Chemical Manufacturing (NAICS code 325) and Merchant Wholesalers, Nondurable Goods (NAI CS code 424). Forty- two firms are divided among 31 NAI CS codes, including NAICS code s 311, 332, and 333, each with four firms), NAI CS code s 335 with 3 firms, NAI CS codes 112, 115, 445, 453, 525, each with two firms, and 17 NAI CS codes with one firm in each.

**Table 3. Producers**  **of Minimum Risk Pesticides**  **3 -**  **digit NAICS Code**  **NAICS Code Desc ription**  **Number of parent firms**  325 Chemical Manufacturing 72 339 Miscellaneous Manufacturing 8 423 Merchant Wholesalers, Durable Goods 11 424 Merchant Wholesalers, Nondurable Goods 32*** Public Review Draft ***

Page **4** of **11** 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).


### 3 **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 compl y with the proposed requirement s. 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 sub section 3.2, the total industry

cost is estimated by

multiplying the cost per label change b y the total number of label changes that result from the proposed rule

. 

### 3.1 **Cost per Label Change Methodology**  In general, the cost of a label change depends on the size and ty pe of packages for products, which determine ty pes 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)

. Itis noted that firms change their labels on a routine basis to update or “refresh” their product labels even if not required b y 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 ( FD A) labeling cost model (FDA, 2003) developed for estimating the labeling cost for food products. Th is 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 th is model, firm’s labeling cost consists of: 1. Setup costs a. Admi nistrative 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*** Public Review Draft ***

Page **5** of **11** often work with a graphic design company to redesign their label graphics. Depending on the ty pe of graphic designs (e.g., number of colors), costs vary . Prepress operations c onvert 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 l abels any way , 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 propose d 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. **3.1.1 Setup Costs**  **per Label Change**

**– Baseline**  In order to successfull y 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 typ e 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 ty pe 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 the se average costs will appl y to the industry as whole (both large and small firms). The average setup costs to re
- label range from $1, 282 to $14 , 76 2. **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 W ith 6 colors*** Public Review Draft ***

Page **6** of **11** 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. **3.1.2 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 anal ys is (EPA, 2005) , EPA determined that many pesticide labels routinely

undergo changes every

1 to 3 years. Based on this information , for the current cost anal ys is, EPA assumes that firms will routinely re - label ev ery three ye ars, although some firms may re

- label more or less frequently

. Also, the 2005 EPA analy sis 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 d ue 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 prev ious 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 b y addin g 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 routinel y 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 lab el is estimate d to range from $5 84 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) = $5 84

.*** Public Review Draft ***

Page **7** of **11** 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 relabeling2 $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 c ost 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 stock s that have to be discarded requiring additional printing costs to replace discarded label stock s. However, EPA assume s that firms will be able to plan in advance and not have any unused inventory stock s, thus avoiding this cost with two or more ye ars 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. 

### 3.2 **Industry Cost** T o 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 ty pes per product. Since there is no data regarding the number of SKUs per product for the minimum risk pesticide industry , EPA uses 1 .5 3 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 probabl y 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 b y 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 pub lic comment period on the number of SKUs per product would be useful since the cost of this rule is proportional to this number.*** Public Review Draft ***

Page **8** of **11** Using the average cost estimates from the last column of Table 5 EPA estimate s the industry

cost under three different rule implementation periods, assuming firms are o n a three

- year relabeling cycle: immediate relabeling, two years, and three ye ars. To estimate the cost of the rule under each implementation period, the number of SKUs per product (1.53) is multiplied by the to tal 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 : Industr** **y Cost U**  **nder Three Rule Implementation Periods Immediate**  **2 years 3 years**  Total number of SKUs a 1,158 1,158 1,158 Average cost per SKU labe l 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 ye ars, 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 a

bout $780,000. 

### 4 **Small Firm Impact Analysis** The Regulatory

Flexibility

Act (RFA) of 1980, as amended b y 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 t erms “significant” or “substantial” with regard s 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 likel y 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. 

### 4.1 **Profile of Small Businesses**  Firms are classified as small or large b y the Small Business Administration (SBA). SBA uses either the number of employee s or annual gross revenue as a threshold*** Public Review Draft ***

Page **9** of **11** 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 emplo ye es is less than 500, 750, or 1,000, depending on the more refined classification scheme (that is, the 6

- digit NAI CS code) (see Table 3). The firms in the next most common NAI CS code

– 424: Merchant Wholesalers, Nondurable Goo ds

– 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 fir ms (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. 1 Base on this information, EPA certif

ies that there wil l not be a significant impact on a substantial number of small entities (SI SNOSE)

. This conclusion is based on our finding that the following criteria are met: Fewer than 25 small businesses are likel y to experience an economic impact of 1% or more of gross sales, and less than 25% of the small businesses are likel y 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 likel y to experience an economic impact of such magnitude. 

### 4.2 **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 anal ys is 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 avera ge 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 likel y 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 S ection 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 impl ementation 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 gro ss revenue of small firms, under

1 The average revenue is based on 85 small parent firms for which revenue information is available in Dun & Bradstreet (2009) database.*** Public Review Draft ***

Page **10** of **11** each rule implementation period . This means that under a two

- ye ar 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 SKU s per firm (3.8 products per firm × 1.53 SKUs per product)

. b Given average revenue per small firm of $2.8 million. Thus, for the two

- ye ar and three

- ye ar 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 v ery unlikel y 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” f irms. 

### 4.3 **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 propose d rule on these firms more closel y 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 approximat ely 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 le ss 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 b y mul tiplying 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 b y the total number of SKUs for each firm. These firm

- specific costs, as a percent of ea ch firm’s annual revenue, are used as a measure of the impact of the proposed rule on small businesses.*** Public Review Draft ***

Page **11** of **11** The impacts of the proposed rule on small businesses are reported in Table 8

. With a two

- year compliance period as currentl y proposed, 26 small fi rms (or 2 7 % of all small firms) are likel y 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 criteri a described above, EPA concludes that there will be no significant impact on a substantial number of small entities (SI SNOSE) 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 all owing firms sufficient time to comply with the re

- label requirement s the impact on small firms can be reduced. For example, from Table 8, if given three ye ars to comply , the impact on small businesses can be greatl y reduced. **Table 8 . Small Business Impac**  **ts**

**– 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 % (2 6 ) 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

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